22 TAC §§291.32, 291.33, 291.36
The Texas State Board of Pharmacy adopts amendments to §291.32,
concerning Personnel, §291.33, concerning Operational Standards, and §291.36,
concerning Class A Pharmacies Compounding Sterile Pharmaceuticals. The amendments
to §§291.32, 291.33, and 291.36 are adopted with changes to the
proposed text as published in the March 31, 2000, issue of the
Texas Register
(25 TexReg 2747).
The amendments: (1) clarify the duties which may be performed by pharmacy
technicians; (2) specify the requirements for a temporary absence of the pharmacist;
and (3) make changes resulting from a rule review of §291.36. Changes
as a result of the rule review of §291.36 include: (1) updates citations
as a result of the codification of the Texas Pharmacy Act by the 76th Legislature;
(2) allows the use of electronic signatures in certain circumstances; (3)
clarifies pharmaceutical care duties; (4) clarifies the definition of "state";
(5) makes provisions for dispensing Schedule II controlled substances issued
by out-of-state physicians; and (6) updates the requirements for transferring
prescriptions.
Changes made to §291.33(b)(4) and §291.36(d)(2)(D), concerning
temporary absence of a pharmacist, changed the term "pharmacy" to the term
"prescription department" as necessary to differentiate between the licensed
facility and the portion of the facility where prescription drugs are maintained.
A change was made to §291.36(e)(2)(B)(iv)(II)(-a-)(-3-) to correct
an error which would have allowed a prescription for a Schedule II controlled
substance to be dispensed after the seventh day after the date on which the
prescription was issued. This change brings this section into agreement with
the provisions of the Texas Controlled Substances Act.
The Texas Federation of Drug Stores (TFDS) made the following comments.
Section 291.32(c)(2)(C) concerning the duties which may be performed by pharmacy
technicians should be amended to "...including but not limited to the following."
This clarifies that the list is not all inclusive. The Board agrees with this
comment and made the appropriate change. Section 291.33(b)(4) should be changed
to allow other pharmacy personnel as well as pharmacy technicians to remain
in the prescription department in the temporary absence of the pharmacist.
The Board agrees provided one certified pharmacy technician remains in the
prescription department. Appropriate changes were made to the language. Section
291.33(b)(4)(A)(ii) should be changed from "2 hours in a 24 hour period" to
"1 hour in a 12 hour period." The TFDS believes this is more in line with
actual staffing patterns where a pharmacist receives a 30 minute lunch and
two 15 minute breaks during a shift. The Board agrees and made appropriate
changes. The TFDS believes the phrase "for reasons of security or otherwise"
in §291.33(b)(4)(A)(iii) is redundant. The Board agrees and strikes the
phrase. The TFDS commented that §291.33(b)(4)(A)(iv)(II) should add "or
the patient's agent" to the phrase, "...not be delivered to the patient or
the patient's agent until the pharmacist returns..." The Board concurs and
made changes to include the patient's agent. The TFDS also commented that
an agent of a pharmacist should continue to be able to deliver dispensed prescriptions
to patients or their agents for up to a two hour period when a pharmacist
is not in the pharmacy. The TFDS believes this is in the best interest of
the patient, permitting them to pick up their dispensed, already verified,
medications for a longer period of time. The Board concurs and adds deleted
language back into the rule which previously permitted this activity. The
final comment concerned pharmacies with two or more pharmacists on duty. The
TFDS commented that the rule language should be changed to state that the
pharmacist should try to stagger their breaks and meal periods so that the
prescription department is not left without a pharmacist on duty. The Board
disagrees with this comment and believes that the public is best served in
these situations by having a pharmacist available in the prescription department.
The same changes have been made in §291.36 to make the rules consistent.
The amendments are adopted under §§551.002, 554.051,
554.005, and 554.053 of the Texas Pharmacy Act (Chapters 551-566, 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 §554.005 as authorizing the agency to regulate the delivery
or distribution of prescription drugs as they relate to the practice of pharmacy
and to specify the minimum standards for the maintenance of prescription drug
records. The Board interprets §554.053 as authorizing the agency to adopt
rules for the use and the duties of pharmacy technicians in a pharmacy.
§291.32.Personnel.
(a)
Pharmacist-in-charge.
(1)
General.
(A)
Each Class A pharmacy shall have one pharmacist-in-charge
who is employed on a full-time basis, who may be the pharmacist-in-charge
for only one such pharmacy; provided, however, such pharmacist-in-charge may
be the pharmacist-in-charge of more than one Class A pharmacy, if the additional
Class A pharmacies are not open to provide pharmacy services simultaneously.
(B)
The pharmacist-in-charge shall comply with the provisions
of §291.17 of this title (relating to Inventory Requirements).
(2)
Responsibilities. The pharmacist-in-charge shall
have responsibility for, at a minimum, the following:
(A)
dispensing of drugs, including:
(i)
packaging, preparation, compounding, and labeling; and
(ii)
ensuring that drugs are dispensed safely, and accurately
as prescribed;
(B)
delivery of drugs to the patient or the patient's agent,
including ensuring that drugs are delivered safely, and accurately as prescribed;
(C)
assuring that a pharmacist communicates to the patient
or the patient's agent information about the prescription drug or device which
in the exercise of the pharmacist's professional judgment, the pharmacist
deems significant as specified in §291.33(c) of this title (relating
to Operational Standards);
(D)
assuring that a pharmacist communicates to the patient
or the patient's agent on their request, information concerning any prescription
drugs dispensed to the patient by the pharmacy;
(E)
assuring that a reasonable effort is made to obtain, record,
and maintain patient medication records;
(F)
education and training of pharmacy technicians;
(G)
establishment of policies for procurement of prescription
drugs and devices and other products dispensed from the Class A pharmacy;
(H)
disposal and distribution of drugs from the Class A pharmacy;
(I)
bulk compounding of drugs;
(J)
storage of all materials, including drugs, chemicals, and
biologicals;
(K)
maintaining records of all transactions of the Class A
pharmacy necessary to maintain accurate control over and accountability for
all pharmaceutical materials required by applicable state and federal laws
and sections;
(L)
establishment and maintenance of effective controls against
the theft or diversion of prescription drugs, and records for such drugs;
(M)
maintenance of records in a data processing system such
that the data processing system is in compliance with Class A (community)
pharmacy requirements;
(N)
legal operation of the pharmacy, including meeting all
inspection and other requirements of all state and federal laws or sections
governing the practice of pharmacy; and
(O)
effective September 1, 2000, if the pharmacy uses an automated
pharmacy dispensing system, shall be responsible for the following:
(i)
reviewing and approving all policies and procedures for
system operation, safety, security, accuracy and access, patient confidentiality,
prevention of unauthorized access, and malfunction;
(ii)
inspecting medications in the automated pharmacy dispensing
system, at least monthly, for expiration date, misbranding, physical integrity,
security, and accountability;
(iii)
assigning, discontinuing, or changing personnel access
to the automated pharmacy dispensing system;
(iv)
ensuring that pharmacy technicians and licensed healthcare
professionals performing any services in connection with an automated pharmacy
dispensing system have been properly trained on the use of the system and
can demonstrate comprehensive knowledge of the written policies and procedures
for operation of the system; and
(v)
ensuring that the automated pharmacy dispensing system
is stocked accurately and an accountability record is maintained in accordance
with the written policies and procedures of operation.
(b)
Pharmacists.
(1)
General.
(A)
The pharmacist-in-charge shall be assisted by sufficient
number of additional licensed pharmacists as may be required to operate the
Class A pharmacy competently, safely, and adequately to meet the needs of
the patients of the pharmacy.
(B)
All pharmacists shall assist the pharmacist-in-charge in
meeting his or her responsibilities in ordering, dispensing, and accounting
for prescription drugs.
(C)
Pharmacists are solely responsible for the direct supervision
of pharmacy technicians and for designating and delegating duties, other than
those listed in paragraph (2) of this subsection, to pharmacy technicians.
Each pharmacist:
(i)
shall verify the accuracy of all acts, tasks, and functions
performed by pharmacy technicians; and
(ii)
shall be responsible for any delegated act performed by
pharmacy technicians under his or her supervision.
(D)
All pharmacists while on duty, shall be responsible for
complying with all state and federal laws or rules governing the practice
of pharmacy.
(E)
A dispensing pharmacist shall ensure that the drug is dispensed
and delivered safely, and accurately as prescribed.
(2)
Duties. Duties which may only be performed by
a pharmacist are as follows:
(A)
receiving oral prescription drug orders and reducing these
orders to writing, either manually or electronically;
(B)
interpreting prescription drug orders;
(C)
selection of drug products;
(D)
performing the final check of the dispensed prescription
before delivery to the patient to ensure that the prescription has been dispensed
accurately as prescribed;
(E)
communicating to the patient or patient's agent information
about the prescription drug or device which in the exercise of the pharmacist's
professional judgement, the pharmacist deems significant, as specified in §291.33(c)
of this title;
(F)
communicating to the patient or the patient's agent on
his or her request information concerning any prescription drugs dispensed
to the patient by the pharmacy;
(G)
assuring that a reasonable effort is made to obtain, record,
and maintain patient medication records;
(H)
interpreting patient medication records and performing
drug regimen reviews; and
(I)
performing a specific act of drug therapy management for
a patient delegated to a pharmacist by a written protocol from a physician
licensed in this state in compliance with the Medical Practice Act.
(3)
Special requirements for nonsterile compounding.
(A)
All pharmacists engaged in compounding shall possess the
education, training, and proficiency necessary to properly and safely perform
compounding duties undertaken or supervised. Continuing education shall include
training in the art and science of compounding and the legal requirements
for compounding.
(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.
(c)
Pharmacy technicians.
(1)
Qualifications.
(A)
General. All pharmacy technicians shall:
(i)
have a high school or equivalent degree, e.g., GED, or
be currently enrolled in a program which awards such a degree; and
(ii)
complete a structured didactic and experiential training
program, which provides instruction and experience in the areas listed in
paragraph (4) of this subsection.
(iii)
Effective January 1, 2001, all pharmacy technicians must
have taken and passed the National Pharmacy Technician Certification Exam
or other examination approved during an open meeting by the Board or be a
pharmacy technician trainee.
(B)
Pharmacy Technician Trainee.
(i)
A person shall be designated as a pharmacy technician trainee
while participating in a pharmacy's technician training program in preparation
for the National Pharmacy Technician Certification Exam or other examination
approved during an open meeting by the Board.
(ii)
A person may be designated a pharmacy technician trainee
for no more than one year. A person may not be a technician trainee if they
fail to pass the certification exam within this one year training period.
This clause does not apply to a pharmacy technician trainee working in a pharmacy
as part of a training program accredited by the American Society of Health-System
Pharmacists.
(C)
Certified Pharmacy Technicians. All certified pharmacy
technicians shall have taken and passed the National Pharmacy Technician Certification
Exam or other examination approved during an open meeting by the Board and
maintain a current certification with the Pharmacy Technician Certification
Board or any other entity providing an examination approved by the Board.
(2)
Duties.
(A)
Pharmacy technicians may not perform any of the duties
listed in subsection (b)(2) of this section.
(B)
A pharmacist may delegate to pharmacy technicians any nonjudgmental
technical duty associated with the preparation and distribution of prescription
drugs provided:
(i)
a pharmacist verifies the accuracy of all acts, tasks,
and functions performed by pharmacy technicians;
(ii)
pharmacy technicians are under the direct supervision
of and responsible to a pharmacist; and
(iii)
effective September 1, 2000, only pharmacy technicians
who have been properly trained on the use of an automated pharmacy dispensing
system and can demonstrate comprehensive knowledge of the written policies
and procedures for the operation of the system may be allowed access to the
system; and
(C)
Pharmacy technicians may perform only nonjudgmental technical
duties associated with the preparation and distribution of prescription drugs,
including but not limited to the following:
(i)
initiating and receiving refill authorization requests;
(ii)
entering prescription data into a data processing system;
(iii)
taking a stock bottle from the shelf for a prescription;
(iv)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(v)
affixing prescription labels and auxiliary labels to the
prescription container provided:
(I)
the pharmacy technician has completed the education and
training requirements outlined in paragraphs (1) and (4) of this subsection;
and
(II)
effective January 1, 2001, only certified pharmacy technicians
may affix a label to a prescription container.
(vi)
reconstituting medications;
(vii)
prepackaging and labeling prepackaged drugs;
(viii)
loading bulk unlabeled drugs into an automated dispensing
system provided a pharmacist verifies that the system is properly loaded prior
to use;
(ix)
compounding non-sterile prescription drug orders; and
(x)
bulk compounding.
(3)
Ratio of pharmacist to pharmacy technicians.
(A)
The ratio of pharmacists to pharmacy technicians may not
exceed 1:2
(B)
The ratio of pharmacists to pharmacy technicians may be
1:3 provided that at least one of the three technicians is certified.
(4)
Training.
(A)
pharmacy technicians shall complete initial training as
outlined by the pharmacist-in-charge in a training manual. Such training:
(i)
shall include training and experience as outlined in paragraph
(5) of this subsection; and
(ii)
may not be transferred to another pharmacy unless:
(I)
the pharmacies are under common ownership and control and
have a common training program; and
(II)
the pharmacist-in-charge of each pharmacy in which the
pharmacy technician works certifies that the pharmacy technician is competent
to perform the duties assigned in that pharmacy.
(B)
A pharmacy technician shall be designated a pharmacy technician
trainee until completing the full training program. A pharmacy technician
trainee:
(i)
may perform all of the duties of a pharmacy technician
except affix a label to a prescription container;
(ii)
may be designated a pharmacy technician trainee for no
longer than one year; and
(iii)
shall be counted in the pharmacist to pharmacy technician
ratio.
(C)
The pharmacist-in-charge shall assure the continuing competency
of pharmacy technicians through in-service education and training to supplement
initial training.
(D)
The pharmacist-in-charge shall document the completion
of the training program and certify the competency of pharmacy technicians
completing the training. A written record of initial and in-service training
of pharmacy technicians shall be maintained and contain the following information:
(i)
name of the person receiving the training;
(ii)
date(s) of the training;
(iii)
general description of the topics covered;
(iv)
a statement or statements that certifies that the pharmacy
technician is competent to perform the duties assigned;
(v)
name of the person supervising the training; and
(vi)
signature of the pharmacy technician and the pharmacist-in-charge
or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge
as responsible for training of pharmacy technicians.
(E)
A person who has previously completed training as a pharmacy
technician, or a licensed nurse or physician assistant is not required to
complete the entire training program if the person is able to show competency
through a documented assessment of competency. Such competency assessment
may be conducted by personnel designated by the pharmacist-in-charge, but
the final acceptance of competency must be approved by the pharmacist-in-charge.
(5)
Training program. Pharmacy technician training
shall be outlined in a training manual. Such training manual shall, at a minimum,
contain the following:
(A)
written procedures and guidelines for the use and supervision
of pharmacy technicians. Such procedures and guidelines shall:
(i)
specify the manner in which the pharmacist responsible
for the supervision of pharmacy technicians will supervise such personnel
and verify the accuracy and completeness of all acts, tasks, and functions
performed by such personnel; and
(ii)
specify duties which may and may not be performed by pharmacy
technicians; and
(B)
instruction in the following areas and any additional areas
appropriate to the duties of pharmacy technicians in the pharmacy:
(i)
Orientation;
(ii)
Job descriptions;
(iii)
Communication techniques;
(iv)
Laws and rules;
(v)
Security and safety;
(vi)
Prescription drugs:
(I)
Basic pharmaceutical nomenclature;
(II)
Dosage forms;
(vii)
Prescription drug orders:
(I)
Prescribers;
(II)
Directions for use;
(III)
Commonly-used abbreviations and symbols;
(IV)
Number of dosage units;
(V)
Strengths and systems of measurement;
(VI)
Routes of administration;
(VII)
Frequency of administration;
(VIII)
Interpreting directions for use;
(viii)
Prescription drug order preparation:
(I)
Creating or updating patient medication records;
(II)
Entering prescription drug order information into the
computer or typing the label in a manual system;
(III)
Selecting the correct stock bottle;
(IV)
Accurately counting or pouring the appropriate quantity
of drug product;
(V)
Selecting the proper container;
(VI)
Affixing the prescription label;
(VII)
Affixing auxiliary labels, if indicated; and
(VIII)
Preparing the finished product for inspection and final
check by pharmacists;
(ix)
Other functions;
(x)
Drug product prepackaging;
(xi)
Compounding of non-sterile pharmaceuticals;
(xii)
Written policy and guidelines for use of and supervision
of pharmacy technicians.
(d)
Identification of pharmacy personnel. All pharmacy personnel
shall be identified as follows.
(1)
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, pharmacy technician, or a certified
pharmacy technician.
(2)
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.
(3)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
§291.33.Operational Standards.
(a)
Licensing requirements.
(1)
A Class A 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)
A Class A 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).
(3)
A Class A 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).
(4)
A Class A 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).
