TITLE examining-boards

Part XV. Texas State Board of Pharmacy

Chapter 291. Pharmacies

Subchapter B. Community Pharmacy (Class A)

22 TAC §§291.31, 291.32, 291.36

The Texas State Board of Pharmacy proposes amendments to §291.31, concerning Definitions, §291.32, concerning Personnel, and §291.36, concerning Class A Pharmacies Compounding Sterile Pharmaceuticals. The amendments, if adopted, will: (1) define the terms "certified pharmacy technician," "pharmacy technician," and "pharmacy technician trainee"; (2) update the term "supportive personnel" to the term "pharmacy technician"; (3) clarify the qualifications, duties, and ratio to pharmacists after the requirement for certification of pharmacy technicians becomes effective; and (4) update identification requirements for pharmacy personnel.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Dodson has also determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be increased safety of the prescription drug supply by clarifying the qualifications, duties, and supervision of pharmacy technicians. Since certification is required by current rule, there are no additional economic costs anticipated for individuals who are required to comply with the rule. No additional economic costs are anticipated for small or large businesses.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942.

The amendments are proposed under sections 4, 16(a), 17(b), and 17(o) of the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes). The Board interprets section 4 as authorizing the agency to adopt rules to protect the public health, safety, and welfare through the effective control and regulation of the practice of pharmacy. The Board interprets section 16(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets section 17(b) as authorizing the agency to regulate the delivery or distribution of prescription drugs as they relate to the practice of pharmacy. The Board interprets section 17(o) as authorizing the agency to adopt rules relating to the use, duties, training, and supervision of pharmacy technicians.

The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.

§291.31.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1)-(6)

(No change.)

(7)

Certified Pharmacy Technician--A pharmacy technician who has:

(A)

completed the pharmacy technician training program of the pharmacy;

(B)

taken and passed the National Pharmacy Technician Certification Exam; and

(C)

maintains a current certification with the Pharmacy Technician Certification Board.

(8)

[ (7) ] Component--Any ingredient intended for use in the compounding of a drug product, including those that may not appear in such product.

(9)

[ (8) ] Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device:

(A)

as the result of a practitioner's prescription drug order or initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice;

(B)

in anticipation of prescription drug 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.

(10)

[ (9) ] Confidential record--Any health-related record maintained by a pharmacy or pharmacist, such as a patient medication record, prescription drug order, or medication order.

(11)

[ (10) ] 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 Schedules I, II, III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).

(12)

[ (11) ] 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."

(13)

[ (12) ] 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).

(14)

[ (13) ] 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.

(15)

[ (14) ] Designated agent--

(A)

a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner to communicate 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; or

(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 the Medical Practice Act, §3.06(d)(5) or (6) (Texas Civil Statutes, Article 4495b).

(16)

[ (15) ] 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.

(17)

[ (16) ] Dispensing pharmacist--The pharmacist responsible for the final check of the dispensed prescription before delivery to the patient.

(18)

[ (17) ] Distribute--The delivery of a prescription drug or device other than by administering or dispensing.

(19)

[ (18) ] Downtime--Period of time during which a data processing system is not operable.

(20)

[ (19) ] Drug regimen review--An evaluation of 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; and

(J)

proper utilization, including overutilization or underutilization.

(21)

[ (20) ] Electronic prescription drug order--A prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).

(22)

[ (21) ] Full-time pharmacist--A pharmacist who works in a pharmacy from 30 to 40 hours per week or, if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open.

(23)

[ (22) ] Hard copy--A physical document that is readable without the use of a special device (i.e., cathode ray tube (CRT), microfiche reader, etc.).

(24)

[ (23) ] Manufacturing--The production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis and includes any packaging or repackaging of the substances or labeling or relabeling of the container and the promotion and marketing of such drugs or devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons but does not include compounding.

(25)

[ (24) ] Medical Practice Act--The Texas Medical Practice Act, Texas Civil Statutes, Article 4495b, as amended.

(26)

[ (25) ] Medication order--A written order from a practitioner or a verbal order from a practitioner or his authorized agent for administration of a drug or device.

(27)

[ (26) ] 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.)

(28)

[ (27) ] Original prescription--The:

(A)

original written prescription drug order; or

(B)

original verbal or electronic prescription drug order reduced to writing either manually or electronically by the pharmacist.

(29)

[ (28) ] Part-time pharmacist--A pharmacist who works less than full-time.

(30)

[ (29) ] 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.

(31)

[ (30) ] 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.

(32)

[ (31) ] 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.

(33)

Pharmacy technician--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 and pharmacy technician trainees.

(34)

Pharmacy technician trainee--a pharmacy technician participating in a pharmacy's technician training program.

(35)

[ (32) ] Physician assistant--A physician assistant recognized by the Texas State Board of Medical Examiners as having the specialized education and training required under the Medical Practice Act, §3.06(d), and issued an identification number by the Texas State Board of Medical Examiners.

(36)

[ (33) ] 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.

(37)

[ (34) ] 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.

