Part 15.
TEXAS STATE BOARD OF PHARMACY
Chapter 281.
ADMINISTRATIVE PRACTICE AND PROCEDURES
Subchapter A. GENERAL PROVISIONS
22 TAC §281.8
The Texas State Board of Pharmacy adopts amendments to §281.8,
concerning Grounds for Discipline for a Pharmacy License. Section 281.8 is
adopted with changes to the proposed text as published in the March 26, 2004,
issue of the
Texas Register
(29 TexReg 3042).
The changes are based on staff recommendations to clarify that the rule applies
to pharmacists, pharmacist-interns, and pharmacy technicians.
The adopted amendment clarifies the activities which could result in disciplinary
action being taken against the holder of a pharmacy license.
No comments were received regarding the amendments.
The amendments are adopted under §§551.002, 554.051,
and 565.002 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas
Occupations Code). The Board interprets §551.002 as authorizing the agency
to protect the public through the effective control and regulation of the
practice of pharmacy. The Board interprets §554.051 as authorizing the
agency to adopt rules for the proper administration and enforcement of the
Act. The Board interprets §565.002 as authorizing the agency to clarify
the activities which could result in disciplinary action being taken against
the holder of a pharmacy license.
The statutes affected by the amendment: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
§281.8.Grounds for Discipline for a Pharmacy License.
(a)
For the purposes of §565.002(9) of the Act, a pharmacy
fails to establish and maintain effective controls against diversion of prescription
drugs when:
(1)
there is inadequate security or procedures to prevent unauthorized
access to prescription drugs; or
(2)
there is inadequate security or procedures to prevent the
diversion of prescription drugs.
(b)
For the purposes of §565.002(3) of the Act, it is
grounds for discipline for a pharmacy license when:
(1)
during the time an individual's license to practice pharmacy,
either as a pharmacist or a pharmacist-intern, or a pharmacy technician's
registration has been disciplined by the Board, resulting in the license or
registration being revoked, canceled, retired, surrendered, denied or suspended,
the pharmacy employs or allows such individual access to prescription drugs;
(2)
the pharmacy possesses or engages in the sale, purchase,
or trade or the offer to sell, purchase, or trade prescription drug samples;
provided however, this paragraph does not apply to:
(A)
prescription drugs provided by a manufacturer as starter
prescriptions or as replacement for such manufacturer's outdated drugs;
(B)
prescription drugs provided by a manufacturer in replacement
for such manufacturer's drugs that were dispensed pursuant to written starter
prescriptions; or
(C)
prescription drug samples possessed by a pharmacy of a
health care entity which provides health care primarily to indigent or low
income patients at no or reduced cost and if:
(i)
the samples are possessed in compliance with the Prescription
Drug Marketing Act of 1987;
(ii)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986, or by a city, state or county government;
and
(iii)
the samples are for dispensing or provision at no charge
to patients of such health care entity;
(3)
the pharmacy possesses or engages in the sale, purchase,
or trade or the offer to sell, purchase, or trade of prescription drugs:
(A)
sold for export use only;
(B)
purchased by a public or private hospital or other health
care entity; or
(C)
donated or supplied at a reduced price to a charitable
organization described in the Internal Revenue Code of 1986, §501(c)(3),
and possessed by a pharmacy other than one owned by the charitable organization;
(D)
provided that subparagraphs (A) - (C) of this paragraph
do not apply to:
(i)
the purchase or other acquisition by a hospital or other
health care entity which is a member of a group purchasing organization or
from other hospitals or health care entities which are members of such organization;
(ii)
the sale, purchase, or trade of a drug or an offer to
sell, purchase, or trade a drug by an organization described in paragraph
(2)(C)(ii) of this subsection to a nonprofit affiliate of the organization
to the extent otherwise permitted by law;
(iii)
the sale, purchase or trade of a drug or an offer to
sell, purchase, or trade a drug among hospitals or other health care entities
which are under common control;
(iv)
the sale, purchase, or trade of a drug or an offer to
sell, purchase, or trade a drug for emergency medical reasons including the
transfer of a drug between pharmacies to alleviate temporary shortages of
the drug arising from delays in or interruptions of regular distribution schedules;
(v)
the dispensing of a prescription drug pursuant to a valid
prescription drug order to the extent otherwise permitted by law; or
(4)
the pharmacy engages in the sale, purchase, or trade or
the offer to sell, purchase, or trade of:
(A)
misbranded prescription drugs; or
(B)
prescription drugs beyond the manufacturer's expiration
date.
(c)
For the purposes of §565.002(10) of the Act, the terms
"fraud," "deceit," or "misrepresentation" in operating a pharmacy or in seeking
a license to operate shall be defined as follows:
(1)
"Fraud" means an intentional perversion of truth for the
purpose of inducing another in reliance upon it to part with some valuable
thing belonging to him, or to surrender a legal right, or to issue a license;
a false representation of a matter of fact, whether by words or by conduct,
by false or misleading allegations, or by concealment of that which should
have been disclosed, which deceives or is intended to deceive another;
(2)
"Deceit" means the assertion, as a fact, of that which
is not true by any means whatsoever to deceive or defraud another, and
(3)
"Misrepresentation" means a manifestation by words or other
conduct which is a false representation of a matter of fact.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on May 17, 2004.
TRD-200403297
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: June 6, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 305-8028
Subchapter A. ALL CLASSES OF PHARMACIES
22 TAC §291.6
The Texas State Board of Pharmacy adopts amendments to §291.6,
concerning Pharmacy License Fees. The amendments are adopted without changes
to the proposed text as published in the March 26, 2004, issue of the
The adopted amendments make adjustments to the initial pharmacy licensing
fee by decreasing the amount charged by the Board to process an application
from $351 to $341 and will add a $10 fee to fund TexasOnline. The total initial
licensing fee of $368 for a two-year registration is not changed.
No comments were received regarding the amendments.
The amendments are adopted under §554.006 of the Texas Pharmacy
Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board
interprets §554.006 as authorizing the agency to establish reasonable
and necessary fees to produce sufficient revenue to cover the cost of administering
the Texas Pharmacy Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 17, 2004.
TRD-200403298
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 1, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 305-8028
22 TAC §291.25
The Texas State Board of Pharmacy (TSBP) adopts new §291.25,
concerning Pharmacies Compounding Non-Sterile Pharmaceuticals. Section 291.25
is adopted with changes to the proposed text as published in the March 26,
2004, issue of the
Texas Register
(29 TexReg
3043). The changes are based on comments received. The Board is deleting references
to compounding for "office use" by physicians and for other pharmacies.
The new section outlines operating standards for pharmacies that compound
non-sterile pharmaceuticals, implements the recommendations of the TSBP appointed
Task Force on Compounding, and incorporates many of the provisions included
in the United States Pharmacopeia (USP) new General Chapter 795 (Pharmaceutical
Compounding Non-sterile Preparations).
The agency received oral comments on the proposed rules at a public hearing
on May 4, 2004, and also received numerous written comments. The majority
of the comments opposed the restriction of "office use" compounding. The Board
agreed with the comments and deleted the reference to compounding for "office
use" by physicians and for other pharmacies as noted above. One individual
provided written comments in support of requiring a specific prescription
for compounded medications. The Board agrees with this comment but also recognizes
the need for "office use" compounding.
The Texas Pharmacy Association testified in support of the recommended
changes made by Board staff.
The new section is adopted under §§551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568
- 569, Texas Occupations Code). The Board interprets §551.002 as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act. The Board interprets §554.051(b) as authorizing the agency to
adopt rules concerning the operation of a licensed pharmacy located in this
state applicable to a pharmacy licensed by the board that is located in another
state, if the board determines the rule is necessary to protect the health
and welfare of the citizens of this state.
The statutes affected by the new section: Chapters 551 - 566 and 568 -
569, Texas Occupations Code.
§291.25.Pharmacies Compounding Non-Sterile Pharmaceuticals.
(a)
Purpose. The purpose of this section is to provide standards
for the compounding of non-sterile pharmaceuticals in Class A (Community),
Class B (Nuclear), Class C (Institutional) and Class E (Non-resident) pharmacies.
Pharmacies compounding non-sterile pharmaceuticals shall comply with the requirements
of this section in addition to all provisions for their specific license classification.
(b)
Definitions. In addition to the definitions for specific
license classifications, the following words and terms, when used in this
section, shall have the following meanings, unless the context clearly indicates
otherwise.
(1)
Beyond-use date--The date after which a compounded preparation
should not be used and is determined from the date the preparation was compounded.
(2)
Component--Any ingredient intended for use in the compounding
of a drug product, including those that may not appear in such product.
(3)
Compounding--The preparation, mixing, assembling, packaging,
or labeling of a drug or device:
(A)
as the result of a practitioner's prescription drug or
medication order, or an initiative based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(B)
in anticipation of prescription drug or medication orders
based on routine, regularly observed prescribing patterns; or
(C)
for the purpose of or as an incident to research, teaching,
or chemical analysis and not for sale or dispensing.
(4)
Manufacturing--The production, preparation, propagation,
conversion, or processing of a drug or device, either directly or indirectly,
by extraction from substances of natural origin or independently by means
of chemical or biological synthesis and includes any packaging or repackaging
of the substances or labeling or relabeling of the container and the promotion
and marketing of such drugs or devices. Manufacturing also includes the preparation
and promotion of commercially available products from bulk compounds for resale
by pharmacies, practitioners, or other persons but does not include compounding.
(5)
SOPs--Standard operating procedures.
(6)
USP/NF--the current edition of the United States Pharmacopeia/National
Formulary
(c)
Personnel.
(1)
Pharmacist-in-charge. In addition to the responsibilities
for the specific class of pharmacy, the pharmacist-in-charge shall have the
responsibility for, at a minimum, the following concerning non-sterile compounding:
(A)
determining that all personnel involved in non-sterile
compounding possess the education, training, and proficiency necessary to
properly and safely perform compounding duties undertaken or supervised;
(B)
determining that all personnel involved in non-sterile
compounding obtain continuing education appropriate for the type of compounding
done by the personnel;
(C)
assuring that the equipment used in compounding is properly
maintained;
(D)
maintaining an appropriate environment in areas where non-sterile
compounding occurs; and
(E)
assuring that effective quality control procedures are
developed and followed.
(2)
Pharmacists. Special requirements for non-sterile compounding.
(A)
All pharmacists engaged in compounding shall:
(i)
possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken or supervised;
and
(ii)
obtain continuing education appropriate for the type of
compounding done by the pharmacist.
(B)
A pharmacist shall inspect and approve all components,
drug product containers, closures, labeling, and any other materials involved
in the compounding process.
(C)
A pharmacist shall review all compounding records for accuracy
and conduct in-process and final checks to assure that errors have not occurred
in the compounding process.
(D)
A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(3)
Pharmacy technicians. All technicians engaged in compounding
shall:
(A)
possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken;
(B)
obtain continuing education appropriate for the type of
compounding done by the pharmacy technician: and
(C)
perform compounding duties under the direct supervision
of and responsible to a pharmacist.
(4)
Training.
(A)
All training activities shall be documented and covered
by appropriate SOPs as outlined in subsection (d)(7)(A) of this section.
(B)
All personnel involved in non-sterile compounding shall
be well trained and must participate in continuing relevant training programs.
(d)
Operational Standards.
(1)
General requirements.
(A)
Non-sterile drug products may be compounded in licensed
pharmacies:
(i)
upon presentation of a practitioner's prescription drug
or medication order based on a valid pharmacist/patient/prescriber relationship;
or
(ii)
in anticipation of future prescription drug or medication
orders based on routine, regularly observed prescribing patterns.
(B)
Non-sterile compounding in anticipation of future prescription
drug or medication orders must be based upon a history of receiving valid
prescriptions issued within an established pharmacist/patient/prescriber relationship,
provided that in the pharmacist's professional judgment the quantity prepared
is stable for the anticipated shelf time.
(i)
The pharmacist's professional judgment shall be based on
the criteria used to determine a beyond-use date outlined in paragraph (4)(C)
of this subsection.
(ii)
Documentation of the criteria used to determine the stability
for the anticipated shelf time must be maintained and be available for inspection.
(iii)
Any product compounded in anticipation of future prescription
drug or medication orders shall be labeled. Such label shall contain:
(I)
name and strength of the compounded medication or list
of the active ingredients and strengths;
(II)
facility's lot number;
(III)
beyond-use date as determined by the pharmacist using
appropriate documented criteria as outlined in clause (i) of this subparagraph;
and
(IV)
quantity or amount in the container.
(C)
Commercially available products may be compounded for dispensing
to individual patients provided the following conditions are met:
(i)
the commercial product is not reasonably available from
normal distribution channels in a timely manner to meet patient's needs; and
(ii)
the prescribing practitioner has requested that the drug
be compounded.
(D)
A pharmacy may enter into an agreement to compound and
dispense prescription/medication orders for another pharmacy provided the
pharmacy complies with the provisions of §291.37 of this title (relating
to Centralized Prescription Dispensing).
(E)
Compounding pharmacies/pharmacists may advertise and promote
the fact that they provide non-sterile prescription compounding services,
which may include specific drug products and classes of drugs.
(2)
Environment.
(A)
Pharmacies regularly engaging in compounding shall have
a designated and adequate area for the safe and orderly compounding of drug
products, including the placement of equipment and materials. Pharmacies involved
in occasional compounding shall prepare an area prior to each compounding
activity which is adequate for safe and orderly compounding.
(B)
Only personnel authorized by the responsible pharmacist
shall be in the immediate vicinity of a drug compounding operation.
(C)
A sink with hot and cold running water, exclusive of rest
room facilities, shall be accessible to the compounding areas and be maintained
in a sanitary condition. Supplies necessary for adequate washing shall be
accessible in the immediate area of the sink and include:
(i)
soap or detergent; and
(ii)
air-driers or single-use towels.
(D)
If drug products which require special precautions to prevent
contamination, such as penicillin, are involved in a compounding operation,
appropriate measures, including dedication of equipment for such operations
or the meticulous cleaning of contaminated equipment prior to its use for
the preparation of other drug products, must be used in order to prevent cross-contamination.
(3)
Equipment and Supplies. The pharmacy shall:
(A)
have a Class A prescription balance, or analytical balance
and weights which shall be properly maintained and subject to inspection at
least every three years by the Texas State Board of Pharmacy; and
(B)
have equipment and utensils necessary for the proper compounding
of prescription drug or medication orders. Such equipment and utensils used
in the compounding process shall be:
(i)
of appropriate design and capacity, and be operated within
designed operational limits;
(ii)
of suitable composition so that surfaces that contact
components, in-process material, or drug products shall not be reactive, additive,
or absorptive so as to alter the safety, identity, strength, quality, or purity
of the drug product beyond the desired result;
(iii)
cleaned and sanitized immediately prior to each use;
and
(iv)
routinely inspected, calibrated (if necessary), or checked
to ensure proper performance.
(4)
Labeling. In addition to the labeling requirements of the
pharmacy's specific license classification, the label dispensed or distributed
pursuant to a prescription drug or medication order shall contain the following.
(A)
The generic name(s) or the official name(s) of the principal
active ingredient(s) of the compounded preparation.
(B)
A statement that the preparation has been compounded by
the pharmacy. (An auxiliary label may be used on the container to meet this
requirement).
(C)
A beyond-use date after which the compounded preparation
should not be used. The beyond-use date shall be determined as outlined in
Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations
including the following.
(i)
The pharmacist shall consider:
(I)
physical and chemical properties of active ingredients;
(II)
use of preservatives and/or stabilizing agents;
(III)
dosage form;
(IV)
storage containers and conditions; and
(V)
scientific, laboratory, or reference data.
(ii)
In the absence of stability information applicable for
a specific drug or preparation, the following maximum beyond-use dates are
to be used when the compounded preparation is packaged in tight, light-resistant
containers and stored at controlled room temperatures.
(I)
Nonaqueous liquids and solid formulations (Where the manufactured
drug product is the source of active ingredient): 25% of the time remaining
until the product's expiration date or 6 months, whichever is earlier.
(II)
Water-containing formulations (Prepared from ingredients
in solid form): Not later than 14 days when refrigerated between 2 - 8 degrees
Celsius (36 - 46 degrees Fahrenheit)
(III)
All other formulations: Intended duration of therapy
or 30 days, whichever is earlier.
(iii)
Beyond-use date limits may be exceeded when supported
by valid scientific stability information for the specific compounded preparation.
(5)
Written drug information. Written information about the
compounded drug or its major active ingredient(s) shall be given to the patient
at the time of dispensing. A statement which indicates that the product was
compounded by the pharmacy must be included in this written information. If
there is no written information available, the patient should be advised in
writing that the drug has been compounded and how to contact a pharmacist,
and if appropriate the prescriber, concerning the drug.
(6)
Drugs, components, and materials used in non-sterile compounding.
(A)
Drugs used in non-sterile compounding shall preferably
be a USP/NF grade substances manufactured in an FDA-registered facility.
(B)
If USP/NF grade substances are not available, or when food,
cosmetics, or other substances are, or must be used, the substance shall be
of a chemical grade in one of the following categories:
(i)
Chemically Pure (CP);
(ii)
Analytical Reagent (AR); or
(iii)
American Chemical Society (ACS); or
(iv)
Food Chemical Codex; or
(C)
If a drug, component or material is not purchased from
a FDA-registered facility, the pharmacist shall establish purity and stability
by obtaining a Certificate of Analysis from the supplier.
(D)
A manufactured drug product may be a source of active ingredient.
Only manufactured drugs from containers labeled with a batch control number
and a future expiration date are acceptable as a potential source of active
ingredients. When compounding with manufactured drug products the pharmacist
must consider all ingredients present in the drug product relative to the
intended use of the compounded preparation.
(E)
All components shall be stored in properly labeled containers
in a clean, dry area, under proper temperatures.
(F)
Drug product containers and closures shall not be reactive,
additive, or absorptive so as to alter the safety, identity, strength, quality,
or purity of the compounded drug product beyond the desired result.
(G)
Components, drug product containers, and closures shall
be rotated so that the oldest stock is used first.
(H)
Container closure systems shall provide adequate protection
against foreseeable external factors in storage and use that can cause deterioration
or contamination of the compounded drug product.
(I)
A pharmacy may not compound a drug product which appears
on a federal Food and Drug Administration list of drug products withdrawn
or removed from the market for safety reasons.
(7)
Compounding process.
(A)
All significant procedures performed in the compounding
area shall be covered by written SOPs designed to ensure accountability, accuracy,
quality, safety, an uniformity in the compounding process. At a minimum, SOPs
shall be developed for:
(i)
the facility;
(ii)
equipment;
(iii)
personnel;
(iv)
actual compounding;
(v)
product evaluation;
(vi)
packaging; and
(vii)
storage of compounded preparations.
(B)
Any compounded preparation with an official monograph in
the USP/NF shall be compounded, labeled, and packaged in conformity with the
USP/NF monograph for the drug.
(C)
Any person with an apparent illness or open lesion that
may adversely affect the safety or quality of a drug product being compounded
shall be excluded from direct contact with components, drug product containers,
closures, any materials involved in the compounding process, and drug products
until the condition is corrected.
(D)
Personnel engaged in the compounding of drug products shall
wear clean clothing appropriate to the operation being performed. Protective
apparel, such as coats/jackets, aprons, hair nets, gowns, hand or arm coverings,
or masks shall be worn as necessary to protect personnel from chemical exposure
and drug products from contamination.
(E)
At each step of the compounding process, the pharmacist
shall assure that components used in compounding are accurately weighed, measured,
or subdivided as appropriate to conform to the formula being prepared.
(8)
Quality Control.
(A)
The pharmacy shall follow established quality control procedures
to monitor the output of compounded drug products for uniformity and consistency
such as capsule weight variations, adequacy of mixing, clarity, or pH of solutions.
When developing these procedures, pharmacy personnel shall consider the provisions
of Chapter 795, concerning Pharmacy Compounding Non-Sterile Preparations,
Chapter 1075, concerning Good Compounding Practices, and Chapter 1160, concerning
Pharmaceutical Calculations in Prescription Compounding contained in the current
USP/NF. Such procedures shall be documented and be available for inspection.
(B)
Compounding procedures that are routinely performed, including
batch compounding, shall be completed and verified according to written procedures.
The act of verification of a compounding procedure involves checking to ensure
that calculations, weighing and measuring, order of mixing, and compounding
techniques were appropriate and accurately performed.
(C)
Unless otherwise indicated or appropriate, compounded preparations
are to be prepared to ensure that each preparation shall contain not less
than 90.0 percent and not more than 110.0 percent of the theoretically calculated
and labeled quantity of active ingredient per unit weight or volume and not
less than 90.0 percent and not more than 110.0 percent of the theoretically
calculated weight or volume per unit of the preparation.
(e)
Records.
(1)
Maintenance of records. Every record required by this section
shall be kept by the pharmacy for at least two years.
(2)
Compounding records.
(A)
Compounding records for all compounded preparations shall
be maintained by the pharmacy electronically or manually as part of the prescription
drug or medication order, formula record, formula book, or compounding log
and shall include:
(i)
the date of preparation;
(ii)
a complete formula, including methodology and necessary
equipment which includes the brand name(s) of the raw materials, or if no
brand name, the generic name(s) and name(s) of the manufacturer(s) of the
raw materials and the quantities of each;
(iii)
signature or initials of the pharmacist or pharmacy technician
performing the compounding;
(iv)
signature or initials of the pharmacist responsible for
supervising pharmacy technicians and other supportive personnel and conducting
in-process and final checks of compounded preparations if pharmacy technicians
perform the compounding function;
(v)
the quantity in units of finished products or amount of
raw materials;
(vi)
the container used and the number of units prepared;
(vii)
a reference to the location of the following documentation
which may be maintained with other records, such as quality control records:
(I)
the criteria used to determine the beyond-use date; and
(II)
documentation of performance of quality control procedures.
Documentation of the performance of quality control procedures is not required
if the compounding process is done pursuant to a patient specific order and
involves the mixing of two or more commercially available oral liquids or
commercially available preparations when the final product is intended for
external use.
(B)
Compounding records when batch compounding or compounding
in anticipation of future prescription drug or medication orders.
(i)
Master work sheet. A master work sheet shall be developed
and approved by a pharmacist for formulations prepared in batch. Once approved,
a duplicate of the master work sheet shall be used as the preparation work
sheet from which each batch is prepared and on which all documentation for
that batch occurs. The master work sheet shall contain at a minimum:
(I)
the formula;
(II)
the components;
(III)
the compounding directions;
(IV)
a sample label;
(V)
evaluation and testing requirements;
(VI)
specific equipment used during preparation; and
(VII)
storage requirements.
(ii)
Preparation work sheet. The preparation work sheet for
each batch of preparations shall document the following:
(I)
identity of all solutions and ingredients and their corresponding
amounts, concentrations, or volumes;
(II)
lot number or each component;
(III)
component manufacturer/distributor or suitable identifying
number;
(IV)
container specifications (e.g., syringe, pump cassette);
(V)
unique lot or control number assigned to batch;
(VI)
beyond use date of batch-prepared products;
(VII)
date of preparation;
(VIII)
name, initials, or electronic signature of the person(s)
involved in the preparation;
(IX)
name, initials, or electronic signature of the responsible
pharmacist;
(X)
end-product evaluation and testing specifications, if applicable;
and
(XI)
comparison of actual yield to anticipated yield, when
appropriate.
This agency hereby certifies that the
adoption has been reviewed by legal counsel and found to be a valid exercise
of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 17, 2004.
TRD-200403299
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: June 6, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 305-8028
22 TAC §291.26
The Texas State Board of Pharmacy (TSBP) adopts new §291.26,
concerning Pharmacies Compounding Sterile Pharmaceuticals with changes to
the proposed text as published in the March 26, 2004, issue of the
Texas Register
(29 TexReg 3048). Section 291.26 is adopted with changes
based on comments received. The Board is deleting references to compounding
for "office use" by physicians and for other pharmacies.
The new section outlines operating standards for pharmacies that compound
sterile pharmaceuticals, implements the recommendations of the TSBP appointed
Task Force on Compounding, and incorporates many of the provisions included
in the United States Pharmacopeia (USP) new General Chapter 797 (Pharmaceutical
Compounding Sterile Preparations).
The agency received oral comments on the proposed new section at a public
hearing on May 4, 2004, and also received numerous written comments. The majority
of the comments opposed the restriction of "office use" compounding. The Board
agreed with the comments and deleted the reference to compounding for "office
use" by physicians and for other pharmacies as noted above. One individual
provided written comments in support of requiring a specific prescription
for compounded medications. The Board agrees with this comment but also recognizes
the need for "office use" compounding. One individual provided written comments
indicating that the rules did not fully implement USP Chapter 797. The Board
disagrees with this comment and adopted the rules as indicated because the
rules adequately protect the public. One written comment suggested clarifying
storage requirements for low risk sterile compounded products. The Board agrees
with the comment and amended the rule to reflect the clarification.
The Texas Pharmacy Association testified in support of the recommended
changes made by Board staff.
The new section is adopted under §§551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568
- 569, Texas Occupations Code). The Board interprets §551.002 as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act. The Board interprets §554.051(b) as authorizing the agency to
adopt rules concerning the operation of a licensed pharmacy located in this
state applicable to a pharmacy licensed by the board that is located in another
state, if the board determines the rule is necessary to protect the health
and welfare of the citizens of this state.
The statutes affected by this rule: Chapters 551 - 566 and 568 - 569, Texas
Occupations Code.
§291.26.Pharmacies Compounding Sterile Pharmaceuticals.
(a)
Purpose. The purpose of this section is to provide standards
for the compounding of sterile pharmaceuticals by all in Class A (Community),
Class B (Nuclear), Class C (Institutional) and Class E (Non-resident) pharmacies.
Pharmacies compounding sterile pharmaceuticals shall comply with all requirements
for their specific license classification and this section.
(b)
Definitions. In addition to the definitions for specific
license classifications, the following words and terms, when used in this
section, shall have the following meanings, unless the context clearly indicates
otherwise.
(1)
ACPE--Accreditation Council for Pharmacy Education.
(2)
Airborne particulate cleanliness class--The level of cleanliness
specified by the maximum allowable number of particles per cubic meter of
air as specified in the International Organization of Standardization (ISO)
Classification Air Cleanliness (ISO 14644-1). For example:
(A)
ISO Class 5 (formerly Class 100) is an atmospheric environment
which contains less than 3,520 particles 0.5 microns in diameter per cubic
meter of air (formerly stated as 100 particles 0.5 microns in diameter per
cubic foot of air);
(B)
ISO Class 7 (formerly Class 10,000) is an atmospheric environment
which contains less than 352,000 particles 0.5 microns in diameter per cubic
meter of air (formerly stated as 10,000 particles 0.5 microns in diameter
per cubic foot of air); and
(C)
ISO Class 8 (formerly Class 100,000) is an atmospheric
environment which contains less than 3,520,000 particles 0.5 microns in diameter
per cubic meter of air (formerly stated as 100,000 particles 0.5 microns in
diameter per cubic foot of air).
(3)
Ancillary supplies--Supplies necessary for the administration
of compounded sterile pharmaceuticals.
(4)
Aseptic preparation--The technique involving procedures
designed to preclude contamination of drugs, packaging, equipment, or supplies
by microorganisms during processing.
(5)
Automated compounding or counting device--An automated
device that compounds, measures, counts, and or packages a specified quantity
of dosage units for a designated drug product.
(6)
Batch preparation compounding--Compounding of multiple
sterile-product units, in a single discrete process, by the same individual(s),
carried out during one limited time period. Batch preparation/compounding
does not include the preparation of multiple sterile-product units pursuant
to patient specific medication orders.
(7)
Beyond-use date--The date after which a compounded preparation
should not be used and is determined from the date the preparation was compounded.
(8)
Biological Safety Cabinet--Containment unit suitable for
the preparation of low to moderate risk agents where there is a need for protection
of the product, personnel, and environment, according to the International
Organization of Standardization (ISO), Specifications for testing and monitoring
to prove continued compliance with ISO 14644-1 and/or ISO 14644-2.