(5)
A Class A 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).
(6)
A separate license is required for each principal
place of business and only one pharmacy license may be issued to a specific
location.
(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 Class A pharmacy, licensed under the provisions
of the Act, §560.051(a)(1), which also operates another type of pharmacy
which would otherwise be required to be licensed under the Act, §560.051(a)(2)
concerning Nuclear Pharmacy (Class B), 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 §291.51 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.
(9)
A Class A (community) pharmacy engaged in the compounding
of sterile pharmaceuticals shall comply with the provisions of §291.36
of this title (relating to Class A Pharmacies Compounding Sterile Pharmaceuticals).
(b)
Environment.
(1)
General requirements.
(A)
The pharmacy shall be arranged in an orderly fashion and
kept clean. All required equipment shall be clean and in good operating condition.
(B)
A Class A pharmacy shall have a sink with hot and cold
running water within the pharmacy, exclusive of restroom facilities, available
to all pharmacy personnel and maintained in a sanitary condition.
(C)
A Class A pharmacy which serves the general public shall
contain an area which is suitable for confidential patient counseling.
(i)
Such counseling area shall:
(I)
be easily accessible to both patient and pharmacists and
not allow patient access to prescription drugs;
(II)
be designed to maintain the confidentiality and privacy
of the pharmacist/patient communication.
(ii)
In determining whether the area is suitable for confidential
patient counseling and designed to maintain the confidentiality and privacy
of the pharmacist/patient communication, the board may consider factors such
as the following:
(I)
the proximity of the counseling area to the check-out or
cash register area;
(II)
the volume of pedestrian traffic in and around the counseling
area;
(III)
the presence of walls or other barriers between the counseling
area and other areas of the pharmacy; and
(IV)
any evidence of confidential information being overheard
by persons other than the patient or patient's agent or the pharmacist or
agents of the pharmacist.
(D)
The pharmacy shall be properly lighted and ventilated.
(E)
The temperature of the 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.
(F)
Animals, including birds and reptiles, shall not be kept
within the pharmacy and in immediately adjacent areas under the control of
the pharmacy. This provision does not apply to fish in aquariums, guide dogs
accompanying disabled persons, or animals for sale to the general public in
a separate area that is inspected by local health jurisdictions.
(2)
Special requirements for nonsterile compounding.
(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 utilized in order to prevent
cross-contamination.
(3)
Security.
(A)
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.
(B)
The prescription department shall be locked by key or combination
so as to prevent access when a pharmacist is not on-site. However, the pharmacist-in-charge
may designate persons who may enter the pharmacy to perform functions designated
by the pharmacist-in-charge (e.g., janitorial services).
(4)
Temporary absence of pharmacist.
(A)
If a pharmacy is staffed by a single pharmacist, the pharmacist
may leave the prescription department for breaks and meal periods without
closing the prescription department and removing pharmacy technicians and
other pharmacy personnel from the prescription department provided the following
conditions are met:
(i)
at least one certified pharmacy technician remains in the
prescription department;
(ii)
the pharmacist remains on-site at the licensed location
of the pharmacy and available for an emergency;
(iii)
the absence does not exceed 30 minutes at a time and
a total of one hour in a 12 hour period;
(iv)
the pharmacist reasonably believes that the security of
the prescription department will be maintained in his or her absence. If in
the professional judgment of the pharmacist, the pharmacist determines that
the prescription department should close during his or her absence, then the
pharmacist shall close the prescription department and remove the pharmacy
technicians or other pharmacy personnel from the prescription department during
his or her absence; and
(v)
a notice is posted which includes the following information:
(I)
the fact that pharmacist is on a break and the time the
pharmacist will return; and
(II)
the fact that pharmacy technicians may begin the processing
of prescription drug orders or refills brought in during the pharmacist absence
but the prescription or refill may not be delivered to the patient or the
patient's agent until the pharmacist returns and verifies the accuracy of
the prescription.
(B)
During the time a pharmacist is absent from the prescription
department, only pharmacy technicians who have completed the pharmacy's training
program may perform the following duties, provided a pharmacist verifies the
accuracy of all acts, tasks, and functions performed by the pharmacy technicians
prior to delivery of the prescription to the patient or the patient's agent:
(i)
initiating and receiving refill authorization requests;
(ii)
entering prescription data into a data processing system;
(iii)
taking a stock bottle from the shelf for a prescription;
(iv)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(v)
affixing prescription labels and auxiliary labels to the
prescription container. After January 1, 2001, only certified pharmacy technicians
may affix prescription labels to prescription containers; and
(vi)
prepackaging and labeling prepackaged drugs.
(C)
Upon return to the prescription department, the pharmacist
shall:
(i)
conduct a drug regimen review as specified in subsection
(c)(2) of this section; and
(ii)
verify the accuracy of all acts, tasks, and functions
performed by the certified pharmacy technicians prior to delivery of the prescription
to the patient or the patient's agent.
(D)
An agent of the pharmacist may deliver a prescription drug
order to the patient or his or her agent provided a record of the delivery
is maintained containing the following information:
(i)
date of the delivery;
(ii)
unique identification number of the prescription drug
order;
(iii)
patient's name;
(iv)
patient's phone number or the phone number of the person
picking up the prescription; and
(v)
signature of the person picking up the prescription.
(E)
Any prescription delivered to a patient when a pharmacist
is not in the prescription department must meet the requirements for a prescription
delivered to a patient as described in subsection (c)(1)(F) of this section.
(F)
During the times a pharmacist is absent from the prescription
department a pharmacist intern shall be considered a certified pharmacy technician
and may perform only the duties of a certified pharmacy technician.
(G)
In pharmacies with two or more pharmacists on duty, the
pharmacists shall stagger their breaks and meal periods so that the prescription
department is not left without a pharmacist on duty.
(c)
Prescription dispensing and delivery.
(1)
Patient counseling and provision of drug information.
(A)
To optimize drug therapy, a pharmacist shall communicate
to the patient or the patient's agent, information about the prescription
drug or device which in the exercise of the pharmacist's professional judgment
the pharmacist deems significant, such as the following:
(i)
the name and description of the drug or device;
(ii)
dosage form, dosage, route of administration, and duration
of drug therapy;
(iii)
special directions and precautions for preparation, administration,
and use by the patient;
(iv)
common severe side or adverse effects or interactions
and therapeutic contraindications that may be encountered, including their
avoidance, and the action required if they occur;
(v)
techniques for self monitoring of drug therapy;
(vi)
proper storage;
(vii)
refill information; and
(viii)
action to be taken in the event of a missed dose.
(B)
Such communication:
(i)
shall be provided with each new prescription drug order,
once yearly on maintenance medications, and if the pharmacist deems appropriate,
with prescription drug order refills. (For the purposes of this clause, maintenance
medications are defined as any medication the patient has taken for one year
or longer);
(ii)
shall be provided for any prescription drug order dispensed
by the pharmacy on the request of the patient or patient's agent;
(iii)
shall be communicated orally in person unless the patient
or patient's agent is not at the pharmacy or a specific communication barrier
prohibits such oral communication; and
(iv)
shall be reinforced with written information. The following
is applicable concerning this written information.
(I)
Written information designed for the consumer such as the
USP DI patient information leaflets shall be provided.
(II)
When a compounded product is dispensed, information shall
be provided for the major active ingredient(s), if available.
(III)
For new drug entities, if no written information is initially
available, the pharmacist is not required to provide information until such
information is available, provided:
(-a-)
the pharmacist informs the patient or the patient's agent
that the product is a new drug entity and written information is not available;
(-b-)
the pharmacist documents the fact that no written
information was provided; and
(-c-)
if the prescription is refilled after written information
is available, such information is provided to the patient or patient's agent.
(C)
Only a pharmacist may verbally provide drug information
to a patient or patient's agent and answer questions concerning prescription
drugs. Non-pharmacist personnel may not ask questions of a patient or patient's
agent which are intended to screen and/or limit interaction with the pharmacist.
(D)
Nothing in this subparagraph shall be construed as requiring
a pharmacist to provide consultation when a patient or patient's agent refuses
such consultation. The pharmacist shall document such refusal for consultation.
(E)
In addition to the requirements of subparagraphs (A)-(D)
of this paragraph, if a prescription drug order is delivered to the patient
at the pharmacy, the following is applicable.
(i)
So that a patient will have access to information concerning
his or her prescription, a prescription may not be delivered to a patient
unless a pharmacist is in the pharmacy, except as provided in subsection (b)(4)
of this section or clause (ii) of this subparagraph.
(ii)
An agent of the pharmacist may deliver a prescription
drug order to the patient or his or her agent during short periods of time
when a pharmacist is absent from the pharmacy, provided the short periods
of time do not exceed two hours, and provided a record of the delivery is
maintained containing the following information:
(I)
date of the delivery;
(II)
unique identification number of the prescription drug
order;
(III)
patient's name;
(IV)
patient's phone number or the phone number of the person
picking up the prescription; and
(V)
signature of the person picking up the prescription.
(iii)
Any prescription delivered to a patient when a pharmacist
is not in the pharmacy must meet the requirements described in subparagraph
(F) of this paragraph.
(iv)
A Class A pharmacy shall make available for use by the
public a current or updated edition of the United States Pharmacopeia Dispensing
Information, Volume II (Advice to the Patient), or another source of such
information designed for the consumer.
(F)
In addition to the requirements of subparagraphs (A)-(D)
of this paragraph, if a prescription drug order is delivered to the patient
or his or her agent at the patient's residence or other designated location,
the following is applicable.
(i)
The information specified in subparagraph (A) of this paragraph
shall be delivered with the dispensed prescription in writing.
(ii)
If prescriptions are routinely delivered outside the area
covered by the pharmacy's local telephone service, the pharmacy shall provide
a toll-free telephone line which is answered during normal business hours
to enable communication between the patient and a pharmacist.
(iii)
The pharmacist shall place on the prescription container
or on a separate sheet delivered with the prescription container in both English
and Spanish the local and if applicable, toll-free telephone number of the
pharmacy and the statement: "Written information about this prescription has
been provided for you. Please read this information before you take the medication.
If you have questions concerning this prescription, a pharmacist is available
during normal business hours to answer these questions at (insert the pharmacy's
local and toll-free telephone numbers)."
(iv)
The pharmacy shall maintain and use adequate storage or
shipment containers and use shipping processes to ensure drug stability and
potency. Such shipping processes shall include the use of appropriate packaging
material and/or devices to ensure that the drug is maintained at an appropriate
temperature range to maintain the integrity of the medication throughout the
delivery process.
(v)
The pharmacy shall use a delivery system which is designed
to assure that the drugs are delivered to the appropriate patient.."
(G)
The provisions of this paragraph do not apply to patients
in facilities where drugs are administered to patients by a person required
to do so by the laws of the state (i.e., nursing homes).
(2)
Pharmaceutical care services.
(A)
Drug regimen review.
(i)
For the purpose of promoting therapeutic appropriateness,
a pharmacist shall at the time of dispensing a prescription drug order, review
the patient's medication record. Such review shall at a minimum identify clinically
significant:
(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; and
(X)
proper utilization, including overutilization or underutilization.
(ii)
Upon identifying any clinically significant conditions,
situations, or items listed in clause (i) of this subparagraph, the pharmacist
shall take appropriate steps to avoid or resolve the problem including consultation
with the prescribing practitioner. The pharmacist shall document such occurrences.
(B)
Other pharmaceutical care services which may be provided
by pharmacists include, but are not limited to, the following:
(i)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practices;
(ii)
administering immunizations and vaccinations under written
protocol of a physician;
(iii)
managing patient compliance programs;
(iv)
providing preventative health care services; and
(v)
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.
(3)
Prescription containers.
(A)
A drug dispensed pursuant to a prescription drug order
shall be dispensed in a child-resistant container unless:
(i)
the patient or the practitioner requests the prescription
not be dispensed in a child-resistant container; or
(ii)
the product is exempted from requirements of the Poison
Prevention Packaging Act of 1970.
(B)
A drug dispensed pursuant to a prescription drug order
shall be dispensed in an appropriate container as specified on the manufacturer's
container.
(C)
Prescription containers or closures shall not be re-used.
(4)
Labeling.
(A)
At the time of delivery of the drug, the dispensing container
shall bear a label with at least the following information:
(i)
name, address and phone number of the pharmacy;
(ii)
unique identification number of the prescription;
(iii)
date the prescription is dispensed;
(iv)
initials or an identification code of the dispensing pharmacist;
(v)
name of the prescribing practitioner;
(vi)
name of the patient or if such drug was prescribed for
an animal, the species of the animal and the name of the owner;
(vii)
instructions for use;
(viii)
quantity dispensed;
(ix)
appropriate ancillary instructions such as storage instructions
or cautionary statements such as warnings of potential harmful effects of
combining the drug product with any product containing alcohol;
(x)
if the prescription is for a Schedule II-IV controlled
substance, the statement "Caution: Federal law prohibits the transfer of this
drug to any person other than the patient for whom it was prescribed";
(xi)
if the pharmacist has selected a generically equivalent
drug pursuant to the provisions of the Act, Chapters 562 and 563, the statement
"Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where
"Brand Name" is the actual name of the brand name product prescribed;
(xii)
the name of the advanced practice nurse or physician
assistant, if the prescription is carried out or signed by an advanced practice
nurse or physician assistant in compliance with Subtitle B, Chapter 157, Occupations
Code; and
(xiii)
the name and strength of the actual drug product dispensed,
unless otherwise directed by the prescribing practitioner.
(I)
The name shall be either:
(-a-)
the brand name; or
(-b-)
if no brand name, then the generic name and name
of the manufacturer or distributor of such generic drug. (The name of the
manufacturer or distributor may be reduced to an abbreviation or initials,
provided the abbreviation or initials are sufficient to identify the manufacturer
or distributor. For combination drug products or non-sterile compounded drug
products having no brand name, the principal active ingredients shall be indicated
on the label.)
(II)
Except as provided in clause (xi) of this subparagraph,
the brand name of the prescribed drug shall not appear on the prescription
container label unless it is the drug product actually dispensed.
(B)
The dispensing container is not required to bear the label
specified in subparagraph (A) of this paragraph if:
(i)
the drug is prescribed for administration to an ultimate
user who is institutionalized in a licensed health care institution (e.g.,
nursing home, hospice, hospital);
(ii)
no more than a 34-day supply or 100 dosage units, whichever
is less, is dispensed at one time;
(iii)
the drug is not in the possession of the ultimate user
prior to administration;
(iv)
the pharmacist-in-charge has determined that the institution:
(I)
maintains medication administration records which include
adequate directions for use for the drug(s) prescribed;
(II)
maintains records of ordering, receipt, and administration
of the drug(s); and
(III)
provides for appropriate safeguards for the control and
storage of the drug(s); and
(v)
the system employed by the pharmacy in dispensing the prescription
drug order adequately:
(I)
identifies the:
(-a-)
pharmacy by name and address;
(-b-)
unique identification number of the prescription;
(-c-)
name and strength of the drug dispensed;
(-d-)
name of the patient;
(-e-)
name of the prescribing practitioner; and
(II)
sets forth the directions for use and cautionary statements,
if any, contained on the prescription drug order or required by law.
(d)
Equipment and supplies.
(1)
Class A pharmacies dispensing prescription drug orders
shall have the following equipment and supplies:
(A)
typewriter or comparable equipment;
(B)
refrigerator;
(C)
adequate supply of child-resistant, light-resistant, tight,
and if applicable, glass containers;
(D)
adequate supply of prescription, poison, and other applicable
labels;
(E)
appropriate equipment necessary for the proper preparation
of prescription drug orders; and
(F)
metric-apothecary weight and measure conversion charts.
(2)
If the community pharmacy compounds prescription
drug orders, the pharmacy shall:
(A)
have a Class A prescription balance, or analytical balance
and weights which shall be properly maintained and inspected at least every
three years by the appropriate authority as prescribed by local, state, or
federal law or regulations; and
(B)
have equipment and utensils necessary for the proper compounding
of prescription drug 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 acceptable standards;
(iii)
cleaned and sanitized immediately prior to each use;
and
(iv)
routinely inspected, calibrated (if necessary), or checked
to ensure proper performance.
(e)
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 rules; and
(D)
Federal Controlled Substances Act and rules (or official
publication describing the requirements of the Federal Controlled Substances
Act and rules);
(2)
at least one current or updated reference from
each of the following categories:
(A)
patient information:
(i)
United States Pharmacopeia Dispensing Information, Volume
II (Advice to the Patient); or
(ii)
a reference text or information leaflets which provide
patient information;
(B)
drug interactions: a reference text on drug interactions,
such as Phillip D. Hansten's Drug Interactions;
(C)
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)
American Hospital Formulary Service with current supplements;
or
(iv)
Remington's Pharmaceutical Sciences; and
(3)
basic antidote information and the telephone
number of the nearest Regional Poison Control Center.
(f)
Drugs.