(38)

[ (35) ] Prescription drug order--

(A)

a written order from a practitioner or a verbal order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or

(B)

a written order or a verbal order pursuant to the Medical Practice Act, §3.06(d)(5) and (6).

(39)

[ (36) ] Prospective drug use review--A review of the patient's drug therapy and prescription drug order or medication order prior to dispensing or distributing the drug.

[(37)

Supportive personnel/Pharmacy technician--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.]

(40)

[ (38) ] Texas Controlled Substances Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended.

(41)

[ (39) ] Written protocol--A physician's 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, (Texas Civil Statutes, Article 4495b).

§291.32.Personnel.

(a)

Pharmacist-in-charge.

(1)

(No change.)

(2)

Responsibilities. The pharmacist-in-charge shall have responsibility for, at a minimum, the following:

(A)-(E)

(No change.)

(F)

education and training of pharmacy technicians; [ supportive personnel; ]

(G)-(N)

(No change.)

(b)

Pharmacists.

(1)

General.

(A)-(B)

(No change.)

(C)

Pharmacists are solely responsible for the direct supervision of pharmacy technicians [ supportive personnel ] and for designating and delegating duties, other than those listed in paragraph (2) of this subsection, to pharmacy technicians. [ supportive personnel. ] Each pharmacist:

(i)

shall verify the accuracy of all acts, tasks, or functions performed by pharmacy technicians; [ supportive personnel; ] and

(ii)

shall be responsible for any delegated act performed by pharmacy technicians [ supportive personnel ] under his or her supervision.

(D)-(E)

(No change.)

(2)-(3)

(No change.)

(c)

Pharmacy technicians. [ Supportive personnel/pharmacy technician. ]

(1)

Qualifications.

(A)

General.

(i)

All pharmacy technicians [ Supportive personnel ] shall:

(I)

[ (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)

[ (ii) ] complete a structured didactic and experiential training program, which provides instruction and experience in the areas listed in paragraph (4) of this subsection.

[(B)

supportive personnel employed in a pharmacy before March 1, 1996, are not required to comply with the education requirements listed in subparagraph (A)(i) of this paragraph, but must complete the training program specified in subparagraph (A)(ii) of this paragraph by January 1, 1997, or cease performing the duties of a supportive person.]

[ (C)

All supportive personnel employed in a pharmacy on or after March 1, 1996, must meet the education requirements listed in subparagraph (A)(i) of this paragraph and complete the training program specified in subparagraph (A)(ii) of this paragraph by January 1, 1997, or cease performing the duties of a supportive person. ]

(III)

[ (D) ] Effective January 1, 2001, all pharmacy technicians [ supportive personnel ] must have taken and passed the National Pharmacy Technician Certification Exam or be a pharmacy technician trainee .

(ii)

[ (E) ] For the purpose of this subsection, pharmacy technicians [ supportive personnel ] are those persons who perform nonjudgmental technical duties associated with the dispensing of a prescription drug order.

(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.

(ii)

A person may be designated a pharmacy technician trainee for no more than one year or until the trainee fails, or fails to take, the next regularly-scheduled exam to become a certified pharmacy technician after completion of training.

(C)

Certified Pharmacy Technicians. All certified pharmacy technicians shall have taken and passed the National Pharmacy Technician Certification Exam and maintain a current certification with the Pharmacy Technician Certification Board.

(2)

Duties.

(A)

General.

(i)

pharmacy technicians [ Supportive personnel ] may not perform any of the duties listed in subsection (b)(2) of this section.

(ii)

[ (B) ] A pharmacist may delegate to pharmacy technicians [ supportive personnel ] any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided:

(I)

[ (i) ] a pharmacist conducts in-process and final checks; and

(II)

[ (ii) ] pharmacy technicians [ supportive personnel ] are under the direct supervision of and responsible to a pharmacist.

(B)

Labeling.

(i)

[ (C) ] A pharmacist may not delegate the act of affixing a label to a prescription container unless the pharmacy technician [ supportive person/pharmacy technician ] has completed the education and training requirements outlined in paragraphs (1) and (4) of this subsection.

(ii)

Effective January 1, 2001, only certified pharmacy technicians may affix a label to a prescription container.

(3)

Ratio of pharmacist to pharmacy technicians. [ supportive personnel. ]

(A)

The ratio of pharmacists to pharmacy technicians [ supportive personnel ] may not exceed [ shall be no greater than ] 1:2

(B)

Effective January 1, 2001, the ratio of pharmacists to pharmacy technicians may be 1:3 provided no more than two of the technicians are pharmacy technician trainees. [ For the purposes of this paragraph, supportive personnel are those persons who perform nonjudgmental technical duties associated with the preparation of a prescription drug order. ]

(4)

Training.

(A)

pharmacy technicians [ Supportive personnel ] shall complete initial training as outlined by the pharmacist-in-charge in a training manual . [ , prior to the regular performance of their duties. ] 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 [ supportive person ] works certifies that the pharmacy technician [ supportive person ] 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 or as specified in paragraph (1)(B) of this subsection; 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 [ supportive personnel ] through in-service education and training to supplement initial training.