(9)
Clean room--A room in which the concentration of airborne
particles is controlled and there are one or more clean zones according to
the International Organization of Standardization (ISO), Specifications for
testing and monitoring to prove continued compliance with ISO 14644-1 and/or
ISO 14644-2.
(10)
Clean zone--A defined space in which the concentration
of airborne particles is controlled to meet a specified airborne particulate
cleanliness class.
(11)
Component--Any ingredient intended for use in the compounding
of a drug product, including those that may not appear in such product.
(12)
Compounding--The preparation, mixing, assembling, packaging,
or labeling of a drug or device:
(A)
as the result of a practitioner's prescription drug or
medication order or initiative based on the practitioner-patient pharmacist
relationship in the course of professional practice;
(B)
in anticipation of prescription drug or medication orders
based on routine, regularly observed prescribing patterns; or
(C)
for the purpose of or as an incident to research, teaching,
or chemical analysis and not for sale or dispensing.
(13)
Controlled area--A controlled area is the area designated
for preparing sterile pharmaceuticals.
(14)
Critical site--Any opening providing a direct pathway
between a sterile product and the environment or any surface coming in direct
contact with the product and the environment.
(15)
Cytotoxic--A pharmaceutical that has the capability of
killing living cells.
(16)
Device--An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article,
including any component part or accessory, that is required under federal
or state law to be ordered or prescribed by a practitioner.
(17)
Process validation--Documented evidence providing a high
degree of assurance that a specific process will consistently produce a product
meeting its predetermined specifications and quality attributes.
(18)
SOPs--Standard operating procedures.
(19)
Quality assurance--The set of activities used to assure
that the process used in the preparation of sterile drug products lead to
products that meet predetermined standards of quality.
(20)
Quality control--The set of testing activities used to
determine that the ingredients, components (e.g., containers), and final sterile
pharmaceuticals prepared meet predetermined requirements with respect to identity,
purity, non-pyrogenicity, and sterility.
(21)
Sterile pharmaceutical--A dosage form free from living
micro-organisms.
(22)
USP/NF--The current edition of the United States Pharmacopeia/National
Formulary.
(c)
Personnel.
(1)
Pharmacist-in-charge.
(A)
General. The pharmacy shall have a pharmacist-in-charge
in compliance with the specific license classification of the pharmacy.
(B)
Responsibilities. In addition to the responsibilities for
the specific class of pharmacy, the pharmacist-in-charge shall have the responsibility
for, at a minimum, the following concerning sterile compounding:
(i)
developing a system to assure that all pharmacy personnel
responsible for compounding and/or supervising the compounding of sterile
pharmaceuticals within the pharmacy receive appropriate education and training
and competency evaluation;
(ii)
determining that all pharmacists involved in compounding
sterile pharmaceuticals obtain continuing education appropriate for the type
of compounding done by the pharmacist;
(iii)
supervising a system to assure appropriate procurement
of drugs and devices and storage of all pharmaceutical materials including
pharmaceuticals, components used in the compounding of pharmaceuticals, and
drug delivery devices;
(iv)
assuring that the equipment used in compounding is properly
maintained;
(v)
developing a system for the disposal and distribution of
drugs from the pharmacy;
(vi)
developing a system for bulk compounding or batch preparation
of drugs;
(vii)
developing a system for the compounding, sterility assurance,
quality assurance and quality control of sterile pharmaceuticals; and
(viii)
if applicable, assuring that the pharmacy has a system
to dispose of cytotoxic and/or biohazardous waste in a manner so as not to
endanger the public health.
(2)
Pharmacists. Special requirements for sterile compounding.
(A)
All pharmacists engaged in compounding shall:
(i)
possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken or supervised;
and
(ii)
obtain continuing education appropriate for the type of
compounding done by the pharmacist.
(B)
A pharmacist shall inspect and approve all components,
drug product containers, closures, labeling, and any other materials involved
in the compounding process.
(C)
A pharmacist shall review all compounding records for accuracy
and conduct in-process and final checks to assure that errors have not occurred
in the compounding process.
(D)
A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(E)
A pharmacist shall be accessible at all times to respond
to patients' and other health professionals' questions and needs. Such access
may be through a telephone which is answered 24 hours a day.
(3)
Pharmacy technicians. Pharmacy technicians may compound
sterile pharmaceuticals provided the pharmacy technicians:
(A)
have completed the education and training specified in
paragraph (4) of this subsection; and
(B)
are supervised by a pharmacist who has completed the training
specified in paragraph (4) of this subsection, conducts in-process and final
checks, and affixes his or her initials to the appropriate quality control
records.
(4)
Special education, training, and evaluation requirements
for pharmacy personnel compounding or responsible for the direct supervision
of pharmacy personnel compounding sterile pharmaceuticals.
(A)
General.
(i)
All pharmacy personnel preparing sterile pharmaceuticals
shall receive didactic and experiential training and competency evaluation
through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge
and described in the policy and procedure or training manual. Such training
shall include instruction and experience in the following areas:
(I)
aseptic technique;
(II)
critical area contamination factors;
(III)
environmental monitoring;
(IV)
facilities;
(V)
equipment and supplies;
(VI)
sterile pharmaceutical calculations and terminology;
(VII)
sterile pharmaceutical compounding documentation;
(VIII)
quality assurance procedures;
(IX)
aseptic preparation procedures including proper gowning
and gloving technique;
(X)
handling of cytotoxic and hazardous drugs, if applicable;
and
(XI)
general conduct in the controlled area.
(ii)
The aseptic technique of each person compounding or responsible
for the direct supervision of personnel compounding sterile pharmaceuticals
shall be observed and evaluated as satisfactory through written or practical
tests and process validation and such evaluation documented.
(iii)
Although process validation may be incorporated into
the experiential portion of a training program, process validation must be
conducted at each pharmacy where an individual compounds sterile pharmaceuticals.
No product intended for patient use shall be compounded by an individual until
the on-site process validation test indicates that the individual can competently
perform aseptic procedures, except that a pharmacist may temporarily compound
sterile pharmaceuticals and supervise pharmacy technicians compounding sterile
pharmaceuticals without process validation provided the pharmacist:
(I)
has completed a recognized course in an accredited college
of pharmacy or a course sponsored by an ACPE approved provider which provides
20 hours of instruction and experience in the areas listed in this subparagraph;
and
(II)
completes the on-site process validation within seven
days of commencing work at the pharmacy.
(iv)
Process validation procedures for assessing the preparation
of specific types of sterile pharmaceuticals shall be representative of all
types of manipulations, products, risk levels, and batch sizes that personnel
preparing that type of pharmaceutical are likely to encounter.
(v)
The pharmacist-in-charge shall assure continuing competency
of pharmacy personnel through in-service education, training, and process
validation to supplement initial training. Personnel competency shall be evaluated:
(I)
during orientation and training prior to the regular performance
of those tasks;
(II)
whenever the quality assurance program yields an unacceptable
result;
(III)
whenever unacceptable techniques are observed; and
(IV)
at least on an annual basis.
(B)
Pharmacists.
(i)
All pharmacists who compound sterile pharmaceuticals or
supervise pharmacy technicians compounding sterile pharmaceuticals shall:
(I)
complete through a single course, a minimum of 20 hours
of instruction and experience in the areas listed in subparagraph (A) of this
paragraph. Such training shall be completed at least every seven years and
may be obtained through:
(-a-)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 20 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may not be transferred to another pharmacy unless the pharmacies are under
common ownership and control and use a common training program; or
(-b-)
completion of a recognized course in an accredited college
of pharmacy or a course sponsored by an ACPE approved provider which provides
20 hours of instruction and experience in the areas listed in subparagraph
(A) of this paragraph; and
(II)
every two years complete six hours of continuing education
related to sterile product compounding offered by a provider approved by ACPE.
(These hours may be applied towards the hours required for renewal of a license
to practice pharmacy.)
(III)
possess knowledge about:
(-a-)
aseptic processing;
(-b-)
quality control and quality assurance as related to environmental,
component, and end-product testing;
(-c-)
chemical, pharmaceutical, and clinical properties of
drugs;
(-d-)
container, equipment, and closure system selection; and
(-e-)
sterilization techniques.
(ii)
The required experiential portion of the training programs
specified in this subparagraph must be supervised by an individual who has
already completed training as specified in subparagraph (B) or (C) of this
paragraph.
(C)
Pharmacy technicians. In addition to qualifications for
specific license classifications all pharmacy technicians who compound sterile
pharmaceuticals shall:
(i)
have a high school or equivalent education;
(ii)
have initial training obtained either through completion
of:
(I)
a single course, a minimum of 40 hours of instruction and
experience in the areas listed in subparagraph (A) of this paragraph. Such
training may be obtained through:
(-a-)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 40 hours of instruction and
experience in the areas listed in subparagraph (A) of this paragraph. Such
training may not be transferred to another pharmacy unless the pharmacies
are under common ownership and control and use a common training program;
or
(-b-)
completion of a course sponsored by an ACPE approved
provider which provides 40 hours of instruction and experience in the areas
listed in subparagraph (A) of this paragraph; or
(II)
a training program which is accredited by the American
Society of Health-System Pharmacists (formerly the American Society of Hospital
Pharmacists). Individuals enrolled in training programs accredited by the
American Society of Health-System Pharmacists may compound sterile pharmaceuticals
in a licensed pharmacy provided:
(-a-)
the compounding occurs only during times the individual
is assigned to a pharmacy as a part of the experiential component of the American
Society of Health-System Pharmacists training program;
(-b-)
the individual is under the direct supervision of and
responsible to a pharmacist who has completed training as specified in subparagraph
(B) of this paragraph; and
(-c-)
the supervising pharmacist conducts in- process and final
checks;
(iii)
acquire the required experiential portion of the training
programs specified in this subparagraph under the supervision of an individual
who has already completed training as specified in subparagraph (B) or (C)
of this paragraph; and
(iv)
every two years complete six hours of continuing education
related to sterile product compounding. (These hours may be applied towards
the hours required for renewal of a pharmacy technician's registration.)
(D)
Documentation of Training. A written record of initial
and in-service training and the results of written or practical testing and
process validation of pharmacy personnel shall be maintained and contain the
following information:
(i)
name of the person receiving the training or completing
the testing or process validation;
(ii)
date(s) of the training, testing, or process validation;
(iii)
general description of the topics covered in the training
or testing or of the process validated;
(iv)
name of the person supervising the training, testing,
or process validation; and
(v)
signature (first initial and last name or full signature)
of the person receiving the training or completing the testing or process
validation and the pharmacist-in-charge or other pharmacist employed by the
pharmacy and designated by the pharmacist-in-charge as responsible for training,
testing, or process validation of personnel.
(d)
Operational Standards.
(1)
General Requirements.
(A)
Sterile drug products may be compounded in licensed pharmacies:
(i)
upon presentation of a practitioner's prescription drug
or medication order based on a valid pharmacist/patient/prescriber relationship;
or
(ii)
in anticipation of future prescription drug or medication
orders based on routine, regularly observed prescribing patterns.
(B)
Sterile compounding in anticipation of future prescription
drug or medication orders must be based upon a history of receiving valid
prescriptions issued within an established pharmacist/patient/prescriber relationship,
provided that in the pharmacist's professional judgment the quantity prepared
is stable for the anticipated shelf time.
(i)
The pharmacist's professional judgment shall be based on
the criteria used to determine a beyond-use date outlined in paragraph (5)(C)
of this subsection.
(ii)
Documentation of the criteria used to determine the stability
for the anticipated shelf time must be maintained and be available for inspection.
(iii)
Any product compounded in anticipation of future prescription
drug or medication orders shall be labeled. Such label shall contain:
(I)
name and strength of the compounded medication or list
of the active ingredients and strengths;
(II)
facility's lot number;
(III)
beyond-use date as determined by the pharmacist using
appropriate documented criteria as outlined in clause (i) of this subparagraph;
(IV)
quantity or amount in the container;
(V)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including cytotoxic warning labels where appropriate;
and
(VI)
device-specific instructions, where appropriate.
(C)
Commercially available products may be compounded for dispensing
to individual patients provided the following conditions are met:
(i)
the commercial product is not reasonably available from
normal distribution channels in a timely manner to meet patient's needs; and
(ii)
the prescribing practitioner has requested that the drug
be compounded.
(D)
A pharmacy may enter into an agreement to compound and
dispense prescription/medication orders for another pharmacy provided the
pharmacy complies with the provisions of §291.37 of this title (relating
to Centralized Prescription Dispensing).
(E)
Compounding pharmacies/pharmacists may advertise and promote
the fact that they provide sterile prescription compounding services, which
may include specific drug products and classes of drugs.
(2)
Risk levels for compounded sterile pharmaceuticals. Risk
Levels for sterile compounded preparations shall be as outlined in USP/NF
Chapter 797 Pharmacy Compounding Sterile Preparations and as listed below.
(A)
Low-risk level compounded sterile pharmaceuticals.
(i)
Low-risk level compounded sterile pharmaceuticals are those
compounded under all of the following conditions.
(I)
The compounded sterile preparations are compounded with
aseptic manipulations entirely within ISO Class 5 or better air quality using
only sterile ingredients, products, components, and devices.
(II)
The compounding involves only transfer, measuring, and
mixing manipulations with closed or sealed packaging systems that are performed
promptly and attentively.
(III)
Manipulations are limited to aseptically opening ampuls,
penetrating sterile stoppers on vials with sterile needles and syringes, and
transferring sterile liquids in sterile syringes to sterile administration
devices and packages of other sterile products.
(IV)
For a low-risk preparation, in the absence of passing
a sterility test, the storage periods cannot exceed the following periods:
before administration, 48 hours at controlled room temperature, for not more
than 14 days if stored in cold temperatures, and for 45 days if stored in
a frozen state at minus 20 degrees Celsius or colder). For delayed activation
device systems, the storage period begins when the device is activated.
(ii)
Examples of low-risk compounding include the following.
(I)
Single transfers of sterile dosage forms from ampuls, bottles,
bags, and vials using sterile syringes with sterile needles, other administration
devices, and other sterile containers. The contents of ampuls require sterile
filtration to remove glass particles.
(II)
Manually measuring and mixing no more than three manufactured
products to compound drug admixtures and nutritional solutions.
(B)
Medium-risk level compounded sterile pharmaceuticals.
(i)
Medium-risk level compounded sterile pharmaceuticals are
those compounded aseptically under low-risk conditions and one or more of
the of the following conditions exists.
(I)
Multiple individual or small doses of sterile products
are combined or pooled to prepare a compounded sterile pharmaceutical that
will be administered either to multiple patients or to one patient on multiple
occasions.
(II)
The compounding process includes complex aseptic manipulations
other than the single-volume transfer.
(III)
The compounding process requires unusually long duration,
such as that required to complete the dissolution or homogenous mixing.
(IV)
The sterile compounded pharmaceutical's do not contain
broad-spectrum bacteriostatic substances, and they are administered over several
days.
(V)
For a medium-risk preparation, in the absence of passing
sterility test, the storage periods cannot exceed the following time periods:
before administration, the compounded sterile preparations are properly stored
and are exposed for not more than 30 hours at controlled room temperature
for not more than 7 days at a cold temperature, and for 45 days in solid frozen
state at minus 20 degrees or colder.
(ii)
Examples of medium-risk compounding include the following.
(I)
Compounding of total parenteral nutrition fluids using
a manual or automated device during which there are multiple injections, detachments,
and attachments of nutrient source products to the device or machine to deliver
all nutritional components to a final sterile container.
(II)
Filling of reservoirs of injection and infusion devices
with multiple sterile drug products and evacuations of air from those reservoirs
before the filled device is dispensed.
(III)
Filling of reservoirs of injection and infusion devices
with volumes of sterile drug solutions that will be administered over several
days at ambient temperatures between 25 and 40 degrees Celsius (77 and 104
degrees Fahrenheit).
(IV)
Transfer of volumes from multiple ampuls or vials into
a single, final sterile container or product.
(C)
High-risk level compounded sterile pharmaceuticals.
(i)
High-risk level compounded sterile pharmaceuticals are
those compounded under any of the following conditions.
(I)
Non-sterile ingredients, including manufactured products
are incorporated, or a non-sterile device is employed before terminal sterilization.
(II)
Sterile ingredients, components, devices, and mixtures
are exposed to air quality inferior to ISO Class 5. This includes storage
in environments inferior to ISO Class 5 of opened or partially used packages
of manufactured sterile products that lack antimicrobial preservatives.
(III)
Non-sterile preparations are exposed no more than 6 hours
before being sterilized.
(IV)
It is assumed, and not verified by examination of labeling
and documentation from suppliers or by direct determination, that the chemical
purity and content strength of ingredients meet their original or compendial
specifications in unopened or in opened packages of bulk ingredients.
(V)
For a high-risk preparation, in the absence of passing
sterility test, the storage periods cannot exceed the following time periods:
before administration, the compounded sterile preparations are properly stored
and are exposed for not more than 24 hours at controlled room temperature
for not more than 3 days at a cold temperature, and for 45 days in solid frozen
state at minus 20 degrees or colder.
(ii)
Examples of high-risk compounding include the following.
(I)
Dissolving non-sterile bulk drug and nutrient powders to
make solutions, which will be terminally sterilized.
(II)
Sterile ingredients, components, devices, and mixtures
are exposed to air quality inferior to ISO Class 5. This includes storage
in environments inferior to ISO Class 5 of opened or partially used packages
of manufactured sterile products that lack antimicrobial preservatives.
(III)
Measuring and mixing sterile ingredients in non-sterile
devices before sterilization is performed.
(IV)
Assuming, without appropriate evidence or direct determination,
that packages of bulk ingredients contain at least 95% by weight of their
active chemical moiety and have not been contaminated or adulterated between
uses.
(3)
Environment.
(A)
Special requirements for the compounding of sterile pharmaceuticals.
When the pharmacy compounds sterile pharmaceuticals, the following is applicable.
(i)
Controlled area.
(I)
Low and Medium Risk Preparations. The pharmacy shall have
a designated controlled area for the compounding of sterile pharmaceuticals
that is functionally separate from areas for the preparation of non-sterile
pharmaceuticals and is constructed to minimize the opportunities for particulate
and microbial contamination. This controlled area for the preparation of sterile
pharmaceuticals shall:
(-a-)
have a controlled environment that is aseptic or contains
an aseptic environmental control device(s). If the aseptic environmental control
device is located within the controlled area, the controlled area must extend
a minimum of six feet from the device and clearly marked to identify the separation
between the controlled and non-controlled area;
(-b-)
be clean, well lighted, and of sufficient size to support
sterile compounding activities;
(-c-)
be used only for the compounding of sterile pharmaceuticals;
(-d-)
be designed to avoid outside traffic and air flow;
(-e-)
be designed such that hand sanitizing and gowning occurs
outside the controlled area but is accessible without use of the hands of
the compounding personnel;
(-f-)
have non-porous and washable floors or floor covering
to enable regular disinfection;
(-g-)
be ventilated in a manner not interfering with aseptic
environmental control conditions;
(-h-)
have walls, ceilings, and fixtures, shelving, counters,
and cabinets that are smooth, impervious, free from cracks and crevices, and
nonshedding. (acoustical ceiling tiles that are coated with an acrylic paint
are acceptable);
(-i-)
have drugs and supplies stored on shelving areas above
the floor to permit adequate floor cleaning; and
(-j-)
contain only the appropriate compounding supplies and
not be used for bulk storage for supplies and materials. Objects that shed
particles may not be brought into the controlled area.
(II)
High-risk Preparations. In addition to the requirements
in subclause (I) of this clause, when high-risk preparations are compounded,
the aseptic environment control device(s) shall be located in a controlled
area that maintains at least an ISO Class 8 (formerly Class 100,000) environment.
(ii)
Aseptic environment control device(s). The pharmacy shall
prepare sterile pharmaceuticals in an appropriate aseptic environmental control
device(s) or area, such as a laminar air flow hood, biological safety cabinet,
clean room which is capable of maintaining at least ISO Class 5 (formerly
Class 100) conditions during normal activity, or other aseptic environmental
control devices that produce ISO Class 5 (formerly Class 100) environmental
conditions or better. The aseptic environmental control device(s) shall:
(I)
be certified by an independent contractor according to
the International Organization of Standardization (ISO) Classification of
Particulate Matter in Room Air (ISO 14644-1) for operational efficiency at
least every six months or when it is relocated; and
(II)
have pre-filters inspected periodically and replaced as
needed, in accordance with written policies and procedures, and the inspection
and/or replacement date documented.
(iii)
Automated compounding or counting device. If automated
compounding or counting devices are used, the pharmacy shall have a method
to calibrate and verify the accuracy of automated compounding or counting
devices used in aseptic processing and document the calibration and verification
on a routine basis.
(iv)
Cytotoxic drugs. In addition to the requirements specified
in clause (ii) of this subparagraph, if the product is also cytotoxic, the
following is applicable.
(I)
General.
(-a-)
All personnel involved in the compounding of cytotoxic
products shall wear appropriate protective apparel, such as masks, gloves,
and gowns or coveralls with tight cuffs.
(-b-)
Appropriate safety and containment techniques for compounding
cytotoxic drugs shall be used in conjunction with aseptic techniques required
for preparing sterile pharmaceuticals.
(-c-)
Disposal of cytotoxic waste shall comply with all applicable
local, state, and federal requirements.
(-d-)
Prepared doses of cytotoxic drugs must be dispensed,
labeled with proper precautions inside and outside, and distributed in a manner
to minimize patient contact with cytotoxic agents.
(II)
Aseptic environment control device(s).
(-a-)
Cytotoxic drugs must be prepared in a vertical flow biological
safety cabinet, or other aseptic environmental control devices that produce
ISO Class 5 (formerly Class 100) environmental conditions or better and provide
protection from cytotoxic products to personnel.
(-b-)
If the aseptic environment control device is also used
to prepare non-cytotoxic sterile pharmaceuticals, the device must be thoroughly
cleaned prior to its use to prepare non-cytotoxic sterile pharmaceuticals.
(B)
Security requirements. The pharmacy may authorize personnel
to gain access to that area of the pharmacy containing dispensed sterile pharmaceuticals,
in the absence of the pharmacist, for the purpose of retrieving dispensed
prescriptions to deliver to patients. If the pharmacy allows such after-hours
access, the area containing the dispensed sterile pharmaceuticals shall be
an enclosed and lockable area separate from the area containing undispensed
prescription drugs. A list of the authorized personnel having such access
shall be in the pharmacy's policy and procedure manual.
(C)
Storage requirements. All drugs shall be stored at the
proper temperature and conditions, as defined in the USP/NF. The most commonly
used definitions are as follows:
(i)
freezer A place in which the temperature maintained thermostatically
between minus 25 degrees and minus 10 degrees Celsius (minus 13 degrees and
14 degrees Fahrenheit).
(ii)
cold Any temperature not exceeding 8 degrees Celsius (46
degrees Fahrenheit. A refrigerator is a cold place in which the temperature
maintained thermostatically between 2 degrees and 8 degrees Celsius (36 degrees
and 46 degrees Fahrenheit);
(iii)
cool--temperature between 8 degrees and 15 degrees Celsius
(46 degrees and 59 degrees Fahrenheit) which may, alternatively, be stored
in a refrigerator unless otherwise specified on the labeling; and
(iv)
controlled room temperature--temperature maintained thermostatically
between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit).
(4)
Equipment and supplies. Pharmacies compounding sterile
pharmaceuticals shall have the following equipment and supplies:
(A)
a system or device (i.e., thermometer) to monitor the temperature
and humidity to ensure that proper storage requirements are met, if sterile
pharmaceuticals are stored in the refrigerator;
(B)
a system or device to monitor the temperature and humidity
where bulk chemicals are stored;
(C)
if applicable, a Class A prescription balance, or analytical
balance and weights. Such balance shall be properly maintained and subject
to inspection at least every three years by the Texas State Board of Pharmacy;
(D)
have equipment and utensils necessary for the proper compounding
of prescription drug or medication orders. Such equipment and utensils used
in the compounding process shall be:
(i)
of appropriate design, appropriate capacity, and be operated
within designed operational limits;
(ii)
of suitable composition so that surfaces that contact
components, in-process material, or drug products shall not be reactive, additive,
or absorptive so as to alter the safety, identity, strength, quality, or purity
of the drug product beyond the desired result;
(iii)
cleaned and sanitized immediately prior to each use;
and
(iv)
routinely inspected, calibrated (if necessary), or checked
to ensure proper performance;
(E)
appropriate disposal containers for used needles, syringes,
etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic
agents, and/or biohazardous waste;
(F)
appropriate packaging or delivery containers to maintain
proper storage conditions for products;
(G)
infusion devices, if applicable; and
(H)
all necessary supplies, including:
(i)
disposable needles, syringes, and other supplies for aseptic
mixing;
(ii)
disinfectant cleaning solutions;
(iii)
hand washing agents with bactericidal action;
(iv)
disposable, lint free towels or wipes;
(v)
appropriate filters and filtration equipment;
(vi)
cytotoxic spill kits, if applicable; and
(vii)
masks, caps, coveralls or gowns with tight cuffs, shoe
covers, and gloves, as applicable.
(5)
Labeling. In addition to the labeling requirements for
the pharmacy's specific license classification, the label dispensed or distributed
pursuant to a prescription drug or medication order shall contain the following.
(A)
The generic name(s) or the official name(s) of the principal
active ingredient(s) of the compounded pharmaceutical.
(B)
A statement that the preparation has been compounded by
the pharmacy. (An auxiliary label may be used on the container to meet this
requirement).
(C)
A beyond-use date after which the compounded pharmaceutical
should not be used. The beyond-use date shall be determined as outlined in
Chapter 797 of the USP/NF concerning Pharmacy Compounding Sterile Preparations.
(D)
If the sterile pharmaceutical is compounded in a batch,
the following should also be included on the batch label.
(i)
unique lot number assigned to the batch;
(ii)
quantity;
(iii)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including cytotoxic warning labels where appropriate;
and
(iv)
device-specific instructions, where appropriate.
(6)
Written drug information. Written information about the
compounded drug or its major active ingredient(s) shall be given to the patient
at the time of dispensing. A statement which indicates that the product was
compounded by the pharmacy must be included in this written information. If
there is no written information available, the patient should be advised in
writing that the drug has been compounded and how to contact a pharmacist,
and if appropriate the prescriber, concerning the drug.
(7)
Pharmaceutical Care Services. In addition to the pharmaceutical
care requirements for the pharmacy's specific license classification, the
following requirements must be met.
(A)
Sterile pharmaceuticals compounded pursuant to prescription
drug orders (outpatients and long-term care facility patients).
(i)
Primary provider. There shall be a designated physician
primarily responsible for the patient's medical care. There shall be a clear
understanding between the physician, the patient, and the pharmacy of the
responsibilities of each in the areas of the delivery of care, and the monitoring
of the patient. This shall be documented in the patient medication record
(PMR).
(ii)
Patient training. The pharmacist-in-charge shall develop
policies that assure that the patient and/or patient's caregiver receives
information regarding drugs and their safe and appropriate use, including
instruction when applicable, regarding:
(I)
appropriate disposition of hazardous solutions and ancillary
supplies;
(II)
proper disposition of controlled substances in the home;
(III)
self-administration of drugs, where appropriate;
(IV)
emergency procedures, including how to contact an appropriate
individual in the event of problems or emergencies related to drug therapy;
and
(V)
if the patient or patient's caregiver prepares sterile
preparations in the home, the following additional information shall be provided:
(-a-)
safeguards against microbial contamination, including
aseptic techniques for compounding intravenous admixtures and aseptic techniques
for injecting additives to premixed intravenous solutions;
(-b-)
appropriate storage methods, including storage durations
for sterile pharmaceuticals and expirations of self-mixed solutions;
(-c-)
handling and disposition of premixed and self- mixed
intravenous admixtures; and
(-d-)
proper disposition of intravenous admixture compounding
supplies such as syringes, vials, ampules, and intravenous solution containers.