(1)
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 and nonprescription Schedule
V controlled substances 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)
controlled room temperature--temperature maintained thermostatically
between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit);
(ii)
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;
(iii)
refrigerate--temperature maintained thermostatically
between 2 degrees and 8 degrees Celsius (36 degrees and 46 degrees Fahrenheit);
and
(iv)
freeze--temperature maintained thermostatically between
-20 degrees and -10 degrees Celsius (-4 degrees and 14 degrees Fahrenheit).
(2)
Out-of-date 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 drugs or devices shall be removed from dispensing
stock and shall be quarantined together until such drugs or devices are disposed
of properly.
(3)
Nonprescription Schedule V controlled substances.
(A)
Schedule V controlled substances containing codeine, dihydrocodeine,
or any of the salts of codeine or dihydrocodeine may not be distributed without
a prescription drug order from a practitioner.
(B)
A pharmacist may distribute nonprescription Schedule V
controlled substances which contain no more than 15 milligrams of opium per
29.5729 ml or per 28.35 Gm provided:
(i)
such distribution is made only by a pharmacist; a nonpharmacist
employee may not distribute a nonprescription Schedule V controlled substance
even if under the supervision of a pharmacist; however, after the pharmacist
has fulfilled professional and legal responsibilities, the actual cash, credit
transaction, or delivery may be completed by a nonpharmacist:
(ii)
not more than 240 ml (eight fluid ounces), or not more
than 48 solid dosage units of any substance containing opium, may be distributed
to the same purchaser in any given 48-hour period without a prescription drug
order;
(iii)
the purchaser is at least 18 years of age; and
(iv)
the pharmacist requires every purchaser not known to the
pharmacist to furnish suitable identification (including proof of age where
appropriate).
(C)
A record of such distribution shall be maintained by the
pharmacy in a bound record book. The record shall contain the following information:
(i)
true name of the purchaser;
(ii)
current address of the purchaser;
(iii)
name and quantity of controlled substance purchased;
(iv)
date of each purchase; and
(v)
signature or written initials of the distributing pharmacist.
(4)
Drugs, components, and materials used in
nonsterile compounding.
(A)
Drugs used in nonsterile compounding shall:
(i)
meet official compendia requirements; or
(ii)
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
(iii)
in the professional judgment of the pharmacist, be of
high quality and obtained from acceptable and reliable alternative sources.
(B)
All components shall be stored in properly labeled containers
in a clean, dry area, under proper temperatures as defined in paragraph (1)
of this subsection.
(C)
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.
(D)
Components, drug product containers, and closures shall
be rotated so that the oldest stock is used first.
(E)
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.
(5)
Class A Pharmacies may not sell, purchase, trade
or possess prescription drug samples, unless the pharmacy meets all of the
following conditions:
(A)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986, or by a city, state or county government;
(B)
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;
(C)
the samples are for dispensing or provision at no charge
to patients of such health care entity; and
(D)
the samples are possessed in compliance with the federal
Prescription Drug Marketing Act of 1986.
(g)
Prepackaging of drugs and loading bulk unlabeled drugs
into automated drug dispensing system.
(1)
Drugs may be prepackaged in quantities suitable for internal
distribution only by a pharmacist or by supportive personnel under the direction
and direct supervision of a pharmacist.
(2)
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 the quantity is greater than one.
(3)
Records of prepackaging shall be maintained to
show:
(A)
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.
(4)
Stock packages, repackaged units, and control
records shall be quarantined together until checked/released by the pharmacist.
(h)
Customized patient medication packages.
(1)
Purpose. In lieu of dispensing two or more prescribed drug
products in separate containers, a pharmacist may, with the consent of the
patient, the patient's caregiver, or the prescriber, provide a customized
patient medication package (patient med-pak).
(2)
Definition. A patient med-pak is a package prepared
by a pharmacist for a specific patient comprising a series of containers and
containing two or more prescribed solid oral dosage forms. The patient med-pak
is so designed or each container is so labeled as to indicate the day and
time, or period of time, that the contents within each container are to be
taken.
(3)
Label.
(A)
The patient med-pak shall bear a label stating:
(i)
the name of the patient;
(ii)
the unique identification number for the patient med-pak
itself and a separate unique identification number for each of the prescription
drug orders for each of the drug products contained therein;
(iii)
the name, strength, physical description or identification,
and total quantity of each drug product contained therein;
(iv)
the directions for use and cautionary statements, if any,
contained in the prescription drug order for each drug product contained therein;
(v)
if applicable, a warning of the potential harmful effect
of combining any form of alcoholic beverage with any drug product contained
therein;
(vi)
any storage instructions or cautionary statements required
by the official compendia;
(vii)
the name of the prescriber of each drug product;
(viii)
the date of preparation of the patient med-pak and the
beyond-use date assigned to the patient med-pak (which such beyond-use date
shall not be later than 60 days from the date of preparation);
(ix)
the name, address, and telephone number of the pharmacy;
(x)
the initials or an identification code of the dispensing
pharmacist; and
(xi)
any other information, statements, or warnings required
for any of the drug products contained therein.
(B)
If the patient med-pak allows for the removal or separation
of the intact containers therefrom, each individual container shall bear a
label identifying each of the drug product contained therein.
(C)
The dispensing container is not required to bear the label
specified in subparagraph (A) of this paragraph if:
(i)
the drug is prescribed for administration to an ultimate
user who is institutionalized in a licensed health care institution (e.g.,
nursing home, hospice, hospital);
(ii)
no more than a 34-day supply or 100 dosage units, whichever
is less, is dispensed at one time;
(iii)
the drug is not in the possession of the ultimate user
prior to administration;
(iv)
the pharmacist-in-charge has determined that the institution:
(I)
maintains medication administration records which include
adequate directions for use for the drug(s) prescribed;
(II)
maintains records of ordering, receipt, and administration
of the drug(s); and
(III)
provides for appropriate safeguards for the control and
storage of the drug(s); and
(v)
the system employed by the pharmacy in dispensing the prescription
drug order adequately:
(I)
identifies the:
(-a-)
pharmacy name and address;
(-b-)
unique identification number of the prescription;
(-c-)
name and strength each drug product dispensed;
(-d-)
name of the patient;
(-e-)
name of the prescribing practitioner of each drug
product; and
(II)
for each drug product sets forth the directions for use
and cautionary statements, if any contained on the prescription drug order
or required by law.
(4)
Labeling. The patient med-pak shall
be accompanied by a patient package insert, in the event that any drug contained
therein is required to be dispensed with such insert as accompanying labeling.
Alternatively, such required information may be incorporated into a single,
overall educational insert provided by the pharmacist for the total patient
med-pak.
(5)
Packaging. In the absence of more stringent packaging
requirements for any of the drug products contained therein, each container
of the patient med-pak shall comply with official packaging standards. Each
container shall be either not reclosable or so designed as to show evidence
of having been opened.
(6)
Guidelines. It is the responsibility of the dispensing
pharmacist when preparing a patient med-pak, to take into account any applicable
compendial requirements or guidelines and the physical and chemical compatibility
of the dosage forms placed within each container, as well as any therapeutic
incompatibilities that may attend the simultaneous administration of the drugs.
(7)
Recordkeeping. In addition to any individual prescription
filing requirements, a record of each patient med-pak shall be made and filed.
Each record shall contain, as a minimum:
(A)
the name and address of the patient;
(B)
the unique identification number for the patient med-pak
itself and a separate unique identification number for each of the prescription
drug orders for each of the drug products contained therein;
(C)
the name of the manufacturer or distributor and lot number
for each drug product contained therein;
(D)
information identifying or describing the design, characteristics,
or specifications of the patient med-pak sufficient to allow subsequent preparation
of an identical patient med-pak for the patient;
(E)
the date of preparation of the patient med-pak and the
beyond-use date that was assigned;
(F)
any special labeling instructions; and
(G)
the initials or an identification code of the dispensing
pharmacist.
(i)
Nonsterile compounding.
(1)
Purpose. The purpose of this subsection is to provide standards
for the compounding of nonsterile drug products in licensed pharmacies for
dispensing and/or administration to humans or animals. Licensed pharmacies
compounding nonsterile drug products shall comply with the following paragraphs
in addition to all other provisions of this section and §§291.31,
291.32, 291.34, and 291.35 of this title (relating to Definitions, Personnel,
Records, and Triplicate Prescription Requirements).
(2)
General requirements.
(A)
Nonsterile drug products may be compounded in licensed
pharmacies:
(i)
when there exists a valid pharmacist/patient/prescriber
relationship and upon the presentation of a valid prescription drug order;
or
(ii)
in anticipation of future prescription drug orders based
on routine, regularly observed prescribing patterns.
(B)
Nonsterile compounding in anticipation of future prescription
drug 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 should be based
on criteria such as:
(I)
physical and chemical properties of active ingredients;
(II)
use of preservatives and/or stabilizing agents;
(III)
dosage form;
(IV)
storage conditions; and
(V)
scientific, laboratory, or reference data.
(ii)
Documentation of the criteria used to determine the stability
for the anticipated shelf time must be maintained with the nonsterile compounding
record.
(iii)
Any product compounded in anticipation of future prescription
drug 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)
"use by" 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 drug products may be compounded
for individual patients under the provisions of subparagraph (A) of this paragraph
provided the prescribing practitioner has requested that the drug product
be compounded.
(D)
Drug products may be compounded for the exclusive use of
the pharmacy where the products are compounded. Compounded drug products may
not be distributed for resale, including distribution to pharmacies under
common ownership or control, except that a practitioner may obtain compounded
drug products for administration to patients, but not for dispensing. Products
compounded for physician administration to patients shall be labeled. Such
label shall contain:
(i)
the statement: "For Office Use Only";
(ii)
name and strength of the compounded medication or list
of the active ingredients and strengths;
(iii)
facility's control number;
(iv)
"use by" date as determined by the pharmacist using appropriate
documented criteria as outlined in subparagraph (B)(i) of this paragraph;
and
(v)
quantity or amount in the container.
(E)
Compounding pharmacies/pharmacists may advertise and promote
the fact that they provide nonsterile prescription compounding services, but
shall not solicit business by promoting to compound specific drug products.
(3)
Compounding process.
(A)
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.
(B)
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.
(C)
At each step of the compounding process, the pharmacist
shall ensure that components used in compounding are accurately weighed, measured,
or subdivided as appropriate to conform to the formula being prepared.
(D)
The pharmacist shall establish and conduct 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. Such procedures shall be documented in the nonsterile
compounding record.
(E)
Compounding records for all drugs compounded in anticipation
of future prescription drug orders shall be maintained by the pharmacy electronically
or manually as part of the prescription, formula record, formula book, or
compounding log and shall include:
(i)
the date of preparation;
(ii)
facility's lot number;
(iii)
manufacturer's lot number(s) and expiration date(s) for
all components (if the original manufacturer's lot number(s) and expiration
date(s) are not known, the pharmacy shall record the source of acquisition
of the components);
(iv)
a complete formula, including methodology and necessary
equipment;
(v)
signature or initials of the pharmacist or supportive person
performing the compounding;
(vi)
signature or initials of the pharmacist responsible for
supervising supportive personnel and conducting in-process and finals checks
of compounded products if supportive personnel perform the compounding function;
(vii)
the brand name(s) of the raw materials, or if no brand
name, the generic name(s) and the name(s) of the manufacturer(s) of the raw
materials;
(viii)
the quantity in units of finished products or grams
of raw materials;
(ix)
the package size and the number of units prepared;
(x)
documentation of performance of quality control procedures;
and
(xi)
the criteria used to determine the "use by" date.
(F)
Compounding records for all drugs compounded pursuant to
an individual prescription and not in anticipation of future prescription
drug orders shall be maintained by the pharmacy electronically or manually
as part of the prescription, formula record, formula book, or compounding
log and shall include:
(i)
the date of preparation;
(ii)
a complete formula 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 supportive
person performing the compounding;
(iv)
signature or initials of the pharmacist responsible for
supervising supportive personnel and conducting in-process and finals checks
of compounded products if supportive personnel perform the compounding function;
(v)
the quantity in units of finished products or grams of
raw materials;
(vi)
the package size and the number of units prepared; and
(vii)
documentation of performance of quality control procedures.
Documentation of the performance of quality control procedures is not required
if the compounding process involves the mixing of two or more commercially
available oral liquids or commercially available preparations when the final
product is intended for external use.
(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)
quantity added to the automated compounded or counting
device;
(vi)
date of loading;
(vii)
name, initials, or electronic signature of the person
loading the automated compounding or counting device; and
(viii)
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 pharmacy dispensing systems. This paragraph
becomes effective September 1, 2000.
(A)
Authority to use automated pharmacy dispensing systems.
A pharmacy may use an automated pharmacy dispensing system to fill prescription
drug orders provided that:
(i)
the pharmacist-in-charge is responsible for the supervision
of the operation of the system;
(ii)
the automated pharmacy dispensing 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 pharmacy dispensing
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
pharmacy dispensing system to fill prescription drug orders shall operate
according to a written program for quality assurance of the automated pharmacy
dispensing system which:
(i)
requires continuous monitoring of the automated pharmacy
dispensing system; and
(ii)
establishes mechanisms and procedures to test the accuracy
of the automated pharmacy dispensing 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 pharmacy dispensing system is used to
fill prescription drug 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 pharmacy dispensing
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, approval, and accountability
for the transmission of each original or new prescription drug order to the
automated pharmacy dispensing system before the transmission is made;
(III)
provide for access to the automated pharmacy dispensing
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)
require prior to use, that a pharmacist checks, verifies,
and documents that the automated pharmacy dispensing system has been accurately
filled each time the system is stocked;
(V)
provide for an accountability record to be maintained which
documents all transactions relative to stocking and removing medications from
the automated pharmacy dispensing system;
(VI)
require a prospective drug regimen review is conducted
as specified in subsection (c)(2) of this section; and
(VII)
establish and make provisions for documentation of a
preventative maintenance program for the automated pharmacy dispensing system.
(ii)
A pharmacy which uses an automated pharmacy dispensing
system to fill prescription drug 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 pharmacy
dispensing system to fill prescription drug orders shall maintain a written
plan for recovery from a disaster or any other situation which interrupts
the ability of the automated pharmacy dispensing 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 pharmacy dispensing system is experiencing downtime;
(ii)
procedures for response when an automated pharmacy dispensing
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, each patient
of the pharmacy, and other appropriate agencies whenever an automated pharmacy
dispensing 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.
§291.36.Class A Pharmacies Compounding Sterile Pharmaceuticals.
(a)
Purpose. The purpose of this section is to provide standards
for the preparation, labeling, and distribution of compounded sterile pharmaceuticals
by licensed pharmacies, pursuant to a prescription drug order. The intent
of these standards is to provide a minimum level of pharmaceutical care to
the patient so that the patient's health is protected while striving to produce
positive patient outcomes.
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
ACPE--The American Council on Pharmaceutical Education.
(2)
Act--The Texas Pharmacy Act, Chapter 551-556, Occupations
Code, as amended.
(3)
Accurately as prescribed--Dispensing, delivering,
and/or distributing a 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 Chapters 562 and 563 of the Texas
Pharmacy Act.
(4)
Advanced practice nurse--A registered nurse approved
by the Texas State Board of Nurse Examiners to practice as an advanced practice
nurse on the basis of completion of an advanced education program. The term
includes a nurse practitioner, a nurse midwife, a nurse anesthetist, and a
clinical nurse specialist.
(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 is an atmospheric environment which contains
less than 100 particles 0.5 microns in diameter per cubic foot of air;
(B)
Class 10,000 is an atmospheric environment which contains
less than 10,000 particles 0.5 microns in diameter per cubic foot of air;
and
(C)
Class 100,000 is an atmospheric environment which contains
less than 100,000 particles 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)
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.
(9)
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.
(10)
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.
(11)
Board--The Texas State Board of Pharmacy.
(12)
Carrying out or signing a prescription drug order--The
completion of a prescription drug order presigned by the delegating physician,
or the signing of a prescription by an advanced practice nurse or physician
assistant after the person has been designated with the Texas State Board
of Medical Examiners by the delegating physician as a person delegated to
sign a prescription. The following information shall be provided on each prescription:
(A)
patient's name and address;
(B)
name, strength, and quantity of the drug to be dispensed;
(C)
directions for use;
(D)
the intended use of the drug, if appropriate;
(E)
the name, address, and telephone number of the physician;
(F)
the name, address, telephone number, and identification
number of the advanced practice nurse or physician assistant completing the
prescription drug order;
(G)
the date; and
(H)
the number of refills permitted.
(13)
Certified Pharmacy Technician--A pharmacy technician
who:
(A)
has completed the pharmacy technician training program
of the pharmacy;
(B)
has taken and passed the National Pharmacy Technician Certification
Exam or other examination approved during an open meeting by the Board; and
(C)
maintains a current certification with the Pharmacy Technician
Certification Board or any other entity providing an examination approved
by the Board.
(14)
Clean room--A room in which the concentration
of airborne particles is controlled and there are one or more clean zones
according to Federal Standard 209E, et seq.