(D)

[ (C) ] The pharmacist-in-charge shall document the completion of the training program and certify the competency of pharmacy technicians [ supportive personnel ] completing the training. A written record of initial and in-service training of pharmacy technicians [ supportive personnel ] shall be maintained and contain the following information:

(i)-(iii)

(No change.)

(iv)

a statement or statements that certifies that the pharmacy technician [ supportive person ] is competent to perform the duties assigned;

(v)

name of the person supervising the training; and

(vi)

signature of the pharmacy technician [ supportive person ] 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. [ supportive personnel. ]

(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 [ Supportive personnel ] 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 [ supportive personnel ]. Such procedures and guidelines shall:

(i)

specify the manner in which the pharmacist responsible for the supervision of pharmacy technicians [ supportive personnel ] 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; [ supportive personnel; ] and

(B)

instruction in the following areas and any additional areas appropriate to the duties of pharmacy technicians [ supportive personnel ] in the pharmacy:

(i)-(xi)

(No change.)

(xii)

Written policy and guidelines for use of and supervision of pharmacy technicians. [ supportive personnel. ]

(d)

Identification of pharmacy personnel. All pharmacy personnel [ Supportive personnel and pharmacist interns ] shall be identified as follows.

(1)

Pharmacy technicians. [ Supportive personnel. ] All pharmacy technicians [ supportive personnel ] 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. [ supportive person. ]

(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.

§291.36.Class A Pharmacies Compounding Sterile Pharmaceuticals.

(a)

(No change.)

(b)

Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

(1)-(12)

(No change.)

(13)

Certified Pharmacy Technician -- A pharmacy technician who has:

(A)

completed the pharmacy technician training program of the pharmacy;

(B)

taken and passed the National Pharmacy Technician Certification Exam; and

(C)

maintains a current certification with the Pharmacy Technician Certification Board.

(14)

[ (13) ] 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)

[ (14) ] Clean zone--A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class.

(16)

[ (15) ] 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)

[ (16) ] Confidential record--Any health related record maintained by a pharmacy or pharmacist such as a patient medication record, prescription drug order, or medication drug order.

(18)

[ (17) ] Controlled area--A controlled area is the area designated for preparing sterile pharmaceuticals.

(19)

[ (18) ] 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)

[ (19) ] Critical areas--Any area in the controlled area where products or containers are exposed to the environment.

(21)

[ (20) ] Cytotoxic--A pharmaceutical that has the capability of killing living cells.

(22)

[ (21) ] 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)

[ (22) ] 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)

[ (23) ] 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)

[ (24) ] 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; or

(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 Medical Practice Act, Article 4495b, §3.06(d)(5) or (6).

(26)

[ (25) ] 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)

[ (26) ] 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)

[ (27) ] Dispensing pharmacist--The pharmacist responsible for the final check of the dispensed prescription before delivery to the patient.

(29)

[ (28) ] Distribute--The delivery of a prescription drug or device other than by administering or dispensing.

(30)

[ (29) ] Downtime--Period of time during which a data processing system is not operable.

(31)

[ (30) ] 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)

[ (31) ] Electronic prescription drug order--A prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).

(33)

[ (32) ] Expiration date--The date (and time, when applicable) beyond which a product should not be used.

(34)

[ (33) ] 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.

(35)

[ (34) ] Hard copy--A physical document that is readable without the use of a special device (i.e., cathode ray tube (CRT), microfiche reader, etc.).

(36)

[ (35) ] Medical Practice Act--The Texas Medical Practice Act, Texas Civil Statutes, Article 4495b, as amended.

(37)

[ (36) ] 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.)

(38)

[ (37) ] 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.

(39)

[ (38) ] Part-time pharmacist--A pharmacist who works less than full-time.

(40)

[ (39) ] 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.

(41)

[ (40) ] 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.

(42)

[ (41) ] 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.

(43)

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 and pharmacy technician trainees.

(44)

Pharmacy technician trainee--a pharmacy technician participating in a pharmacy's technician training program.

(45)

[ (42) ] Physician assistant--A physician assistant recognized by the Texas State Board of Medical Examiners as having the specialized education and training required under the Medical Practice Act, §3.06(d), and issued an identification number by the Texas State Board of Medical Examiners.

(46)

[ (43) ] 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.

(47)

[ (44) ] 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.

(48)

[ (45) ] 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.

(49)

[ (46) ] 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 Medical Practice Act, §3.06(d)(5) or (6).

(50)

[ (47) ] 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.

(51)

[ (48) ] 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.

(52)

[ (49) ] 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.

(53)

[ (50) ] Sample--A prescription drug which is not intended to be sold and is intended to promote the sale of the drug.

(54)

[ (51) ] Sterile pharmaceutical--A dosage form free from living micro-organisms.

[(52)

Supportive personnel/Pharmacy technician--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.]

(55)

[ (53) ] Texas Controlled Substances Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended.