(iii)
Pharmacist-patient relationship. It is imperative that
a pharmacist-patient relationship be established and maintained throughout
the patient's course of therapy. This shall be documented in the patient's
medication record (PMR).
(iv)
Patient monitoring. The pharmacist-in-charge shall develop
policies to ensure that:
(I)
the patient's response to drug therapy is monitored and
conveyed to the appropriate health care provider; and
(II)
the first dose of any new drug therapy is administered
in the presence of an individual qualified to monitor for and respond to adverse
drug reactions.
(B)
Sterile pharmaceutical compounded pursuant to medication
orders (inpatients).
(i)
Education. The pharmacist-in-charge in cooperation with
appropriate multi-disciplinary staff of the facility shall develop policies
that assure that:
(I)
the patient and/or patient's caregiver receives information
regarding drugs and their safe and appropriate use; and
(II)
health care providers are provided with patient specific
drug information.
(ii)
Patient monitoring. The pharmacist-in-charge in cooperation
with appropriate multi-disciplinary staff of the facility shall develop policies
to ensure that the patient's response to drug therapy is monitored and conveyed
to the appropriate health care provider.
(8)
Drugs, components, and materials used in sterile compounding.
(A)
Drugs used in sterile compounding shall preferably be a
USP/NF grade substances manufactured in an FDA-registered facility.
(B)
If USP/NF grade substances are not available shall be of
a chemical grade in one of the following categories:
(i)
Chemically Pure (CP);
(ii)
Analytical Reagent (AR); or
(iii)
American Chemical Society (ACS); or
(iv)
Food Chemical Codex; or
(C)
If a drug, component or material is not purchased from
a FDA- registered facility, the pharmacist shall establish purity and stability
by obtaining a Certificate of Analysis from the supplier.
(D)
All components shall:
(i)
preferably be manufactured in an FDA-registered facility;
or
(ii)
in the professional judgment of the pharmacist, be of
high quality and obtained from acceptable and reliable alternative sources;
and
(iii)
stored in properly labeled containers in a clean, dry
area, under proper temperatures.
(E)
Drug product containers and closures shall not be reactive,
additive, or absorptive so as to alter the safety, identity, strength, quality,
or purity of the compounded drug product beyond the desired result.
(F)
Components, drug product containers, and closures shall
be rotated so that the oldest stock is used first.
(G)
Container closure systems shall provide adequate protection
against foreseeable external factors in storage and use that can cause deterioration
or contamination of the compounded drug product.
(H)
A pharmacy may not compound a drug product which appears
on a federal Food and Drug Administration list of drug products withdrawn
or removed from the market for safety reasons.
(9)
Compounding process.
(A)
All significant procedures performed in the compounding
area shall be covered by written SOPs designed to ensure accountability, accuracy,
quality, safety, and uniformity in the compounding process. At a minimum,
SOPs shall be developed for:
(i)
the facility;
(ii)
equipment;
(iii)
personnel;
(iv)
actual compounding;
(v)
product evaluation;
(vi)
packaging; and
(vii)
storage of compounded pharmaceuticals.
(B)
Any compounded formulation with an official monograph in
the USP/NF shall be compounded, labeled, and packaged in conformity with the
USP/NF monograph for the drug.
(C)
Any person with an apparent illness or open lesion that
may adversely affect the safety or quality of a drug product being compounded
shall be excluded from direct contact with components, drug product containers,
closures, any materials involved in the compounding process, and drug products
until the condition is corrected.
(D)
Personnel engaged in the compounding of drug products shall
wear clean clothing appropriate to the operation being performed. Protective
apparel, such as coats/jackets, aprons, hair nets, gowns, hand or arm coverings,
or masks shall be worn as necessary to protect personnel from chemical exposure
and drug products from contamination.
(E)
At each step of the compounding process, the pharmacist
shall assure that components used in compounding are accurately weighed, measured,
or subdivided as appropriate to conform to the formula being prepared.
(10)
Quality control.
(A)
Quality control procedures. The pharmacy shall follow established
quality control procedures to monitor the quality of compounded drug products
for conformity with the quality indicators established for the product. When
developing these procedures, pharmacy personnel shall consider the provisions
of Chapter 797, concerning Pharmaceutical Compounding Sterile Preparations,
Chapter 1075, concerning Good Compounding Practices, and Chapter 1160, concerning
Pharmaceutical Calculations in Prescription Compounding contained in the current
USP/NF. Such procedures shall be documented and be available for inspection.
(B)
End product evaluations.
(i)
The pharmacy shall conduct and document end product evaluations
appropriate for the preparation in accordance with written SOPs. End product
evaluations for non-batch compounded pharmaceuticals may be performed on random
samples. All batch compounded pharmaceuticals shall have end product evaluations.
(ii)
High-risk level compounded sterile pharmaceutical for
administration by injection into the vascular and central nervous systems
that are prepared in groups of more than 25 identical individual single-dose
packages (such as ampuls, bags, syringes, and vials), or in multiple dose
vials for administration to multiple patients, or are exposed longer than
12 hours at 2 - 8 degrees Celsius (36 - 46 degrees Fahrenheit) and longer
than six hours at warmer than 8 degrees Celsius (46 degrees Fahrenheit) before
they are sterilized shall be tested to ensure they are sterile and do not
contain excessive bacterial endotoxins as specified in Chapter 797 of the
USP/NF. If the preparation is a suspension, it should be tested to assure
it is not contaminated by fungus.
(e)
Records.
(1)
Maintenance of records. Every record required by this section
shall be kept by the pharmacy for at least two years.
(2)
Compounding records.
(A)
Compounding pursuant to patient specific prescription drug
or medication orders. Compounding records for all compounded pharmaceuticals
shall be maintained by the pharmacy electronically or manually as part of
the prescription drug or medication order, formula record, formula book, or
compounding log and shall include:
(i)
the date of preparation;
(ii)
a complete formula, including methodology and necessary
equipment which includes the brand name(s) of the raw materials, or if no
brand name, the generic name(s) or official name and name(s) of the manufacturer(s)
or distributor of the raw materials and the quantities of each;
(iii)
signature or initials of the pharmacist or pharmacy technician
performing the compounding;
(iv)
signature or initials of the pharmacist responsible for
supervising pharmacy technicians and other supportive personnel and conducting
in-process and finals checks of compounded pharmaceuticals if pharmacy technicians
perform the compounding function;
(v)
the quantity in units of finished products or amount of
raw materials;
(vi)
the container used and the number of units prepared; and
(vii)
a reference to the location of the following documentation
which may be maintained with other records, such as quality control records:
(I)
the criteria used to determine the beyond-use date; and
(II)
documentation of performance of quality control procedures.
(B)
Batch compounding or compounding in anticipation of future
prescription drug or medication orders.
(i)
Master work sheet. A master work sheet shall be developed
and approved by a pharmacist for pharmaceuticals prepared in batch. Once approved,
a duplicate of the master work sheet shall be used as the preparation work
sheet from which each batch is prepared and on which all documentation for
that batch occurs. The master work sheet shall contain at a minimum:
(I)
the formula;
(II)
the components;
(III)
the compounding directions;
(IV)
a sample label;
(V)
evaluation and testing requirements;
(VI)
specific equipment used during preparation; and
(VII)
storage requirements.
(ii)
Preparation work sheet. The preparation work sheet for
each batch of pharmaceuticals shall document the following:
(I)
identity of all solutions and ingredients and their corresponding
amounts, concentrations, or volumes;
(II)
lot number for each component;
(III)
component manufacturer/distributer or suitable identifying
number;
(IV)
container specifications (e.g., syringe, pump cassette);
(V)
unique lot or control number assigned to batch;
(VI)
expiration date of batch-prepared products;
(VII)
date of preparation;
(VIII)
name, initials, or electronic signature of the person(s)
involved in the preparation;
(IX)
name, initials, or electronic signature of the responsible
pharmacist;
(X)
end-product evaluation and testing specifications, if applicable;
and
(XI)
comparison of actual yield to anticipated yield, when
appropriate.
This agency hereby certifies that the
adoption has been reviewed by legal counsel and found to be a valid exercise
of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 17, 2004.
TRD-200403300
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: June 6, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 305-8028
22 TAC §§291.31 - 291.34
The Texas State Board of Pharmacy adopts amendments to §291.31,
concerning Definitions; §291.32, concerning Personnel; §291.33,
concerning Operational Standards; and §291.34, concerning Records in
a Class A (Community) Pharmacy. The amendments are adopted without changes
to the proposed text as published in the March 26, 2004, issue of the
The amendments to §§291.31 - 291.33 remove the current provisions
relating to compounding of non-sterile and sterile pharmaceuticals and reference
new §291.25 and §291.26 which outline new provisions for the compounding
of non-sterile and sterile pharmaceuticals. The amendments to §291.34
specify that only a pharmacist may verify the receipt of controlled substances
by a pharmacy; require written prescriptions which are electronically signed
to be on security paper to prevent alteration or copying; and clarify electronically
transmitted confidential patient information must be in compliance with other
state and federal laws.
One individual provided written comments in support of §291.34 regarding
written prescriptions which are electronically signed to be on security paper.
The amendments are adopted under §§551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568
- 569, Texas Occupations Code). The Board interprets §551.002 as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 17, 2004.
TRD-200403301
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: June 6, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 305-8028
22 TAC §291.36
The Texas State Board of Pharmacy (TSBP) adopts repeal of §291.36,
concerning Class A Pharmacies Compounding Sterile Pharmaceuticals without
changes to the proposal as published in the March 26, 2004, issue of the
The repeal eliminates a section that is no longer necessary since the provisions
of this section are incorporated into new §291.26. New §291.26 outlines
operating standards for pharmacies that compound sterile pharmaceuticals,
implements the recommendations of the TSBP appointed Task Force on Compounding
(Task Force), and incorporates many of the provisions included in the United
States Pharmacopeia (USP) new General Chapter 797 (Pharmaceutical Compounding
Sterile Preparations).
No comments were received regarding the repeal.
The repeal is adopted under §§551.002, 551.003, 554.001,
and 554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas
Occupations Code). The Board interprets §551.002 as authorizing the agency
to protect the public through the effective control and regulation of the
practice of pharmacy. The Board interprets §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by the repeal: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 17, 2004.
TRD-200403302
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: June 6, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 305-8028
22 TAC §§291.52 - 291.55
The Texas State Board of Pharmacy (TSBP) adopts amendments
to §291.52, concerning Definitions; §291.53, concerning Personnel; §291.54,
concerning Operational Standards; and §291.55, concerning Records in
a Class B (Nuclear) Pharmacy with changes to the proposed text as published
in the March 26, 2004, issue of the
Texas Register
(29 TexReg 3069). The amendments are adopted with changes based on
comments received.
The amendments to §§291.52 - 291.54 amend the current provisions
relating to compounding of sterile pharmaceuticals to match new §291.26
which outlines new provisions for the compounding of sterile pharmaceuticals.
New §291.26 outlines operating standards for pharmacies that compound
sterile pharmaceuticals, implements the recommendations of the TSBP appointed
Task Force on Compounding (Task Force), and incorporates many of the provisions
included in the United States Pharmacopeia (USP) new General Chapter 797 (Pharmaceutical
Compounding Sterile Preparations). The amendments to §291.55 specify
that only a pharmacist may verify the receipt of controlled substances by
a pharmacy and clarify electronically transmitted confidential patient information
must be in compliance with other state and federal laws.
One comment suggested clarifying storage requirements for low risk sterile
compounded products. The Board agrees with the comment and amended the rule
to reflect the clarification.
The amendments are adopted under §§551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568
- 569, Texas Occupations Code). The Board interprets §551.002 as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
§291.52.Definitions
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise. Any
term not defined in this section shall have the definition set forth in the
Act, §551.003.
(1)
Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568
- 569, Occupations Code, as amended.
(2)
Accurately as prescribed--Dispensing, delivering, and/or
distributing a prescription drug order or radioactive prescription drug order:
(A)
to the correct patient (or agent of the patient) for whom
the drug or device was prescribed;
(B)
with the correct drug in the correct strength, quantity,
and dosage form ordered by the practitioner; and
(C)
with correct labeling (including directions for use) as
ordered by the practitioner. Provided, however, that nothing herein shall
prohibit pharmacist substitution if substitution is conducted in strict accordance
with applicable laws and rules, including Subchapter A, Chapter 562 of the
Texas Pharmacy Act.
(3)
ACPE--Accreditation Council for Pharmacy Education.
(4)
Administer--The direct application of a prescription drug
and/or radiopharmaceutical, by injection, inhalation, ingestion, or any other
means to the body of a patient by:
(A)
a practitioner, an authorized agent under his supervision,
or other person authorized by law; or
(B)
the patient at the direction of a practitioner.
(5)
Airborne particulate cleanliness class--The level of cleanliness
specified by the maximum allowable number of particles per cubic foot of air
as specified in Federal Standard 209E, et seq. For example:
(A)
Class 100 (ISO Class 5) is an atmospheric environment which
contains less than 100 particles no greater than 0.5 microns in diameter per
cubic foot of air;
(B)
Class 10,000 (ISO Class 7) is an atmospheric environment
which contains less than 10,000 particles no greater than 0.5 microns in diameter
per cubic foot of air; and
(C)
Class 100,000 (ISO Class 8) is an atmospheric environment
which contains less than 100,000 particles no greater than 0.5 microns in
diameter per cubic foot of air.
(6)
Ancillary supplies--Supplies necessary for the administration
of compounded sterile pharmaceuticals.
(7)
Aseptic preparation--The technique involving procedures
designed to preclude contamination of drugs, packaging, equipment, or supplies
by microorganisms during processing.
(8)
Authentication of product history--Identifying the purchasing
source, the intermediate handling, and the ultimate disposition of any component
of a radioactive drug.
(9)
Authorized nuclear pharmacist--A pharmacist who has completed
the specialized training requirements specified by these rules for the preparation
and distribution of radiopharmaceuticals.
(10)
Authorized user--Any individual named on a Texas radioactive
material license, issued by the Texas Department of Health, Bureau of Radiation
Control.
(11)
Automated compounding or drug dispensing device--An automated
device that compounds, measures, counts, packages, and/or labels a specified
quantity of dosage units for a designated drug product.
(12)
Biological Safety Cabinet--Containment unit suitable for
the preparation of low to moderate risk agents where there is a need for protection
of the product, personnel, and environment, according to National Sanitation
Foundation (NSF) Standard 49.
(13)
Board--The Texas State Board of Pharmacy.
(14)
Class B pharmacy license or nuclear pharmacy license--A
license issued to a pharmacy dispensing or providing radioactive drugs or
devices for administration to an ultimate user.
(15)
Clean room--A room in which the concentration of airborne
particles is controlled and there are one or more clean zones according to
the International Organization of Standardization (ISO), Specifications for
testing and monitoring to prove continued compliance with ISO 14644-1 and/or
ISO 14644-2.
(16)
Clean zone--A defined space in which the concentration
of airborne particles is controlled to meet a specified airborne particulate
cleanliness class.
(17)
Component--Any ingredient intended for use in the compounding
of a drug product, including those that may not appear in such product.
(18)
Compounding--The preparation, mixing, assembling, packaging,
or labeling of a drug or device:
(A)
as the result of a practitioner's prescription drug or
medication order or initiative based on the practitioner-patient pharmacist
relationship in the course of professional practice;
(B)
in anticipation of prescription drug or medication orders
based on routine, regularly observed prescribing patterns; or
(C)
for the purpose of or as an incident to research, teaching,
or chemical analysis and not for sale or dispensing.
(19)
Controlled area--A controlled area is the area designated
for preparing sterile radiopharmaceuticals.
(20)
Controlled substance--A drug, immediate precursor, or
other substance listed in Schedules I - V or Penalty Groups 1-4 of the Texas
Controlled Substances Act, as amended, or a drug, immediate precursor, or
other substance included in Schedule I, II, III, IV, or V of the Federal Comprehensive
Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).
(21)
Critical site--Any opening providing a direct pathway
between a sterile product and the environment or any surface coming in direct
contact with the product and the environment.
(22)
Dangerous drug--A drug or device that:
(A)
is not included in Penalty Group 1, 2, 3, or 4, Chapter
481, Health and Safety Code, and is unsafe for self-medication; or
(B)
bears or is required to bear the legend:
(i)
"Caution: federal law prohibits dispensing without prescription"
or "Rx only" or another legend that complies with federal law; or
(ii)
"Caution: federal law restricts this drug to use by or
on the order of a licensed veterinarian."
(23)
Data communication device--An electronic device that receives
electronic information from one source and transmits or routes it to another
(e.g., bridge, router, switch, or gateway).
(24)
Deliver or delivery--The actual, constructive, or attempted
transfer of a prescription drug or device, radiopharmaceutical, or controlled
substance from one person to another, whether or not for a consideration.
(25)
Designated agent--
(A)
a licensed nurse, physician assistant, pharmacist, or other
individual designated by a practitioner, and for whom the practitioner assumes
legal responsibility, who communicates radioactive prescription drug orders
to a pharmacist; or
(B)
a licensed nurse, physician assistant, or pharmacist employed
in a health care facility to whom the practitioner communicates a radioactive
prescription drug order.
(26)
Device--An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related articles,
including any component parts or accessory that is required under federal
or state law to be ordered or prescribed by a practitioner.
(27)
Diagnostic prescription drug order--A radioactive prescription
drug order issued for a diagnostic purpose.
(28)
Dispense--Preparing, packaging, compounding, or labeling
for delivery a prescription drug or device, or a radiopharmaceutical in the
course of professional practice to an ultimate user or his agent by or pursuant
to the lawful order of a practitioner.
(29)
Dispensing pharmacist--The authorized nuclear pharmacist
responsible for the final check of the dispensed prescription before delivery
to the patient.
(30)
Distribute--The delivering of a prescription drug or device,
or a radiopharmaceutical other than by administering or dispensing.
(31)
Electronic radioactive prescription drug order--A radioactive
prescription drug order which is transmitted by an electronic device to the
receiver (pharmacy).
(32)
Internal test assessment--Validation of tests for quality
control necessary to insure the integrity of the test.
(33)
Nuclear pharmacy technique--The mechanical ability required
to perform the nonjudgmental, technical aspects of preparing and dispensing
radiopharmaceuticals.
(34)
Original prescription--The:
(A)
original written radioactive prescription drug orders;
or
(B)
original verbal or electronic radioactive prescription
drug orders reduced to writing either manually or electronically by the pharmacist.
(35)
Pharmacist-in-charge--The pharmacist designated on a pharmacy
license as the pharmacist who has the authority or responsibility for a pharmacy's
compliance with laws and rules pertaining to the practice of pharmacy.
(36)
Pharmacy technician--An individual whose responsibility
in a pharmacy is to provide technical services that do not require professional
judgment regarding preparing and distributing drugs and who works under the
direct supervision of and is responsible to a pharmacist. Pharmacy technician
includes registered pharmacy technicians and pharmacy technician trainees.
(37)
Pharmacy technician trainee--A person who is not registered
as a pharmacy technician by the board and is either:
(A)
participating in a pharmacy's technician training program;
or
(B)
currently enrolled in a:
(i)
pharmacy technician training program accredited by the
American Society of Health-System Pharmacists; or
(ii)
health science technology education program in a Texas
high school that is accredited by the Texas Education Agency.
(38)
Process validation--Documented evidence providing a high
degree of assurance that a specific process will consistently produce a product
meeting its predetermined specifications and quality attributes.
(39)
Quality assurance--The set of activities used to assure
that the process used in the preparation of sterile drug products lead to
products that meet predetermined standards of quality.
(40)
Radiopharmaceutical--A prescription drug or device that
exhibits spontaneous disintegration of unstable nuclei with the emission of
a nuclear particle(s) or photon(s), including any nonradioactive reagent kit
or nuclide generator that is intended to be used in preparation of any such
substance.
(41)
Radioactive drug quality control--The set of testing activities
used to determine that the ingredients, components (e.g., containers), and
final radiopharmaceutical prepared meets predetermined requirements with respect
to identity, purity, non-pyrogenicity, and sterility and the interpretation
of the resulting data in order to determine the feasibility for use in humans
and animals including internal test assessment, authentication of product
history, and the keeping of mandatory records.
(42)
Radioactive drug service--The act of distributing radiopharmaceuticals;
the participation in radiopharmaceutical selection and the performance of
radiopharmaceutical drug reviews.
(43)
Radioactive prescription drug order--An order from a practitioner
or a practitioner's designated agent for a radiopharmaceutical to be dispensed.
(44)
Sterile radiopharmaceutical--A dosage form of a radiopharmaceutical
free from living micro-organisms.
(45)
Therapeutic prescription drug order--A radioactive prescription
drug order issued for a specific patient for a therapeutic purpose.
(46)
Ultimate user--A person who has obtained and possesses
a prescription drug or radiopharmaceutical for his or her own use or for the
use of a member of his or her household.
§291.53.Personnel.
(a)
Pharmacists-in-Charge.
(1)
General.
(A)
Every nuclear pharmacy shall have an authorized nuclear
pharmacist designated on the nuclear pharmacy license as the pharmacist-in-charge
who shall be responsible for a nuclear pharmacy's compliance with laws and
regulations, both state and federal, pertaining to the practice of nuclear
pharmacy.
(B)
The nuclear pharmacy pharmacist-in-charge shall see that
directives from the board are communicated to the owner(s), management, other
pharmacists, and interns of the nuclear pharmacy.
(C)
An authorized nuclear pharmacist may be pharmacist-in-charge
for no more than one nuclear pharmacy at any one given time.
(2)
Responsibilities. The pharmacist-in-charge shall have the
responsibility for, at a minimum, the following:
(A)
ensuring that radiopharmaceuticals are dispensed and delivered
safely and accurately as prescribed;
(B)
developing a system to assure that all pharmacy personnel
responsible for compounding and/or supervising the compounding of radiopharmaceuticals
within the pharmacy receive appropriate education and training and competency
evaluation;
(C)
determining that all pharmacists involved in compounding
sterile radiopharmaceuticals obtain continuing education appropriate for the
type of compounding done by the pharmacist;
(D)
supervising a system to assure appropriate procurement
of drugs and devices and storage of all pharmaceutical materials including
radiopharmaceuticals, components used in the compounding of radiopharmaceuticals,
and drug delivery devices;
(E)
assuring that the equipment used in compounding is properly
maintained;
(F)
developing a system for the disposal and distribution of
drugs from the Class B pharmacy;
(G)
developing a system for bulk compounding or batch preparation
of radiopharmaceuticals;
(H)
developing a system for the compounding, sterility assurance,
and quality control of sterile radiopharmaceuticals;
(I)
maintaining records of all transactions of the Class B
pharmacy necessary to maintain accurate control over and accountability for
all pharmaceutical materials including radiopharmaceuticals, required by applicable
state and federal laws and rules;
(J)
developing a system to assure the maintenance of effective
controls against the theft or diversion of prescription drugs, and records
for such drugs;
(K)
assuring that the pharmacy has a system to dispose of radioactive
and cytotoxic waste in a manner so as not to endanger the public health; and
(L)
legal operation of the pharmacy, including meeting all
inspection and other requirements of all state and federal laws or rules governing
the practice of pharmacy.
(b)
Authorized nuclear pharmacists.
(1)
General.
(A)
The pharmacist-in-charge shall be assisted by a sufficient
number of additional authorized nuclear pharmacists as may be required to
operate the pharmacy competently, safely, and adequately to meet the needs
of the patients of the pharmacy.
(B)
All personnel performing tasks in the preparation and distribution
of radiopharmaceuticals shall be under the direct supervision of an authorized
nuclear pharmacist. General qualifications for an authorized nuclear pharmacist
are the following. A pharmacist shall:
(i)
meet minimal standards of training and experience in the
handling of radioactive materials in accordance with the requirements of the
Texas Regulations for Control of Radiation of the Bureau of Radiation Control,
Texas Department of Health;
(ii)
be a pharmacist licensed by the board to practice pharmacy
in Texas; and
(iii)
submit to the board either:
(I)
written certification that he or she has current board
certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties;
or
(II)
written certification signed by preceptor authorized nuclear
pharmacist that he or she has achieved a level of competency sufficient to
independently operate as an authorized nuclear pharmacist and has satisfactorily
completed 700 hours in a structured educational program consisting of both:
(-a-)
200 hours of didactic training in a program accepted
by the Bureau of Radiation Control, Texas Department of Health in the following
areas:
(-1-)
radiation physics and instrumentation;
(-2-)
radiation protection;
(-3-)
mathematics pertaining to the use and measurement of
radioactivity;
(-4-)
radiation biology; and
(-5-)
chemistry of radioactive material for medical use; and
(-b-)
500 hours of supervised experience in a nuclear pharmacy
involving the following:
(-1-)
shipping, receiving, and performing related radiation
surveys;
(-2-)
using and performing checks for proper operation of dose
calibrators, survey meters, and, if appropriate, instruments used to measure
alpha- or beta-emitting radionuclides;
(-3-)
calculating, assaying, and safely preparing dosages for
patients or human research subjects;
(-4-)
using administrative controls to avoid mistakes in the
administration of radioactive material; and
(-5-)
using procedures to prevent or minimize contamination
and using proper decontamination procedures.
(C)
The board may issue a letter of notification that the evidence
submitted by the pharmacist meets the requirements of subparagraph (B)(i)
- (iii) of this paragraph and has been accepted by the board and that, based
thereon, the pharmacist is recognized as an authorized nuclear pharmacist.
(D)
Authorized nuclear pharmacists are solely responsible for
the direct supervision of pharmacy technicians and for delegating nuclear
pharmacy techniques and additional duties, other than those listed in paragraph
(2) of this subsection, to pharmacy technicians. Each authorized nuclear pharmacist:
(i)
shall verify the accuracy of all acts, tasks, or functions
performed by pharmacy technicians; and
(ii)
shall be responsible for any delegated act performed by
pharmacy technicians under his or her supervision.
(E)
All authorized nuclear pharmacists while on duty, shall
be responsible for complying with all state and federal laws or rules governing
the practice of pharmacy.
(F)
The dispensing pharmacist shall ensure that the drug is
dispensed and delivered safely and accurately as prescribed.
(2)
Special requirements for sterile compounding.
(A)
All pharmacists engaged in compounding shall:
(i)
possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken or supervised;
and
(ii)
obtain continuing education appropriate for the type of
compounding done by the pharmacist.
(B)
A pharmacist shall inspect and approve all components,
drug product containers, closures, labeling, and any other materials involved
in the compounding process.
(C)
A pharmacist shall review all compounding records for accuracy
and conduct in-process and final checks to assure that errors have not occurred
in the compounding process.
(D)
A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(3)
Duties. Duties which may only be performed by an authorized
nuclear pharmacist are as follows:
(A)
receiving verbal therapeutic prescription drug orders and
reducing these orders to writing, either manually or electronically;
(B)
receiving verbal, diagnostic prescription drug orders in
instances where patient specificity is required for patient safety (e.g.,
radiolabeled blood products, radiolabeled antibiodies) and reducing these
orders to writing, either manually or electronically;
(C)
interpreting and evaluating radioactive prescription drug
orders;
(D)
selection of drug products; and
(E)
performing the final check of the dispensed prescription
before delivery to the patient to ensure that the radioactive prescription
drug order has been dispensed accurately as prescribed.
(c)
Pharmacy Technicians.
(1)
General.
(A)
On June 1, 2004, all persons employed as pharmacy technicians
must be either registered pharmacy technicians or pharmacy technician trainees
as follows.
(i)
All persons who have passed the required pharmacy technician
certification examination must be registered with the board under the provisions
this section.
(ii)
All persons who have not taken and passed the required
pharmacy certification examination shall be designated pharmacy technician
trainees under the provisions of §297.5 of this title (relating to Pharmacy
Technician Trainees).