(15)
Clean zone--A defined space in which the concentration
of airborne particles is controlled to meet a specified airborne particulate
cleanliness class.
(16)
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.
(17)
Confidential record--Any health related record
that contains information that identifies an individual and that is maintained
by a pharmacy or pharmacist such as a patient medication record, prescription
drug order, or medication drug order.
(18)
Controlled area--A controlled area is the area designated
for preparing sterile pharmaceuticals.
(19)
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).
(20)
Critical areas--Any area in the controlled area where
products or containers are exposed to the environment.
(21)
Cytotoxic--A pharmaceutical that has the capability
of killing living cells.
(22)
Dangerous drug--Any drug or device that is not included
in Penalty Groups 1-4 of the Controlled Substances Act and that is unsafe
for self-medication or any drug or device that bears or is required to bear
the legend:
(A)
"Caution: federal law prohibits dispensing without prescription";
or
(B)
"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 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 prescription drug orders to a pharmacist;
(B)
a licensed nurse, physician assistant, or pharmacist employed
in a health care facility to whom the practitioner communicates a prescription
drug order;
(C)
an advanced practice nurse or physician assistant authorized
by a practitioner to carry out or sign a prescription drug order for dangerous
drugs under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations
Code); or
(D)
a person who is a licensed vocational nurse or has an education
equivalent to or greater than that required for a licensed vocational nurse
designated by the practitioner to communicate prescriptions for an advanced
practice nurse or physician assistant authorized by the practitioner to sign
prescription drug orders under Chapter 157 of the Medical Practice Act (Subtitle
B, Occupations Code).
(26)
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.
(27)
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.
(28)
Dispensing pharmacist--The pharmacist responsible
for the final check of the dispensed prescription before delivery to the patient.
(29)
Distribute--The delivery of a prescription drug or
device other than by administering or dispensing.
(30)
Downtime--Period of time during which a data processing
system is not operable.
(31)
Drug regimen review--An evaluation of prescription
drug or medication orders and patient medication records for:
(A)
known allergies;
(B)
rational therapy--contraindications;
(C)
reasonable dose and route of administration;
(D)
reasonable directions for use;
(E)
duplication of therapy;
(F)
drug-drug interactions;
(G)
drug-food interactions;
(H)
drug-disease interactions;
(I)
adverse drug reactions; and
(J)
proper utilization, including overutilization or underutilization.
(32)
Electronic prescription drug order--A prescription
drug order which is transmitted by an electronic device to the receiver (pharmacy).
(33)
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.
(34)
Expiration date--The date (and time, when applicable)
beyond which a product should not be used.
(35)
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.
(36)
Hard copy--A physical document that is readable without
the use of a special device (i.e., cathode ray tube (CRT), microfiche reader,
etc.).
(37)
Medical Practice Act--The Texas Medical Practice
Act, Subtitle B, Occupations Code, as amended.
(38)
New prescription drug order--A prescription drug
order that:
(A)
has not been dispensed to the patient in the same strength
and dosage form by this pharmacy within the last year;
(B)
is transferred from another pharmacy; and/or
(C)
is a discharge prescription drug order. (Note: furlough
prescription drug orders are not considered new prescription drug orders.)
(39)
Original prescription--The:
(A)
original written prescription drug orders; or
(B)
original verbal or electronic prescription drug orders
reduced to writing either manually or electronically by the pharmacist.
(40)
Part-time pharmacist--A pharmacist who works
less than full-time.
(41)
Patient counseling--Communication by the pharmacist
of information to the patient or patient's agent, in order to improve therapy
by ensuring proper use of drugs and devices.
(42)
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.
(43)
Pharmaceutical care--The provision of drug therapy
and other pharmaceutical services intended to assist in the cure or prevention
of a disease, elimination or reduction of a patient's symptoms, or arresting
or slowing of a disease process.
(44)
Pharmacy technicians--Those individuals utilized
in pharmacies whose responsibility it shall be to provide technical services
that do not require professional judgment concerned with the preparation and
distribution of drugs under the direct supervision of and responsible to a
pharmacist. Pharmacy technician includes certified pharmacy technicians, pharmacy
technicians, and pharmacy technician trainees.
(45)
Pharmacy technician trainee--a pharmacy technician:
(A)
participating in a pharmacy's technician training program;
or
(B)
a person currently enrolled in a technician training program
accredited by the American Society of Health-System Pharmacists provided:
(i)
the person is working 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 person is under the direct supervision of and responsible
to a pharmacist; and
(iii)
the supervising pharmacist conducts in-process and final
checks.
(46)
Physician assistant--A physician assistant
recognized by the Texas State Board of Medical Examiners as having the specialized
education and training required under Subtitle B, Chapter 157, Occupations
Code, and issued an identification number by the Texas State Board of Medical
Examiners.
(47)
Practitioner--
(A)
a physician, dentist, podiatrist, veterinarian, or other
person licensed or registered to prescribe, distribute, administer, or dispense
a prescription drug or device in the course of professional practice in this
state;
(B)
a person licensed by another state in a health field in
which, under Texas law, licensees in this state may legally prescribe dangerous
drugs or a person practicing in another state and licensed by another state
as a physician, dentist, veterinarian, or podiatrist, having a current federal
Drug Enforcement Administration registration number, and who may legally prescribe
Schedule II, III, IV, or V controlled substances in such other state; or
(C)
a person licensed in the Dominion of Canada or the United
Mexican States in a health field in which, under the laws of this state, a
licensee may legally prescribe dangerous drugs;
(D)
does not include a person licensed under the Texas Pharmacy
Act.
(48)
Prepackaging--The act of repackaging and relabeling
quantities of drug products from a manufacturer's original commercial container
into a prescription container for dispensing by a pharmacist to the ultimate
consumer.
(49)
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
(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.
(50)
Prescription drug order--
(A)
an order from a practitioner or a practitioner's designated
agent to a pharmacist for a drug or device to be dispensed; or
(B)
an order pursuant to the Subtitle B, Chapter 157, Occupations
Code.
(51)
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.
(52)
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.
(53)
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.
(54)
Sample--A prescription drug which is not intended
to be sold and is intended to promote the sale of the drug.
(55)
State--One of the 50 United States of America, a
U.S. territory, or the District of Columbia.
(56)
Sterile pharmaceutical--A dosage form free from living
micro-organisms.
(57)
Texas Controlled Substances Act--The Texas Controlled
Substances Act, Health and Safety Code, Chapter 481, as amended.
(58)
Unit-dose packaging--The ordered amount of drug in
a dosage form ready for administration to a particular patient, by the prescribed
route at the prescribed time, and properly labeled with name, strength, and
expiration date of the drug.
(59)
Unusable drugs--Drugs or devices that are unusable
for reasons such as they are adulterated, misbranded, expired, defective,
or recalled.
(60)
Written protocol--A physicians order, standing medical
order, standing delegation order, or other order or protocol as defined by
rule of the Texas State Board of Medical Examiners under the Texas Medical
Practice Act.
(c)
Personnel.
(1)
Pharmacist-in-charge.
(A)
General.
(i)
Each Class A pharmacy compounding sterile pharmaceuticals
shall have one pharmacist-in-charge who is employed on a full-time basis,
who may be the pharmacist-in-charge for only one such pharmacy; provided,
however, such pharmacist-in-charge may be the pharmacist-in-charge of more
than one Class A pharmacy, if the additional Class A pharmacies are not open
to provide pharmacy services simultaneously.
(ii)
The pharmacist-in-charge shall comply with the provisions
of 291.17 of this title (relating to Inventory Requirements).
(B)
Responsibilities. The pharmacist-in-charge shall have the
responsibility for, at a minimum, the following:
(i)
ensuring that drugs and/or devices are dispensed and delivered
safely and accurately as prescribed;
(ii)
that a pharmacist communicates to the patient or the patient's
agent information about the prescription drug or device which in the exercise
of the pharmacist's professional judgment, the pharmacist deems significant
as specified in subsection (d)(3) of this section;
(iii)
assuring that a pharmacist communicates to the patient
or the patient's agent on his or her request, information concerning any prescription
drugs dispensed to the patient by the pharmacy;
(iv)
assuring that a reasonable effort is made to obtain, record,
and maintain patient medication records;
(v)
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;
(vi)
establishing policies for procurement of drugs and devices
and storage of all pharmaceutical materials including pharmaceuticals, components
used in the compounding of pharmaceuticals, and drug delivery devices;
(vii)
developing a system for the disposal and distribution
of drugs from the Class A pharmacy;
(viii)
developing a system for bulk compounding or batch preparation
of drugs;
(ix)
developing a system for the compounding, sterility assurance,
quality assurance and quality control of sterile pharmaceuticals;
(x)
participating in those aspects of the patient care evaluation
program relating to pharmaceutical material utilization and effectiveness;
(xi)
implementing the policies and decisions relating to pharmaceutical
services;
(xii)
maintaining records of all transactions of the Class
A pharmacy necessary to maintain accurate control over and accountability
for all pharmaceutical materials required by applicable state and federal
laws and rules;
(xiii)
developing a system to assure the maintenance of effective
controls against the theft or diversion of prescription drugs, and records
for such drugs;
(xiv)
assuring that records in a data processing system are
maintained such that the data processing system is in compliance with this
section;
(xv)
assuring that the pharmacy has a system to dispose of
cytotoxic waste in a manner so as not to endanger the public health; and
(xvi)
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.
(2)
Pharmacists.
(A)
General.
(i)
The pharmacist-in-charge shall be assisted by sufficient
number of additional licensed pharmacists as may be required to operate the
pharmacy competently, safely, and adequately to meet the needs of the patients
of the pharmacy.
(ii)
All pharmacists shall assist the pharmacist-in-charge
in meeting his or her responsibilities in ordering, dispensing, and accounting
for prescription drugs.
(iii)
Pharmacists are solely responsible for the direct supervision
of pharmacy technicians and for designating and delegating duties, other than
those listed in subparagraph (B) of this paragraph, to pharmacy technicians.
Each pharmacist:
(I)
shall verify the accuracy of all acts, tasks, and functions
performed by pharmacy technicians; and
(II)
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.
(v)
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.
(vi)
A dispensing pharmacist shall ensure that the drug is
dispensed and delivered safely, and accurately as prescribed.
(B)
Duties. Duties which may only be performed by a pharmacist
are as follows:
(i)
receiving verbal prescription drug orders and reducing
these orders to writing, either manually or electronically;
(ii)
interpreting and evaluating prescription drug orders;
(iii)
selection of drug products;
(iv)
interpreting patient medication records and performing
drug regimen reviews;
(v)
performing the final check of the dispensed prescription
before delivery to the patient to ensure that the prescription has been dispensed
accurately as prescribed;
(vi)
communicating to the patient or patient's agent information
about the prescription drug or device which in the exercise of the pharmacist's
professional judgment, the pharmacist deems significant as specified in paragraph
(3) of this subsection;
(vii)
communicating to the patient or the patient's agent on
his or her request, information concerning any prescription drugs dispensed
to the patient by the pharmacy;
(viii)
assuring that a reasonable effort is made to obtain,
record, and maintain patient medication records; and
(ix)
performing a specific act of drug therapy management for
a patient delegated to a pharmacist by a written protocol from a physician
licensed in this state in compliance with the Medical Practice Act.
(3)
Pharmacy technicians.
(A)
Qualifications.
(i)
General. All pharmacy technicians shall:
(I)
have a high school or equivalent degree, e.g., GED, or
be currently enrolled in a program which awards such a degree; and
(II)
complete a structured didactic and experiential training
program, which provides instruction and experience in the areas listed in
subparagraph (D) of this paragraph.
(III)
Effective January 1, 2001, all pharmacy technicians must
have taken and passed the National Pharmacy Technician Certification Exam
or other examination approved during an open meeting by the Board or be a
pharmacy technician trainee.
(ii)
Pharmacy Technician Trainee.
(I)
A person shall be designated as a pharmacy technician trainee
while participating in a pharmacy's technician training program in preparation
for the National Pharmacy Technician Certification Exam or other examination
approved during an open meeting by the Board.
(II)
A person may be designated a pharmacy technician trainee
for no more than one year. A person may not be a technician trainee if they
fail to pass the certification exam within this one year training period.
This subclause does not apply to a pharmacy technician trainee working in
a pharmacy as part of a training program accredited by the American Society
of Health-System Pharmacists.
(iii)
Certified Pharmacy Technicians. All certified pharmacy
technicians shall have taken and passed the National Pharmacy Technician Certification
Exam or other examination approved during an open meeting by the Board and
maintain a current certification with the Pharmacy Technician Certification
Board or any other entity providing an examination approved by the Board.
(B)
Duties.
(i)
pharmacy technicians may not perform any of the duties
listed in paragraph (2)(B) of this subsection.
(ii)
A pharmacist may delegate to pharmacy technicians any
nonjudgmental technical duty associated with the preparation and distribution
of prescription drugs provided:
(I)
a pharmacist verifies the accuracy of all acts, tasks,
and functions performed by pharmacy technicians; and
(II)
pharmacy technicians are under the direct supervision
of and responsible to a pharmacist.
(iii)
Pharmacy technicians may perform only nonjudgmental technical
duties associated with the preparation and distribution of prescription drugs,
including but not limited to the following.
(I)
initiating and receiving refill authorization requests;
(II)
entering prescription data into a data processing system;
(III)
taking a stock bottle from the shelf for a prescription;
(IV)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(V)
affixing prescription labels and auxiliary labels to the
prescription container provided:
(-a-)
the pharmacy technician has completed the education and
training requirements outlined in subparagraphs (A) and (D) of this subsection;
and
(-b-)
effective January 1, 2001, only certified pharmacy
technicians may affix a label to a prescription container.
(VI)
reconstituting medications;
(VII)
prepackaging and labeling prepackaged drugs;
(VIII)
loading bulk unlabeled drugs into an automated dispensing
system provided a pharmacist verifies that the system is properly loaded prior
to use;
(IX)
compounding sterile pharmaceuticals provided:
(-a-)
the pharmacy technician has completed the education and
training specified in paragraph (4) of this subsection and the pharmacy technician
is supervised by a pharmacist who has completed the training specified in
paragraph (4) of this subsection; and
(-b-)
effective January 1, 2001, only certified pharmacy
technicians may compound sterile pharmaceuticals.
(X)
compounding non-sterile prescription drug orders; and
(XI)
bulk compounding.
(iv)
Certified pharmacy technicians. Effective January 1, 2001,
only certified pharmacy technicians may:
(I)
affix a label to a prescription container; and
(II)
compound sterile pharmaceuticals.
(C)
Ratio of pharmacist to pharmacy technicians.
(i)
The ratio of pharmacists to pharmacy technicians may not
exceed 1:2 provided that only one pharmacy technician may be engaged in the
compounding of sterile pharmaceuticals.
(ii)
The ratio of pharmacists to pharmacy technicians may be
1:3 provided that at least one of the three technicians is certified and only
one may be engaged in the compounding of sterile pharmaceuticals.
(D)
Training.
(i)
pharmacy technicians shall complete initial training as
outlined by the pharmacist-in-charge in a training manual which includes training
and experience as outlined in subparagraph (E) of this paragraph prior to
the regular performance of their duties. Such training:
(I)
shall include training and experience as outlined in subparagraph
(E) of this paragraph; and
(II)
may not be transferred to another pharmacy unless:
(-a-)
the pharmacies are under common ownership and control
and have a common training program; and
(-b-)
the pharmacist-in-charge of each pharmacy in which
the pharmacy technician works certifies that the pharmacy technician is competent
to perform the duties assigned in that pharmacy.
(ii)
A pharmacy technician shall be designated a pharmacy technician
trainee until completing the full training program. A pharmacy technician
trainee:
(I)
may perform all of the duties of a pharmacy technician
except affix a label to a prescription container and effective January 1,
2001, compound sterile pharmaceuticals;
(II)
may be designated a pharmacy technician trainee for no
longer than one year; and
(III)
shall be counted in the pharmacist to pharmacy technician
ratio.
(iii)
The pharmacist-in-charge shall assure the continuing
competency of pharmacy technicians through-in-service education and training
to supplement initial training.
(iv)
The pharmacist-in-charge shall document the completion
of the training program and certify the competency of pharmacy technicians
completing the training. A written record of initial and in-service training
of pharmacy technicians shall be maintained and contain the following information:
(I)
name of the person receiving the training;
(II)
date(s) of the training;
(III)
general description of the topics covered;
(IV)
a statement or statements that certifies that the pharmacy
technician is competent to perform the duties assigned;
(V)
name of the person supervising the training; and
(VI)
signature of the pharmacy technician and the pharmacist-in-charge
or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge
as responsible for training of pharmacy technicians.
(v)
A person who has previously completed training as a pharmacy
technician, or a licensed nurse or physician assistant is not required to
complete the entire training program if the person is able to show competency
through a documented assessment of competency. Such competency assessment
may be conducted by personnel designated by the pharmacist-in-charge, but
the final acceptance of competency must be approved by the pharmacist-in-charge.