(56)

[ (54) ] 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.

(57)

[ (55) ] Unusable drugs--Drugs or devices that are unusable for reasons such as they are adulterated, misbranded, expired, defective, or recalled.

(58)

[ (56) ] 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 (Texas Civil Statutes, Article 4495b).

(c)

Personnel.

(1)

(No change.)

(2)

Pharmacists.

(A)

General.

(i)-(ii)

(No change.)

(iii)

Pharmacists are solely responsible for the direct supervision of pharmacy technicians [ supportive personnel ] and for designating and delegating duties, other than those listed in subparagraph (B) of this paragraph, to pharmacy technicians [ supportive personnel ]. Each pharmacist:

(I)

shall verify the accuracy of all acts, tasks, or functions performed by pharmacy technicians [ supportive personnel ]; and

(II)

shall be responsible for any delegated act performed by pharmacy technicians [ supportive personnel ] under his or her supervision.

(iv)-(vi)

(No change.)

(B)

(No change.)

(3)

Pharmacy technicians. [ Supportive personnel/pharmacy technicians. ]

(A)

Qualifications.

(i)

General.

(I)

All pharmacy technicians [ Supportive personnel ] shall:

(-a-)

[ (I) ] have a high school or equivalent degree, e.g., GED, or be currently enrolled in a program which awards such a degree; and

(-b-)

[ (II) ] complete a structured didactic and experiential training program, which provides instruction and experience in the areas listed in subparagraph (D) of this paragraph [ (E) of this subsection ].

[ (ii)

supportive personnel employed in a pharmacy before March 1, 1996, are not required to comply with the education requirements listed in clause (i)(I) of this subparagraph, but must complete the training program specified in clause (i)(II) of this subparagraph by January 1, 1997, or cease performing the duties of a supportive person. ]

[ (iii)

All supportive personnel employed in a pharmacy on or after March 1, 1996, must meet the education requirements listed in clause (i)(I) of this subparagraph and complete the training program specified in clause (i)(II) of this subparagraph by January 1, 1997, or cease performing the duties of a supportive person. ]

(-c-)

[ (iv) ] Effective January 1, 2001, all pharmacy technicians [ supportive personnel ] must have taken and passed the National Pharmacy Technician Certification Exam or be a pharmacy technician trainee .

(II)

[ (v) ] For the purpose of this section, pharmacy technicians [ supportive personnel ] are those persons who perform nonjudgmental technical duties associated with the dispensing of a prescription drug order.

(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.

(II)

A person may be designated a pharmacy technician trainee for no more than one year or until the trainee fails, or fails to take, the next regularly-scheduled exam to become a certified pharmacy technician after completion of training.

(iii)

Certified Pharmacy Technicians. All certified pharmacy technicians shall have taken and passed the National Pharmacy Technician Certification Exam and maintain a current certification with the Pharmacy Technician Certification Board.

(B)

Duties.

(i)

General.

(I)

pharmacy technicians [ supportive personnel ] may not perform any of the duties listed in paragraph (2)(B) of this subsection.

(II)

[ (ii) ] A pharmacist may delegate to pharmacy technicians [ supportive personnel ] any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided:

(-a-)

[ (I) ] a pharmacist conducts in-process and final checks; and

(-b-)

[ (II) ] pharmacy technicians [ supportive personnel ] are under the direct supervision of and responsible to a pharmacist.

(III)

A pharmacist may not delegate the act of affixing a label to a prescription container unless the pharmacy technician has completed the education and training requirements of subparagraph (A) and (D) of this paragraph.

(ii)

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.

[(iii)

A pharmacist may not delegate the act of affixing a label to a prescription container unless the supportive person/pharmacy technician has completed the education and training requirements outlined in subparagraphs (A) and (D) of this paragraph.]

(C)

Ratio of pharmacist to pharmacy technicians. [ supportive personnel. ]

(i)

The ratio of pharmacists to pharmacy technicians [ supportive personnel ] may not exceed [ shall be no greater than ] 1:2 provided that only one pharmacy technician [ supportive person ] may be engaged in the compounding of sterile pharmaceuticals.

(ii)

Effective January 1, 2001, the ratio of pharmacists to pharmacy technicians may be 1:3 provided no more than two of the technicians are pharmacy technician trainees and only one may be engaged in the compounding of sterile pharmaceuticals.

(D)

Training.

(i)

pharmacy technicians [ Supportive personnel ] 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 [ supportive person ] works certifies that the pharmacy technician [ supportive person ] 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 or until the trainee fails, or fails to take, the next regularly-scheduled exam to become a certified pharmacy technician after completion of training; and

(III)

shall be counted in the pharmacist to pharmacy technician ratio.

(iii)

[ (ii) ] The pharmacist-in-charge shall assure the continuing competency of pharmacy technicians [ supportive personnel ] through-in-service education and training to supplement initial training.