(B)
Between January 1, 2004, and May 31, 2004, all persons
employed as pharmacy technicians who are qualified for registration by the
board shall register according to the schedule designated by the board. Between
January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled
time for registration and persons who have applied for registration, but the
registration has not been completed shall comply with the rules in effect
prior to January 1, 2004, relating to requirements and duties for certified
pharmacy technicians.
(C)
All pharmacy technicians shall meet the training requirements
specified in §297.6 of this title (relating to Pharmacy Technician Training).
(2)
Special requirements for sterile compounding. Pharmacy
technicians may compound sterile pharmaceuticals provided the pharmacy technicians:
(A)
have completed the education and training specified in
subsection (d) of this subsection; and
(B)
are supervised by a pharmacist who has completed the training
specified in subsection (d) of this subsection, conducts in-process and final
checks, and affixes his or her initials to the appropriate quality control
records.
(3)
Duties.
(A)
General. Pharmacy technicians may perform any nuclear pharmacy
technique delegated by an authorized nuclear pharmacist which is associated
with the preparation and distribution of radiopharmaceuticals other than those
duties listed in subsection (b)(3) of this section provided:
(i)
an authorized nuclear pharmacist conducts in-process and
final checks; and
(ii)
pharmacy technicians are under the direct supervision
of and responsible to an authorized nuclear pharmacist.
(B)
Labeling. Only registered pharmacy technicians may affix
a label to a prescription container.
(4)
Ratio of authorized nuclear pharmacist to pharmacy technicians.
(A)
The ratio of authorized nuclear pharmacists to pharmacy
technicians may not exceed 1:2, provided that only one pharmacy technician
may be engaged in the compounding of a sterile radiopharmaceutical.
(B)
The ratio of authorized nuclear pharmacists to pharmacy
technicians may be 1:3 provided that at least one of the three technicians
is a registered pharmacy technician and only one may be engaged in the compounding
of a sterile radiopharmaceutical.
(d)
Special education, training, and evaluation requirements
for pharmacy personnel compounding or responsible for the direct supervision
of pharmacy personnel compounding sterile radiopharmaceuticals.
(1)
General.
(A)
All pharmacy personnel preparing sterile radiopharmaceuticals
shall receive didactic and experiential training and competency evaluation
through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge
and described in the policy and procedure or training manual. Such training
shall include instruction and experience in the following areas:
(i)
aseptic technique;
(ii)
critical area contamination factors;
(iii)
environmental monitoring;
(iv)
facilities;
(v)
equipment and supplies;
(vi)
sterile pharmaceutical and radiopharmaceutical calculations
and terminology;
(vii)
sterile radiopharmaceutical compounding documentation;
(viii)
quality assurance procedures;
(ix)
aseptic preparation procedures including proper gowning
and gloving technique;
(x)
handling of hazardous drugs, if applicable; and
(xi)
general conduct in the controlled area.
(B)
The aseptic technique of each person compounding or responsible
for the direct supervision of personnel compounding sterile radiopharmaceuticals
shall be observed, evaluated, and documented as satisfactory through written
or practical tests and process validation.
(C)
Although process validation may be incorporated into the
experiential portion of a training program, process validation must be conducted
at each pharmacy where an individual compounds sterile radiopharmaceuticals.
No product intended for patient use shall be compounded by an individual until
the on-site process validation test indicates that the individual can competently
perform aseptic procedures, except that an authorized nuclear pharmacist may
temporarily compound sterile radiopharmaceuticals and supervise pharmacy technicians
compounding sterile radiopharmaceuticals without process validation provided
the authorized nuclear pharmacist:
(i)
has completed a recognized course in an accredited college
of pharmacy or a course sponsored by an ACPE approved provider which provides
20 hours of instruction and experience in the areas listed in this paragraph;
and
(ii)
completes the on-site process validation within seven
days of commencing work at the pharmacy.
(D)
Process validation procedures for assessing the preparation
of specific types of sterile radiopharmaceuticals shall be representative
of all types of manipulations, products, risk levels and batch sizes that
personnel preparing that type of radioradiopharmaceutical are likely to encounter.
(E)
The pharmacist-in-charge shall assure continuing competency
of pharmacy personnel through in-service education, training, and process
validation to supplement initial training. Personnel competency shall be evaluated:
(i)
during orientation and training prior to the regular performance
of those tasks;
(ii)
whenever the quality assurance program yields an unacceptable
result;
(iii)
whenever unacceptable techniques are observed; and
(iv)
at least on an annual basis.
(2)
Pharmacists.
(A)
All pharmacists who compound sterile radiopharmaceuticals
or supervise pharmacy technicians compounding sterile radiopharmaceuticals
shall:
(i)
complete through a single course, a minimum of 20 hours
of instruction and experience in the areas listed in paragraph (1) of this
subsection. Such training may be obtained through:
(I)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 20 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may not be transferred to another pharmacy unless the pharmacies are under
common ownership and control and use a common training program; or
(II)
completion of a recognized course in an accredited college
of pharmacy or a course sponsored by an ACPE approved provider which provides
20 hours of instruction and experience in the areas listed in paragraph (1)
of this subsection; and
(ii)
possess knowledge about:
(I)
aseptic processing;
(II)
quality control and quality assurance as related to environmental,
component, and end-product testing;
(III)
chemical, pharmaceutical, and clinical properties of
drugs;
(IV)
container, equipment, and closure system selection; and
(V)
sterilization techniques; and
(iii)
every two years complete six hours of continuing education
related to sterile or nuclear product compounding offered by a provider approved
by ACPE. (These hours may be applied towards the hours required for renewal
of a license to practice pharmacy.)
(B)
The required experiential portion of the training programs
specified in this paragraph must be supervised by an individual who has already
completed training in the compounding of sterile pharmaceuticals as specified
in paragraph (2) or (3) of this subsection.
(3)
Pharmacy technicians. In addition to the qualifications
and training outlined in subsection (c) of this section, all pharmacy technicians
who compound sterile radiopharmaceuticals shall:
(A)
have a high school or equivalent education;
(B)
have initial training obtained either through completion
of:
(i)
a single course, a minimum of 40 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may be obtained through:
(I)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 40 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may not be transferred to another pharmacy unless the pharmacies are under
common ownership and control and use a common training program; or
(II)
completion of a course sponsored by an ACPE approved provider
which provides 40 hours of instruction and experience in the areas listed
in paragraph (1) of this subsection; or
(ii)
a training program which is accredited by the American
Society of Health-System Pharmacists (formerly the American Society of Hospital
Pharmacists). Individuals enrolled in training programs accredited by the
American Society of Health-System Pharmacists may compound sterile pharmaceuticals
in a licensed pharmacy provided:
(I)
the compounding occurs only during times the individual
is assigned to a pharmacy as a part of the experiential component of the American
Society of Health-System Pharmacists training program;
(II)
the individual is under the direct supervision of and
responsible to a pharmacist who has completed training as specified in paragraph
(1) of this subsection; and
(III)
the supervising pharmacist conducts in-process and final
checks; and
(C)
repeat the training specified in subparagraph (B) of this
paragraph at least every seven years; and
(D)
acquire the required experiential portion of the training
programs specified in this subparagraph under the supervision of an individual
who has already completed training as specified in paragraph (2) or (3) of
this subsection.
(E)
every two years complete six hours of continuing education
related to sterile product compounding. (These hours may be applied towards
the hours required for renewal of a pharmacy technician's registration.)
(4)
Documentation of Training. A written record of initial
and in-service training and the results of written or practical testing and
process validation of pharmacy personnel shall be maintained and contain the
following information:
(A)
name of the person receiving the training or completing
the testing or process validation;
(B)
date(s) of the training, testing, or process validation;
(C)
general description of the topics covered in the training
or testing or of the process validated;
(D)
name of the person supervising the training, testing, or
process validation; and
(E)
signature (first initial and last name or full signature)
of the person receiving the training or completing the testing or process
validation and the pharmacist-in-charge or other pharmacist employed by the
pharmacy and designated by the pharmacist-in-charge as responsible for training,
testing, or process validation of personnel.
§291.54.Operational Standards.
(a)
Licensing requirements.
(1)
It is unlawful for a person to provide radioactive drug
services unless such provision is performed by a person licensed to act as
an authorized nuclear pharmacist, as defined by the board, or is a person
acting under the direct supervision of an authorized nuclear pharmacist acting
in accordance with the Act and its rules, and the regulations of the Texas
Department of Health, Bureau of Radiation Control. Subsection (a) of this
section does not apply to:
(A)
a licensed practitioner or his or her designated agent
for administration to his or her patient, provided no person may receive,
possess, use, transfer, own, acquire, or dispose of radiopharmaceuticals except
as authorized in a specific or a general license as provided in Texas Regulations
for Control of Radiation, Part 41, Texas Department of Health, or the Act;
(B)
institutions and/or facilities with nuclear medicine services
operated by practitioners and who are licensed by the Texas Department of
Health, Bureau of Radiation Control, to prescribe, administer, and dispense
radioactive materials (drugs and/or devices).
(2)
An applicant for a Class B pharmacy shall provide evidence
to the board of the possession of a Texas Department of Health Radiation Control
Number.
(3)
A Class B pharmacy shall register annually with the board
on a pharmacy license application provided by the board, following the procedures
specified in §291.1 of this title (relating to Pharmacy License Application).
(4)
A Class B pharmacy which changes ownership shall notify
the board within ten days of the change of ownership and apply for a new and
separate license as specified in §291.4 of this title (relating to Change
of Ownership).
(5)
A Class B pharmacy which changes location and/or name shall
notify the board within ten days of the change and file for an amended license
as specified in §291.2 of this title (relating to Change of Location
and/or Name).
(6)
A Class B pharmacy owned by a partnership or corporation
which changes managing officers shall notify the board in writing of the names
of the new managing officers within ten days of the change, following the
procedures in §291.3 of this title (relating to Change of Managing Officers).
(7)
A Class B pharmacy shall notify the board in writing within
ten days of closing, following the procedures in §291.5 of this title
(relating to Closed Pharmacies).
(8)
A separate license is required for each principal place
of business and only one pharmacy license may be issued to a specific location.
(9)
A fee as specified in §291.6 of this title (relating
to Pharmacy License Fees) will be charged for the issuance and renewal of
a license and the issuance of an amended license.
(10)
A Class B pharmacy, licensed under the provisions of the
Act, §560.051(a)(2), which also operates another type of pharmacy which
would otherwise be required to be licensed under the Act, §560.051(a)(1),
concerning community pharmacy (Class A), is not required to secure a license
for such other type of pharmacy; provided, however, such licensee is required
to comply with the provisions of §291.31 of this title (relating to Definitions); §291.32
of this title (relating to Personnel); §291.33 of this title (relating
to Operational Standards); §291.34 of this title (relating to Records);
and §291.35 of this title (relating to Official Prescription Requirements),
to the extent such rules are applicable to the operation of the pharmacy.
(11)
A Class B pharmacy engaged in nonsterile compounding of
drug products shall comply with the provisions of §291.25 of this title
(relating to Pharmacies Compounding Non-Sterile Pharmaceuticals)
(12)
A Class B pharmacy engaged in sterile compounding of pharmaceutical
drug products other than radiopharmaceuticals shall comply with the provisions
of §291.26 of this title (relating to Pharmacies Compounding Sterile
Pharmaceuticals).
(b)
Risk levels for compounded sterile pharmaceuticals. Risk
Levels for sterile compounded preparations shall be as outlined in USP/NF
Chapter 797 Pharmacy Compounding Sterile Preparations and as listed below.
(1)
Low-risk level compounded sterile pharmaceuticals.
(A)
Low-risk level compounded sterile pharmaceuticals are those
compounded under all of the following conditions.
(i)
The compounded sterile preparations are compounded with
aseptic manipulations entirely within ISO Class 5 or better air quality using
only sterile ingredients, products, components, and devices.
(ii)
The compounding involves only transfer, measuring, and
mixing manipulations with closed or sealed packaging systems that are performed
promptly and attentively.
(iii)
Manipulations are limited to aseptically opening ampuls,
penetrating sterile stoppers on vials with sterile needles and syringes, and
transferring sterile liquids in sterile syringes to sterile administration
devices and packages of other sterile products.
(iv)
For a low-risk preparation, in the absence of passing
a sterility test, the storage periods cannot exceed the following periods:
before administration, 48 hours at controlled room temperature, for not more
than 14 days if stored in cold temperatures, and for 45 days if stored in
a frozen state at minus 20 degrees Celsius or colder). For delayed activation
device systems, the storage period begins when the device is activated.
(B)
Examples of low-risk compounding include the following.
(i)
Single transfers of sterile dosage forms from ampuls, bottles,
bags, and vials using sterile syringes with sterile needles, other administration
devices, and other sterile containers. The contents of ampuls require sterile
filtration to remove glass particles.
(ii)
Manually measuring and mixing no more than three manufactured
products to compound drug admixtures and nutritional solutions.
(2)
Medium-risk level compounded sterile pharmaceuticals.
(A)
Medium-risk level compounded sterile pharmaceuticals are
those compounded aseptically under low-risk conditions and one or more of
the of the following conditions exists.
(i)
Multiple individual or small doses of sterile products
are combined or pooled to prepare a compounded sterile pharmaceutical that
will be administered either to multiple patients or to one patient on multiple
occasions.
(ii)
The compounding process includes complex aseptic manipulations
other than the single-volume transfer.
(iii)
The compounding process requires unusually long duration,
such as that required to complete the dissolution or homogenous mixing.
(iv)
The sterile compounded pharmaceutical's do not contain
broad-spectrum bacteriostatic substances, and they are administered over several
days.
(v)
For a medium-risk preparation, in the absence of passing
sterility test, the storage periods cannot exceed the following time periods:
before administration, the compounded sterile preparations are properly stored
and are exposed for not more than 30 hours at controlled room temperature
for not more than 7 days at a cold temperature, and for 45 days in solid frozen
state at minus 20 degrees or colder.
(B)
Examples of medium-risk compounding include the following.
(i)
Compounding of total parenteral nutrition fluids using
a manual or automated device during which there are multiple injections, detachments,
and attachments of nutrient source products to the device or machine to deliver
all nutritional components to a final sterile container.
(ii)
Filling of reservoirs of injection and infusion devices
with multiple sterile drug products and evacuations of air from those reservoirs
before the filled device is dispensed.
(iii)
Filling of reservoirs of injection and infusion devices
with volumes of sterile drug solutions that will be administered over several
days at ambient temperatures between 25 and 40 degrees Celsius (77 and 104
degrees Fahrenheit).
(iv)
Transfer of volumes from multiple ampuls or vials into
a single, final sterile container or product.
(3)
High-risk level compounded sterile pharmaceuticals.
(A)
High-risk level compounded sterile pharmaceuticals are
those compounded under any of the following conditions.
(i)
Non-sterile ingredients, including manufactured products
are incorporated, or a non-sterile device is employed before terminal sterilization.
(ii)
Sterile ingredients, components, devices, and mixtures
are exposed to air quality inferior to ISO Class 5. This includes storage
in environments inferior to ISO Class 5 of opened or partially used packages
of manufactured sterile products that lack antimicrobial preservatives.
(iii)
Non-sterile preparations are exposed no more than 6 hours
before being sterilized.
(iv)
It is assumed, and not verified by examination of labeling
and documentation from suppliers or by direct determination, that the chemical
purity and content strength of ingredients meet their original or compendial
specifications in unopened or in opened packages of bulk ingredients.
(v)
For a high-risk preparation, in the absence of passing
sterility test, the storage periods cannot exceed the following time periods:
before administration, the compounded sterile preparations are properly stored
and are exposed for not more than 24 hours at controlled room temperature
for not more than 3 days at a cold temperature, and for 45 days in solid frozen
state at minus 20 degrees or colder.
(B)
Examples of high-risk compounding include the following.
(i)
Dissolving non-sterile bulk drug and nutrient powders to
make solutions, which will be terminally sterilized.
(ii)
Sterile ingredients, components, devices, and mixtures
are exposed to air quality inferior to ISO Class 5. This includes storage
in environments inferior to ISO Class 5 of opened or partially used packages
of manufactured sterile products that lack antimicrobial preservatives.
(iii)
Measuring and mixing sterile ingredients in non-sterile
devices before sterilization is performed.
(iv)
Assuming, without appropriate evidence or direct determination,
that packages of bulk ingredients contain at least 95% by weight of their
active chemical moiety and have not been contaminated or adulterated between
uses.
(c)
Environment.
(1)
Generic Substitution. A pharmacist may substitute on a
prescription drug order issued for a brand name product provided the substitution
is authorized and performed in compliance with Chapter 309 of this title (relating
to Generic Substitution).
(2)
Special requirements for the compounding of sterile radiopharmaceuticals.
When the pharmacy compounds sterile radiopharmaceuticals, the following is
applicable.
(A)
A drug dispensed pursuant to a radioactive prescription
drug order shall be dispensed in an appropriate immediate inner container
as follows.
(i)
If a drug is susceptible to light, the drug shall be dispensed
in a light-resistant container.
(ii)
If a drug is susceptible to moisture, the drug shall be
dispensed in a tight container.
(iii)
The container should not interact physically or chemically
with the drug product placed in it so as to alter the strength, quality, or
purity of the drug beyond the official requirements.
(B)
Controlled area.
(i)
Low and Medium Risk Preparations. The pharmacy shall have
a designated controlled area for the compounding of sterile radiopharmaceuticals
that is functionally separate from areas for the preparation of non-sterile
pharmaceuticals and is constructed to minimize the opportunities for particulate
and microbial contamination. This controlled area for the preparation of sterile
pharmaceuticals shall:
(I)
have a controlled environment that is aseptic or contains
an aseptic environmental control device(s). If the aseptic environmental control
device is located within the controlled area, the controlled area must extend
a minimum of six feet from the device and clearly marked to identify the separation
between the controlled and non-controlled area;
(II)
be clean, well lighted, and of sufficient size to support
sterile compounding activities;
(III)
be used only for the compounding of sterile pharmaceuticals;
(IV)
be designed to avoid outside traffic and air flow;
(V)
be designed such that hand sanitizing and gowning occurs
outside the controlled area but accessible without use of the hands of the
compounding personnel;
(VI)
have non-porous and washable floors or floor covering
to enable regular disinfection;
(VII)
be ventilated in a manner not interfering with aseptic
environmental control conditions;
(VIII)
have walls, ceilings, and fixtures, shelving, counters,
and cabinets that are smooth, impervious, free from cracks and crevices, and
nonshedding. (acoustical ceiling tiles that are coated with an acrylic paint
are acceptable);
(IX)
have drugs and supplies stored on shelving areas above
the floor to permit adequate floor cleaning; and
(X)
contain only the appropriate compounding supplies and not
be used for bulk storage for supplies and materials. Objects that shed particles
may not be brought into the controlled area.
(ii)
High-risk Preparations. In addition to the requirements
in subclause (I), when high-risk preparations are compounded, the aseptic
environment control device(s) shall be located in a controlled area that maintains
at least an ISO Class 8 (formerly Class 100,000) environment.
(C)
Automated compounding device(s). If automated compounding
device(s) are used, the pharmacy shall have a method to calibrate and verify
the accuracy of automated compounding devices used in aseptic processing and
document the calibration and verification on a routine basis.
(3)
Security requirements.
(A)
All areas occupied by a pharmacy shall be capable of being
locked by key or combination, so as to prevent access by unauthorized personnel
when a pharmacist is not on-site.
(B)
The pharmacy may authorize personnel to gain access to
that area of the pharmacy containing dispensed sterile radiopharmaceuticals,
in the absence of the pharmacist, for the purpose of retrieving dispensed
prescriptions to deliver to patients. If the pharmacy allows such after-hours
access, the area containing the dispensed sterile radiopharmaceuticals shall
be an enclosed and lockable area separate from the area containing undispensed
prescription drugs. A list of the authorized personnel having such access
shall be in the pharmacy's policy and procedure manual.
(C)
Each pharmacist while on duty shall be responsible for
the security of the prescription department, including provisions for effective
control against theft or diversion of prescription drugs, and records for
such drugs
(d)
Prescription dispensing and delivery.
(1)
Generic Substitution. A pharmacist may substitute on a
prescription drug order issued for a brand name product provided the substitution
is authorized and performed in compliance with Chapter 309 of this title (relating
to Generic Substitution).
(2)
Prescription containers (immediate inner containers).
(A)
A drug dispensed pursuant to a radioactive prescription
drug order shall be dispensed in an appropriate immediate inner container
as follows.
(i)
If a drug is susceptible to light, the drug shall be dispensed
in a light-resistant container.
(ii)
If a drug is susceptible to moisture, the drug shall be
dispensed in a tight container.
(iii)
The container should not interact physically or chemically
with the drug product placed in it so as to alter the strength, quality, or
purity of the drug beyond the official requirements.
(B)
Immediate inner prescription containers or closures shall
not be re-used.
(3)
Delivery containers (outer containers).
(A)
Prescription containers may be placed in suitable containers
for delivery which will transport the radiopharmaceutical safely in compliance
with all applicable laws and regulations.
(B)
Delivery containers may be re-used provided they are maintained
in a manner to prevent cross contamination.
(4)
Labeling.
(A)
The immediate inner container of a radiopharmaceutical
shall be labeled with:
(i)
standard radiation symbol;
(ii)
the words "caution-radioactive material";
(iii)
the name of the radiopharmaceutical; and
(iv)
the unique identification number of the prescription.
(B)
The outer container of a radiopharmaceutical shall be labeled
with:
(i)
the name, address, and phone number of the pharmacy;
(ii)
the date dispensed;
(iii)
the directions for use, if applicable;
(iv)
the unique identification number of the prescription;
(v)
the name of the patient if known, or the statement, "for
physician use" if the patient is unknown;
(vi)
the standard radiation symbol;
(vii)
the words "caution-radioactive material";
(viii)
the name of the radiopharmaceutical;
(ix)
the amount of radioactive material contained in millicuries
(mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that
applies to this activity, if different from the requested calibration date
and time;
(x)
the name or initials of the person preparing the product
and the authorized nuclear pharmacist who checked and released the final product
unless documents are maintained in the pharmacy identifying these individuals
for each prescription dispensed;
(xi)
if a liquid, the volume in milliliters;
(xii)
the requested calibration date and time; and
(xiii)
the expiration date and/or time.
(C)
The amount of radioactivity shall be determined by radiometric
methods for each individual preparation immediately at the time of dispensing
and calculations shall be made to determine the amount of activity that will
be present at the requested calibration date and time, due to radioactive
decay in the intervening period, and this activity and time shall be placed
on the label per requirements set out in paragraph (4) of this subsection.
(e)
Pharmaceutical Care Services.
(1)
The following minimum level of pharmaceutical care services
shall be provided whenever a therapeutic prescription drug order is dispensed
and, when in the professional judgement of the pharmacist dispensing a diagnostic
prescription drug order, the services are necessary to protect the patient's
health while striving to produce positive patient outcomes. When it is determined
that the following services are necessary, the dispensing pharmacist shall
assure that efforts are made to gather the information necessary to properly
perform the services.
(A)
Drug utilization review. A systematic ongoing process of
drug utilization review shall be designed, followed, and documented to increase
the probability of desired patient outcomes and decrease the probability of
undesired outcomes from drug therapy with radiopharmaceuticals.
(B)
Drug regimen review.
(i)
For the purpose of promoting therapeutic appropriateness,
an authorized nuclear pharmacist shall, prior to or at the time of dispensing,
evaluate therapeutic prescription drug orders and patient medication history
for:
(I)
known allergies;
(II)
rational therapy contraindications;
(III)
reasonable dose and route of administration;
(IV)
reasonable directions for use;
(V)
duplication of therapy;
(VI)
drug-drug interactions;
(VII)
drug-food interactions;
(VIII)
drug-disease interactions;
(IX)
adverse drug reactions;
(X)
proper utilization, including overutilization or underutilization;
and
(XI)
clinical laboratory or clinical monitoring methods to
monitor and evaluate drug effectiveness, side effects, toxicity, or adverse
effects, and appropriateness to continued use of the drug in its current regimen.
(ii)
Upon identifying any clinically significant conditions,
situations, or items listed in clause (i) of this subparagraph, the authorized
nuclear pharmacist shall take appropriate steps to avoid or resolve the problem
including consultation with the prescribing practitioner.
(iii)
The drug regimen review may be conducted by remotely
accessing the pharmacy's electronic data base from outside the pharmacy by
an individual Texas licensed pharmacist employee of the pharmacy, provided
the pharmacy establishes controls to protect the privacy of the patient and
the security of confidential records.
(2)
Other pharmaceutical care services which may be provided
by authorized nuclear pharmacists include, but are not limited to, the following:
(A)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practice Act;
(B)
managing patient compliance programs;
(C)
providing preventative health care services; and
(D)
providing case management of patients who are being treated
with high-risk or high-cost drugs, or who are considered "high risk" due to
their age, medical condition, family history, or related concern.
(f)
Equipment. The following minimum equipment is required
in a nuclear pharmacy:
(1)
vertical laminar flow hood;
(2)
dose calibrator;
(3)
refrigerator and a system or device (i.e., thermometer)
to monitor the temperature and humidity to ensure that proper storage requirements
are met, if sterile pharmaceuticals are stored in the refrigerator;
(4)
Class A prescription balance, and accurate weights or balance
of greater sensitivity if compounding occurs in the pharmacy which requires
weighing;
(5)
scintillation analyzer;
(6)
microscope and hemocytometer;
(7)
equipment and utensils necessary for the proper compounding
of prescription drug or medication orders. Such equipment and utensils used
in the compounding process shall be:
(A)
of appropriate design, appropriate capacity, and be operated
within designed operational limits;
(B)
of suitable composition so that surfaces that contact components,
in-process material, or drug products shall not be reactive, additive, or
absorptive so as to alter the safety, identity, strength, quality, or purity
of the drug product beyond acceptable standards;
(C)
cleaned and sanitized immediately prior to each use; and
(D)
routinely inspected, calibrated (if necessary), or checked
to ensure proper performance;
(8)
appropriate disposal containers for used needles, syringes,
etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic
agents, and/or biohazardous waste;
(9)
all necessary supplies, including:
(A)
disposable needles, syringes, and other aseptic mixing;
(B)
disinfectant cleaning solutions;
(C)
hand washing agents with bactericidal action;
(D)
disposable, lint free towels or wipes;
(E)
appropriate filters and filtration equipment;
(F)
cytotoxic spill kits, if applicable; and
(G)
masks, caps, coveralls or gowns with tight cuffs, shoe
covers, and gloves, as applicable.
(10)
adequate glassware, utensils, gloves, syringe shields
and remote handling devices, and adequate equipment for product quality control;
(11)
adequate shielding material;
(12)
typewriter or comparable equipment;
(13)
radiation dosimeters for visitors and personnel and log
entry book;
(14)
exhaust/fume hood with monitor, for storage and handling
of all volatile radioactive drugs if applicable, to be determined by the Texas
Radiation Control Bureau;
(15)
calculator; and
(16)
adequate radiation monitor(s).
(g)
Library. A nuclear pharmacy shall maintain a reference
library which shall include the following in hard copy or electronic format:
(1)
United States Pharmacopoeia/National Formulary with supplements;
(2)
federal and state laws and regulations relating to Texas
pharmacy;
(3)
Texas Regulations for Control of Radiation;
(4)
reference on the safe handling of radioactive materials;
(5)
a minimum of three texts dealing with nuclear medicine
science;
(6)
reference on sterile product preparation; and
(7)
Code of Federal Regulations, Title 49, Parts 106-199, with
recent amendments.
(h)
Radiopharmaceuticals and/or radioactive materials.
(1)
General requirements.
(A)
Radiopharmaceuticals may only be dispensed pursuant to
a radioactive prescription drug order.
(B)
An authorized nuclear pharmacist may distribute radiopharmaceuticals
to authorized users for patient use. A nuclear pharmacy may also furnish radiopharmaceuticals
for departmental or physicians' use if such authorized users maintain a Texas
radioactive materials license, and the radiopharmaceutical is labeled "for
physician use," provided such distribution is documented in the control system.