(E)
Training program. Pharmacy technicians training shall be
outlined in a training manual. Such training manual shall, at a minimum, contain
the following:
(i)
written procedures and guidelines for the use and supervision
of pharmacy technicians. Such procedures and guidelines shall:
(I)
specify the manner in which the pharmacist responsible
for the supervision of pharmacy technicians will supervise such personnel
and verify the accuracy and completeness of all acts, task and functions performed
by such personnel; and
(II)
specify duties which may and may not be performed by pharmacy
technicians; and
(ii)
instruction in the following areas and any additional
areas appropriate to the duties of pharmacy technicians in the pharmacy:
(I)
Orientation;
(II)
Job descriptions;
(III)
Communication techniques;
(IV)
Laws and rules;
(V)
Security and safety;
(VI)
Prescription drugs:
(-a-)
Basic pharmaceutical nomenclature;
(-b-)
Dosage forms;
(VII)
Prescription drug orders:
(-a-)
Prescribers;
(-b-)
Directions for use;
(-c-)
Commonly-used abbreviations and symbols;
(-d-)
Number of dosage units;
(-e-)
Strength and systems of measurement;
(-f-)
Route of administration;
(-g-)
Frequency of administration;
(-h-)
Interpreting directions for use;
(VIII)
Prescription drug order preparation:
(-a-)
Creating or updating patient medication records;
(-b-)
Entering prescription drug order information into
the computer or typing the label in a manual system;
(-c-)
Selecting the correct stock bottle;
(-d-)
Accurately counting or pouring the appropriate quantity
of drug product;
(-e-)
Selecting the proper container;
(-f-)
Affixing the prescription label;
(-g-)
Affixing auxiliary labels, if indicated; and
(-h-)
Preparing the finished product for inspection and
final check by pharmacists;
(IX)
Other functions;
(X)
Drug product prepackaging;
(XI)
Compounding of non-sterile pharmaceuticals;
(XII)
Written policy and guidelines for use of and supervision
of pharmacy technicians.
(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 American Council on Pharmaceutical
Education 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, 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 may be 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 American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in subparagraph (A) of this paragraph; and
(II)
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 the qualifications
and training outlined in paragraph (3) of this subsection, all pharmacy technicians
who compound sterile pharmaceuticals shall:
(i)
have a high school or equivalent education;
(ii)
either:
(I)
complete through 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 the:
(-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)
completion of 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; and
(iii)
on January 1, 2001, discontinue preparation of sterile
pharmaceuticals if the technician has not taken and passed the National Pharmacy
Technician Certification Exam or other examination approved during an open
meeting by the Board. Such pharmacy technicians may continue to compound sterile
pharmaceuticals during the interim between the effective date of these rules
and January 1, 2001, if they maintain documentation of completion of the training
specified in clause (ii) of this subparagraph.
(iv)
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.
(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.
(5)
Identification of pharmacy personnel. Pharmacy
personnel shall be identified 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, pharmacy technician, or a certified
pharmacy technician.
(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)
A Class A pharmacy compounding sterile pharmaceuticals
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).
(B)
A Class A pharmacy compounding sterile pharmaceuticals
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).
(C)
A Class A pharmacy compounding sterile pharmaceuticals
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).
(D)
A Class A pharmacy compounding sterile pharmaceuticals
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).
(E)
A Class A pharmacy compounding sterile pharmaceuticals
shall notify the board in writing within ten days of closing, following the
procedures in §291.5 of this title (relating to Closed Pharmacies).
(F)
A separate license is required for each principal place
of business and only one pharmacy license may be issued to a specific location.
(G)
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.
(H)
A Class A pharmacy compounding sterile pharmaceuticals,
licensed under the provisions of the Act, §560.051(a)(1), which also
operates another type of pharmacy which would otherwise be required to be
licensed under the Act, §560.051(a)(2), concerning nuclear pharmacy (Class
B), 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 §291.51
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.
(I)
A Class A pharmacy engaged in nonsterile compounding of
drug products shall comply with the provisions of §§291.31-291.34
of this title (relating to Definitions, Personnel, Operational Standards,
and Records for Class A (Community) Pharmacies) to the extent such rules are
applicable to nonsterile compounding of drug products.
(2)
Environment.
(A)
General requirements.
(i)
The pharmacy shall be enclosed and lockable.
(ii)
The 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.
(iii)
The pharmacy shall be arranged in an orderly fashion
and shall be kept clean. All required equipment shall be clean and in good
operating condition.
(iv)
A sink with hot and cold running water, exclusive of restroom
facilities, designated primarily for use of admixtures, shall be available
within the pharmacy facility to all pharmacy personnel and shall be maintained
in a sanitary condition at all times.
(v)
The pharmacy shall be properly lighted and ventilated.
(vi)
The temperature of the 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.
(vii)
If prescription drug orders are delivered to the patient
at the pharmacy, the pharmacy shall contain an area which is suitable for
confidential patient counseling.
(I)
Such counseling area shall:
(-a-)
be easily accessible to both patient and pharmacists
and not allow patient access to prescription drugs;
(-b-)
be designed to maintain the confidentiality and
privacy of the pharmacist/patient communication.
(II)
In determining whether the area is suitable for confidential
patient counseling and designed to maintain the confidentiality and privacy
of the pharmacist/patient communication, the board may consider factors such
as the following:
(-a-)
the proximity of the counseling area to the check-out
or cash register area;
(-b-)
the volume of pedestrian traffic in and around the
counseling area;
(-c-)
the presence of walls or other barriers between
the counseling area and other areas of the pharmacy; and
(-d-)
any evidence of confidential information being overheard
by persons other than the patient or patient's agent or the pharmacist or
agents of the pharmacist.
(viii)
Animals, including birds and reptiles, shall not be
kept within the pharmacy and in immediately adjacent areas under the control
of the pharmacy. This provision does not apply to fish in aquariums, guide
dogs accompanying disabled persons, or animals for sale to the general public
in a separate area that is inspected by local health jurisdictions.
(B)
Special requirements for the compounding of sterile pharmaceuticals.
When the pharmacy compounds sterile pharmaceuticals, the following is applicable.
(i)
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,
or clean room which is capable of maintaining at least Class 100 conditions
during normal activity. The aseptic environmental control device(s) shall:
(I)
be certified by an independent contractor according to
Federal Standard 209E, et seq, 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.
(ii)
Controlled area. 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:
(I)
have a controlled environment that is aseptic or contains
an aseptic environmental control device(s);
(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)
have non-porous and washable floors or floor covering to
enable regular disinfection;
(VI)
be ventilated in a manner not interfering with aseptic
environmental control conditions;
(VII)
have hard cleanable walls and ceilings (acoustical ceiling
tiles that are coated with an acrylic paint are acceptable);
(VIII)
have drugs and supplies stored on shelving areas above
the floor to permit adequate floor cleaning;
(IX)
contain only the appropriate compounding supplies and
not be used for bulk storage for supplies and materials.
(iii)
End-product evaluation.
(I)
The responsible pharmacist shall verify that the sterile
pharmaceutical was compounded accurately with respect to the use of correct
ingredients, quantities, containers, and reservoirs.
(II)
end product sterility testing according to policies and
procedures, which include a statistically valid sampling plan and acceptance
criteria for the sampling and testing, shall be performed if deemed appropriate
by the pharmacist-in-charge;
(III)
the pharmacist-in-charge shall establish a mechanism
for recalling all products of a specific batch if end-product testing procedures
yield unacceptable results.
(iv)
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.
(v)
Cytotoxic drugs. In addition to the requirements specified
in clause (i) 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.
(-b-)
If the vertical flow biological safety cabinet is
also used to prepare non-cytotoxic sterile pharmaceuticals, the cabinet must
be thoroughly cleaned prior to its use to prepare non-cytotoxic sterile pharmaceuticals.
(C)
Security requirements.
(i)
The pharmacy shall have locked storage for Schedule II
controlled substances and other controlled drugs requiring additional security.
(ii)
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.
(iii)
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.
(iv)
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)
Temporary absence of pharmacist.
(i)
If a pharmacy is staffed by a single pharmacist, the pharmacist
may leave the prescription department for breaks and meal periods without
closing the prescription department and removing pharmacy technicians and
other pharmacy personnel from the prescription department provided the following
conditions are met:
(I)
at least one certified pharmacy technician remains in the
prescription department;
(II)
the pharmacist remains on-site at the licensed location
of the pharmacy and available for an emergency;
(III)
the absence does not exceed 30 minutes at a time and
a total of one hours in a 12 hour period;
(IV)
the pharmacist reasonably believes that the security of
the prescription department will be maintained in his or her absence. If in
the professional judgment of the pharmacist, the pharmacist determines that
the prescription department should close during his or her absence, then the
pharmacist shall close the prescription department and remove the pharmacy
technicians and other pharmacy personnel from the prescription department
during his or her absence; and
(V)
a notice is posted which includes the following information:
(-a-)
the fact that pharmacist is on a break and the time the
pharmacist will return; and
(-b-)
the fact that pharmacy technicians may begin the
processing of prescription drug orders or refills brought in during the pharmacist
absence but the prescription or refill may not be delivered to the patient
or the patient's agent until the pharmacist returns and verifies the accuracy
of the prescription.
(ii)
During the time a pharmacist is absent from the prescription
department, only pharmacy technicians who have completed the pharmacy's training
program may perform the following duties, provided a pharmacist verifies the
accuracy of all acts, tasks, and functions performed by the pharmacy technicians
prior to delivery of the prescription to the patient or the patient's agent:
(I)
initiating and receiving refill authorization requests;
(II)
entering prescription data into a data processing system;
(III)
taking a stock bottle from the shelf for a prescription;
(IV)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(V)
affixing prescription labels and auxiliary labels to the
prescription container. After January 1, 2001, only certified pharmacy technicians
may affix prescription labels to prescription containers; and
(VI)
prepackaging and labeling prepackaged drugs.
(iii)
Upon return to the prescription department, the pharmacist
shall:
(I)
conduct a drug regimen review as specified in paragraph
(4)(A)(ii) of this subsection; and
(II)
verify the accuracy of all acts, tasks, and functions
performed by pharmacy technicians prior to delivery of the prescription to
the patient or the patient's agent.
(iv)
An agent of the pharmacist may deliver a prescription
drug order to the patient or his or her agent provided a record of the delivery
is maintained containing the following information:
(I)
date of the delivery;
(II)
unique identification number of the prescription drug
order;
(III)
patient's name;
(IV)
patient's phone number or the phone number of the person
picking up the prescription; and
(V)
signature of the person picking up the prescription.
(v)
Any prescription delivered to a patient when a pharmacist
is not in the prescription department must meet the requirements for a prescription
delivered to a patient as described in paragraph (3)(A)(v) of this subsection.
(vi)
During the times a pharmacist is absent from the prescription
department a pharmacist intern shall be considered a certified pharmacy technician
and may perform only the duties of a certified pharmacy technician.
(vii)
In pharmacies with two or more pharmacists on duty, the
pharmacists shall stagger their breaks and meal periods so that the prescription
department is not left without a pharmacist on duty.
(3)
Prescription dispensing and delivery.
(A)
Patient counseling and provision of drug information.
(i)
To optimize drug therapy, a pharmacist shall communicate
to the patient or the patient's agent, information about the prescription
drug or device which in the exercise of the pharmacist's professional judgment
the pharmacist deems significant, such as the following:
(I)
the name and description of the drug or device;
(II)
dosage form, dosage, route of administration, and duration
of drug therapy;
(III)
special directions and precautions for preparation, administration,
and use by the patient;
(IV)
common severe side or adverse effects or interactions
and therapeutic contraindications that may be encountered, including their
avoidance, and the action required if they occur;
(V)
techniques for self monitoring of drug therapy;
(VI)
proper storage;
(VII)
refill information; and
(VIII)
action to be taken in the event of a missed dose.
(ii)
Such communication:
(I)
shall be provided with each new prescription drug order,
once yearly on maintenance medications, and if the pharmacist deems appropriate,
with prescription drug order refills. (For the purposes of this clause, maintenance
medications are defined as any medication the patient has taken for one year
or longer);
(II)
shall be provided for any prescription drug order dispensed
by the pharmacy on the request of the patient or patient's agent;
(III)
shall be communicated orally in person unless the patient
or patient's agent is not at the pharmacy or a specific communication barrier
prohibits such oral communication; and
(IV)
shall be reinforced with written information. The following
is applicable concerning this written information.
(-a-)
Written information designed for the consumer such as
the USP DI Patient Information Leaflets shall be provided.
(-b-)
When a compounded product is dispensed, information
shall be provided for the major active ingredient(s), if available.
(-c-)
For new drug entities, if no written information
is initially available, the pharmacist is not required to provide information
until such information is available, provided:
(-1-)
the pharmacist informs the patient or the patient's agent
that the product is a new drug entity and written information is not available;
(-2-)
the pharmacist documents the fact that no written information
was provided; and
(-3-)
if the prescription is refilled after written information
is available, such information is provided to the patient or patient's agent.
(iii)
Only a pharmacist may verbally provide drug information
to a patient or patient's agent and answer questions concerning prescription
drugs. Non-pharmacist personnel may not ask questions of a patient or patient's
agent which are intended to screen and/or limit interaction with the pharmacist.
(iv)
Nothing in this subparagraph shall be construed as requiring
a pharmacist to provide consultation when a patient or patient's agent refuses
such consultation. The pharmacist shall document such refusal for consultation.
(v)
In addition to the requirements of clauses (i)-(iv) of
this subparagraph, if a prescription drug order is delivered to the patient
at the pharmacy, the following is applicable.
(I)
So that a patient will have access to information concerning
his or her prescription, a prescription may not be delivered to a patient
unless a pharmacist is in the pharmacy, except as provided in paragraph (2)(D)
of this subsection or subclause (II) of this clause.
(II)
An agent of the pharmacist may deliver a prescription
drug order to the patient or his or her agent during short periods of time
when a pharmacist is absent from the pharmacy, provided the short periods
of time do not exceed two hours, and provided a record of the delivery is
maintained containing the following information:
(-a-)
date of the delivery;
(-b-)
unique identification number of the prescription
drug order;
(-c-)
patient's name;
(-d-)
patient's phone number or the phone number of the
person picking up the prescription; and
(-e-)
signature of the person picking up the prescription.
(III)
Any prescription delivered to a patient when a pharmacist
is not in the pharmacy must meet the requirements described in clause (vi)
of this subparagraph.
(IV)
A Class A pharmacy compounding sterile pharmaceuticals
that delivers prescriptions to patients or their agents on-site shall make
available for use by the public a current or updated edition of the United
States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient),
or another source of such information, such as patient information leaflets.
(vi)
In addition to the requirements of clauses (i)-(iv) of
this subparagraph, if a prescription drug order is delivered to the patient
or his or her agent at the patient's residence or other designated location,
the following is applicable.
(I)
The information specified in clause (i) of this subparagraph
shall be delivered with the dispensed prescription in writing.
(II)
If prescriptions are routinely delivered outside the area
covered by the pharmacy's local telephone service, the pharmacy shall provide
a toll-free telephone line which is answered during normal business hours
to enable communication between the patient and a pharmacist.
(III)
The pharmacist shall place on the prescription container
or on a separate sheet delivered with the prescription container in both English
and Spanish the local and if applicable, toll-free telephone number of the
pharmacy and the statement: "Written information about this prescription has
been provided for you. Please read this information before you take the medication.
If you have questions concerning this prescription, a pharmacist is available
during normal business hours to answer these questions at (insert the pharmacy's
local and toll-free telephone numbers)."
(IV)
The pharmacist-in-charge shall assure that:
(-a-)
the pharmacy maintain and use adequate storage or shipment
containers and shipping processes to ensure drug stability and potency. Such
shipping processes shall include the use of appropriate packaging material
and/or devices to ensure that the drug is maintained at an appropriate temperature
range to maintain the integrity of the medication throughout the delivery
process; and
(-b-)
the pharmacy uses a delivery system which is designed
to assure that the drugs are delivered to the appropriate patient.
(vii)
The provisions of this subparagraph do not apply to patients
in facilities where drugs are administered to patients by a person authorized
to do so by the laws of the state (i.e., nursing homes).
(B)
Prescription containers.
(i)
A drug dispensed pursuant to a prescription drug order
shall be dispensed in an appropriate container as specified on the manufacturer's
container.
(ii)
Prescription containers or closures shall not be re-used.
(C)
Labeling.