(iv)

[ (iii) ] The pharmacist-in-charge shall document the completion of the training program and certify the competency of pharmacy technicians [ supportive personnel ] completing the training. A written record of initial and in-service training of pharmacy technicians [ supportive personnel ] shall be maintained and contain the following information:

(I)-(III)

(No change.)

(IV)

a statement or statements that certifies that the pharmacy technician [ supportive person ] is competent to perform the duties assigned;

(V)

name of the person supervising the training; and

(VI)

signature of the pharmacy technician [ supportive person ] 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 [ supportive personnel ].

(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 [ Supportive personnel ] 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 [ supportive personnel ]. Such procedures and guidelines shall:

(I)

specify the manner in which the pharmacist responsible for the supervision of pharmacy technicians [ supportive personnel ] 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 [ supportive personnel ]; and

(ii)

instruction in the following areas and any additional areas appropriate to the duties of pharmacy technicians [ supportive personnel ] in the pharmacy:

(I)-(XI)

(No change.)

(XII)

Written policy and guidelines for use of and supervision of pharmacy technicians [ supportive personnel ].

(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)-(ii)

(No change.)

(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 [ supportive personnel ] compounding sterile pharmaceuticals without process validation provided the pharmacist:

(I)-(II)

(No change.)

(iv)-(v)

(No change.)

(B)

Pharmacists.

(i)

All pharmacists who compound sterile pharmaceuticals or supervise pharmacy technicians [ supportive personnel ] compounding sterile pharmaceuticals shall:

(I)

[ effective March 1, 1996, ] 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-)-(-b-)

(No change.)

(II)

(No change.)

(ii)

[ Pharmacists shall discontinue preparation of sterile pharmaceuticals if the training specified in clause (i) of this subparagraph is not completed by March 1, 1996. Such pharmacists may continue to compound sterile pharmaceuticals and supervise supportive personnel compounding sterile pharmaceuticals during the interim between the effective date of these rules and March 1, 1996, if they comply with the previous requirements of these rules and maintain documentation of completion of 20 hours of on-the-job training in the preparation, sterilization, and admixture of sterile pharmaceuticals. ]

[ (iii) ]

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. [ Supportive personnel/pharmacy technicians. ] In addition to the qualifications and training outlined in paragraph (3) of this subsection, all pharmacy technicians [ supportive personnel ] who compound sterile pharmaceuticals shall:

(i)-(ii)

(No change.)

(iii)

shall discontinue preparation of sterile pharmaceuticals if the technician has not taken and passed the National Pharmacy Technician Certification Exam by January 1, 2001. 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)

[ (iii) ] acquire the required experiential portion of the training programs specified in this subparagraph under the supervision of an individual who has already completed training as specified in subparagraph (B) or (C) of this paragraph.

(D)

(No change.)

(5)

Identification of pharmacy personnel. Pharmacy personnel shall be identified as follows.

(A)

Pharmacy technicians [ Supportive personnel ]. All pharmacy technicians [ supportive personnel ] 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. [ supportive person. ]

(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)-(7)

(No change.)

(8)

Prepackaging of drugs and loading bulk drugs into automated compounding or drug dispensing systems.

(A)

Prepackaging of drugs.

(i)

Drugs may be prepackaged in quantities suitable for internal distribution only by a pharmacist or by pharmacy technicians [ supportive personnel ] under the direction and direct supervision of a pharmacist.

(ii)-(iv)

(No change.)

(B)

Loading bulk drugs into automated compounding or drug dispensing systems.

(i)

Automated compounding or drug dispensing systems may be loaded with bulk drugs only by a pharmacist or by pharmacy technicians [ supportive personnel ] under the direction and direct supervision of a pharmacist.

(ii)-(iv)

(No change.)

(9)

(No change.)

(e)-(f)

(No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 24, 1999.

TRD-9903769

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: August 8, 1999

For further information, please call: (512) 305-8028

Subchapter C. Nuclear Pharmacy (Class B)

22 TAC §291.52, §291.53

The Texas State Board of Pharmacy proposes amendments to §291.52, concerning Definitions, and §291.53, concerning Personnel. The amendments, if adopted, will: (1) define the terms "certified pharmacy technician," "pharmacy technician," and "pharmacy technician trainee"; (2) update the term "supportive personnel" to the term "pharmacy technician"; (3) clarify the qualifications, duties, and ratio to pharmacists after the requirement for certification of pharmacy technicians becomes effective; and (4) require certification of pharmacy technicians effective January 1, 2001.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Dodson has also determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be increased safety of the prescription drug supply through the certification of pharmacy technicians and by clarifying the qualifications, duties, and supervision of pharmacy technicians. Economic costs anticipated for individuals who are required to comply with the rule include a $105 fee for the national pharmacy technician certification exam and depending on individual choices, $50 to $300 for training manuals and/or training courses. No additional economic costs are anticipated for small or large businesses unless the business chooses to share in the costs to an individual required to comply with the rule.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942.