(C)
An authorized nuclear pharmacist may transfer to authorized
users radioactive materials not intended for drug use in accordance with Part
41 of the Texas Regulations for Control of Radiation, Texas Department of
Health.
(D)
The transportation of radioactive materials from the nuclear
pharmacy must be in accordance with current state and federal transportation
regulations.
(2)
Procurement and storage.
(A)
The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from other
appropriate staff relative to such responsibility.
(B)
Prescription drugs and devices shall be stored within the
prescription department or a locked storage area.
(C)
All drugs shall be stored at the proper temperature, as
defined by the following terms.
(i)
Cold--Any temperature not exceeding 8 degrees Centigrade
(46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature
is maintained thermostatically between 2 and 8 degrees Centigrade (36 and
46 degrees Fahrenheit). A freezer is a cold place in which the temperature
is maintained thermostatically between -20 and -10 degrees Centigrade (-4
and -14 degrees Fahrenheit).
(ii)
Cool--Any temperature between 8 and 15 degrees Centigrade
(46 and 59 degrees Fahrenheit). An article for which storage in a cool place
is directed may, alternatively, be stored in a refrigerator unless otherwise
specified in the labeling.
(iii)
Room temperature--The temperature prevailing in a working
area. Controlled room temperature is a temperature thermostatically between
15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit).
(iv)
Warm--Any temperature between 30 and 40 degrees Centigrade
(86 and 104 degrees Fahrenheit).
(v)
Excessive heat--Temperature above 40 degrees Centigrade
(104 degrees Fahrenheit).
(vi)
Protection from freezing where, in addition to the risk
of breakage of the container, freezing subjects a product to loss of strength
or potency, or to destructive alteration of the dosage form, the container
label bears an appropriate instruction to protect the product from freezing.
(3)
Out-of-date and other unusable drugs or devices.
(A)
Any drug or device bearing an expiration date shall not
be dispensed beyond the expiration date of the drug or device.
(B)
Outdated and other unusable drugs or devices shall be removed
from dispensing stock and shall be quarantined together until such drugs or
devices are disposed of properly.
(i)
Loading bulk drugs into automated compounding devices.
(1)
Automated compounding device may be loaded with bulk drugs
only by an authorized nuclear pharmacist or by supportive personnel under
the direction and direct supervision of an authorized pharmacist.
(2)
The label of an automated compounding device container
shall indicate the brand name and strength of the drug; or if no brand name,
then the generic name, strength, and name of the manufacturer or distributor.
(3)
Records of loading bulk drugs into an automated compounding
device shall be maintained to show:
(A)
name of the drug, strength, and dosage form;
(B)
manufacturer or distributor;
(C)
manufacturer's lot number;
(D)
expiration date;
(E)
quantity added to the automated compounding device;
(F)
date of loading;
(G)
name, initials, or electronic signature of the person loading
the automated compounding device; and
(H)
name, initials, or electronic signature of the responsible
authorized nuclear pharmacist.
(4)
The automated compounding device shall not be used until
an authorized nuclear pharmacist verifies that the system is properly loaded
and affixes his or her signature or electronic signature to the record specified
in paragraph (3) of this subsection.
(j)
Sterile radiopharmaceuticals.
(1)
Expiration date.
(A)
The expiration date assigned shall be based on:
(i)
established manufacturer's guidelines;
(ii)
published literature; or
(iii)
in-house or contracted stability studies.
(B)
The method for establishing expiration dates shall be documented.
(2)
Radioactive Drug Quality control. There shall be a documented,
ongoing quality control program that monitors and evaluates personnel performance,
equipment and facilities. Procedures shall be in place to assure that the
pharmacy is capable of consistently preparing radiopharmaceuticals which are
sterile and stable. Quality control procedures shall include, but are not
limited to, the following:
(A)
recall procedures;
(B)
storage and dating;
(C)
documentation of appropriate functioning of refrigerator,
freezer, and other equipment;
(D)
documentation of aseptic environmental control device(s)
certification at least every year and the regular replacement of pre-filters
as necessary;
(E)
a process to evaluate and confirm the quality of the prepared
radiopharmaceutical; and
(F)
documentation of facility maintenance such as cleaning
and environmental testing.
§291.55.Records.
(a)
Maintenance of records.
(1)
Every inventory or other record required to be kept under
this section shall be kept by the pharmacy and be available, for at least
two years from the date of such inventory or record, for inspecting and copying
by the board or its representative, and other authorized local, state, or
federal law enforcement agencies.
(2)
Records of controlled substances listed in Schedules I
and II shall be maintained separately from all other records of the pharmacy.
(3)
Records of controlled substances, other than original prescription
drug orders, listed in Schedules III-V shall be maintained separately or readily
retrievable from all other records of the pharmacy. For purposes of this subsection,
"readily retrievable" means that the controlled substances shall be asterisked,
red-lined, or in some other manner readily identifiable apart from all other
items appearing on the record.
(4)
Records, except when specifically required to be maintained
in original or hard-copy form, may be maintained in an alternative data retention
system, such as a data processing system or direct imaging system provided:
(A)
the records maintained in the alternative system contain
all of the information required on the manual record; and
(B)
the data processing system is capable of producing a hard
copy of the record upon the request of the board, its representative, or other
authorized local, state, or federal law enforcement or regulatory agencies.
(b)
Prescriptions.
(1)
Professional responsibility. Pharmacists shall exercise
sound professional judgment with respect to the accuracy and authenticity
of any radioactive prescription drug order they dispense. If the pharmacist
questions the accuracy or authenticity of a radioactive prescription drug
order, he/she shall verify the order with the practitioner prior to dispensing.
(2)
Verbal radioactive prescription drug orders.
(A)
Only an authorized nuclear pharmacist or a pharmacist-intern
under the direct supervision of an authorized nuclear pharmacist may receive
from a practitioner or a practitioner's designated agent:
(i)
a verbal therapeutic prescription drug order; or
(ii)
a verbal diagnostic prescription drug order in instances
where patient specificity is required for patient safety (e.g., radiolabeled
blood products, radiolabeled antibodies).
(B)
A practitioner shall designate in writing the name of each
agent authorized by the practitioner to communicate prescriptions verbally
for the practitioner. The practitioner shall maintain at the practitioner's
usual place of business a list of the designated agents. The practitioner
shall provide a pharmacist with a copy of the practitioner's written authorization
for a specific agent on the pharmacist's request.
(C)
A pharmacist may not dispense a verbal radioactive prescription
drug order for a Schedule III, IV, or V controlled substance issued by a practitioner
licensed in another state unless the practitioner is also registered under
the Texas Controlled Substances Act.
(D)
A pharmacist may not dispense a verbal radioactive prescription
drug order for a dangerous drug or a controlled substance issued by a practitioner
licensed in the Dominion of Canada or the United Mexican States unless the
practitioner is also licensed in Texas.
(3)
Written radioactive prescription drug orders.
(A)
Practitioner's signature. Written radioactive prescription
drug orders shall be manually signed by the practitioner (electronically produced
or rubber stamped signatures may not be used).
(i)
A practitioner may sign a radioactive prescription drug
order in the same manner as he would sign a check or legal document, e.g.,
J.H. Smith or John H. Smith.
(ii)
The radioactive prescription drug order may not be signed
by a practitioner's agent but may be prepared by an agent for the signature
of a practitioner. However, the prescribing practitioner is responsible in
case the radioactive prescription drug order does not conform in all essential
respects to the law and regulations.
(B)
Radioactive prescription drug orders written by practitioners
in another state.
(i)
Dangerous drug prescription orders. A pharmacist may dispense
a radioactive prescription drug order for dangerous drugs issued by practitioners
in a state other than Texas in the same manner as radioactive prescription
drug orders for dangerous drugs issued by practitioners in Texas are dispensed.
(ii)
Controlled substance prescription drug orders. A pharmacist
may dispense radioactive prescription drug orders for controlled substances
in Schedule III, IV, or V issued by a practitioner in another state provided:
(I)
the radioactive prescription drug order is an original
written prescription issued by a person practicing in another state and licensed
by another state as a physician, dentist, veterinarian, or podiatrist, who
has a current federal Drug Enforcement Administration registration number,
and who may legally prescribe Schedule III, IV, or V controlled substances
in such other state;
(II)
the radioactive prescription drug order is not dispensed
or refilled more than six months from the initial date of issuance and may
not be refilled more than five times; and
(III)
if there are no refill instructions on the original written
radioactive prescription drug order (which shall be interpreted as no refills
authorized) or if all refills authorized on the original written radioactive
prescription drug order have been dispensed, a new written radioactive prescription
drug order is obtained from the prescribing practitioner prior to dispensing
any additional quantities of controlled substances.
(C)
Radioactive prescription drug orders written by practitioners
in the United Mexican States or the Dominion of Canada.
(i)
Controlled substance prescription drug orders. A pharmacist
may not dispense a radioactive prescription drug order for a Schedule II,
III, IV, or V controlled substance issued by a practitioner licensed in the
Dominion of Canada or the United Mexican States.
(ii)
Dangerous drug prescription drug orders. A pharmacist
may dispense a radioactive prescription drug order for a dangerous drug issued
by a person licensed in the Dominion of Canada or the United Mexican States
as a physician, dentist, veterinarian, or podiatrist provided:
(I)
the radioactive prescription drug order is an original
written prescription; and
(II)
if there are no refill instructions on the original written
radioactive prescription drug order (which shall be interpreted as no refills
authorized) or if all refills authorized on the original written radioactive
prescription drug order have been dispensed, a new written radioactive prescription
drug order shall be obtained from the prescribing practitioner prior to dispensing
any additional quantities of dangerous drugs.
(iii)
Prescription drug orders for Schedule II controlled substances.
No Schedule II controlled substance may be dispensed without a written prescription
drug order of a practitioner on a official prescription form as required by
the Texas Controlled Substances Act, §481.075.
(4)
Electronic radioactive prescription drug orders. For the
purpose of this paragraph, electronic radioactive prescription drug orders
shall be considered the same as verbal radioactive prescription drug orders.
(A)
An electronic radioactive prescription drug order may be
transmitted by a practitioner or a practitioner's designated agent:
(i)
directly to a pharmacy; or
(ii)
through the use of a data communication device provided:
(I)
the confidential prescription information is not altered
during transmission; and
(II)
confidential patient information is not accessed or maintained
by the operator of the data communication device other than for legal purposes
under federal and state law.
(B)
A practitioner shall designate in writing the name of each
agent authorized by the practitioner to electronically transmit prescriptions
for the practitioner. The practitioner shall maintain at the practitioner's
usual place of business a list of the designated agents. The practitioner
shall provide a pharmacist with a copy of the practitioner's written authorization
for a specific agent on the pharmacist's request.
(C)
A pharmacist may not dispense an electronic radioactive
prescription drug order for a:
(i)
Schedule II controlled substance except as authorized for
faxed prescriptions in §481.074, Health and Safety Code;
(ii)
Schedule III, IV, or V controlled substance issued by
a practitioner licensed in another state unless the practitioner is also registered
under the Texas Controlled Substances Act; or
(iii)
dangerous drug or controlled substance issued by a practitioner
licensed in the Dominion of Canada or the United Mexican States unless the
practitioner is also licensed in Texas.
(5)
Original prescription drug order records.
(A)
Original prescriptions shall be maintained by the pharmacy
in numerical order and remain legible for a period of two years from the date
of filling or the date of the last refill dispensed.
(B)
If an original prescription drug order is changed, such
prescription order shall be invalid and of no further force and effect; if
additional drugs are to be dispensed, a new prescription drug order with a
new and separate number is required.
(C)
Original prescriptions shall be maintained in one of the
following formats:
(i)
in three separate files as follows:
(I)
prescriptions for controlled substances listed in Schedule
II;
(II)
prescriptions for controlled substances listed in Schedule
III-V; and
(III)
prescriptions for dangerous drugs and nonprescription
drugs; or
(ii)
within a patient medication record system provided that
original prescriptions for controlled substances are maintained separate from
original prescriptions for noncontrolled substances and triplicate prescriptions
for Schedule II controlled substances are maintained separate from all other
original prescriptions.
(D)
Original prescription records other than triplicate prescriptions
may be stored on microfilm, microfiche, or other system which is capable of
producing a direct image of the original prescription record, e.g., digitalized
imaging system. If original prescription records are stored in a direct imaging
system, the following is applicable.
(i)
The record of refills recorded on the original prescription
must also be stored in this system.
(ii)
The original prescription records must be maintained in
numerical order and as specified in subparagraph (C) of this paragraph.
(iii)
The pharmacy must provide immediate access to equipment
necessary to render the records easily readable.
(6)
Prescription drug order information.
(A)
All original radioactive prescription drug orders shall
bear:
(i)
name of the patient, if applicable at the time of the order;
(ii)
name of the institution;
(iii)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner
(iv)
name of the radiopharmaceutical;
(v)
amount of radioactive material contained in millicuries
(mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that
applies to this activity, if different than the requested calibration date
and time;
(vi)
date and time of calibration;
(vii)
if a liquid, the volume in milliliters;
(viii)
date of issuance; and
(ix)
if telephoned to the pharmacy by a designated agent, the
full name of the designated agent.
(B)
All original electronic radioactive prescription drug orders
shall bear:
(i)
name of the patient, if applicable at the time of the order;
(ii)
name of the institution;
(iii)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner;
(iv)
name of the radiopharmaceutical;
(v)
amount of radioactive material contained in millicuries
(mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that
applies to this activity, if different than the requested calibration date
and time;
(vi)
date and time of calibration;
(vii)
if a liquid, the volume in milliliters;
(viii)
a statement which indicates that the prescription has
been electronically transmitted (e.g., Faxed to or electronically transmitted
to:);
(ix)
name, address, and electronic access number of the pharmacy
to which the prescription was transmitted;
(x)
telephone number of the prescribing practitioner;
(xi)
date the prescription drug order was electronically transmitted
to the pharmacy, if different from the date of issuance of the prescription;
(xii)
date of issuance; and
(xiii)
if telephoned to the pharmacy by a designated agent,
the full name of the designated agent.
(C)
At the time of dispensing, a pharmacist is responsible
for the addition of the following information to the original prescription:
(i)
unique identification number of the prescription drug order;
(ii)
initials or identification code of the person who compounded
the sterile radiopharmaceutical and the pharmacist who checked and released
the product;
(iii)
name, quantity, lot number, and expiration date of each
product used in compounding the sterile radiopharmaceutical; and
(iv)
date of dispensing, if different from the date of issuance.
(7)
Refills. A radioactive prescription drug order must be
filled from an original prescription which may not be refilled.
(c)
Policy and procedure manual.
(1)
All nuclear pharmacies shall maintain a policy and procedure
manual. The nuclear pharmacy policy and procedure manual is a compilation
of written policy and procedure statements.
(2)
A technical operations manual governing all nuclear pharmacy
functions shall be prepared. It shall be continually revised to reflect changes
in techniques, organizations, etc. All pharmacy personnel shall be familiar
with the contents of the manual.
(3)
The nuclear pharmacy policies and procedures manual shall
be prepared by the pharmacist-in-charge with input from the affected personnel
and from other involved staff and committees to govern procurement, preparation,
distribution, storage, disposal, and control of all drugs used and the need
for policies and procedures relative to procurement of multisource items,
inventory, investigational drugs, and new drug applications.
(d)
Other records. Other records to be maintained by a pharmacy:
(1)
a permanent log of the initials or identification codes
which will identify each dispensing pharmacist by name (the initials or identification
code shall be unique to ensure that each pharmacist can be identified, i.e.,
identical initials or identification codes shall not be used);
(2)
copy 3 of DEA order form (DEA 222) which has been properly
dated, initialed, and filed, and all copies of each unaccepted or defective
order form and any attached statements or other documents;
(3)
a hard copy of the power of attorney to sign DEA 222 order
forms (if applicable);
(4)
suppliers' invoices of dangerous drugs and controlled substances;
a pharmacist shall verify that the controlled drugs listed on the invoices
were actually received by clearly recording his/her initials and the actual
date of receipt of the controlled substances;
(5)
suppliers' credit memos for controlled substances and dangerous
drugs;
(6)
a hard copy of inventories required by §291.17 of
this title (relating to Inventory Requirements);
(7)
hard-copy reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal agency;
(8)
records of distribution of controlled substances and/or
dangerous drugs to other pharmacies, practitioners, or registrants; and
(9)
a hard copy of any notification required by the Texas Pharmacy
Act or these sections, including, but not limited to, the following:
(A)
reports of theft or significant loss of controlled substances
to DEA, DPS, and the board;
(B)
notifications of a change in pharmacist-in-charge of a
pharmacy; and
(C)
reports of a fire or other disaster which may affect the
strength, purity, or labeling of drugs, medications, devices, or other materials
used in the diagnosis or treatment of injury, illness, and disease.
(e)
Permission to maintain central records. Any pharmacy that
uses a centralized recordkeeping system for invoices and financial data shall
comply with the following procedures.
(1)
Controlled substance records. Invoices and financial data
for controlled substances may be maintained at a central location provided
the following conditions are met.
(A)
Prior to the initiation of central recordkeeping, the pharmacy
submits written notification by registered or certified mail to the divisional
director of the Drug Enforcement Administration as required by the Code of
Federal Regulations, Title 21, §1304.04(a), and submits a copy of this
written notification to the Texas State Board of Pharmacy. Unless the registrant
is informed by the divisional director of the Drug Enforcement Administration
that permission to keep central records is denied, the pharmacy may maintain
central records commencing 14 days after receipt of notification by the divisional
director.
(B)
The pharmacy maintains a copy of the notification required
in subparagraph (A) of this paragraph.
(C)
The records to be maintained at the central record location
shall not include executed DEA order forms, prescription drug orders, or controlled
substance inventories, which shall be maintained at the pharmacy.
(2)
Dangerous drug records. Invoices and financial data for
dangerous drugs may be maintained at a central location.
(3)
Access to records. If the records are kept on microfilm,
computer media, or in any form requiring special equipment to render the records
easily readable, the pharmacy shall provide access to such equipment with
the records.
(4)
Delivery of records. The pharmacy agrees to deliver all
or any part of such records to the pharmacy location within two business days
of written request of a board agent or any other authorized official.
(5)
Ownership of pharmacy records. For purposes of these sections,
a pharmacy licensed under the Act is the only entity which may legally own
and maintain prescription drug records.
(f)
Confidentiality.
(1)
A pharmacist shall provide adequate security of radioactive
prescription drug order and patient medication records to prevent indiscriminate
or unauthorized access to confidential health information. If radioactive
prescription drug orders, requests for refill authorization, or other confidential
health information are not transmitted directly between a pharmacy and a physician
but are transmitted through a data communication device, confidential health
information may not be accessed or maintained by the operator of the data
communication device unless specifically authorized to obtain the confidential
information by this subsection.
(2)
Confidential records are privileged and may be released
only to:
(A)
the patient or the patient's agent;
(B)
practitioners and other pharmacists when, in the pharmacist's
professional judgment, such release is necessary to protect the patient's
health and well-being;
(C)
other persons, the board, or other state or federal agencies
authorized by law to receive such information;
(D)
a law enforcement agency engaged in investigation of suspected
violations of the Controlled Substances Act or the Dangerous Drug Act;
(E)
a person employed by any state agency which licenses a
practitioner as defined in the Act if such person is engaged in the performance
of the person's official duties; or
(F)
an insurance carrier or other third party payor authorized
by a patient to receive such information.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office of
the Secretary of State on May 17, 2004.
TRD-200403303
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: June 6, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 305-8028
22 TAC §§291.72 - 291.76
The Texas State Board of Pharmacy (TSBP) adopts amendments
to §291.72, concerning Definitions and §291.73 concerning Personnel,
without changes to the proposed text published in the March 26, 2004, issue
of the
Texas Register
(29 TexReg 3080). The
Board adopts §291.74, concerning Operational Standards; §291.75,
concerning Records in a Class C (Institutional) Pharmacy; and §291.76,
concerning Class C Pharmacies Located in a Freestanding Ambulatory Surgical
Center with changes to the proposed text based on staff recommendations to
correct citations.
The adopted amendments to §§291.72 - 291.74 and §291.76
amend the current provisions relating to compounding of sterile pharmaceuticals
to match new section §291.26 which outlines new provisions for the compounding
of sterile pharmaceuticals. New §291.26 outlines operating standards
for pharmacies that compound sterile pharmaceuticals, implements the recommendations
of the TSBP appointed Task Force on Compounding (Task Force), and incorporates
many of the provisions included in the United States Pharmacopeia (USP) new
General Chapter 797 (Pharmaceutical Compounding Sterile Preparations). The
amendments to §291.75 and §291.76(e), specify that only a pharmacist
may verify the receipt of controlled substances by a pharmacy.
No comments were received regarding amendments.
The amendments are adopted under §§551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568
- 569, Texas Occupations Code). The Board interprets §551.002 as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
§291.74.Operational Standards.
(a)
Licensing requirements.
(1)
A Class C pharmacy shall register annually or biennially
with the board on a pharmacy license application provided by the board, following
the procedures specified in §291.1 of this title (relating to Pharmacy
License Application).
(2)
If the institutional pharmacy is owned or operated by a
hospital management or consulting firm, the following conditions apply.
(A)
The pharmacy license application shall list the hospital
management or consulting firm as the owner or operator.
(B)
The hospital management or consulting firm shall obtain
DEA and DPS controlled substance registrations that are issued in their name,
unless the following occurs:
(i)
the hospital management or consulting firm and the facility
cosign a contractual pharmacy service agreement which assigns overall responsibility
for controlled substances to the facility; and
(ii)
such hospital pharmacy management or consulting firm maintains
dual responsibility for the controlled substances.
(3)
A Class C pharmacy which changes ownership shall notify
the board within 10 days of the change of ownership and apply for a new and
separate license as specified in §291.4 of this title (relating to Change
of Ownership).
(4)
A Class C pharmacy which changes location and/or name shall
notify the board within 10 days of the change and file for an amended license
as specified in §291.2 if this title (relating to Change of Location
and/or Name).
(5)
A Class C pharmacy owned by a partnership or corporation
which changes managing officers shall notify the board in writing of the names
of the new managing officers within 10 days of the change following the procedures
in §291.3 of this title (relating to Change of Managing Officers).
(6)
A Class C pharmacy shall notify the board in writing within
10 days of closing, following the procedures in §291.5 of this title
(relating to Closed Pharmacies).
(7)
A fee as specified in §291.6 of this title (relating
to Pharmacy License Fees) will be charged for the issuance and renewal of
a license and the issuance of an amended license.
(8)
A separate license is required for each principal place
of business and only one pharmacy license may be issued to a specific location.
(9)
A Class C pharmacy, licensed under the Act, §560.051(a)(3),
which also operates another type of pharmacy which would otherwise be required
to be licensed under the Act, §560.051(a)(1) (Community Pharmacy (Class
A)) or the Act, §560.051(a)(2) (Nuclear Pharmacy (Class B)), is not required
to secure a license for the such other type of pharmacy; provided, however,
such licensee is required to comply with the provisions of §291.31 of
this title (relating to Definitions), §291.32 of this title (relating
to Personnel), §291.33 of this title (relating to Operational Standards), §291.34
of this title (relating to Records), and §291.35 of this title (relating
to Official Prescription Records), contained in Community Pharmacy (Class
A), or §291.51 of this title (relating to Purpose), §291.52 of this
title (relating to Definitions), §291.53 of this title (relating to Personnel), §291.54
of this title (relating to Operational Standards), and §291.55 of this
title (relating to Records), contained in Nuclear Pharmacy (Class B), to the
extent such sections are applicable to the operation of the pharmacy.
(10)
A Class C (Institutional) pharmacy engaged in non-sterile
compounding of drug products for inpatients of the hospital shall comply with
the provisions of §291.25 of this title (relating to Pharmacies Compounding
Non-Sterile Pharmaceuticals);
(11)
A Class C (Institutional) pharmacy engaged in the compounding
of sterile pharmaceuticals shall comply with the provisions of §291.26
of this title (relating to Pharmacies Compounding Sterile Pharmaceuticals).
(12)
A Class C (Institutional) pharmacy engaged in the provision
of remote pharmacy services, including storage and dispensing of prescription
drugs, shall comply with the provisions of §291.20 of this title (relating
to Remote Pharmacy Services).
(13)
A Class C (Institutional) pharmacy engaged in centralized
prescription dispensing and/or prescription drug or medication order processing
shall comply with the provisions of §291.37 of this title (relating to
Centralized Prescription Dispensing) and/or §291.38 of this title (relating
to Centralized Prescription Drug or Medication Order Processing).
(b)
Environment.
(1)
General requirements.
(A)
The institutional pharmacy shall be enclosed and lockable.
(B)
The institutional pharmacy shall have adequate space necessary
for the storage, compounding, labeling, dispensing, and sterile preparation
of drugs prepared in the pharmacy, and additional space, depending on the
size and scope of pharmaceutical services.
(C)
The institutional pharmacy shall be arranged in an orderly
fashion and shall be kept clean. All required equipment shall be clean and
in good operating condition.
(D)
A sink with hot and cold running water exclusive of restroom
facilities shall be available to all pharmacy personnel and shall be maintained
in a sanitary condition at all times.
(E)
The institutional pharmacy shall be properly lighted and
ventilated.
(F)
The temperature of the institutional pharmacy shall be
maintained within a range compatible with the proper storage of drugs. The
temperature of the refrigerator shall be maintained within a range compatible
with the proper storage of drugs requiring refrigeration.
(G)
If the institutional pharmacy has flammable materials,
the pharmacy shall have a designated area for the storage of flammable materials.
Such area shall meet the requirements set by local and state fire laws.
(H)
The institutional pharmacy shall store antiseptics, other
drugs for external use, and disinfectants separately from internal and injectable
medications.
(2)
Security requirements.
(A)
All areas occupied by an institutional pharmacy shall be
capable of being locked by key or combination, so as to prevent access by
unauthorized personnel by force.
(B)
Each pharmacist on duty shall be responsible for the security
of the institutional pharmacy, including provisions for adequate safeguards
against theft or diversion of dangerous drugs, controlled substances, and
records for such drugs.
(C)
The institutional pharmacy shall have locked storage for
Schedule II controlled substances and other drugs requiring additional security.
(c)
Equipment and supplies. Institutional pharmacies distributing
medication orders shall have the following equipment:
(1)
typewriter or comparable equipment; and
(2)
refrigerator and a system or device (e.g., thermometer)
to monitor the temperature and humidity to ensure that proper storage requirements
are met.
(d)
Library. A reference library shall be maintained which
includes the following in hard- copy or electronic format:
(1)
current copies of the following:
(A)
Texas Pharmacy Act and rules;
(B)
Texas Dangerous Drug Act and rules;
(C)
Texas Controlled Substances Act and regulations; and
(D)
Federal Controlled Substances Act and regulations (or official
publication describing the requirements of the Federal Controlled Substances
Act and regulations);
(2)
at least one current or updated reference from each of
the following categories:
(A)
drug interactions. A reference text on drug interactions,
such as Drug Interaction Facts. A separate reference is not required if other
references maintained by the pharmacy contain drug interaction information
including information needed to determine severity or significance of the
interaction and appropriate recommendations or actions to be taken;
(B)
a general information reference text, such as:
(i)
Facts and Comparisons with current supplements;
(ii)
United States Pharmacopeia Dispensing Information Volume
I (Drug Information for the Healthcare Provider);
(iii)
AHFS Drug Information with current supplements;
(iv)
Remington's Pharmaceutical Sciences; or
(v)
Clinical Pharmacology;
(3)
a current or updated reference on injectable drug products,
such as Handbook of Injectable Drugs;
(4)
basic antidote information and the telephone number of
the nearest regional poison control center;
(5)
metric-apothecary weight and measure conversion charts.
(e)
Absence of a pharmacist.
(1)
Medication orders.