(i)
At the time of delivery of the drug, the dispensing container
of a sterile pharmaceutical shall bear a label with at least the following
information:
(I)
name, address and phone number of the pharmacy, including
a phone number which is answered 24 hours a day;
(II)
date dispensed;
(III)
name of prescribing practitioner;
(IV)
name of patient;
(V)
directions for use, including infusion rate and directions
to the patient for the addition of additives, if applicable;
(VI)
unique identification number of the prescription;
(VII)
name and amount of the base solution and of each drug
added unless otherwise directed by the prescribing practitioner;
(VIII)
initials or identification code of the person preparing
the product and the pharmacist who checked and released the final product;
(IX)
expiration date of the preparation based on published
data;
(X)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including cytotoxic/biohazardous warning labels
where applicable;
(XI)
if the prescription is for a Schedule II-IV controlled
substance, the statement "Caution: Federal law prohibits the transfer of this
drug to any person other than the patient for whom it was prescribed";
(XII)
if the pharmacist has selected a generically equivalent
drug pursuant to the provisions of the Act, Chapters 562 and 563, the statement
"Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where
"Brand Name" is the actual name of the brand name product prescribed; and
(XIII)
the name of the advanced practice nurse or physician
assistant, if the prescription is carried out by an advanced practice nurse
or physician assistant in compliance with Subtitle B, Chapter 157, Occupations
Code.
(ii)
The dispensing container is not required to bear the label
specified in subparagraph (A) of this paragraph if:
(I)
the drug is prescribed for administration to an ultimate
user who is institutionalized in a licensed health care facility (e.g., nursing
home, hospice, hospital);
(II)
no more than a 34-day supply or 100 dosage units, whichever
is less, is dispensed at one time;
(III)
the drug is not in the possession of the ultimate user
prior to administration;
(IV)
the pharmacist-in-charge has determined that the institution:
(-a-)
maintains medication administration records which include
adequate directions for use for the drug(s) prescribed;
(-b-)
maintains records of ordering, receipt, and administration
of the drug(s); and
(-c-)
provides for appropriate safeguards for the control
and storage of the drug(s);
(V)
the system employed by the pharmacy in dispensing the prescription
drug order adequately identifies the:
(-a-)
pharmacy by name and address;
(-b-)
unique identification number of the prescription;
(-c-)
name and strength of the drug dispensed;
(-d-)
the name of the patient;
(-e-)
name of the prescribing practitioner; and
(VI)
the system employed by the pharmacy in dispensing the
prescription drug order adequately sets forth the directions for use and cautionary
statements, if any, contained on the prescription drug order or required by
law.
(4)
Pharmaceutical care services.
(A)
The following pharmaceutical care services shall be provided
by pharmacists of the pharmacy.
(i)
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.
(ii)
Drug regimen review.
(I)
For the purpose of promoting therapeutic appropriateness,
a pharmacist shall evaluate prescription drug orders and patient medication
records for:
(-a-)
known allergies;
(-b-)
rational therapy--contraindications;
(-c-)
reasonable dose and route of administration;
(-d-)
reasonable directions for use;
(-e-)
duplication of therapy;
(-f-)
drug-drug interactions;
(-g-)
drug-food interactions;
(-h-)
drug-disease interactions;
(-i-)
adverse drug reactions;
(-j-)
proper utilization, including overutilization or
underutilization; and
(-k-)
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 subclause (I) of this clause, the pharmacist
shall take appropriate steps to avoid or resolve the problem including consultation
with the prescribing practitioner. The pharmacist shall document such occurrences.
(iii)
Patient care guidelines.
(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 regarding:
(-a-)
appropriate disposition of hazardous solutions and ancillary
supplies;
(-b-)
proper disposition of controlled substances in the
home;
(-c-)
self-administration of drugs, where appropriate;
(-d-)
emergency procedures, including how to contact an
appropriate individual in the event of problems or emergencies related to
drug therapy; and
(-e-)
if the patient or patient's caregiver prepares sterile
preparations in the home, the following additional information shall be provided:
(-1-)
safeguards against microbial contamination, including
aseptic techniques for compounding intravenous admixtures and aseptic techniques
for injecting additives to premixed intravenous solutions;
(-2-)
appropriate storage methods, including storage durations
for sterile pharmaceuticals and expirations of self-mixed solutions;
(-3-)
handling and disposition of premixed and self-mixed intravenous
admixtures; and
(-4-)
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:
(-a-)
the patient's response to drug therapy is monitored and
conveyed to the appropriate health care provider; and
(-b-)
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)
Other pharmaceutical care services which may be provided
by pharmacists include, but are not limited to, the following:
(i)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practice Act;
(ii)
administering immunizations and vaccinations under written
protocol of a physician;
(iii)
managing patient compliance programs;
(iv)
providing preventative health care services; and
(v)
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.
(5)
Equipment and supplies. Class A pharmacies
compounding sterile pharmaceuticals shall have the following equipment and
supplies:
(A)
typewriter or comparable equipment;
(B)
refrigerator and, if sterile pharmaceuticals are stored
in the refrigerator, a system or device (i.e., thermometer) to monitor the
temperature daily to ensure that proper storage requirements are met;
(C)
adequate supply of prescription, poison, and other applicable
labels;
(D)
appropriate equipment necessary for the proper preparation
of prescription drug orders;
(E)
metric-apothecary weight and measure conversion charts;
(F)
if the pharmacy compounds prescription drug orders which
require the use of a balance, a Class A prescription balance, or analytical
balance and weights. Such balance shall be properly maintained and inspected
at least every three years by the appropriate authority as prescribed by local,
state, or federal law or regulations.
(G)
appropriate disposal containers for used needles, syringes,
etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic
agents, and/or biohazardous waste;
(H)
temperature controlled delivery containers;
(I)
infusion devices, if applicable;
(J)
all necessary supplies, including:
(i)
disposable needles, syringes, and other aseptic mixing;
(ii)
disinfectant cleaning solutions;
(iii)
hand washing agents with bacteriocidal 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.
(6)
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; and
(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)
patient information (if prescriptions are delivered to
patients or their agents on-site):
(I)
United States Pharmacopeia Dispensing Information, Volume
II (Advice to the Patient); or
(II)
a reference text or information leaflets which provide
patient information;
(ii)
drug interactions. A reference text on drug interactions,
such as Hansten's and Horn's Drug Interactions;
(iii)
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)
Micromedex;
(iv)
sterile pharmaceuticals. A current or updated reference
text on injectable drug products, such as Handbook on Injectable Drug Products;
(C)
a specialty reference appropriate for the scope of pharmacy
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;
(D)
patient education manuals; and
(E)
basic antidote information and the telephone number of
the nearest regional poison control center.
(7)
Drugs.
(A)
Procurement 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 relative to such responsibility.
(ii)
Prescription drugs and devices shall be stored within
the prescription department or a locked storage area.
(iii)
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.
(B)
Out-of-date and other unusable drugs or devices.
(i)
Any drug or device bearing an expiration date shall not
be dispensed beyond the expiration date of the drug or device.
(ii)
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.
(C)
Class A 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.
(8)
Prepackaging of drugs and loading bulk drugs
into automated compounding or counting devices.
(A)
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:
(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.
(iii)
Records of prepackaging 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, signature, or electronic signature of
the prepacker; and
(X)
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.
(B)
Loading bulk drugs into automated compounding or counting
devices.
(i)
Automated compounding or counting devices may be loaded
with bulk drugs only by a pharmacist or by pharmacy technicians under the
direction and direct supervision of a pharmacist.
(ii)
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.
(iii)
Records of loading bulk 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)
quantity added to the automated compounding or counting
device;
(VI)
date of loading;
(VII)
name, initials, signature, or electronic signature of
the person loading the automated compounding or counting device; and
(VIII)
signature or electronic signature of the responsible
pharmacist.
(iv)
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 or electronic signature to the record specified
in clause (iii) of this subparagraph.
(9)
Sterile pharmaceuticals.
(A)
Batch preparation.
(i)
Master work sheet. A master work sheet shall be developed
and approved by a pharmacist for each batch of sterile pharmaceuticals to
be prepared. 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)
sterilization method(s);
(VII)
specific equipment used during aseptic preparation (e.g.,
specific automated compounding or counting device); and
(VIII)
storage requirements.
(ii)
Preparation work sheet. The preparation work sheet for
each batch of sterile pharmaceuticals shall document the following:
(I)
identity of all solutions and ingredients and their corresponding
amounts, concentrations, or volumes;
(II)
manufacturer lot number for each component;
(III)
component manufacturer 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.
(iii)
Label. The label of each batch prepared sterile pharmaceutical
shall bear at a minimum:
(I)
the unique lot number assigned to the batch;
(II)
all solution and ingredient names, amounts, strengths,
and concentrations, when applicable;
(III)
quantity;
(IV)
expiration date and time, when applicable;
(V)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including cytotoxic warning labels where appropriate;
and
(VI)
device-specific instructions, when appropriate.
(B)
Expiration date.
(i)
The expiration date assigned shall be based on currently
available drug stability information and sterility considerations or appropriate
in-house or contract service stability testing.
(ii)
Sources of drug stability information shall include the
following:
(I)
references (e.g., Remington's Pharmaceutical Sciences,
Handbook on Injectable Drugs);
(II)
manufacturer recommendations; and
(III)
reliable, published research.
(iii)
When interpreting published drug stability information,
the pharmacist shall consider all aspects of the final sterile product being
prepared (e.g., drug reservoir, drug concentration, storage conditions).
(iv)
Methods used for establishing expiration dates shall be
documented.
(C)
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 pharmaceuticals which are sterile and stable.
Quality control procedures shall include, but are not limited to, the following:
(i)
recall procedures;
(ii)
storage and dating;
(iii)
documentation of appropriate functioning of refrigerator,
freezer, and other equipment;
(iv)
documentation of aseptic environmental control device(s)
certification at least every six months and the regular replacement of pre-filters
as necessary; and
(v)
a process to evaluate and confirm the quality of the prepared
pharmaceutical product.
(D)
Quality assurance.
(i)
There shall be a documented, ongoing quality assurance
program for monitoring and evaluating personnel performance and patient outcomes
to assure an efficient drug delivery process, patient safety, and positive
clinical outcomes.
(ii)
There shall be documentation of quality assurance audits
at regular, planned intervals including infection control, sterile technique,
delivery systems/times, order transcription accuracy, drug administration
systems, adverse drug reactions, and drug therapy appropriateness.
(iii)
A plan for corrective action of program of problems identified
by quality assurance audits shall be developed which includes procedures for
documentation of identified problems and action taken.
(iv)
A periodic evaluation of the effectiveness of the quality
assurance activities shall be completed and documented.
(e)
Records.
(1)
Maintenance of records.
(A)
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.
(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, 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.
(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 system or direct imaging system provided:
(i)
the records maintained in the alternative system contain
all of the information required on the manual record; and
(ii)
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.
(2)
Prescriptions.
(A)
Professional responsibility. Pharmacists shall exercise
sound professional judgment with respect to the accuracy and authenticity
of any prescription drug order they dispense. If the pharmacist questions
the accuracy or authenticity of a prescription drug order, he/she shall verify
the order with the practitioner prior to dispensing.
(B)
Written prescription drug orders.
(i)
Practitioner's signature. Written 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 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 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 prescription
drug order does not conform in all essential respects to the law and regulations.
(ii)
Required prescription drug order format.
(I)
A pharmacist may not dispense a written prescription drug
order issued in Texas unless it is ordered on a form containing two signature
lines of equal prominence, side by side, at the bottom of the form. Under
either signature line shall be printed clearly the words "product selection
permitted," and under the other signature line shall be printed clearly the
words "dispense as written."
(II)
The two signature line requirement does not apply to the
following types of prescriptions drug orders:
(-a-)
prescription drug orders issued by a practitioner in
a state other than Texas;
(-b-)
prescription drug orders for dangerous drugs issued
by a practitioner in the United Mexican States or the Dominion of Canada;
and
(-c-)
prescription drug orders issued by practitioners
practicing in a federal facility provided they are acting in the scope of
their employment.
(iii)
Preprinted prescription drug order forms. No prescription
drug order form furnished to a practitioner shall contain a preprinted order
for a drug product by brand name, generic name, or manufacturer.
(iv)
Prescription drug orders written by practitioners in another
state.
(I)
Dangerous drug prescription orders. A pharmacist may dispense
a prescription drug order for dangerous drugs issued by practitioners in a
state other than Texas in the same manner as prescription drug orders for
dangerous drugs issued by practitioners in Texas are dispensed.
(II)
Controlled substance prescription drug orders.
(-a-)
A pharmacist may dispense prescription drug order for
controlled substances in Schedule II issued by a practitioner in another state
provided:
(-1-)
the prescription is filled in compliance with a written
plan approved by the Director of the Texas Department of Public Safety in
consultation with the Board, which provides the manner in which the dispensing
pharmacy may fill a prescription for a Schedule II controlled substance;
(-2-)
the 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 (DEA) registration number, and who may legally
prescribe Schedule II controlled substances in such other state; and
(-3-)
the prescription drug order is not dispensed after the
end of the seventh day after the date on which the prescription is issued.
(-b-)
A pharmacist may dispense prescription drug
orders for controlled substances in Schedule III, IV, or V issued by a practitioner
in another state provided:
(-1-)
the 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;
(-2-)
the 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
(-3-)
if there are no refill instructions on the original written
prescription drug order (which shall be interpreted as no refills authorized)
or if all refills authorized on the original written prescription drug order
have been dispensed, a new written prescription drug order is obtained from
the prescribing practitioner prior to dispensing any additional quantities
of controlled substances.
(v)
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 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 dangerous drug prescription issued by a person licensed in
the Dominion of Canada or the United Mexican States as a physician, dentist,
veterinarian, or podiatrist provided:
(-a-)
the prescription drug order is an original written prescription;
and
(-b-)
if there are no refill instructions on the original
written prescription drug order (which shall be interpreted as no refills
authorized) or if all refills authorized on the original written prescription
drug order have been dispensed, a new written prescription drug order shall
be obtained from the prescribing practitioner prior to dispensing any additional
quantities of dangerous drugs.
(vi)
Prescription drug orders carried out or signed by an advanced
practice nurse or physician assistant.
(I)
A pharmacist may dispense a prescription drug order for
a dangerous drug which is carried out or signed by an advanced practice nurse
or physician assistant provided:
(-a-)
the prescription is for a dangerous drug and not for
a controlled substance; and
(-b-)
the advanced practice nurse or physician assistant
is practicing in accordance with Subtitle B, Chapter 157, Occupations Code.
(II)
Each practitioner shall designate in writing the name
of each advanced practice nurse or physician assistant authorized to carry
out or sign a prescription drug order pursuant to Subtitle B, Chapter 157,
Occupations Code. A list of the advanced practice nurses or physician assistants
designated by the practitioner must be maintained in the practitioner's usual
place of business. On request by a pharmacist, a practitioner shall furnish
the pharmacist with a copy of the written authorization for a specific advanced
practice nurse or physician assistant.
(vii)
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 an official prescription form as required
by the Texas Controlled Substances Act, §481.075.
(C)
Verbal prescription drug orders.
(i)
A verbal prescription drug order from a practitioner or
a practitioner's designated agent may only be received by a pharmacist or
a pharmacist-intern under the direct supervision of a pharmacist.
(ii)
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.
(iii)
If a prescription drug order is transmitted to a pharmacist
verbally, the pharmacist shall note any substitution instructions by the practitioner
or practitioner's agent on the file copy of the prescription drug order. Such
file copy may follow the two-line format indicated in subparagraph (B)(ii)
of this paragraph, or any other format that clearly indicates the substitution
instructions.
(iv)
A pharmacist may not dispense a verbal 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.
(v)
A pharmacist may not dispense a verbal 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.
(D)
Electronic prescription drug orders. For the purpose of
this subparagraph, electronic prescription drug orders shall be considered
the same as verbal prescription drug orders.
(i)
An electronic 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:
(-a-)
the prescription information is not altered during transmission;
and
(-b-)
confidential patient information is not accessed
or maintained by the operator of the data communication device unless the
operator is authorized to receive the confidential information as specified
in subsection (k) of this section.
(ii)
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.
(iii)
A pharmacist may not dispense an electronic prescription
drug order for a:
(I)
Schedule II controlled substance;
(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.
(iv)
The practitioner or practitioner's agent shall note any
substitution instructions on the electronic prescription drug order. Such
electronic prescription drug order may follow the two-line format indicated
in subparagraph (B)(ii) of this paragraph or any other format that clearly
indicated the substitution instructions.
(E)
Authorization for generic substitution.
(i)
A pharmacist may dispense a generically equivalent drug
product if:
(I)
the generic product cost the patient less than the prescribed
drug product;
(II)
the patient does not refuse the substitution; and
(III)
the prescribing practitioner authorizes the substitution
of a generically equivalent product; or
(IV)
the practitioner or practitioner's agent does not clearly
indicate that the verbal or electronic prescription drug order shall be dispensed
as ordered.
(ii)
Practitioners shall indicate their dispensing instructions
by signing on either the "Dispense as Written" or "Product Selection Permitted"
line on the prescription drug order. If the practitioner's signature does
not clearly indicate the prescription drug order shall be dispensed as written,
the pharmacist may substitute a generically equivalent drug product.