The amendments are proposed under sections 4, 16(a), 17(b), and 17(o) of the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes). The Board interprets section 4 as authorizing the agency to adopt rules to protect the public health, safety, and welfare through the effective control and regulation of the practice of pharmacy. The Board interprets section 16(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets section 17(b) as authorizing the agency to regulate the delivery or distribution of prescription drugs as they relate to the practice of pharmacy. The Board interprets section 17(o) as authorizing the agency to adopt rules relating to the use, duties, training, and supervision of pharmacy technicians.

The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.

§291.52.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set forth in the Act, §5.

(1)-(10)

(No change.)

(11)

Certified Pharmacy Technician--A pharmacy technician who has taken and passed the National Pharmacy Technician Certification Exam and maintains a current certification with the Pharmacy Technician Certification Board.

(12)

[ (11) ] Class B pharmacy license or nuclear pharmacy license -- A license issued to a pharmacy dispensing or providing radioactive drugs or devices for administration to an ultimate user.

(13)

[ (12) ] 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.

(14)

[ (13) ] Clean zone--A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class.

(15)

[ (14) ] Controlled area--A controlled area is the area designated for preparing sterile radiopharmaceuticals.

(16)

[ (15) ] 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).

(17)

[ (16) ] Dangerous drug--A device, drug, or radioactive drug that is unsafe for self medication and that is not included in Penalty Groups I through IV of Chapter 481 (Texas Controlled Substances Act). The term includes a device, drug, or radiopharmaceutical that bears or is required to bear the legend:

(A)

"Caution: Federal Law Prohibits Dispensing Without a Prescription"; or

(B)

"Caution: Federal Law Restricts This Drug To Be Used By or on the Order of a Licensed Veterinarian."

(18)

[ (17) ] 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).

(19)

[ (18) ] Deliver or delivery--The actual, constructive, or attempted transfer of a prescription drug or device, radiopharmaceutical, or controlled substance from one person to another, whether or not for a consideration.

(20)

[ (19) ] Designated agent--

(A)

a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner, and for whom the practitioner assumes legal responsibility, who communicates radioactive prescription drug orders to a pharmacist; or

(B)

a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom the practitioner communicates a radioactive prescription drug order.

(21)

[ (20) ] Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related articles, including any component parts or accessory that is required under federal or state law to be ordered or prescribed by a practitioner.

(22)

[ (21) ] Diagnostic prescription drug order--A radioactive prescription drug order issued for a diagnostic purpose.

(23)

[ (22) ] Dispense--Preparing, packaging, compounding, or labeling for delivery a prescription drug or device, or a radiopharmaceutical in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.

(24)

[ (23) ] Dispensing pharmacist--The authorized nuclear pharmacist responsible for the final check of the dispensed prescription before delivery to the patient.

(25)

[ (24) ] Distribute--The delivering of a prescription drug or device, or a radiopharmaceutical other than by administering or dispensing.

(26)

[ (25) ] Electronic radioactive prescription drug order--A radioactive prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).

(27)

[ (26) ] Internal test assessment--Validation of tests for quality control necessary to insure the integrity of the test.

(28)

[ (27) ] Nuclear pharmacy technique--The mechanical ability required to perform the nonjudgmental, technical aspects of preparing and dispensing radiopharmaceuticals.

(29)

[ (28) ] Original prescription--The:

(A)

original written radioactive prescription drug orders; or

(B)

original verbal or electronic radioactive prescription drug orders reduced to writing either manually or electronically by the pharmacist.

(30)

[ (29) ] 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.

(31)

[ (30) ] Pharmacy technician [ Pharmacy technician/Supportive Personnel ]--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 or radiopharmaceuticals under the direct supervision of and responsible to a pharmacist.

(32)

Pharmacy technician trainee--a pharmacy technician participating in a pharmacy's technician training program.

(33)

[ (31) ] 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.

(34)

[ (32) ] Radiopharmaceutical--A prescription drug or device that exhibits spontaneous disintegration of unstable nuclei with the emission of a nuclear particle(s) or photon(s), including any nonradioactive reagent kit or nuclide generator that is intended to be used in preparation of any such substance.

(35)

[ (33) ] Radioactive drug quality control--The set of testing activities used to determine that the ingredients, components (e.g., containers), and final radiopharmaceutical prepared meets predetermined requirements with respect to identity, purity, non-pyrogenicity, and sterility and the interpretation of the resulting data in order to determine the feasibility for use in humans and animals including internal test assessment, authentication of product history, and the keeping of mandatory records.

(36)

[ (34) ] Radioactive drug service--The act of distributing radiopharmaceuticals; the participation in radiopharmaceutical selection and the performance of radiopharmaceutical drug reviews.

(37)

[ (35) ] Radioactive prescription drug order--An order from a practitioner or a practitioner's designated agent for a radiopharmaceutical to be dispensed.

(38)

[ (36) ] Sterile radiopharmaceutical--A dosage form of a radiopharmaceutical free from living micro-organisms.

(39)

[ (37) ] Therapeutic prescription drug order--A radioactive prescription drug order issued for a specific patient for a therapeutic purpose.