(A)
In facilities with a full-time pharmacist, if a practitioner
orders a drug for administration to a bona fide patient of the facility when
the pharmacy is closed, the following is applicable.
(i)
Prescription drugs and devices only in sufficient quantities
for immediate therapeutic needs may be removed from the institutional pharmacy.
(ii)
Only a designated licensed nurse or practitioner may remove
such drugs and devices.
(iii)
A record shall be made at the time of withdrawal by the
authorized person removing the drugs and devices. The record shall contain
the following information:
(I)
name of patient;
(II)
name of device or drug, strength, and dosage form;
(III)
dose prescribed;
(IV)
quantity taken;
(V)
time and date; and
(VI)
signature (first initial and last name or full signature)
or electronic signature of person making withdrawal.
(iv)
The original or direct copy of the medication order may
substitute for such record, providing the medication order meets all the requirements
of clause (iii) of this subparagraph.
(v)
The pharmacist shall verify the withdrawal and perform
a drug regimen review as specified in subsection (g)(1)(B) of this section
as soon as practical, but in no event more than 72 hours from the time of
such withdrawal.
(B)
In facilities with a part-time or consultant pharmacist,
if a practitioner orders a drug for administration to a bona fide patient
of the facility when the pharmacist is not on duty, or when the pharmacy is
closed, the following is applicable.
(i)
Prescription drugs and devices only in sufficient quantities
for therapeutic needs may be removed from the institutional pharmacy.
(ii)
Only a designated licensed nurse or practitioner may remove
such drugs and devices.
(iii)
A record shall be made at the time of withdrawal by the
authorized person removing the drugs and devices; the record shall meet the
same requirements as specified in subparagraph (A)(iii) and (iv) of this paragraph.
(iv)
The pharmacist shall verify the withdrawal and perform
a drug regimen review as specified in subsection (g)(1)(B) of this section
after a reasonable interval, but in no event may such interval exceed seven
days.
(2)
Floor stock. In facilities using a floor stock method of
drug distribution, the following is applicable.
(A)
Prescription drugs and devices may be removed from the
pharmacy only in the original manufacturer's container or prepackaged container.
(B)
Only a designated licensed nurse or practitioner may remove
such drugs and devices.
(C)
A record shall be made at the time of withdrawal by the
authorized person removing the drug or device; the record shall contain the
following information:
(i)
name of the drug, strength, and dosage form;
(ii)
quantity removed;
(iii)
location of floor stock;
(iv)
date and time; and
(v)
signature (first initial and last name or full signature)
or electronic signature of person making the withdrawal.
(D)
The pharmacist shall verify the withdrawal after a reasonable
interval, but in no event may such interval exceed seven days.
(f)
Drugs.
(1)
Procurement, preparation and storage.
(A)
The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from other
appropriate staff of the facility, relative to such responsibility.
(B)
The pharmacist-in-charge shall have the responsibility
for determining specifications of all drugs procured by the facility.
(C)
Institutional pharmacies may not sell, purchase, trade
or possess prescription drug samples, unless the pharmacy meets all of the
following conditions:
(i)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986, or by a city, state or county government;
(ii)
the pharmacy is a part of a health care entity which provides
health care primarily to indigent or low income patients at no or reduced
cost;
(iii)
the samples are for dispensing or provision at no charge
to patients of such health care entity; and
(iv)
the samples are possessed in compliance with the federal
Prescription Drug Marketing Act of 1986.
(D)
All drugs shall be stored at the proper temperatures, as
defined by the following.
(i)
Cold--Any temperature not exceeding 8 degrees Centigrade
(46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature
is maintained thermostatically between 2 and 8 degrees Centigrade (36 and
46 degrees Fahrenheit). A freezer is a cold place in which the temperature
is maintained thermostatically between -20 and -10 degrees Centigrade (-4
and -14 degrees Fahrenheit).
(ii)
Cool--Any temperature between 8 and 15 degrees Centigrade
(46 and 59 degrees Fahrenheit). An article for which storage in a cool place
is directed may, alternatively, be stored in a refrigerator unless otherwise
specified in the labeling.
(iii)
Room temperature--The temperature prevailing in a working
area. Controlled room temperature is a temperature thermostatically between
15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit).
(iv)
Warm--Any temperature between 30 and 40 degrees Centigrade
(86 and 104 degrees Fahrenheit).
(v)
Excessive heat--Any temperature above 40 degrees Centigrade
(104 degrees Fahrenheit).
(vi)
Protection from freezing where, in addition to the risk
of breakage of the container, freezing subjects a product to loss of strength
or potency, or to destructive alteration of the dosage form, the container
label bears an appropriate instruction to protect the product from freezing.
(E)
Any drug bearing an expiration date may not be distributed
beyond the expiration date of the drug.
(F)
Outdated and other unusable drugs shall be removed from
stock and shall be quarantined together until such drugs are disposed of properly.
(2)
Formulary.
(A)
A formulary shall be developed by the facility committee
performing the pharmacy and therapeutics function for the facility.
(B)
The pharmacist-in-charge or pharmacist designated by the
pharmacist-in-charge shall be a full voting member of the committee performing
the pharmacy and therapeutics function for the facility, when such committee
is performing the pharmacy and therapeutics function.
(3)
Pre-packaging of drugs.
(A)
Drugs may be pre-packaged in quantities suitable for internal
distribution only by a pharmacist or by supportive personnel under the direction
and direct supervision of a pharmacist.
(B)
The label of a pre-packaged unit shall indicate:
(i)
brand name and strength of the drug; or if no brand name,
then the generic name, strength, and name of the manufacturer or distributor;
(ii)
facility's unique lot number;
(iii)
expiration date based on currently available literature;
and
(iv)
quantity of the drug, if the quantity is greater than
one.
(C)
Records of pre-packaging shall be maintained to show:
(i)
name of the drug, strength, and dosage form;
(ii)
facility's unique lot number;
(iii)
manufacturer or distributor;
(iv)
manufacturer's lot number;
(v)
expiration date;
(vi)
quantity per prepackaged unit;
(vii)
number of prepackaged units;
(viii)
date packaged;
(ix)
name, initials, or electronic signature of the prepacker;
and
(x)
name, initials, or electronic signature of the responsible
pharmacist.
(D)
Stock packages, repackaged units, and control records shall
be quarantined together until checked/released by the pharmacist.
(4)
Sterile pharmaceuticals prepared in a location other than
the pharmacy. A distinctive supplementary label shall be affixed to the container
of any admixture. The label shall bear at a minimum:
(A)
patient's name and location;
(B)
name and amount of drug(s) added;
(C)
name of the basic solution;
(D)
name or identifying code of person who prepared admixture;
and
(E)
expiration date of solution.
(5)
Distribution.
(A)
Medication orders.
(i)
Drugs may be given to patients in facilities only on the
order of a practitioner. No change in the order for drugs may be made without
the approval of a practitioner.
(ii)
Drugs may be distributed only from the original or a direct
copy of the practitioner's medication order.
(iii)
Supportive personnel may not receive verbal medication
orders.
(iv)
Institutional pharmacies shall be exempt from the labeling
provisions and patient notification requirements of §562.006 and §562.009
of the Act, as respects drugs distributed pursuant to medication orders.
(B)
Procedures.
(i)
Written policies and procedures for a drug distribution
system (best suited for the particular institutional pharmacy) shall be developed
and implemented by the pharmacist-in-charge, with the advice of the committee
performing the pharmacy and therapeutics function for the facility.
(ii)
The written policies and procedures for the drug distribution
system shall include, but not be limited to, procedures regarding the following:
(I)
pharmaceutical care services;
(II)
handling, storage and disposal of cytotoxic drugs and
waste;
(III)
disposal of unusable drugs and supplies;
(IV)
security;
(V)
equipment;
(VI)
sanitation;
(VII)
reference materials;
(VIII)
drug selection and procurement;
(IX)
drug storage;
(X)
controlled substances;
(XI)
investigational drugs, including the obtaining of protocols
from the principal investigator;
(XII)
prepackaging and manufacturing;
(XIII)
stop orders;
(XIV)
reporting of medication errors, adverse drug reactions/events,
and drug product defects;
(XV)
physician orders;
(XVI)
floor stocks;
(XVII)
drugs brought into the facility;
(XVIII)
furlough medications;
(XIX)
self-administration;
(XX)
emergency drug supply;
(XXI)
formulary;
(XXII)
monthly inspections of nursing stations and other areas
where drugs are stored, distributed, administered or dispensed;
(XXIII)
control of drug samples;
(XXIV)
outdated and other unusable drugs;
(XXV)
routine distribution of inpatient medication;
(XXVI)
preparation and distribution of sterile pharmaceuticals;
(XXVII)
handling of medication orders when a pharmacist is
not on duty;
(XXVIII)
use of automated compounding or counting devices;
(XXIX)
use of data processing and direct imaging systems;
(XXX)
drug administration to include infusion devices, drug
delivery systems, and first dose monitoring;
(XXXI)
drug labeling;
(XXXII)
recordkeeping;
(XXXIII)
quality assurance/quality control;
(XXXIV)
duties and education and training of professional and
nonprofessional staff; and
(XXXV)
emergency preparedness plan, to include continuity of
patient therapy and public safety.
(g)
Pharmaceutical care services.
(1)
The pharmacist-in-charge shall assure that at least the
following pharmaceutical care services are provided to patients of the facility.
(A)
Drug utilization review. A systematic ongoing process of
drug utilization review shall be developed in conjunction with the medical
staff to increase the probability of desired patient outcomes and decrease
the probability of undesired outcomes from drug therapy.
(B)
Drug regimen review.
(i)
For the purpose of promoting therapeutic appropriateness,
a pharmacist shall evaluate medication orders and patient medication records
for:
(I)
known allergies;
(II)
rational therapy--contraindications;
(III)
reasonable dose and route of administration;
(IV)
reasonable directions for use;
(V)
duplication of therapy;
(VI)
drug-drug interactions;
(VII)
drug-food interactions;
(VIII)
drug-disease interactions;
(IX)
adverse drug reactions;
(X)
proper utilization, including overutilization or underutilization;
and
(XI)
clinical laboratory or clinical monitoring methods to
monitor and evaluate drug effectiveness, side effects, toxicity, or adverse
effects, and appropriateness to continued use of the drug in its current regimen.
(ii)
The drug regimen review shall be conducted on a prospective
basis when a pharmacist is on duty, except for an emergency order, and on
a retrospective basis as specified in subsection (e)(1) of this section when
a pharmacist is not on duty.
(iii)
Any questions regarding the order must be resolved with
the prescriber and a written notation of these discussions made and maintained.
(iv)
The drug regimen review may be conducted by remotely accessing
the pharmacy's electronic data base from outside the pharmacy by an individual
Texas licensed pharmacist employee of the pharmacy, provided the pharmacy
establishes controls to protect the privacy of the patient and the security
of confidential records.
(C)
Education. The pharmacist-in-charge in cooperation with
appropriate multi-disciplinary staff of the facility shall develop policies
that assure that:
(i)
the patient and/or patient's caregiver receives information
regarding drugs and their safe and appropriate use; and
(ii)
health care providers are provided with patient specific
drug information.
(D)
Patient monitoring. The pharmacist-in-charge in cooperation
with appropriate multi- disciplinary staff of the facility shall develop policies
to ensure that the patient's response to drug therapy is monitored and conveyed
to the appropriate health care provider.
(2)
Other pharmaceutical care services which may be provided
by pharmacists in the facility include, but are not limited to, the following:
(A)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practice Act;
(B)
administering immunizations and vaccinations under written
protocol of a physician;
(C)
managing patient compliance programs;
(D)
providing preventative health care services; and
(E)
providing case management of patients who are being treated
with high-risk or high- cost drugs, or who are considered "high risk" due
to their age, medical condition, family history, or related concern.
(h)
Emergency rooms.
(1)
During the times a pharmacist is on duty in the facility
any prescription drugs supplied to an outpatient, including emergency department
patients, may only be dispensed by a pharmacist.
(2)
When a pharmacist is not on duty in the facility, the following
is applicable for supplying prescription drugs from the emergency room.
(A)
If the patient has been admitted to the emergency room
and assessed by a practitioner at the hospital, the following procedures shall
be observed in supplying prescription drugs from the emergency room.
(i)
Dangerous drugs and/or controlled substances may only be
supplied in accordance with the system of control and accountability for dangerous
drugs and/or controlled substances administered or supplied from the emergency
room; such system shall be developed and supervised by the pharmacist-in-charge
or staff pharmacist designated by the pharmacist- in-charge.
(ii)
Only dangerous drugs and/or controlled substances listed
on the emergency room drug list may be supplied; such list shall be developed
by the pharmacist-in-charge and the facility's emergency department committee
(or like group or person responsible for policy in that department) and shall
consist of dangerous drugs and/or controlled substances of the nature and
type to meet the immediate needs of emergency room patients.
(iii)
Dangerous drugs and/or controlled substances may only
be supplied in prepackaged quantities not to exceed a 72-hour supply in suitable
containers and appropriately prelabeled (including necessary auxiliary labels)
by the institutional pharmacy.
(iv)
At the time of delivery of the dangerous drugs and/or
controlled substances, the practitioner or licensed nurse under the supervision
of a practitioner shall appropriately complete the label with at least the
following information:
(I)
name, address, and phone number of the facility;
(II)
date supplied;
(III)
name of practitioner;
(IV)
name of patient;
(V)
directions for use;
(VI)
brand name and strength of the dangerous drug or controlled
substance; or if no brand name, then the generic name, strength, and the name
of the manufacturer or distributor of the dangerous drug or controlled substance;
(VII)
quantity supplied; and
(VIII)
unique identification number.
(v)
The practitioner, or a licensed nurse under the supervision
of the practitioner, shall give the appropriately labeled, prepackaged drug
to the patient and explain the correct use of the drug.
(vi)
A perpetual record of dangerous drugs and/or controlled
substances supplied from the emergency room shall be maintained in the emergency
room. Such record shall include the following:
(I)
date supplied;
(II)
practitioner's name;
(III)
patient's name;
(IV)
brand name and strength of the dangerous drug or controlled
substance; or if no brand name, then the generic name, strength, and the name
of the manufacturer or distributor of the dangerous drug or controlled substance;
(V)
quantity supplied; and
(VI)
unique identification number.
(vii)
The pharmacist-in-charge, or staff pharmacist designated
by the pharmacist-in-charge, shall verify the correctness of this record at
least once every seven days.
(B)
If the patient has been admitted to the emergency room
of a hospital and a practitioner telephones an order for a dangerous drug
to be supplied, the following is applicable.
(i)
Dangerous drugs may only be supplied to patients of hospitals
after the normal business hours of local pharmacies and when pharmacy services
are not reasonably available to the patient.
(ii)
The practitioner shall cosign any order for a dangerous
drug which is telephoned to the hospital emergency room within 72 hours.
(iii)
The practitioner shall have a previous patient/physician
relationship with the patient admitted to the emergency room.
(iv)
The dangerous drugs may only be supplied in accordance
with the system of control and accountability for drugs administered or supplied
from the emergency room; such system shall be developed and supervised by
the pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge.
(v)
Only dangerous drugs listed on the emergency room drug
list may be supplied; such list shall be developed by the pharmacist-in-charge
and the facility's emergency department committee (or like group or person
responsible for policy in that department) and shall consist of dangerous
drugs of the nature and type to meet the immediate needs of emergency room
patients.
(vi)
The dangerous drugs may only be supplied in prepackaged
quantities not to exceed a 72-hour supply in suitable containers and appropriately
prelabeled (including necessary auxiliary labels) by the institutional pharmacy.
(vii)
At any time of delivery of the dangerous drugs, a licensed
nurse shall complete the label with at least the following information:
(I)
name, address, and phone number of the facility;
(II)
date supplied;
(III)
name of the practitioner;
(IV)
name of the patient;
(V)
directions for use;
(VI)
brand name and strength of the dangerous drug; or if no
brand name, then the generic name, strength, and the name of the manufacturer
or distributor of the dangerous drug;
(VII)
quantity supplied; and
(VIII)
unique identification number.
(viii)
A licensed nurse shall give the appropriately labeled,
prepackaged dangerous drug to the patient and explain the correct use of the
drug.
(ix)
A perpetual record of dangerous drugs supplied from the
emergency room shall be maintained in the emergency room. Such record shall
include the following:
(I)
date supplied;
(II)
practitioner's name;
(III)
patient's name;
(IV)
brand name and strength of the dangerous drug; or if no
brand name, then the generic name, strength, and the name of the manufacturer
or distributor of the dangerous drug;
(V)
quantity supplied; and
(VI)
unique identification number.
(x)
The pharmacist-in-charge or staff pharmacist designated
by the pharmacist-in-charge shall verify the correctness of this record at
least once every seven days.
(C)
Prior to implementing the procedures for supplying dangerous
drugs to emergency room patients of a hospital on the telephone order of a
practitioner, as specified in subparagraph (B) of this paragraph, the hospital
shall notify the board of its intent to implement this policy. Such notification
shall be signed by the hospital administrator, medical director, and pharmacist-in-charge
and contain the following information:
(i)
the hours the hospital pharmacy is open for pharmacy services;
and
(ii)
documentation of the lack of pharmacy services after normal
business hours of the hospital pharmacy.
(i)
Radiology departments.
(1)
During the times a pharmacist is on duty, any prescription
drugs dispensed to an outpatient, including radiology department patients,
may only be dispensed by a pharmacist.
(2)
When a pharmacist is not on duty, the following procedures
shall be observed in supplying prescription drugs from the radiology department.
(A)
Prescription drugs may only be supplied to patients who
have been scheduled for an x- ray examination at the facility.
(B)
Prescription drugs may only be supplied in accordance with
the system of control and accountability for prescription drugs administered
or supplied from the radiology department and supervised by the pharmacist-in-charge
or staff pharmacist designated by the pharmacist-in-charge.
(C)
Only prescription drugs listed on the radiology drug list
may be supplied; such list shall be developed by the pharmacist-in-charge
and the facility's radiology committee (or like group or persons responsible
for policy in that department) and shall consist of drugs for the preparation
of a patient for a radiological procedure.
(D)
Prescription drugs may only be supplied in prepackaged
quantities in suitable containers and prelabeled by the institutional pharmacy
with the following information:
(i)
name and address of the facility;
(ii)
directions for use;
(iii)
name and strength of the prescription drug--if generic
name, the name of the manufacturer or distributor of the prescription drug;
(iv)
quantity;
(v)
facility's lot number and expiration date; and
(vi)
appropriate ancillary label(s).
(E)
At the time of delivery of the prescription drug, the practitioner
or practitioner's agent shall complete the label with the following information:
(i)
date supplied;
(ii)
name of physician;
(iii)
name of patient; and
(iv)
unique identification number.
(F)
The practitioner or practitioner's agent shall give the
appropriately labeled, prepackaged prescription drug to the patient.
(G)
A perpetual record of prescription drugs supplied from
the radiology department shall be maintained in the radiology department.
Such records shall include the following:
(i)
date supplied;
(ii)
practitioner's name;
(iii)
patient's name;
(iv)
brand name and strength of the prescription drug; or if
no brand name, then the generic name, strength, dosage form, and the name
of the manufacturer or distributor of the prescription drug;
(v)
quantity supplied; and
(vi)
unique identification number.
(H)
The pharmacist-in-charge, or a pharmacist designated by
the pharmacist-in-charge, shall verify the correctness of this record at least
once every seven days.
(j)
Automated devices and systems.
(1)
Automated compounding or counting devices. If a pharmacy
uses automated compounding or counting devices:
(A)
the pharmacy shall have a method to calibrate and verify
the accuracy of the automated compounding or counting device and document
the calibration and verification on a routine basis;
(B)
the devices may be loaded with bulk or unlabeled drugs
only by a pharmacist or by pharmacy technicians under the direction and direct
supervision of a pharmacist;
(C)
the label of an automated compounding or counting device
container shall indicate the brand name and strength of the drug; or if no
brand name, then the generic name, strength, and name of the manufacturer
or distributor;
(D)
records of loading bulk or unlabeled drugs into an automated
compounding or counting device shall be maintained to show:
(i)
name of the drug, strength, and dosage form;
(ii)
manufacturer or distributor;
(iii)
manufacturer's lot number;
(iv)
expiration date;
(v)
date of loading;
(vi)
name, initials, or electronic signature of the person
loading the automated compounding or counting device; and
(vii)
signature or electronic signature of the responsible
pharmacist; and
(E)
the automated compounding or counting device shall not
be used until a pharmacist verifies that the system is properly loaded and
affixes his or her signature to the record specified in subparagraph (D) of
this paragraph.
(2)
Automated medication supply systems.
(A)
Authority to use automated medication supply systems. A
pharmacy may use an automated medication supply system to fill medication
orders provided that:
(i)
the pharmacist-in-charge is responsible for the supervision
of the operation of the system;
(ii)
the automated medication supply system has been tested
by the pharmacy and found to dispense accurately. The pharmacy shall make
the results of such testing available to the Board upon request; and
(iii)
the pharmacy will make the automated medication supply
system available for inspection by the board for the purpose of validating
the accuracy of the system.
(B)
Quality assurance program. A pharmacy which uses an automated
medication supply system to fill medication orders shall operate according
to a written program for quality assurance of the automated medication supply
system which:
(i)
requires continuous monitoring of the automated medication
supply system; and
(ii)
establishes mechanisms and procedures to test the accuracy
of the automated medication supply system at least every six months and whenever
any upgrade or change is made to the system and documents each such activity.
(C)
Policies and procedures of operation.
(i)
When an automated medication supply system is used to store
or distribute medications for administration pursuant to medication orders,
it shall be operated according to written policies and procedures of operation.
The policies and procedures of operation shall establish requirements for
operation of the automated medication supply system and shall describe policies
and procedures that:
(I)
include a description of the policies and procedures of
operation;
(II)
provide for a pharmacist's review and approval of each
original or new medication order filled through the use of the automated medication
supply system:
(-a-)
before the order is filled when a pharmacist is on duty
except for an emergency order;
(-b-)
retrospectively within 72 hours in a facility with a
full-time pharmacist when a pharmacist is not on duty at the time the order
is made; or
(-c-)
retrospectively within 7 days in a facility with a part-time
or consultant pharmacist when a pharmacist is not on duty at the time the
order is made;
(III)
provide for access to the automated medication supply
system for stocking and retrieval of medications which is limited to licensed
healthcare professionals or pharmacy technicians acting under the supervision
of a pharmacist;
(IV)
provide that a pharmacist is responsible for the accuracy
of the restocking of the system. The actual restocking may be performed by
a pharmacy technician;
(V)
provide for an accountability record to be maintained which
documents all transactions relative to stocking and removing medications from
the automated medication supply system;
(VI)
require a prospective or retrospective drug regimen review
is conducted as specified in subsection (g) of this section; and
(VII)
establish and make provisions for documentation of a
preventative maintenance program for the automated medication supply system.
(ii)
A pharmacy which uses an automated medication supply system
to fill medication orders shall, at least annually, review its written policies
and procedures, revise them if necessary, and document the review.
(D)
Recovery Plan. A pharmacy which uses an automated medication
supply system to store or distribute medications for administration pursuant
to medication orders shall maintain a written plan for recovery from a disaster
or any other situation which interrupts the ability of the automated medication
supply system to provide services necessary for the operation of the pharmacy.
The written plan for recovery shall include:
(i)
planning and preparation for maintaining pharmacy services
when an automated medication supply system is experiencing downtime;
(ii)
procedures for response when an automated medication supply
system is experiencing downtime;
(iii)
procedures for the maintenance and testing of the written
plan for recovery; and
(iv)
procedures for notification of the Board and other appropriate
agencies whenever an automated medication supply system experiences downtime
for more than two days of operation or a period of time which significantly
limits the pharmacy's ability to provide pharmacy services.
(3)
Verification of medication orders prepared by the pharmacy
department through the use of an automated medication supply system. A pharmacist
must check drugs prepared pursuant to medication orders to ensure that the
drug is prepared for distribution accurately as prescribed. This paragraph
does not apply to automated medication supply systems used for storage and
recordkeeping of medications located outside of the pharmacy department.
(A)
This check shall be considered accomplished if:
(i)
a check of the final product is conducted by a pharmacist
after the automated system has completed preparation of the medication order
and prior to delivery to the patient; or
(ii)
the following checks are conducted by a pharmacist:
(I)
if the automated medication supply system contains bulk
stock drugs, a pharmacist verifies that those drugs have been accurately stocked;
and
(II)
a pharmacist checks the accuracy of the data entry of
each original or new medication order entered into the automated medication
supply system before the order is filled.
(B)
If the final check is accomplished as specified in subparagraph
(A)(ii) of this paragraph, the following additional requirements must be met.
(i)
The medication order preparation process must be fully
automated from the time the pharmacist releases the medication order to the
automated system until a completed medication order, ready for delivery to
the patient, is produced.
(ii)
The pharmacy has conducted initial testing and has a continuous
quality assurance program which documents that the automated medication supply
system dispenses accurately as specified in paragraph (2)(A) and (B) of this
subsection.
(iii)
The automated medication supply system documents and
maintains:
(I)
the name(s), initials, or identification code(s) of each
pharmacist responsible for the checks outlined in subparagraph (A)(ii) of
this paragraph; and
(II)
the name(s), initials, or identification code(s) and specific
activity(ies) of each pharmacist or pharmacy technician who performs any other
portion of the medication order preparation process.
(iv)
The pharmacy establishes mechanisms and procedures to
test the accuracy of the automated medication supply system at least every
month rather than every six months as specified in paragraph (2)(B) of this
subsection.
(4)
Automated checking device.
(A)
For the purpose of this subsection, an automated checking
device is a fully automated device which confirms, after a drug is prepared
for distribution but prior to delivery to the patient, that the correct drug
and strength has been labeled with the correct label for the correct patient.
(B)
The final check of a drug prepared pursuant to a medication
order shall be considered accomplished using an automated checking device
provided:
(i)
a check of the final product is conducted by a pharmacist
prior to delivery to the patient or the following checks are performed by
a pharmacist:
(I)
the prepackaged drug used to fill the order is checked
by a pharmacist who verifies that the drug is labeled and packaged accurately;
and
(II)
a pharmacist checks the accuracy of each original or new
medication order.
(ii)
the medication order is prepared, labeled, and made ready
for delivery to the patient in compliance with Class C (Institutional) Pharmacy
rules; and
(iii)
prior to delivery to the patient:
(I)
the automated checking device confirms that the correct
drug and strength has been labeled with the correct label for the correct
patient; and
(II)
a pharmacist performs all other duties required to ensure
that the medication order has been prepared safely and accurately as prescribed.
(C)
If the final check is accomplished as specified in subparagraph
(B) of this paragraph, the following additional requirements must be met.
(i)
The pharmacy has conducted initial testing of the automated
checking device and has a continuous quality assurance program which documents
that the automated checking device accurately confirms that the correct drug
and strength has been labeled with the correct label for the correct patient.
(ii)
The pharmacy documents and maintains:
(I)
the name(s), initials, or identification code(s) of each
pharmacist responsible for the checks outlined in subparagraph (B)(I) of this
paragraph; and
(II)
the name(s), initials, or identification code(s) and specific
activity(ies) of each pharmacist or pharmacy technician who performs any other
portion of the medication order preparation process.
(iii)
The pharmacy establishes mechanisms and procedures to
test the accuracy of the automated checking device at least monthly.
§291.75.Records.
(a)
Maintenance of records.
(1)
Every inventory or other record required to be kept under
the provisions of §291.71 of this title (relating to Purpose), §291.72
of this title (relating to Definitions), §291.73 of this title (relating
to Personnel), §291.74 of this title (relating to Operational Standards),
and this section contained in Institutional Pharmacy (Class C) shall be kept
by the institutional pharmacy and be available, for at least two years from
the date of such inventory or record, for inspecting and copying by the board
or its representative and to other authorized local, state, or federal law
enforcement agencies.
(2)
Records of controlled substances listed in Schedule I and
II shall be maintained separately from all other records of the pharmacy.