(iii)
A pharmacist may not substitute on prescription drug
orders identified in subparagraph (B)(iv) and (v) of this paragraph unless
the practitioner has authorized substitution on the prescription drug order.
(iv)
If the practitioner has not authorized substitution on
the written prescription drug order, a pharmacist shall not substitute a generically
equivalent drug product unless:
(I)
the pharmacist obtains verbal or written authorization
from the practitioner (such authorization shall be noted on the original prescription
drug order); or
(II)
the pharmacist obtains written documentation regarding
substitution requirements from the State Board of Pharmacy in the state, other
than Texas, in which the prescription drug order was issued. The following
is applicable concerning this documentation.
(-a-)
The documentation shall state that a pharmacist may substitute
on a prescription drug order issued in such other state unless the practitioner
prohibits substitution on the original prescription drug order.
(-b-)
The pharmacist shall note on the original prescription
drug order the fact that documentation from such other state board of pharmacy
is on file.
(-c-)
Such documentation shall be updated yearly.
(F)
Substitution of dosage form.
(i)
A pharmacist may dispense a dosage form of a drug product
different from that prescribed, such as a tablet instead of a capsule or liquid
instead of tablets, provided:
(I)
the patient consents to the dosage form substitution;
(II)
the pharmacist notifies the practitioner of the dosage
form substitution; and
(III)
the dosage form so dispensed:
(-a-)
contains the identical amount of the active ingredients
as the dosage prescribed for the patient;
(-b-)
is not an enteric-coated or time release product;
and
(-c-)
does not alter desired clinical outcomes.
(ii)
Substitution of dosage form may not include the substitution
of a product that has been compounded by the pharmacist unless the pharmacist
contacts the practitioner prior to dispensing and obtains permission to dispense
the compounded product.
(G)
Therapeutic Drug Interchange. A switch to a drug providing
a similar therapeutic response to the one prescribed shall not be made without
prior approval of the prescribing practitioner. This subparagraph does not
apply to generic substitution. For generic substitution, see the requirements
of subparagraphs (E) and (F) of this paragraph.
(i)
The patient shall be notified of the therapeutic drug interchange
prior to, or upon delivery, of the dispensed prescription to the patient.
Such notification shall include:
(I)
a description of the change;
(II)
the reason for the change;
(III)
whom to notify with questions concerning the change;
and
(IV)
instructions for return of the drug if not wanted by the
patient.
(ii)
The pharmacy shall maintain documentation of patient notification
of therapeutic drug interchange which shall include:
(I)
the date of the notification;
(II)
the method of notification;
(III)
a description of the change; and
(IV)
the reason for the change.
(H)
Original prescription drug order records.
(i)
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.
(ii)
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.
(iii)
Original prescriptions shall be maintained in one of
the following formats:
(I)
in three separate files as follows:
(-a-)
prescriptions for controlled substances listed in Schedule
II;
(-b-)
prescriptions for controlled substances listed in
Schedule III-V; and
(-c-)
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 official prescriptions
for Schedule II controlled substances are maintained separate from all other
original prescriptions.
(iv)
Original prescription records other than prescriptions
for Schedule II controlled substances 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 clause (iii) of this subparagraph.
(III)
The pharmacy must provide immediate access to equipment
necessary to render the records easily readable.
(I)
Prescription drug order information.
(i)
All original prescriptions shall bear:
(I)
name of the patient;
(II)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as medication records;
(III)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner;
(IV)
name and strength of the drug prescribed;
(V)
quantity prescribed;
(VI)
directions for use;
(VII)
intended use for the drug unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
(VIII)
date of issuance; and
(IX)
if telephoned to the pharmacist by a designated agent,
the full name of the designated agent.
(ii)
All original prescriptions for dangerous drugs carried
out by an advanced practice nurse or physician assistant in accordance with
Subtitle B, Chapter 157, Occupations Code, shall bear:
(I)
name and address of the patient;
(II)
name, address, and telephone number of the practitioner;
(III)
name, address, telephone number, identification number,
and original signature of the advanced practice nurse or physician assistant;
(IV)
name, strength, and quantity of the dangerous drug;
(V)
directions for use;
(VI)
the intended use of the drug, if appropriate;
(VII)
date of issuance; and
(VIII)
number of refills authorized.
(iii)
All original electronic prescription drug orders shall
bear:
(I)
name of the patient;
(II)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as patient medication records;
(III)
name and strength of the drug prescribed;
(IV)
quantity prescribed;
(V)
directions for use;
(VI)
intended use for the drug unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
(VII)
date of issuance;
(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;
and
(XII)
if transmitted by a designated agent, the full name of
the designated agent.
(iv)
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 pharmaceutical 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 pharmaceutical; and
(IV)
date of dispensing, if different from the date of issuance.
(J)
Refills.
(i)
Refills may be dispensed only in accordance with the prescriber's
authorization as indicated on the original prescription drug order. Such refills
may be indicated as authorization to refill the prescription drug order a
specified number of times or for a specified period of time period, such as
the duration of therapy.
(ii)
If there are no refill instructions on the original prescription
drug order (which shall be interpreted as no refills authorized) or if all
refills authorized on the original prescription drug order have been dispensed,
authorization from the prescribing practitioner shall be obtained prior to
dispensing any refills.
(iii)
Refills of prescription drug orders for dangerous drugs
or nonprescription drugs shall be dispensed as follows.
(I)
Prescription drug orders for dangerous drugs or nonprescription
drugs may not be refilled after one year from the date of issuance of the
original prescription order.
(II)
If one year has expired from the date of issuance of an
original prescription drug order for a dangerous drug or nonprescription drug,
authorization shall be obtained from the prescribing practitioner prior to
dispensing any additional quantities of the drug.
(iv)
Refills of prescription drug orders for Schedule III-V
controlled substances shall be dispensed as follows.
(I)
Prescription drug orders for Schedule III-V controlled
substances may not be refilled more than five times or after six months from
the date of issuance of the original prescription drug order, whichever occurs
first.
(II)
If a prescription drug order for a Schedule III, IV, or
V controlled substance has been refilled a total of five times or if six months
have expired from the date of issuance of the original prescription drug order,
whichever comes first, a new and separate prescription drug order shall be
obtained from the prescribing practitioner prior to dispensing any additional
quantities of controlled substances.
(v)
A pharmacist may exercise his professional judgment in
refilling a prescription drug order for a drug, other than a controlled substance
listed in Schedule II, without the authorization of the prescribing practitioner,
provided:
(I)
failure to refill the prescription might result in an interruption
of a therapeutic regimen or create patient suffering;
(II)
either:
(-a-)
a natural or manmade disaster has occurred which prohibits
the pharmacist from being able to contact the practitioner; or
(-b-)
the pharmacist is unable to contact the practitioner
after a reasonable effort;
(III)
the quantity of prescription drug dispensed does not
exceed a 72-hour supply;
(IV)
the pharmacist informs the patient or the patient's agent
at the time of dispensing that the refill is being provided without such authorization
and that authorization of the practitioner is required for future refills;
(V)
the pharmacist informs the practitioner of the emergency
refill at the earliest reasonable time;
(VI)
the pharmacist maintains a record of the emergency refill
containing the information required to be maintained on a prescription as
specified in this paragraph;
(VII)
the pharmacist affixes a label to the dispensing container
as specified in this paragraph; and
(VIII)
if the prescription was initially filled at another
pharmacy, the pharmacist may exercise his professional judgment in refilling
the prescription provided:
(-a-)
the patient has the prescription container, label, receipt
or other documentation from the other pharmacy which contains the essential
information;
(-b-)
after a reasonable effort, the pharmacist is unable
to contact the other pharmacy to transfer the remaining prescription refills
or there are no refills remaining on the prescription;
(-c-)
the pharmacist, in his professional judgment, determines
that such a request for an emergency refill is appropriate and meets the requirements
of subclauses (I) and (II) of this clause; and
(IX)
the pharmacist complies with the requirements of subclauses
(III)-(V) of this clause.
(3)
Prescription drug order records maintained
in a manual system.
(A)
Original prescriptions. Original prescriptions shall be
maintained in three files as specified in paragraph (2)(H)(iii) of this subsection.
(B)
Refills.
(i)
Each time a prescription drug order is refilled, a record
of such refill shall be made:
(I)
on the back of the prescription by recording the date of
dispensing, the written initials or identification code of the dispensing
pharmacist and the amount dispensed. (If the pharmacist merely initials and
dates the back of the prescription drug order, he or she shall be deemed to
have dispensed a refill for the full face amount of the prescription drug
order); or
(II)
on another appropriate, uniformly maintained, readily
retrievable record, such as patient medication records, which indicates by
patient name the following information:
(-a-)
unique identification number of the prescription;
(-b-)
name, strength, and lot number of each drug product
used in compounding the sterile pharmaceutical;
(-c-)
date of each dispensing;
(-d-)
quantity dispensed at each dispensing;
(-e-)
initials or identification code of person who compounded
the sterile pharmaceutical and the pharmacist who checks and releases the
final product; and
(-f-)
total number of refills for the prescription.
(ii)
If refill records are maintained in accordance with clause
(i)(II) of this subparagraph, refill records for controlled substances in
Schedule III-V shall be maintained separately from refill records of dangerous
drugs and nonprescription drugs.
(C)
Authorization of refills. Practitioner authorization for
additional refills of a prescription drug order shall be noted on the original
prescription, in addition to the documentation of dispensing the refill.
(D)
Transfer of prescription drug order information. For the
purpose of refill or initial dispensing, the transfer of original prescription
drug order information is permissible between pharmacies, subject to the following
requirements.
(i)
The transfer of original prescription drug order information
for controlled substances listed in Schedules III, IV, or V is permissible
between pharmacies on a one-time basis.
(ii)
The transfer of original prescription drug order information
for dangerous drugs is permissible between pharmacies without limitation up
to the number of originally authorized refills.
(iii)
The transfer is communicated directly between pharmacists
and/or pharmacist interns.
(iv)
Both the original and the transferred prescription drug
order are maintained for a period of two years from the date of last refill.
(v)
The pharmacist or pharmacist intern transferring the prescription
drug order information shall:
(I)
write the word "void" on the face of the invalidated prescription
drug order; and
(II)
record on the reverse of the invalidated prescription
drug order the following information:
(-a-)
the name, address, and, if a controlled substance, the
DEA registration number of the pharmacy to which such prescription drug order
is transferred;
(-b-)
the name of the pharmacist or pharmacist intern
receiving the prescription drug order information;
(-c-)
the name of the pharmacist or pharmacist intern
transferring the prescription drug order information; and
(-d-)
the date of the transfer.
(vi)
The pharmacist or pharmacist intern receiving the transferred
prescription drug order information shall:
(I)
write the word "transfer" on the face of the transferred
prescription drug order; and
(II)
record on the transferred prescription drug order the
following information:
(-a-)
original date of issuance and date of dispensing or receipt,
if different from date of issuance;
(-b-)
original prescription number and the number of refills
authorized on the original prescription drug order;
(-c-)
number of valid refills remaining and the date of
last refill, if applicable;
(-d-)
name, address, and, if a controlled substance, the
DEA registration number of the pharmacy from which such prescription information
is transferred; and
(-e-)
name of the pharmacist or pharmacist intern transferring
the prescription drug order information.
(E)
A pharmacist or pharmacist intern may not refuse to transfer
original prescription information to another pharmacist or pharmacist intern
who is acting on behalf of a patient and who is making a request for this
information as specified in subparagraph (D) of this paragraph.
(4)
Prescription drug order records maintained in
a data processing system.
(A)
General requirements for records maintained in a data processing
system.
(i)
Compliance with data processing system requirements. If
a pharmacy's data processing system is not in compliance with this subsection,
the pharmacy must maintain a manual recordkeeping system as specified in paragraph
(3) of this subsection.
(ii)
Original prescriptions. Original prescriptions shall be
maintained as specified in paragraph (2)(F)(iii) of this subsection.
(iii)
Requirements for backup systems.
(I)
The pharmacy 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, at least monthly,
to assure that data is not lost due to system failure.
(II)
Data processing systems shall have a workable (electronic)
data retention system which can produce an audit trail of drug usage for the
preceding two years as specified in subparagraph (B)(vii) of this paragraph.
(iv)
Change or discontinuance of a data processing system.
(I)
Records of dispensing. A pharmacy that changes or discontinues
use of a data processing system must:
(-a-)
transfer the records of dispensing to the new data processing
system; or
(-b-)
purge the records of dispensing to a printout which
contains the same information required on the daily printout as specified
in subparagraph (B) (ii) of this paragraph. The information on this hard-copy
printout shall be sorted and printed by prescription number and list each
dispensing for this prescription 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.
(v)
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.
(B)
Records of dispensing.
(i)
Each time a prescription drug order is filled or refilled,
a record of such dispensing shall be entered into the data processing system.
(ii)
The data processing system shall have the capacity to
produce a daily hard-copy printout of all original prescriptions dispensed
and refilled. This hard-copy printout shall contain the following information:
(I)
unique identification number of the prescription;
(II)
date of dispensing;
(III)
patient name;
(IV)
prescribing practitioner's name;
(V)
name and amount of each drug product used in compounding
the sterile pharmaceutical;
(VI)
total quantity dispensed;
(VII)
initials or an identification code of the dispensing
pharmacist; and
(VIII)
if not immediately retrievable via CRT display, the
following shall also be included on the hard-copy printout:
(-a-)
patient's address;
(-b-)
prescribing practitioner's address;
(-c-)
practitioner's DEA registration number, if the prescription
drug order is for a controlled substance;
(-d-)
quantity prescribed, if different from the quantity
dispensed;
(-e-)
date of issuance of the prescription drug order,
if different from the date of dispensing; and
(-f-)
total number of refills dispensed to date for that
prescription drug order.
(iii)
The daily hard-copy printout shall be produced within
72 hours of the date on which the prescription drug orders were dispensed
and shall be maintained in a separate file at the pharmacy. Records of controlled
substances shall be readily retrievable from records of noncontrolled substances.
(iv)
Each individual pharmacist who dispenses or refills a
prescription drug order shall verify that the data indicated on the daily
hard-copy printout is correct, by dating and signing such document in the
same manner as signing a check or legal document (e.g., J.H. Smith or John
H. Smith) within seven days from the date of dispensing.
(v)
In lieu of the printout described in clause (ii) of this
subparagraph, the pharmacy shall maintain a log book in which each individual
pharmacist using the data processing system shall sign a statement each day,
attesting to the fact that the information entered into the data processing
system that day has been reviewed by him or her and is correct as entered.
Such log book shall be maintained at the pharmacy employing such a system
for a period of two years after the date of dispensing; provided, however,
that the data processing system can produce the hard-copy printout on demand
by an authorized agent of the Texas State Board of Pharmacy, Texas Department
of Public Safety, or Drug Enforcement Administration. If no printer is available
on site, the hard-copy printout shall be available within 48 hours with a
certification by the individual providing the printout which states that the
printout is true and correct as of the date of entry and such information
has not been altered, amended, or modified.
(vi)
The pharmacist-in-charge is responsible for the proper
maintenance of such records and responsible that such data processing system
can produce the records outlined in this section and that such system is in
compliance with this subsection.
(vii)
The data processing system shall be capable of producing
a hard-copy printout of an audit trail for all dispensings (original and refill)
of any specified strength and dosage form of a drug (by either brand or generic
name or both) during a specified time period.
(I)
Such audit trail shall contain all of the information required
on the daily printout as set out in clause (ii) of this subparagraph.
(II)
The audit trail required in this subparagraph shall be
supplied by the pharmacy within 48 hours, if requested by an authorized agent
of the Texas State Board of Pharmacy, Texas Department of Public Safety, or
Drug Enforcement Administration.
(viii)
Failure to provide the records set out in this paragraph,
either on site or within 48 hours for whatever reason, constitutes prima facie
evidence of failure to keep and maintain records.
(ix)
The data processing system shall provide on-line retrieval
(via CRT display or hard-copy printout) of the information set out in clause
(ii) of this subparagraph of:
(I)
the original controlled substance prescription drug orders
currently authorized for refilling; and
(II)
the current refill history for Schedule III, IV, and V
controlled substances for the immediately preceding six-month period.
(x)
In the event that a pharmacy which uses a data processing
system experiences system downtime, the following is applicable:
(I)
an auxiliary procedure shall ensure that refills are authorized
by the original prescription drug order and that the maximum number of refills
has not been exceeded or authorization from the prescribing practitioner shall
be obtained prior to dispensing a refill; and
(II)
all of the appropriate data shall be retained for on-line
data entry as soon as the system is available for use again.
(C)
Authorization of refills. Practitioner authorization for
additional refills of a prescription drug order shall be noted as follows:
(i)
on the hard-copy prescription drug order;
(ii)
on the daily hard-copy printout; or
(iii)
via the CRT display.
(D)
Transfer of prescription drug order information. For the
purpose of refill or initial dispensing, the transfer of original prescription
drug order information is permissible between pharmacies, subject to the following
requirements.