(40)

[ (38) ] Ultimate user--A person who has obtained and possesses a prescription drug or radiopharmaceutical for his or her own use or for the use of a member of his or her household.

§291.53.Personnel.

(a)-(b)

(No change.)

(c)

Pharmacy Technicians.

(1)

General.

(A)

(No change.)

(B)

The pharmacist-in-charge shall document the training 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)-(v)

(No change.)

(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 [ supportive personnel ].

(C)

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 affixing a label to a prescription container and routinely compounding sterile radiopharmaceuticals;

(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.

(D)

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)

Effective January 1, 2001, all pharmacy technicians shall have taken and passed the National Pharmacy Technician Certification Exam.

(2)

Duties.

(A)

General. Pharmacy technicians may perform any nuclear pharmacy technique delegated by an authorized nuclear pharmacist which is associated with the preparation and distribution of radiopharmaceuticals other than those duties listed in subsection (b)(2) of this section provided:

(i)

[ (A) ] an authorized nuclear pharmacist conducts in-process and final checks; and

(ii)

[ (B) ] pharmacy technicians are under the direct supervision of and responsible to an authorized nuclear pharmacist.

(B)

Labeling. Effective January 1, 2001, only certified pharmacy technicians may affix a label to a prescription container.

(3)

Ratio of authorized nuclear pharmacists to pharmacy technicians.

(A)

The ratio of authorized nuclear pharmacists to pharmacy technicians may not exceed [ shall be no greater than ] 1:2, provided that only one pharmacy technician may be engaged in the compounding of a sterile radiopharmaceutical.

(B)

Effective January 1, 2001, the ratio of pharmacists to pharmacy technicians may be 1:3 provided no more than two of the technicians are pharmacy technician trainees and only one may be engaged in the compounding of a sterile radiopharmaceutical.

(d)

Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile radiopharmaceuticals.

(1)-(2)

(No change.)

(3)

Pharmacy technicians. In addition to the qualifications and training outlined in subsection (c) of this section, all pharmacy technicians who compound sterile radiopharmaceuticals shall:

(A)-(C)

(No change.)

(D)

effective January 1, 2001, be certified pharmacy technicians.

(E)

shall discontinue preparation of sterile pharmaceuticals if they have not taken and passed the National Pharmacy Technician Certification Exam by January 1, 2001. 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 subparagraph (B) of this paragraph.

(4)

(No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 24, 1999.

TRD-9903770

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: August 8, 1999

For further information, please call: (512) 305-8028

Subchapter D. Institutional Pharmacy (Class C)

22 TAC §291.72, §291.73

The Texas State Board of Pharmacy proposes amendments to §291.72, concerning Definitions, and §291.73, concerning Personnel. The amendments, if adopted, will: (1) define the terms "certified pharmacy technician," "pharmacy technician," and "pharmacy technician trainee"; (2) update the term "supportive personnel" to the term "pharmacy technician"; (3) clarify the qualifications, duties, and ratio to pharmacists after the requirement for certification of pharmacy technicians becomes effective; and (4) update identification requirements for pharmacy personnel.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Dodson has also determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be increased safety of the prescription drug supply by clarifying the qualifications, duties, and supervision of pharmacy technicians. Since certification is required by current rule, there are no additional economic costs anticipated for individuals who are required to comply with the rule. No additional economic costs are anticipated for small or large businesses.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942.

The amendments are proposed under sections 4, 16(a), 17(b), and 17(o) of the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes). The Board interprets section 4 as authorizing the agency to adopt rules to protect the public health, safety, and welfare through the effective control and regulation of the practice of pharmacy. The Board interprets section 16(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets section 17(b) as authorizing the agency to regulate the delivery or distribution of prescription drugs as they relate to the practice of pharmacy. The Board interprets section 17(o) as authorizing the agency to adopt rules relating to the use, duties, training, and supervision of pharmacy technicians.

The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.

§291.72.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1)-(9)

(No change.)

(10)

Certified Pharmacy Technician--A pharmacy technician who has:

(A)

completed the pharmacy technician training program of the pharmacy;

(B)

taken and passed the National Pharmacy Technician Certification Exam; and

(C)

maintains a current certification with the Pharmacy Technician Certification Board.

(11)

[ (10) ] 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.

(12)

[ (11) ] Clean zone--A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class.

(13)

[ (12) ] Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device:

(A)

as the result of a practitioner's prescription drug or medication order or initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice;

(B)

in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or

(C)

for the purpose of, or as an incident to research, teaching, or chemical analysis and not for sale or dispensing.

(14)

[ (13) ] Confidential record--Any health-related record maintained by a pharmacy or pharmacist, such as a patient medication record, prescription drug order, or medication drug order.

(15)

[ (14) ] Consultant pharmacist--A pharmacist retained by a facility on a routine basis to consult with the facility in areas that pertain to the practice of pharmacy.

(16)

[ (15) ] Controlled area--A controlled area is the area designated for preparing sterile pharmaceuticals.

(17)

[ (16) ] 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 Schedules I-V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).