(3)
Records of controlled substances listed in Schedules III-V
shall be maintained separately or readily retrievable from all other records
of the pharmacy. For purposes of this subsection, readily retrievable means
that the controlled substances shall be asterisked, redlined, or in some other
manner readily identifiable apart from all other items appearing on the record.
(4)
Records, except when specifically required to be maintained
in original or hard-copy form, may be maintained in an alternative data retention
system, such as a data processing or direct imaging system, e.g., microfilm
or microfiche, provided:
(A)
the records in the alternative data retention system contain
all of the information required on the manual record; and
(B)
the alternative data retention system is capable of producing
a hard copy of the record upon the request of the board, its representative,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
(b)
Outpatient records.
(1)
Outpatient records shall be maintained as provided in §291.34
of this title (relating to Records), and §291.35 of this title (relating
to Official Prescription Records), contained in Community Pharmacy (Class
A).
(2)
Outpatient prescriptions, including, but not limited to,
furlough and discharge prescriptions, that are written by the practitioner
must be written on a form which meets the requirements of the Act, §562.006.
Medication order forms or copies thereof do not meet the requirements for
outpatient forms.
(3)
Controlled substances listed in Schedule II must be written
on an official prescription form in accordance with the Texas Controlled Substances
Act, §481.075, and rules promulgated pursuant to the Texas Controlled
Substances Act, unless exempted by the Texas controlled substances regulations, §13.74
(Texas Administrative Code, Title 37, Chapter 13), entitled "Exceptions to
Use of Forms." Outpatient prescriptions for Schedule II controlled substances
that are exempted from the official prescription requirement must be manually
signed by the practitioner.
(c)
Inpatient records.
(1)
Original medication orders.
(A)
Each original medication order shall bear the following
information:
(i)
patient name and room number or identification number;
(ii)
drug name, strength, and dosage form;
(iii)
directions for use;
(iv)
date; and
(v)
signature or electronic signature of the practitioner or
that of his or her authorized agent.
(B)
Original medication order shall be maintained with the
medication administration records of the patients.
(2)
Patient medication records (PMR). A patient medication
record shall be maintained for each inpatient of the facility. The PMR shall
contain at a minimum the following information.
(A)
Patient information:
(i)
patient name and room number or identification number;
(ii)
gender, and date of birth or age;
(iii)
weight and height;
(iv)
known drug sensitivities and allergies to drugs and/or
food;
(v)
primary diagnoses and chronic conditions;
(vi)
primary physician; and
(vii)
other drugs the patient is receiving.
(B)
Medication order information:
(i)
date of distribution;
(ii)
drug name, strength, and dosage form; and
(iii)
directions for use.
(3)
Controlled substances records. Controlled substances records
shall be maintained as follows.
(A)
All records for controlled substances shall be maintained
in a readily retrievable manner.
(B)
Controlled substances records shall be maintained in a
manner to establish receipt and distribution of all controlled substances.
(4)
Schedule II controlled substances records. Records of controlled
substances listed in Schedule II shall be maintained as follows.
(A)
Records of controlled substances listed in Schedule II
shall be maintained separately from records of controlled substances in Schedules
III, IV, and V, and all other records.
(B)
An institutional pharmacy shall maintain a perpetual inventory
of any controlled substance listed in Schedule II.
(C)
Distribution records for controlled substances listed in
Schedule II shall bear the following information:
(i)
patient's name;
(ii)
prescribing or attending practitioner;
(iii)
name of drug, dosage form, and strength;
(iv)
time and date of administration to patient and quantity
administered;
(v)
signature (first initial and last name or full signature)
or electronic signature of the individual administering the controlled substance;
(vi)
returns to the pharmacy; and
(vii)
waste (waste is required to be witnessed and cosigned,
electronically or manually, by another individual).
(5)
Floor stock records.
(A)
Distribution records for Schedule II-V controlled substances
floor stock shall include the following information:
(i)
patient's name;
(ii)
prescribing or attending practitioner;
(iii)
name of controlled substance, dosage form, and strength;
(iv)
time and date of administration to patient;
(v)
quantity administered;
(vi)
signature (first initial and last name or full signature)
or electronic signature of the individual administering drug;
(vii)
returns to the pharmacy; and
(viii)
waste (waste is required to be witnessed and cosigned,
manually or electronically, by another individual).
(B)
The record required by subparagraph (A) of this paragraph
shall be maintained separately from patient records.
(C)
A pharmacist shall review distribution records with medication
orders on a periodic basis to verify proper usage of drugs, not to exceed
30 days between such reviews.
(6)
General requirements for records maintained in a data processing
system.
(A)
Noncompliance with data processing requirements. If a hospital
pharmacy's data processing system is not in compliance with the Board's requirements,
the pharmacy must maintain a manual recordkeeping system.
(B)
Requirements for back-up systems. The facility shall maintain
a back-up copy of information stored in the data processing system using disk,
tape, or other electronic back- up system and update this back-up copy on
a regular basis, at least monthly, to assure that data is not lost due to
system failure.
(C)
Change or discontinuance of a data processing system.
(i)
Records of distribution and return for all controlled substances,
nalbuphine (e.g., Nubain), tripelennamine (e.g., PBZ) and carisoprodol (e.g.,
Soma). A pharmacy that changes or discontinues use of a data processing system
must:
(I)
transfer the records to the new data processing system;
or
(II)
purge the records to a printout which contains the same
information as required on the audit trail printout as specified in paragraph
(7)(B) of this subsection. The information on this printout shall be sorted
and printed by drug name and list all distributions/returns chronologically.
(ii)
Other records. A pharmacy that changes or discontinues
use of a data processing system must:
(I)
transfer the records to the new data processing system;
or
(II)
purge the records to a printout which contains all of
the information required on the original document.
(iii)
Maintenance of purged records. Information purged from
a data processing system must be maintained by the pharmacy for two years
from the date of initial entry into the data processing system.
(D)
Loss of data. The pharmacist-in-charge shall report to
the board in writing any significant loss of information from the data processing
system within 10 days of discovery of the loss.
(7)
Data processing system maintenance of records for the distribution
and return of all controlled substances, nalbuphine (e.g., Nubain), tripelennamine
(e.g., PBZ), and carisoprodol (e.g., Soma) to the pharmacy.
(A)
Each time a controlled substance, nalbuphine (e.g., Nubain),
tripelennamine (e.g., PBZ), or carisoprodol (e.g., Soma) is distributed from
or returned to the pharmacy, a record of such distribution or return shall
be entered into the data processing system.
(B)
The data processing system shall have the capacity to produce
a hard copy printout of an audit trail of drug distribution and return for
any strength and dosage form of a drug (by either brand or generic name or
both) during a specified time period. This printout shall contain the following
information:
(i)
patient's name and room number or patient's facility identification
number;
(ii)
prescribing or attending practitioner's name;
(iii)
name, strength, and dosage form of the drug product actually
distributed;
(iv)
total quantity distributed from and returned to the pharmacy;
(v)
if not immediately retrievable via CRT display, the following
shall also be included on the printout:
(I)
prescribing or attending practitioner's address; and
(II)
practitioner's DEA registration number, if the medication
order is for a controlled substance.
(C)
An audit trail printout for each strength and dosage form
of these drugs distributed during the preceding month shall be produced at
least monthly and shall be maintained in a separate file at the facility.
The information on this printout shall be sorted by drug name and list all
distributions/returns for that drug chronologically.
(D)
The pharmacy may elect not to produce the monthly audit
trail printout if the data processing system has a workable (electronic) data
retention system which can produce an audit trail of drug distribution and
returns for the preceding two years. The audit trail required in this paragraph
shall be supplied by the pharmacy within 72 hours, if requested by an authorized
agent of the Texas State Board of Pharmacy, or other authorized local, state,
or federal law enforcement or regulatory agencies.
(8)
Failure to maintain records. Failure to provide records
set out in this subsection, either on site or within 72 hours for whatever
reason, constitutes prima facie evidence of failure to keep and maintain records.
(9)
Data processing system downtime. In the event that a hospital
pharmacy which uses a data processing system experiences system downtime,
the pharmacy must have an auxiliary procedure which will ensure that all data
is retained for on-line data entry as soon as the system is available for
use again.
(d)
Distribution of controlled substances to another registrant.
A pharmacy may distribute controlled substances to a practitioner, another
pharmacy or other registrant, without being registered to distribute, under
the following conditions.
(1)
The registrant to whom the controlled substance is to be
distributed is registered under the Controlled Substances Act to dispense
that controlled substance.
(2)
The total number of dosage units of controlled substances
distributed by a pharmacy may not exceed 5.0% of all controlled substances
dispensed or distributed by the pharmacy during the 12-month period in which
the pharmacy is registered; if at any time it does exceed 5.0%, the pharmacy
is required to obtain an additional registration to distribute controlled
substances.
(3)
If the distribution is for a Schedule III, IV, or V controlled
substance, a record shall be maintained which indicates:
(A)
the actual date of distribution;
(B)
the name, strength, and quantity of controlled substances
distributed;
(C)
the name, address, and DEA registration number of the distributing
pharmacy; and
(D)
the name, address, and DEA registration number of the pharmacy,
practitioner, or other registrant to whom the controlled substances are distributed.
(4)
If the distribution is for a Schedule I or II controlled
substance, the following is applicable.
(A)
The pharmacy, practitioner or other registrant who is receiving
the controlled substances shall issue copy 1 and copy 2 of a DEA order form
(DEA 222) to the distributing pharmacy.
(B)
The distributing pharmacy shall:
(i)
complete the area on the DEA order form (DEA 222) titled
TO BE FILLED IN BY SUPPLIER;
(ii)
maintain copy 1 of the DEA order form (DEA 222) at the
pharmacy for two years; and
(iii)
forward copy 2 of the DEA order form (DEA 222) to the
divisional office of the Drug Enforcement Administration.
(e)
Other records. Other records to be maintained by a pharmacy:
(1)
a permanent log of the initials or identification codes
which will identify pharmacy personnel by name (the initials or identification
code shall be unique to ensure that each person can be identified, i.e., identical
initials or identification codes cannot be used);
(2)
copy 3 of DEA order form (DEA 222) which has been properly
dated, initialed, and filed, and all copies of each unaccepted or defective
order form and any attached statements or other documents;
(3)
a hard copy of the power of attorney to sign DEA 222 order
forms (if applicable);
(4)
suppliers' invoices of dangerous drugs and controlled substances;
a pharmacist shall verify that the controlled drugs listed on the invoices
were actually received by clearly recording his/her initials and the actual
date of receipt of the controlled substances;
(5)
suppliers' credit memos for controlled substances and dangerous
drugs;
(6)
a hard copy of inventories required by §291.17 of
this title (relating to Inventory Requirements) except that a perpetual inventory
of controlled substances listed in Schedule II may be kept in a data processing
system if the data processing system is capable of producing a hard copy of
the perpetual inventory on-site;
(7)
hard copy reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal agency;
(8)
a hard copy Schedule V nonprescription register book;
(9)
records of distribution of controlled substances and/or
dangerous drugs to other pharmacies, practitioners, or registrants; and
(10)
a hard copy of any notification required by the Texas
Pharmacy Act or these sections including, but not limited to, the following:
(A)
reports of theft or significant loss of controlled substances
to DEA, DPS, and the board;
(B)
notifications of a change in pharmacist-in-charge of a
pharmacy; and
(C)
reports of a fire or other disaster which may affect the
strength, purity, or labeling of drugs, medication, devices, or other materials
used in diagnosis or treatment of injury, illness, and disease.
(f)
Permission to maintain central records. Any pharmacy that
uses a centralized recordkeeping system for invoices and financial data shall
comply with the following procedures.
(1)
Controlled substance records. Invoices and financial data
for controlled substances may be maintained at a central location provided
the following conditions are met.
(A)
Prior to the initiation of central recordkeeping, the pharmacy
submits written notification by registered or certified mail to the divisional
director of the Drug Enforcement Administration as required by Title 21, Code
of Federal Regulations, §1304.04(a), and submits a copy of this written
notification to the Texas State Board of Pharmacy. Unless the registrant is
informed by the divisional director of the Drug Enforcement Administration
that permission to keep central records is denied, the pharmacy may maintain
central records commencing 14 days after receipt of notification by the divisional
director.
(B)
The pharmacy maintains a copy of the notification required
in subparagraph (A) of this paragraph.
(C)
The records to be maintained at the central record location
shall not include executed DEA order forms, prescription drug orders, or controlled
substance inventories, which shall be maintained at the pharmacy.
(2)
Dangerous drug records. Invoices and financial data for
dangerous drugs may be maintained at a central location.
(3)
Access to records. If the records are kept on microfilm,
computer media, or in any form requiring special equipment to render the records
easily readable, the pharmacy shall provide access to such equipment with
the records.
(4)
Delivery of records. The pharmacy agrees to deliver all
or any part of such records to the pharmacy location within two business days
of written request of a board agent or any other authorized official.
(g)
Confidentiality.
(1)
A pharmacist shall provide adequate security of prescription
drug orders, medication orders, and patient medication records to prevent
indiscriminate or unauthorized access to confidential health information.
(2)
Confidential records are privileged and may be released
only to:
(A)
the patient or the patient's agent;
(B)
a practitioner or another pharmacist if, in the pharmacist's
professional judgement, the release is necessary to protect the patient's
health and well being;
(C)
the board or to a person or another state or federal agency
authorized by law to receive the confidential record;
(D)
a law enforcement agency engaged in investigation of a
suspected violation of Chapter 481 or 483, Health and Safety Code, or the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section
801 et seq.);
(E)
a person employed by a state agency that licenses a practitioner,
if the person is performing the person's official duties; or
(F)
an insurance carrier or other third party payor authorized
by a patient to receive such information.
§291.76.Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center.
(a)
Purpose. The purpose of this section is to provide standards
in the conduct, practice activities, and operation of a pharmacy located in
a freestanding ambulatory surgical center that is licensed by the Texas Department
of Health. Class C pharmacies located in a freestanding ambulatory surgical
center shall comply with this section, in lieu of §§291.71 - 291.75
of this title (relating to Purpose; Definitions; Personnel; Operational Standards;
and Records).
(b)
Definitions. The following words and terms, when used in
these sections, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568
- 569, Occupations Code, as amended.
(2)
Ambulatory surgical center (ASC)--A freestanding facility
that is licensed by the Texas Department of Health to provide surgical services
to patients who do not require overnight hospital care.
(3)
Automated drug dispensing system--An automated device that
measures, counts, and/or packages a specified quantity of dosage units for
a designated drug product.
(4)
Board--The Texas State Board of Pharmacy.
(5)
Consultant pharmacist--A pharmacist retained by a facility
on a routine basis to consult with the ASC in areas that pertain to the practice
of pharmacy.
(6)
Controlled substance--A drug, immediate precursor, or other
substance listed in Schedules I-V or Penalty Groups 1-4 of the Texas Controlled
Substances Act, as amended, or a drug immediate precursor, or other substance
included in Schedule I-V of the Federal Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended (Public Law 91-513).
(7)
Direct copy--Electronic copy or carbonized copy of a medication
order including a facsimile (FAX), tele-autograph, or a copy transmitted between
computers.
(8)
Dispense--Preparing, packaging, compounding, or labeling
for delivery a prescription drug or device in the course of professional practice
to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.
(9)
Distribute--The delivery of a prescription drug or device
other than by administering or dispensing.
(10)
Downtime--Period of time during which a data processing
system is not operable.
(11)
Electronic signature--A unique security code or other
identifier which specifically identifies the person entering information into
a data processing system. A facility which utilizes electronic signatures
must:
(A)
maintain a permanent list of the unique security codes
assigned to persons authorized to use the data processing system; and
(B)
have an ongoing security program which is capable of identifying
misuse and/or unauthorized use of electronic signatures.
(12)
Floor stock--Prescription drugs or devices not labeled
for a specific patient and maintained at a nursing station or other ASC department
(excluding the pharmacy) for the purpose of administration to a patient of
the ASC.
(13)
Formulary--List of drugs approved for use in the ASC by
an appropriate committee of the ambulatory surgical center.
(14)
Hard copy--A physical document that is readable without
the use of a special device (i.e., cathode ray tube (CRT), microfiche reader,
etc.).
(15)
Investigational new drug--New drug intended for investigational
use by experts qualified to evaluate the safety and effectiveness of the drug
as authorized by the federal Food and Drug Administration.
(16)
Medication order--A written order from a practitioner
or a verbal order from a practitioner or his authorized agent for administration
of a drug or device.
(17)
Pharmacist-in-charge--Pharmacist designated on a pharmacy
license as the pharmacist who has the authority or responsibility for a pharmacy's
compliance with laws and rules pertaining to the practice of pharmacy.
(18)
Pharmacy--Area or areas in a facility, separate from patient
care areas, where drugs are stored, bulk compounded, delivered, compounded,
dispensed, and/or distributed to other areas or departments of the ASC, or
dispensed to an ultimate user or his or her agent.
(19)
Prescription drug
(A)
A substance for which federal or state law requires a prescription
before it may be legally dispensed to the public;
(B)
A drug or device that under federal law is required, prior
to being dispensed or delivered, to be labeled with either of the following
statements:
(i)
Caution: federal law prohibits dispensing without prescription
or "Rx only" or another legend that complies with federal law; or
(ii)
Caution: federal law restricts this drug to use by or
on order of a licensed veterinarian; or
(C)
A drug or device that is required by any applicable federal
or state law or regulation to be dispensed on prescription only or is restricted
to use by a practitioner only.
(20)
Prescription drug order--
(A)
A written order from a practitioner or verbal order from
a practitioner or his authorized agent to a pharmacist for a drug or device
to be dispensed; or
(B)
A written order or a verbal order pursuant to Subtitle
B, Chapter 157, Occupations Code.
(21)
Full-time pharmacist--A pharmacist who works in a pharmacy
from 30 to 40 hours per week or if the pharmacy is open less than 60 hours
per week, one-half of the time the pharmacy is open.
(22)
Part-time pharmacist--A pharmacist who works less than
full-time.
(23)
Pharmacy technician--An individual whose responsibility
in a pharmacy is to provide technical services that do not require professional
judgment regarding preparing and distributing drugs and who works under the
direct supervision of and is responsible to a pharmacist. Pharmacy technician
includes registered pharmacy technicians and pharmacy technician trainees.
(24)
Pharmacy technician trainee--A person who is:
(A)
not registered as a pharmacy technician by the board, and
either:
(B)
participating in a pharmacy's technician training program;
or
(C)
currently enrolled in a:
(i)
pharmacy technician training program accredited by the
American Society of Health- System Pharmacists; or
(ii)
health science technology education program in a Texas
high school that is accredited by the Texas Education Agency.
(25)
Texas Controlled Substances Act--The Texas Controlled
Substances Act, the Health and Safety Code, Chapter 481, as amended.
(c)
Personnel.
(1)
Pharmacist-in-charge.
(A)
General. Each ambulatory surgical center shall have one
pharmacist-in- charge who is employed or under contract, at least on a consulting
or part-time basis, but may be employed on a full-time basis.
(B)
Responsibilities. The pharmacist-in-charge shall have the
responsibility for, at a minimum, the following:
(i)
establishment of specifications for procurement and storage
of all materials, including drugs, chemicals, and biologicals;
(ii)
participation in the development of a formulary for the
ASC, subject to approval of the appropriate committee of the ASC;
(iii)
distribution of drugs to be administered to inpatients
pursuant to an original or direct copy of the practitioner's medication order;
(iv)
filling and labeling all containers from which drugs are
to be distributed or dispensed;
(v)
maintaining and making available a sufficient inventory
of antidotes and other emergency drugs, both in the pharmacy and inpatient
care areas, as well as current antidote information, telephone numbers of
regional poison control center and other emergency assistance organizations,
and such other materials and information as may be deemed necessary by the
appropriate committee of the ASC;
(vi)
records of all transactions of the ASC pharmacy as may
be required by applicable state and federal law, and as may be necessary to
maintain accurate control over and accountability for all pharmaceutical materials;
(vii)
participation in those aspects of the ASC's patient care
evaluation program which relate to pharmaceutical material utilization and
effectiveness;
(viii)
participation in teaching and/or research programs in
the ASC;
(ix)
implementation of the policies and decisions of the appropriate
committee(s) relating to pharmaceutical services of the ASC;
(x)
effective and efficient messenger and delivery service
to connect the ASC pharmacy with appropriate areas of the ASC on a regular
basis throughout the normal workday of the ASC;
(xi)
labeling, storage, and distribution of investigational
new drugs, including maintenance of information in the pharmacy and nursing
station where such drugs are being administered, concerning the dosage form,
route of administration, strength, actions, uses, side effects, adverse effects,
interactions, and symptoms of toxicity of investigational new drugs;
(xii)
meeting all inspection and other requirements of the
Texas Pharmacy Act and this subsection; and
(xiii)
maintenance of records in a data processing system such
that the data processing system is in compliance with the requirements for
a Class C (institutional) pharmacy located in a freestanding ASC.
(2)
Consultant pharmacist.
(A)
The consultant pharmacist may be the pharmacist-in-charge.
(B)
A written contract shall exist between the ASC and any
consultant pharmacist, and a copy of the written contract shall be made available
to the board upon request.
(3)
Pharmacists.
(A)
General.
(i)
The pharmacist-in-charge shall be assisted by a sufficient
number of additional licensed pharmacists as may be required to operate the
ASC pharmacy competently, safely, and adequately to meet the needs of the
patients of the facility.
(ii)
All pharmacists shall assist the pharmacist-in-charge
in meeting the responsibilities as outlined in paragraph (1)(B) of this subsection
and in ordering, administering, and accounting for pharmaceutical materials.
(iii)
All pharmacists shall be responsible for any delegated
act performed by pharmacy technicians under his or her supervision.
(iv)
All pharmacists while on duty shall be responsible for
complying with all state and federal laws or rules governing the practice
of pharmacy.
(B)
Duties. Duties of the pharmacist-in-charge and all other
pharmacists shall include, but need not be limited to, the following:
(i)
receiving and interpreting prescription drug orders and
oral medication orders and reducing these orders to writing either manually
or electronically;
(ii)
selection of prescription drugs and/or devices and/or
suppliers; and
(iii)
interpreting patient profiles.
(C)
Special requirements for compounding.
(i)
Non-Sterile Pharmaceuticals. All pharmacists engaged in
compounding non-sterile pharmaceuticals shall meet the training requirements
specified in §291.25 of this title (relating to Pharmacies Compounding
Non-Sterile Pharmaceuticals).
(ii)
Sterile Pharmaceuticals. All pharmacists engaged in compounding
non-sterile pharmaceuticals shall meet the training requirements specified
in §291.26 of this title (relating to Pharmacies Compounding Sterile
Pharmaceuticals).
(4)
Pharmacy technicians.
(A)
General
(i)
On June 1, 2004, all persons employed as pharmacy technicians
must be either registered pharmacy technicians or pharmacy technician trainees
as follows.
(I)
All persons who have passed the required pharmacy technician
certification examination must be registered with the board under the provisions
this section.
(II)
All persons who have not taken and passed the required
pharmacy certification examination shall be designated pharmacy technician
trainees under the provisions of §297.5 of this title (relating to Pharmacy
Technician Trainees).
(ii)
Between January 1, 2004, and May 31, 2004, all persons
employed as pharmacy technicians who are qualified for registration by the
board shall register according to the schedule designated by the board. Between
January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled
time for registration and persons who have applied for registration, but the
registration has not been completed shall comply with the rules in effect
prior to January 1, 2004, relating to requirements and duties for certified
or exempt pharmacy technicians.
(iii)
All pharmacy technicians shall meet the training requirements
specified in §297.6 of this title (relating to Pharmacy Technician Training).
(B)
Duties. Duties may include, but need not be limited to,
the following functions, under the direct supervision of a pharmacist:
(i)
prepacking and labeling unit and multiple dose packages,
provided a pharmacist supervises and conducts in-process and final checks
and affixes his or her signature or electronic signature to the appropriate
quality control records;
(ii)
preparing, packaging, compounding, or labeling prescription
drugs pursuant to medication orders, provided a pharmacist supervises and
checks the preparation;
(iii)
compounding sterile pharmaceuticals pursuant to medication
orders provided the pharmacy technicians:
(I)
have completed the training specified in §291.26 of
this title (relating to Pharmacies Compounding Sterile Pharmaceuticals); and
(II)
are supervised by a pharmacist who has completed the sterile
products training specified in §291.26 of this title, conducts in-process
and final checks, and affixes his or her initials to the label or if batch
prepared, to the appropriate quality control records. (The initials are not
required on the label if it is maintained in a permanent record of the pharmacy.)
(iv)
bulk compounding, provided a pharmacist supervises and
conducts in-process and final checks and affixes his or her initials to the
appropriate quality control records;
(v)
distributing routine orders for stock supplies to patient
care areas;
(vi)
entering medication order and drug distribution information
into a data processing system, provided judgmental decisions are not required
and a pharmacist checks the accuracy of the information entered into the system
prior to releasing the order or in compliance with the absence of pharmacist
requirements contained in subsection (d)(6)(E) and (F) of this section;
(vii)
maintaining inventories of drug supplies;
(viii)
maintaining pharmacy records; and
(ix)
loading bulk unlabeled drugs into an automated drug dispensing
system provided a pharmacist supervises, verifies that the system was properly
loaded prior to use, and affixes his or her signature or electronic signature
to the appropriate quality control records.
(C)
Procedures.
(i)
Pharmacy technicians shall handle medication orders in
accordance with standard written procedures and guidelines.
(ii)
Pharmacy technicians shall handle prescription drug orders
in the same manner as pharmacy technicians working in a Class A pharmacy.
(D)
Special requirements for compounding.
(i)
Non-Sterile Pharmaceuticals . All pharmacy technicians
engaged in compounding non-sterile pharmaceuticals shall meet the training
requirements specified in §291.25 of this title.
(ii)
Sterile Pharmaceuticals. Pharmacy technicians may compound
sterile pharmaceuticals pursuant to medication orders provided the pharmacy
technicians:
(I)
have completed the training specified in §291.26 of
this title; and
(II)
are supervised by a pharmacist who has completed the training
specified in §291.26 of this title and who conducts in-process and final
checks, and affixes his or her initials to the label or if batch prepared,
to the appropriate quality control records. (The initials are not required
on the label if it is maintained in a permanent record of the pharmacy).
(5)
Identification of pharmacy personnel. All pharmacy personnel
shall wear an identification tag or badge which bears the person's name and
identifies him or her by title or function as follows:
(A)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge which bears the person's name and identifies
him or her as a pharmacy technician trainee a registered pharmacy technician,
or a certified pharmacy technician, if the technician maintains current certification
with the Pharmacy Technician Certification Board or any other entity providing
an examination approved by the Board.
(B)
Pharmacist interns. All pharmacist interns shall wear an
identification tag or badge which bears the person's name and identifies him
or her as a pharmacist intern.
(C)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
(d)
Operational standards.
(1)
Licensing requirements.
(A)
An ASC pharmacy shall register annually with the board
on a pharmacy license application provided by the board, following the procedures
specified in §291.1 of this title (relating to Pharmacy License Application).
(B)
If the ASC pharmacy is owned or operated by a pharmacy
management or consulting firm, the following conditions apply.
(i)
The pharmacy license application shall list the pharmacy
management or consulting firm as the owner or operator.
(ii)
The pharmacy management or consulting firm shall obtain
DEA and DPS controlled substances registrations that are issued in the name
of the firm, unless the following occur:
(I)
the pharmacy management or consulting firm and the facility
cosign a contractual pharmacy service agreement which assigns overall responsibility
for controlled substances to the facility; and
(II)
such pharmacy management or consulting firm maintains
dual responsibility for the controlled substances.
(C)
An ASC pharmacy which changes ownership shall notify the
board within 10 days of the change of ownership and apply for a new and separate
license as specified in §291.4 of this title (relating to Change of Ownership).