(i)
The transfer of original prescription drug order information
for controlled substances listed in Schedules III, IV, or V is permissible
between pharmacies on a one-time basis only. However, pharmacies electronically
sharing a real-time, on-line database may transfer up to the maximum refills
permitted by law and the prescriber's authorization.
(ii)
The transfer of original prescription drug order information
for dangerous drugs is permissible between pharmacies without limitation up
to the number of originally authorized refills.
(iii)
The transfer is communicated directly between pharmacists
and/or pharmacist interns or as authorized in paragraph (3)(D) of this subsection.
(iv)
Both the original and the transferred prescription drug
orders are maintained for a period of two years from the date of last refill.
(v)
The pharmacist or pharmacist intern transferring the prescription
drug order information shall:
(I)
write the word "void" on the face of the invalidated prescription
drug order; and
(II)
record on the reverse of the invalidated prescription
drug order the following information:
(-a-)
the name, address, and, if a controlled substance, the
DEA registration number of the pharmacy to which such prescription is transferred;
(-b-)
the name of the pharmacist or pharmacist intern
receiving the prescription drug order information;
(-c-)
the name of the pharmacist or pharmacist intern
transferring the prescription drug order information; and
(-d-)
the date of the transfer.
(vi)
The pharmacist or pharmacist intern receiving the transferred
prescription drug order information shall:
(I)
write the word "transfer" on the face of the transferred
prescription drug order; and
(II)
record on the transferred prescription drug order the
following information:
(-a-)
original date of issuance and date of dispensing or receipt,
if different from date of issuance;
(-b-)
original prescription number and the number of refills
authorized on the original prescription drug order;
(-c-)
number of valid refills remaining and the date of
last refill, if applicable;
(-d-)
name, address, and, if a controlled substance, the
DEA registration number of the pharmacy from which such prescription drug
order information is transferred; and
(-e-)
name of the pharmacist or pharmacist intern transferring
the prescription drug order information.
(vii)
Prescription drug orders may not be transferred by non-electronic
means during periods of downtime except on consultation with and authorization
by a prescribing practitioner; provided however, during downtime, a hard copy
of a prescription drug order may be made available for informational purposes
only, to the patient, a pharmacist or pharmacist intern, and the prescription
may be read to a pharmacist or pharmacist intern by telephone.
(viii)
The original prescription drug order shall be invalidated
in the data processing system for purposes of filling or refilling, but shall
be maintained in the data processing system for refill history purposes.
(ix)
If the data processing system has the capacity to store
all the information required in clause (v) and (vi) of this subparagraph,
the pharmacist is not required to record this information on the original
or transferred prescription drug order.
(x)
The data processing system shall have a mechanism to prohibit
the transfer or refilling of controlled substance prescription drug orders
which have been previously transferred.
(E)
Electronic transfer of prescription drug order information
between pharmacies. Pharmacies electronically accessing the same prescription
drug order records may electronically transfer prescription information if
the following requirements are met.
(i)
The original prescription is voided and the following information
is documented in the records of the transferring pharmacy;
(I)
the name, address, and if a controlled substance, the DEA
registration number of the pharmacy to which such prescription is transferred;
(II)
the name of the pharmacist or pharmacist intern receiving
the prescription drug order information; and
(III)
the date of the transfer.
(ii)
Pharmacies not owned by the same person may electronically
access the same prescription drug order records, provided the owner or chief
executive officer of each pharmacy signs an agreement allowing access to such
prescription drug order records.
(F)
A pharmacist or pharmacist intern may not refuse to transfer
original prescription information to another pharmacist or pharmacist intern
who is acting on behalf of a patient and who is making a request for this
information as specified in subparagraph (D) of this paragraph.
(5)
Limitation to one type of recordkeeping system.
When filing prescription drug order information a pharmacy may use only one
of the two systems described in paragraph (3) or (4) of this subsection.
(6)
Policy and procedure manual. A policy and procedure
manual as it relates to the sterile pharmaceuticals shall be maintained at
the pharmacy and be available for inspection. The manual shall include policies
and procedures for:
(A)
pharmaceutical care services;
(B)
handling, storage, and disposal of cytotoxic/biohazardous
drugs and waste;
(C)
disposal of unusable drugs, supplies, and returns;
(D)
security;
(E)
equipment;
(F)
sanitation;
(G)
reference materials;
(H)
drug selection and procurement;
(I)
drug storage;
(J)
drug administration to include infusion devices, drug delivery
systems, and first dose monitoring;
(K)
drug labeling;
(L)
delivery of drugs;
(M)
recordkeeping;
(N)
controlled substances;
(O)
investigational drugs, including the obtaining of protocols
from the principal investigator;
(P)
quality assurance/quality control;
(Q)
duties and education and training of professional and nonprofessional
staff; and
(R)
emergency preparedness plan, to include continuity of patient
and public safety.
(7)
Patient Medication Record (PMR). A PMR shall
be maintained for each patient of the pharmacy. The PMR shall contain at a
minimum the following.
(A)
Patient information:
(i)
patient's full name, gender, and date of birth;
(ii)
weight and height;
(iii)
known drug sensitivities and allergies to drugs and/or
food;
(iv)
primary diagnosis and chronic conditions;
(v)
other drugs the patient is receiving;
(vi)
documentation of patient training;
(vii)
pharmacist's comments relevant to the individual's drug
therapy, including any other information unique to the specific patient or
drug.
(B)
Prescription drug order information:
(i)
date of dispensing each sterile pharmaceutical;
(ii)
unique identification number of the prescription;
(iii)
physician's name;
(iv)
name, quantity, and lot number of each product used in
compounding the sterile pharmaceutical;
(v)
quantity dispensed; and
(vi)
directions for use and method of administration, including
infusion rate if applicable.
(C)
Nothing in this paragraph shall be construed as requiring
a pharmacist to obtain, record, and maintain patient information other than
prescription drug order information when a patient or patient's agent refuses
to provide the necessary information for such patient medication records.
(8)
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 and distributed by the pharmacy during each calendar year in which
the pharmacy is registered; if during the same calendar year 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 222) to the distributing pharmacy.
(ii)
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 at the close of the
month during which the order is filled.
(9)
Other records. Other records to be
maintained by a pharmacy:
(A)
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);
(B)
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;
(C)
a hard copy of the power of attorney to sign DEA 222 order
forms (if applicable);
(D)
suppliers' invoices of dangerous drugs and controlled substances;
pharmacists or other responsible individuals shall verify that the controlled
drugs listed on the invoices were actually received by clearly recording their
initials and the actual date of receipt of the controlled substances;
(E)
suppliers' 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);
(G)
hard-copy reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal agency;
(H)
records of distribution of controlled substances and/or
dangerous drugs to other pharmacies, practitioners, or registrants; and
(I)
a hard copy of any notification required by the Texas Pharmacy
Act or these sections, including, but not limited to, the following:
(i)
reports of theft or significant loss of controlled substances
to DEA, DPS, and the board;
(ii)
notifications 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.
(10)
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, §1304.04(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.
(ii)
The pharmacy maintains a copy of the notification required
in clause (i) of 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.
(E)
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.
(11)
Confidentiality.
(A)
A pharmacist shall provide adequate security of prescription
drug order and patient medication records to prevent indiscriminate or unauthorized
access to confidential health information. If 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.
(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.
(f)
Triplicate prescription requirements. The Texas State Board
of Pharmacy adopts by reference the rules promulgated by the Texas Department
of Public Safety, which are set forth in Subchapter F of 37 TAC §§13.101
- 13.113 concerning triplicate prescriptions.
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 15, 2000.
TRD-200003355
Gay Dodson, R.Ph.
Executive Director
Texas State Board of Pharmacy
Effective date: June 4, 2000
Proposal publication date: March 31, 2000
For further information, please call: (512) 305-8028
Subchapter D. INSTITUTIONAL PHARMACY (CLASS C)
22 TAC §§291.72-291.75
The Texas State Board of Pharmacy adopts amendments to §291.72,
concerning Definitions, §291.73, concerning Personnel, §291.74,
concerning Operational Standards, and §291.75, concerning Records. The
amendments to §§291.72, 291.73, and 291.75 are adopted without change
to the proposed text as published in the March 31, 2000, issue of the Texas Register
(25 TexReg 2756). The amendments
to §291.74 are adopted with changes and will be republished.
The amendments implement the recommendations of the Task Force on Non-Residential
Pharmacies and Pharmacy Automation as those recommendations apply to Class
C (Institutional) Pharmacies. The amendments also make non-substantive housekeeping
changes due to the codification of the Texas Pharmacy Act by the 76th Legislature.
The Texas Federation of Drug Stores commented that there appears to be
inconsistencies between these proposed rules and similar Class A rules adopted
by the Board in February 2000. The Board disagrees. Changes were made to these
rules at the time of their proposal consistent with the Class A rules as adopted
in February 2000. The Board made one change to §291.74(j)(2)(C)(i)(IV)
to clarify who is responsible for the accuracy of the restocking process for
the automated medication supply system.
The amendments are adopted under §§551.002, 554.051,
and 554.005 of the Texas Pharmacy Act (Chapters 551-566, 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 §554.005 as authorizing the agency to regulate the delivery
or distribution of prescription drugs as they relate to the practice of pharmacy
and to specify the minimum standards for the maintenance of prescription drug
records.
§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), §291.35 of this title (relating
to Triplicate Prescription Records), and §291.36 of this title (relating
to Class A Pharmacies Compounding Sterile Pharmaceuticals), 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 pharmacy engaged in non-sterile compounding
of drug products for inpatients of the hospital shall comply with the provisions
of §§291.31-291.34 of this title (relating to Definitions, Personnel,
Operational Standards, and Records for Class A (Community) Pharmacies) to
the extent such rules are applicable to non-sterile compounding of drug products.
(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)
Special requirements for the compounding of sterile
pharmaceuticals in the institutional pharmacy.
(A)
If the institutional pharmacy compounds sterile pharmaceuticals,
the following is applicable.
(i)
Aseptic environment control device(s). The institutional
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, or clean room, which is capable of maintaining at least Class 100
conditions during normal activity. Such aseptic environmental control device(s)
shall:
(I)
be certified by an independent contractor according to
Federal Standard 209E et seq 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.
(ii)
Controlled area. The institutional 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:
(I)
have a controlled environment that is aseptic or contains
an aseptic environmental control device(s);
(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 and
be ventilated in a manner not interfering with aseptic environmental control
conditions;
(V)
have drugs and supplies stored on shelving areas above
the floor to permit adequate floor cleaning;
(VI)
have non-porous and washable floors or floor covering
to enable regular disinfection;
(VII)
have hard cleanable walls and ceilings (acoustical ceiling
tiles that are coated with an acrylic paint are acceptable); and
(VIII)
contain only the appropriate compounding supplies and
not be used for bulk storage for supplies and materials.
(iii)
End-product evaluation.
(I)
The responsible pharmacist shall verify that the sterile
pharmaceutical was compounded accurately with respect to the use of correct
ingredients, quantities, containers, and reservoirs.
(II)
End product sterility testing according to policies and
procedures, which include a statistically valid sampling plan and acceptance
criteria for the sampling and testing, shall be performed if deemed appropriate
by the pharmacist-in-charge.
(III)
The pharmacist-in-charge shall establish a mechanism
for recalling all products of a specific batch if end-product testing procedures
yield unacceptable results.
(B)
Cytotoxic drugs. In addition to the requirements specified
in subparagraph (A) of this subsection, the product is also cytotoxic, the
following is applicable.
(i)
General.
(I)
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.
(II)
Appropriate safety and containment techniques for compounding
cytotoxic drugs shall be used in conjunction with aseptic techniques required
for preparing sterile pharmaceuticals.
(III)
Disposal of cytotoxic waste shall comply with all applicable
local, state, and federal requirements.
(IV)
Prepared doses of cytotoxic drugs must be dispensed, labeled
with proper precautions inside and outside, and distributed in a manner to
minimize contact with cytotoxic agents.
(ii)
Aseptic environment control device(s).
(I)
Cytotoxic drugs must be prepared in a vertical flow biological
safety cabinet.
(II)
If the vertical flow biological safety cabinet is also
used to prepare non-cytotoxic sterile pharmaceuticals, the cabinet must be
thoroughly cleaned prior to its use to prepare non-cytotoxic sterile pharmaceuticals.
(3)
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.
(1)
Institutional pharmacies distributing medication orders
shall have the following equipment:
(A)
typewriter or comparable equipment; and
(B)
refrigerator and a system or device (e.g., thermometer)
to monitor the temperature daily to ensure that proper storage requirements
are met.
(2)
If the institutional pharmacy compounds medication
orders which require the use of a balance, a Class A prescription balance
or analytical balance with weights. Such balance shall be properly maintained
and inspected at least every three years by the appropriate authority as prescribed
by local, state, or federal law or regulations.
(3)
If the institutional pharmacy compounds sterile pharmaceuticals,
the pharmacy shall have the following equipment:
(A)
appropriate disposal containers for used needles, syringes,
etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic
agents, cytotoxic waste;
(B)
infusion devices, if applicable;
(C)
all necessary supplies, including:
(i)
disposable needles, syringes, and other supplies for aseptic
mixing;
(ii)
disinfectant cleaning solutions;
(iii)
hand washing agents with bacteriocidal 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.
(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 Hansten's and Horn's Drug Interactions;
(B)
general information:
(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)
Micromedex;
(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)
if the pharmacy compounds sterile pharmaceuticals:
(A)
American Society of Hospital Pharmacists' Technical Assistance
Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products; and
(B)
specialty reference 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;
(6)
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 compounded in the pharmacy.
(A)
Batch preparation.
(i)
Master work sheet. A master work sheet shall be developed
and approved by a pharmacist for each batch of sterile pharmaceuticals to
be prepared. 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)
sterilization method(s), if applicable;
(VII)
storage requirements; and
(VIII)
specific equipment used during aseptic preparation (e.g.,
specific automated compounding device).
(ii)
Preparation work sheet. The preparation work sheet for
each batch of sterile pharmaceuticals shall document the following:
(I)
identity of all solutions and ingredients and their corresponding
amounts, concentrations, or volumes;
(II)
manufacturer lot number for each component;
(III)
component manufacturer 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.
(B)
Labeling. The label of each sterile pharmaceutical shall
bear at a minimum:
(i)
for patient-specific products, the patient's name and location
or identification number;
(ii)
for batch prepared products, the unique lot or control
number assigned to the batch;
(iii)
all solution and ingredient names, amounts, strengths,
and concentrations, when applicable;
(iv)
expiration date and time, when applicable;
(v)
directions for use, including infusion rate, when appropriate;
(vi)
name or initials of the person preparing the product and,
if prepared by supportive personnel, the name or initials of the pharmacist
who checked and released the final product. (This information is not required
on the label if it is maintained in a permanent record of the pharmacy);
(vii)
appropriate ancillary instructions such as storage instructions
or cautionary statements, including cytotoxic warning labels where appropriate;
and
(viii)
device-specific instructions, when appropriate.
(C)
Expiration date.
(i)
The expiration date assigned shall be based on currently
available drug stability information and sterility considerations or appropriate
in-house or contract service stability testing.
(ii)
Sources of drug stability information shall include the
following:
(I)
references (e.g., Remington's Pharmaceutical Sciences,
Handbook on Injectable Drugs);
(II)
manufacturer recommendations; and
(III)
reliable, published research.
(iii)
When interpreting published drug stability information,
the pharmacist shall consider all aspects of the final sterile product being
prepared (e.g., drug reservoir, drug concentration, storage conditions).
(iv)
Methods used for establishing expiration dates shall be
documented.
(D)
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 pharmaceuticals which are sterile and stable.
Quality control procedures shall include, but are not limited to, the following:
(i)
recall procedures;
(ii)
storage and dating; and
(iii)
documentation of appropriate functioning of refrigerator,
freezer and other equipment;
(iv)
documentation of aseptic environmental control device(s)
certification at least every six months and the regular replacement of pre-filters
as necessary; and
(v)
a process to evaluate and confirm the quality of the prepared
pharmaceutical product.
(E)
Quality assurance.
(i)
There shall be a documented, ongoing quality assurance
program for monitoring and evaluating personnel performance and patient outcomes
to assure an efficient drug delivery process, patient safety, and positive
clinical outcomes.
(ii)
There shall be documentation of quality assurance audits
at regular, planned intervals including infection control, sterile technique,
delivery systems/times, order transcription accuracy, drug administration
systems, adverse drug reactions and drug therapy appropriateness, as applicable.
(iii)
A plan for corrective action of problems identified by
quality assurance audits shall be developed which includes procedures for
documentation of identified problems and action taken.
(iv)
A periodic evaluation of the effectiveness of the quality
assurance activities shall be completed and documented.
(5)
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.
(6)
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 Section 556.006 and 556.009
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.
(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.
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 15, 2000.
TRD-200003354
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: June 4, 2000
Proposal publication date: March 31, 2000
For further information, please call: (512) 305-8028