(D)
An ASC pharmacy which changes location and/or name shall
notify the board of the change within 10 days and file for an amended license
as specified in §291.2 of this title (relating to Change of Location
and/or Name).
(E)
An ASC pharmacy owned by a partnership or corporation which
changes managing officers shall notify the board in writing of the names of
the new managing officers within 10 days of the change, following the procedures
in §291.3 of this title (relating to Change of Managing Officers).
(F)
An ASC pharmacy shall notify the board in writing within
10 days of closing, following the procedures in §291.5 of this title
(relating to Closed Pharmacies).
(G)
A fee as specified in §291.6 of this title (relating
to Pharmacy License Fees) will be charged for issuance and renewal of a license
and the issuance of an amended license.
(H)
A separate license is required for each principal place
of business and only one pharmacy license may be issued to a specific location.
(I)
An ASC pharmacy, licensed under the Act, §560.051(a)(3),
concerning institutional pharmacy (Class C), which also operates another type
of pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(1),
concerning community pharmacy (Class A), or the Act, §560.051(a)(2),
concerning nuclear pharmacy (Class B), is not required to secure a license
for the other type of pharmacy; provided, however, such license is required
to comply with the provisions of §291.31 of this title (relating to Definitions), §291.32
of this title (relating to Personnel), §291.33 of this title (relating
to Operational Standards), §291.34 of this title (relating to Records),
and §291.35 of this title (relating to Official Prescription Records),
or §291.51 of this title (relating to Purpose), §291.52 of this
title (relating to Definitions), §291.53 of this title (relating to Personnel), §291.54
of this title (relating to Operational Standards), and §291.55 of this
title (relating to Records), contained in Nuclear Pharmacy (Class B), to the
extent such sections are applicable to the operation of the pharmacy.
(J)
An ASC pharmacy engaged in non-sterile compounding of drug
products for inpatients of the hospital shall comply with the provisions of §291.25
of this title (relating to Pharmacies Compounding Non-Sterile Pharmaceuticals).
(K)
An ASC pharmacy engaged in the compounding of sterile pharmaceuticals
shall comply with the provisions of §291.26 of this title (relating to
Pharmacies Compounding Sterile Pharmaceuticals).
(L)
An ASC pharmacy engaged in the provision of remote pharmacy
services, including storage and dispensing of prescription drugs, shall comply
with the provisions of §291.20 of this title (relating to Remote Pharmacy
Services).
(M)
An ASC pharmacy engaged in centralized prescription dispensing
and/or prescription drug or medication order processing shall comply with
the provisions of §291.37 of this title (relating to Centralized Prescription
Dispensing) and/or §291.38 of this title (relating to Centralized Prescription
Drug or Medication Order Processing).
(2)
Environment.
(A)
General requirements.
(i)
Each ambulatory surgical center shall have a designated
work area separate from patient areas, and which shall have space adequate
for the size and scope of pharmaceutical services and shall have adequate
space and security for the storage of drugs.
(ii)
The ASC pharmacy shall be arranged in an orderly fashion
and shall be kept clean. All required equipment shall be clean and in good
operating condition.
(B)
Special requirements.
(i)
The ASC pharmacy shall have locked storage for Schedule
II controlled substances and other controlled drugs requiring additional security.
(ii)
The ASC pharmacy shall have a designated area for the
storage of poisons and externals separate from drug storage areas.
(C)
Security.
(i)
Only authorized personnel may have access to storage areas
for prescription drugs and/or devices.
(ii)
All storage areas for prescription drugs and/or devices
shall be locked by key or combination, so as to prevent access by unauthorized
personnel.
(iii)
The pharmacist-in-charge shall consult with ASC personnel
with respect to security of the drug storage areas, including provisions for
adequate safeguards against theft or diversion of prescription drugs and/or
devices.
(3)
Equipment and supplies. Ambulatory surgical centers supplying
drugs for postoperative use shall have the following equipment and supplies:
(A)
typewriter or comparable equipment; and
(B)
adequate supply of child-resistant, moisture-proof, and
light-proof containers;
(C)
adequate supply of prescription labels and other applicable
identification labels;
(4)
Library. A reference library shall be maintained which
includes the following in hard-copy or electronic format:
(A)
current copies of the following:
(i)
Texas Pharmacy Act and rules;
(ii)
Texas Dangerous Drug Act and rules;
(iii)
Texas Controlled Substances Act and rules;
(iv)
Federal Controlled Substances Act and rules or official
publication describing the requirements of the Federal Controlled Substances
Act and rules;
(B)
at least one current or updated reference from each of
the following categories:
(i)
Drug interactions. A reference text on drug interactions,
such as Drug Interaction Facts. A separate reference is not required if other
references maintained by the pharmacy contain drug interaction information
including information needed to determine severity or significance of the
interaction and appropriate recommendations or actions to be taken;
(ii)
General information. A general information reference text,
such as:
(I)
Facts and Comparisons with current supplements;
(II)
United States Pharmacopeia Dispensing Information Volume
I (Drug Information for the Healthcare Provider);
(III)
AHFS Drug Information with current supplements;
(IV)
Remington's Pharmaceutical Sciences; or
(V)
Clinical Pharmacology;
(C)
a current or updated reference on injectable drug products,
such as Handbook of Injectable Drugs;
(D)
basic antidote information and the telephone number of
the nearest regional poison control center.
(E)
if the pharmacy compounds sterile pharmaceuticals, specialty
references appropriate for the scope of services provided by the pharmacy,
e.g., if the pharmacy prepares cytotoxic drugs, a reference text on the preparation
of cytotoxic drugs, such as Procedures for Handling Cytotoxic Drugs.
(F)
metric-apothecary weight and measure conversion charts.
(5)
Drugs.
(A)
Procurement, preparation, and storage.
(i)
The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from other
appropriate staff of the facility, relative to such responsibility.
(ii)
The pharmacist-in-charge shall have the responsibility
for determining specifications of all drugs procured by the facility.
(iii)
All drugs shall be stored at the proper temperatures,
as defined by the following terms.
(I)
Room temperature--temperature maintained between 15 degrees
Celsius (59 degrees Fahrenheit) and 30 degrees Celsius (86 degrees Fahrenheit).
(II)
Cool--temperature between 8 degrees Celsius (46 degrees
Fahrenheit) and 15 degrees Celsius (59 degrees Fahrenheit) which may, alternatively,
be stored in a refrigerator unless otherwise specified on the labeling.
(III)
Refrigerate--temperature that is thermostatically maintained
between 2 degrees Celsius (36 degrees Fahrenheit) and 8 degrees Celsius (46
degrees Fahrenheit).
(IV)
Freeze--temperature that is thermostatically maintained
between -20 degrees Celsius (-4 degrees Fahrenheit) and -10 degrees Celsius
(14 degrees Fahrenheit).
(iv)
Any drug bearing an expiration date may not be dispensed
or distributed beyond the expiration date of the drug.
(v)
Outdated drugs shall be removed from dispensing stock and
shall be quarantined together until such drugs are disposed of.
(B)
Formulary.
(i)
A formulary may be developed by an appropriate committee
of the ambulatory surgical center.
(ii)
The pharmacist-in-charge or consultant pharmacist shall
be a full voting member of any committee which involves pharmaceutical services.
(C)
Prepackaging of drugs and loading of bulk unlabeled drugs
into automated drug dispensing system.
(i)
Prepackaging of drugs.
(I)
Drugs may be prepackaged in quantities suitable for internal
distribution only by a pharmacist or by pharmacy technicians under the direction
and direct supervision of a pharmacist.
(II)
The label of a prepackaged unit shall indicate:
(-a-)
brand name and strength of the drug; or if no brand name,
then the generic name, strength, and name of the manufacturer or distributor;
(-b-)
facility's lot number;
(-c-)
expiration date; and
(-d-)
quantity of the drug, if quantity is greater than one.
(III)
Records of prepackaging shall be maintained to show:
(-a-)
the name of the drug, strength, and dosage form;
(-b-)
facility's lot number;
(-c-)
manufacturer or distributor;
(-d-)
manufacturer's lot number;
(-e-)
expiration date;
(-f-)
quantity per prepackaged unit;
(-g-)
number of prepackaged units;
(-h-)
date packaged;
(-i-)
name, initials, or electronic signature of the prepacker;
and
(-j-)
signature or electronic signature of the responsible
pharmacist.
(IV)
Stock packages, repackaged units, and control records
shall be quarantined together until checked/released by the pharmacist.
(ii)
Loading bulk unlabeled drugs into automated drug dispensing
systems.
(I)
Automated drug dispensing systems may be loaded with bulk
unlabeled drugs only by a pharmacist or by pharmacy technicians under the
direction and direct supervision of a pharmacist.
(II)
The label of an automated drug dispensing system container
shall indicate the brand name and strength of the drug; or if no brand name,
then the generic name, strength, and name of the manufacturer or distributor.
(III)
Records of loading bulk unlabeled drugs into an automated
drug dispensing system shall be maintained to show:
(-a-)
name of the drug, strength, and dosage form;
(-b-)
manufacturer or distributor;
(-c-)
manufacturer's lot number;
(-d-)
expiration date;
(-e-)
date of loading;
(-f-)
name, initials, or electronic signature of the person
loading the automated drug dispensing system; and
(-g-)
signature or electronic signature of the responsible
pharmacist.
(IV)
The automated drug dispensing system shall not be used
until a pharmacist verifies that the system is properly loaded and affixes
his or her signature or electronic signature to the record specified in subclause
(III) of this clause.
(6)
Medication orders.
(A)
Drugs may be administered to patients in ASCs only on the
order of a practitioner. No change in the order for drugs may be made without
the approval of a practitioner.
(B)
Drugs may be distributed only pursuant to the original
or a direct copy of the practitioner's medication order.
(C)
Pharmacy technicians may not receive oral medication orders.
(D)
ASC pharmacies shall be exempt from the labeling provisions
and patient notification requirements of §562.006 and §562.009 of
the Act, as respects drugs distributed pursuant to medication orders.
(E)
In ASCs with a full-time pharmacist, if a practitioner
orders a drug for administration to a bona fide patient of the facility when
the pharmacy is closed, the following is applicable.
(7)
Floor stock. In facilities using a floor stock method of
drug distribution, the following is applicable for removing drugs or devices
in the absence of a pharmacist.
(A)
Prescription drugs and devices may be removed from the
pharmacy only in the original manufacturer's container or prepackaged container.
(B)
Only a designated licensed nurse or practitioner may remove
such drugs and devices.
(C)
A record shall be made at the time of withdrawal by the
authorized person removing the drug or device; the record shall contain the
following information:
(i)
name of the drug, strength, and dosage form;
(ii)
quantity removed;
(iii)
location of floor stock;
(iv)
date and time; and
(v)
signature or electronic signature of person making the
withdrawal.
(D)
A pharmacist shall verify the withdrawal according to the
following schedule.
(i)
In facilities with a full-time pharmacist, the withdrawal
shall be verified as soon as practical, but in no event more than 72 hours
from the time of such withdrawal.
(ii)
In facilities with a part-time or consultant pharmacist,
the withdrawal shall be verified after a reasonable interval, but in no event
may such interval exceed seven days.
(8)
Policies and procedures. Written policies and procedures
for a drug distribution system, appropriate for the ambulatory surgical center,
shall be developed and implemented by the pharmacist-in-charge with the advice
of the appropriate committee. The written policies and procedures for the
drug distribution system shall include, but not be limited to, procedures
regarding the following:
(A)
controlled substances;
(B)
investigational drugs;
(C)
prepackaging and manufacturing;
(D)
medication errors;
(E)
orders of physician or other practitioner;
(F)
floor stocks;
(G)
adverse drug reactions;
(H)
drugs brought into the facility by the patient;
(I)
self-administration;
(J)
emergency drug tray;
(K)
formulary, if applicable;
(L)
drug storage areas;
(M)
drug samples;
(N)
drug product defect reports;
(O)
drug recalls;
(P)
outdated drugs;
(Q)
preparation and distribution of IV admixtures;
(R)
procedures for supplying drugs for postoperative use, if
applicable;
(S)
use of automated drug dispensing systems; and
(T)
use of data processing systems.
(9)
Drugs supplied for postoperative use. Drugs supplied to
patients for postoperative use shall be supplied according to the following
procedures.
(A)
Drugs may only be supplied to patients who have been admitted
to the ambulatory surgical center.
(B)
Drugs may only be supplied in accordance with the system
of control and accountability established for drugs supplied from the ambulatory
surgical center; such system shall be developed and supervised by the pharmacist-in-charge
or staff pharmacist designated by the pharmacist-in-charge.
(C)
Only drugs listed on the approved postoperative drug list
may be supplied; such list shall be developed by the pharmacist-in-charge
and the medical staff and shall consist of drugs of the nature and type to
meet the immediate postoperative needs of the ambulatory surgical center patient.
(D)
Drugs may only be supplied in prepackaged quantities not
to exceed a 72-hour supply in suitable containers and appropriately prelabeled
(including necessary auxiliary labels) by the pharmacy, provided, however
that topicals and ophthalmics in original manufacturer's containers may be
supplied in a quantity exceeding a 72-hour supply.
(E)
At the time of delivery of the drug, the practitioner shall
complete the label, such that the prescription container bears a label with
at least the following information:
(i)
date supplied;
(ii)
name of practitioner;
(iii)
name of patient;
(iv)
directions for use;
(v)
brand name and strength of the drug; or if no brand name,
then the generic name of the drug dispensed, strength, and the name of the
manufacturer or distributor of the drug; and
(vi)
unique identification number.
(F)
After the drug has been labeled by the practitioner, the
practitioner or a licensed nurse under the supervision of the practitioner
shall give the appropriately labeled, prepackaged medication to the patient.
(G)
A perpetual record of drugs which are supplied from the
ASC shall be maintained which includes:
(i)
name, address, and phone number of the facility;
(ii)
date supplied;
(iii)
name of practitioner;
(iv)
name of patient;
(v)
directions for use;
(vi)
brand name and strength of the drug; or if no brand name,
then the generic name of the drug dispensed, strength, and the name of the
manufacturer or distributor of the drug; and
(vii)
unique identification number.
(H)
The pharmacist-in-charge, or a pharmacist designated by
the pharmacist-in-charge, shall review the records at least once every seven
days.
(e)
Records.
(1)
Maintenance of records.
(A)
Every inventory or other record required to be kept under
the provisions of §291.76 of this title (relating to Institutional Pharmacy
(Class C)) shall be kept by the pharmacy and be available, for at least two
years from the date of such inventory or record, for inspecting and copying
by the board or its representative and to other authorized local, state, or
federal law enforcement agencies.
(B)
Records of controlled substances listed in Schedules I
and II shall be maintained separately from all other records of the pharmacy.
(C)
Records of controlled substances listed in Schedules III
- V shall be maintained separately or readily retrievable from all other records
of the pharmacy. For purposes of this subsection, readily retrievable means
that the controlled substances shall be asterisked, red-lined, or in some
other manner readily identifiable apart from all other items appearing on
the record.
(D)
Records, except when specifically required to be maintained
in original or hard-copy form, may be maintained in an alternative data retention
system, such as a data processing or direct imaging system, e.g., microfilm
or microfiche, provided:
(i)
the records in the alternative data retention system contain
all of the information required on the manual record; and
(ii)
the alternative data retention system is capable of producing
a hard copy of the record upon the request of the board, its representative,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
(2)
Outpatient records.
(A)
Only a registered pharmacist may receive, certify, and
receive prescription drug orders.
(B)
Outpatient records shall be maintained as provided in §291.34
of this title (relating to Records), and §291.35 of this title (relating
to Official Prescription Records) contained in Community Pharmacy (Class A).
(C)
Outpatient prescriptions, including, but not limited to,
discharge prescriptions, that are written by the practitioner, must be written
on a form which meets the requirements of the Act, §562.006. Medication
order forms or copies thereof do not meet the requirements for outpatient
forms.
(D)
Controlled substances listed in Schedule II must be written
on an electronic prescription form in accordance with the Texas Controlled
Substances Act, §481.075, and rules promulgated pursuant to the Texas
Controlled Substances Act, unless exempted by the Texas Controlled Substances
Rules, 37 TAC §13.74, entitled to "Exceptions to Use of Forms." Outpatient
prescriptions for Schedule II controlled substances that are exempted from
the official prescription requirement must be manually signed by the practitioner.
(3)
Inpatient records.
(A)
Each original medication order or set of orders issued
together shall bear the following information:
(i)
patient name;
(ii)
drug name, strength, and dosage form;
(iii)
directions for use;
(iv)
date; and
(v)
signature or electronic signature of the practitioner or
that of his or her authorized agent, defined as a licensed nurse employee
or consultant/full or part-time pharmacist of the ASC.
(B)
Original medication orders shall be maintained with the
medication administration record in the medical records of the patient.
(C)
Controlled substances records shall be maintained as follows.
(i)
All records for controlled substances shall be maintained
in a readily retrievable manner.
(ii)
Controlled substances records shall be maintained in a
manner to establish receipt and distribution of all controlled substances.
(D)
Records of controlled substances listed in Schedule II
shall be maintained as follows.
(i)
Records of controlled substances listed in Schedule II
shall be maintained separately from records of controlled substances in Schedules
III, IV, and V, and all other records.
(ii)
An ASC pharmacy shall maintain a perpetual inventory of
any controlled substance listed in Schedule II.
(iii)
Distribution records for Schedule II-V controlled substances
floor stock shall include the following information:
(I)
patient's name;
(II)
practitioner who ordered drug;
(III)
name of drug, dosage form, and strength;
(IV)
time and date of administration to patient and quantity
administered;
(V)
signature or electronic signature of individual administering
controlled substance;
(VI)
returns to the pharmacy; and
(VII)
waste (waste is required to be witnessed and cosigned,
manually or electronically, by another individual).
(E)
Floor stock records shall be maintained as follows.
(i)
Distribution records for Schedules III - V controlled substances
floor stock shall include the following information:
(I)
patient's name;
(II)
practitioner who ordered controlled substance;
(III)
name of controlled substance, dosage form, and strength;
(IV)
time and date of administration to patient;
(V)
quantity administered;
(VI)
signature or electronic signature of individual administering
drug;
(VII)
returns to the pharmacy; and
(VIII)
waste (waste is required to be witnessed and cosigned,
manually or electronically, by another individual).
(ii)
The record required by clause (i) of this subparagraph
shall be maintained separately from patient records.
(iii)
A pharmacist shall review distribution records with medication
orders on a periodic basis to verify proper usage of drugs, not to exceed
30 days between such reviews.
(F)
General requirements for records maintained in a data processing
system are as follows.
(i)
If an ASC pharmacy's data processing system is not in compliance
with the board's requirements, the pharmacy must maintain a manual recordkeeping
system.
(ii)
Requirements for backup systems. The facility shall maintain
a backup copy of information stored in the data processing system using disk,
tape, or other electronic backup system and update this backup copy on a regular
basis to assure that data is not lost due to system failure.
(iii)
Change or discontinuance of a data processing system.
(I)
Records of distribution and return for all controlled substances,
nalbuphine (Nubain), and tripelennamine (PBZ). A pharmacy that changes or
discontinues use of a data processing system must:
(-a-)
transfer the records to the new data processing system;
or
(-b-)
purge the records to a printout which contains the same
information as required on the audit trail printout as specified in subparagraph
(G)(ii) of this paragraph. The information on this printout shall be sorted
and printed by drug name and list all distributions/returns chronologically.
(II)
Other records. A pharmacy that changes or discontinues
use of a data processing system must:
(-a-)
transfer the records to the new data processing system;
or
(-b-)
purge the records to a printout which contains all of
the information required on the original document.
(III)
Maintenance of purged records. Information purged from
a data processing system must be maintained by the pharmacy for two years
from the date of initial entry into the data processing system.
(iv)
Loss of data. The pharmacist-in-charge shall report to
the board in writing any significant loss of information from the data processing
system within 10 days of discovery of the loss.
(G)
Data processing system maintenance of records for the distribution
and return of all controlled substances, nalbuphine (Nubain), or tripelennamine
(PBZ) to the pharmacy.
(i)
Each time a controlled substance, nalbuphine (Nubain),
or tripelennamine (PBZ) is distributed from or returned to the pharmacy, a
record of such distribution or return shall be entered into the data processing
system.
(ii)
The data processing system shall have the capacity to
produce a hard-copy printout of an audit trail of drug distribution and return
for any strength and dosage form of a drug (by either brand or generic name
or both) during a specified time period. This printout shall contain the following
information:
(I)
patient's name and room number or patient's facility identification
number;
(II)
prescribing or attending practitioner's name;
(III)
name, strength, and dosage form of the drug product actually
distributed;
(IV)
total quantity distributed from and returned to the pharmacy;
(V)
if not immediately retrievable via CRT display, the following
shall also be included on the printout:
(-a-)
prescribing or attending practitioner's address; and
(-b-)
practitioner's DEA registration number, if the medication
order is for a controlled substance.
(iii)
An audit trail printout for each strength and dosage
form of these drugs distributed during the preceding month shall be produced
at least monthly and shall be maintained in a separate file at the facility.
The information on this printout shall be sorted by drug name and list all
distributions/returns for that drug chronologically.
(iv)
The pharmacy may elect not to produce the monthly audit
trail printout if the data processing system has a workable (electronic) data
retention system which can produce an audit trail of drug distribution and
returns for the preceding two years. The audit trail required in this clause
shall be supplied by the pharmacy within 72 hours, if requested by an authorized
agent of the Texas State Board of Pharmacy, or other authorized local, state,
or federal law enforcement or regulatory agencies.
(H)
Failure to maintain records. Failure to provide records
set out in this subsection, either on site or within 72 hours for whatever
reason, constitutes prima facie evidence of failure to keep and maintain records.
(I)
Data processing system downtime. In the event that an ASC
pharmacy which uses a data processing system experiences system downtime,
the pharmacy must have an auxiliary procedure which will ensure that all data
is retained for on-line data entry as soon as the system is available for
use again.
(4)
Distribution of controlled substances to another registrant.
A pharmacy may distribute controlled substances to a practitioner, another
pharmacy, or other registrant, without being registered to distribute, under
the following conditions.
(A)
The registrant to whom the controlled substance is to be
distributed is registered under the Controlled Substances Act to dispense
that controlled substance.
(B)
The total number of dosage units of controlled substances
distributed by a pharmacy may not exceed 5.0% of all controlled substances
dispensed by the pharmacy during the 12-month period in which the pharmacy
is registered; if at any time it does exceed 5.0%, the pharmacy is required
to obtain an additional registration to distribute controlled substances.
(C)
If the distribution is for a Schedule III, IV, or V controlled
substance, a record shall be maintained which indicates:
(i)
the actual date of distribution;
(ii)
the name, strength, and quantity of controlled substances
distributed;
(iii)
the name, address, and DEA registration number of the
distributing pharmacy; and
(iv)
the name, address, and DEA registration number of the
pharmacy, practitioner, or other registrant to whom the controlled substances
are distributed.
(D)
If the distribution is for a Schedule I or II controlled
substance, the following is applicable.
(i)
The pharmacy, practitioner, or other registrant who is
receiving the controlled substances shall issue Copy 1 and Copy 2 of a DEA
order form (DEA 222C) to the distributing pharmacy.
(ii)
The distributing pharmacy shall:
(I)
complete the area on the DEA order form (DEA 222C) titled
"To Be Filled in by Supplier";
(II)
maintain Copy 1 of the DEA order form (DEA 222C) at the
pharmacy for two years; and
(III)
forward Copy 2 of the DEA order form (DEA 222C) to the
divisional office of the Drug Enforcement Administration.
(5)
Other records. Other records to be maintained by the pharmacy
include:
(A)
a permanent log of the initials or identification codes
which will identify each pharmacist by name. The initials or identification
code shall be unique to ensure that each pharmacist can be identified, i.e.,
identical initials or identification codes cannot be used;
(B)
Copy 3 of DEA order form (DEA 222C), which has been properly
dated, initialed, and filed, and all copies of each unaccepted or defective
order form and any attached statements or other documents;
(C)
a hard copy of the power of attorney to sign DEA 222C order
forms (if applicable);
(D)
suppliers' invoices of dangerous drugs and controlled substances;
a pharmacist shall verify that the controlled drugs listed on the invoices
were actually received by clearly recording his/her initials and the actual
date of receipt of the controlled substances;
(E)
supplier's credit memos for controlled substances and dangerous
drugs;
(F)
a hard copy of inventories required by §291.17 of
this title (relating to Inventory Requirements) except that a perpetual inventory
of controlled substances listed in Schedule II may be kept in a data processing
system if the data processing system is capable of producing a hard copy of
the perpetual inventory on-site;
(G)
hard-copy reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal agency;
(H)
a hard-copy Schedule V nonprescription register book;
(I)
records of distribution of controlled substances and/or
dangerous drugs to other pharmacies, practitioners, or registrants; and
(J)
a hard copy of any notification required by the Texas Pharmacy
Act or these rules, including, but not limited to, the following:
(i)
reports of theft or significant loss of controlled substances
to DEA, DPS, and the board;
(ii)
notification of a change in pharmacist-in-charge of a
pharmacy; and
(iii)
reports of a fire or other disaster which may affect
the strength, purity, or labeling of drugs, medications, devices, or other
materials used in the diagnosis or treatment of injury, illness, and disease.
(6)
Permission to maintain central records. Any pharmacy that
uses a centralized recordkeeping system for invoices and financial data shall
comply with the following procedures.
(A)
Controlled substance records. Invoices and financial data
for controlled substances may be maintained at a central location provided
the following conditions are met.
(i)
Prior to the initiation of central recordkeeping, the pharmacy
submits written notification by registered or certified mail to the divisional
director of the Drug Enforcement Administration as required by the Code of
Federal Regulations, Title 21, §1304(a), and submits a copy of this written
notification to the Texas State Board of Pharmacy. Unless the registrant is
informed by the divisional director of the Drug Enforcement Administration
that permission to keep central records is denied, the pharmacy may maintain
central records commencing 14 days after receipt of notification by the divisional
director.
(ii)
The pharmacy maintains a copy of the notification required
in this subparagraph.
(iii)
The records to be maintained at the central record location
shall not include executed DEA order forms, prescription drug orders, or controlled
substance inventories, which shall be maintained at the pharmacy.
(B)
Dangerous drug records. Invoices and financial data for
dangerous drugs may be maintained at a central location.
(C)
Access to records. If the records are kept on microfilm,
computer media, or in any form requiring special equipment to render the records
easily readable, the pharmacy shall provide access to such equipment with
the records.
(D)
Delivery of records. The pharmacy agrees to deliver all
or any part of such records to the pharmacy location within two business days
of written request of a board agent or any other authorized official.
(7)
Confidentiality.
(A)
A pharmacist shall provide adequate security of prescription
drug orders, medication orders, and patient medication records to prevent
indiscriminate or unauthorized access to confidential health information.
(B)
Confidential records are privileged and may be released
only to:
(i)
the patient or the patient's agent;
(ii)
a practitioner or another pharmacist if, in the pharmacist's
professional judgement, the release is necessary to protect the patient's
health and well being;
(iii)
the board or to a person or another state or federal
agency authorized by law to receive the confidential record;
(iv)
a law enforcement agency engaged in investigation of a
suspected violation of Chapter 481 or 483, Health and Safety Code, or the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section
801 et seq.);
(v)
a person employed by a state agency that licenses a practitioner,
if the person is performing the person's official duties; or
(vi)
an insurance carrier or other third party payor authorized
by a patient to receive such information.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office of
the Secretary of State on May 17, 2004.
TRD-200403304
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: June 6, 2004
Proposal publication date: March 26, 2004
For further information, please call: (512) 305-8028
Chapter 291.
PHARMACIES
Subchapter B. COMMUNITY PHARMACY (CLASS A)
Subchapter C. NUCLEAR PHARMACY (CLASS B)
Subchapter D. INSTITUTIONAL PHARMACY (CLASS C)
Subchapter F. NON-RESIDENT PHARMACY (CLASS E)