(18)

[ (17) ] Critical areas--Any area in the controlled area where products or containers are exposed to the environment.

(19)

[ (18) ] Cytotoxic--A pharmaceutical that has the capability of killing living cells.

(20)

[ (19) ] Dangerous drug--Any drug or device [ 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."

(21)

[ (20) ] 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.

(22)

[ (21) ] Direct copy--Electronic copy or carbonized copy of a medication order, including a facsimile (FAX), tele-autograph, or a copy transmitted between computers.

(23)

[ (22) ] 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.

(24)

[ (23) ] Distribute--The delivery of a prescription drug or device other than by administering or dispensing.

(25)

[ (24) ] Distributing pharmacist--The pharmacist who checks the medication order prior to distribution.

(26)

[ (25) ] Downtime--Period of time during which a data processing system is not operable.

(27)

[ (26) ] Drug regimen review--

(A)

An evaluation of 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; and

(x)

proper utilization, including overutilization or underutilization.

(B)

The drug regimen review may be conducted prior to administration of the first dose (prospective) or after administration of the first dose (retrospective).

(28)

[ (27) ] 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.

(29)

[ (28) ] Expiration date--The date (and time, when applicable) beyond which a product should not be used.

(30)

[ (29) ] Facility--Hospital or other inpatient facility that is licensed under the Texas Hospital Licensing Law, the Health and Safety Code, Chapter 241, or Texas Mental Health Code, Chapter 6, Texas Civil Statutes, Article 5547-1 et seq., or that is maintained or operated by the state.

(31)

[ (30) ] Floor stock--Prescription drugs or devices not labeled for a specific patient and maintained at a nursing station or other hospital department (excluding the pharmacy) for the purpose of administration to a patient of the facility.

(32)

[ (31) ] Formulary--List of drugs approved for use in the facility by the committee which performs the pharmacy and therapeutics function for the facility.

(33)

[ (32) ] 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.

(34)

[ (33) ] Hard copy--A physical document that is readable without the use of a special device (i.e., cathode ray tube (CRT), microfiche reader, etc).

(35)

[ (34) ] Inpatient--A person who is duly admitted to the hospital or who is receiving long term care services or Medicare extended care services in a swing bed on the hospital premise or an adjacent, readily accessible facility which is under the authority of the hospital's governing body. For the purposes of this definition, the term "long term care services" means those services received in a skilled nursing facility which is a distinct part of the hospital and the distinct part is not licensed separately or formally approved as a nursing home by the state, even though it is designated or certified as a skilled nursing facility.

(36)

[ (35) ] Institutional pharmacy--Area or areas in a facility where drugs are stored, bulk compounded, delivered, compounded, dispensed, and distributed to other areas or departments of the facility, or dispensed to an ultimate user or his or her agent.

(37)

[ (36) ] Investigational new drug--New drug intended for investigational use by experts qualified to evaluate the safety and effectiveness of the drug as authorized by the Food and Drug Administration.

(38)

[ (37) ] Medication order--A written order from a practitioner or a verbal order from a practitioner or his authorized agent for administration of a drug or device.

(39)

[ (38) ] Part-time pharmacist--A pharmacist either employed or under contract, who routinely works less than full-time.

(40)

[ (39) ] Perpetual inventory--An inventory which documents all receipts and distributions of a drug product, such that an accurate, current balance of the amount of the drug product present in the pharmacy is indicated.

(41)

[ (40) ] 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.

(42)

[ (41) ] Pharmacist-in-charge--Pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy.

(43)

[ (42) ] Pharmacy and therapeutics function--Committee of the medical staff in the facility which assists in the formulation of broad professional policies regarding the evaluation, selection, distribution, handling, use, and administration, and all other matters relating to the use of drugs and devices in the facility.

(44)

Pharmacy technician--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 and pharmacy technician trainees.

(45)

Pharmacy technician trainee--a pharmacy technician participating in a pharmacy's technician training program.

(46)

[ (43) ] Pre-packaging--The act of re-packaging and re-labeling quantities of drug products from a manufacturer's original container into unit-dose packaging or a multiple dose container for distribution within the facility.

(47)

[ (44) ] 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.

(48)

[ (45) ] Prescription drug order--

(A)

a written order from a practitioner or a verbal order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or

(B)

a written order or a verbal order pursuant to the Medical Practice Act, §3.06(d)(5) or (6).

(49)

[ (46) ] 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.

(50)

[ (47) ] 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.

(51)

[ (48) ] 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.

(52)

[ (49) ] Sample--A prescription drug which is not intended to be sold and is intended to promote the sale of the drug.

(53)

[ (50) ] Sterile pharmaceutical--A dosage form free from living micro-organisms.

[ (51)

Supportive personnel/pharmacy technicians--Those individuals utilized in institutional 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.]

(54)

[ (52) ] Texas Controlled Substances Act--The Texas Controlled Substances Act, the Health and Safety Code, Chapter 481, as amended.

(55)

[ (53) ] 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.

(56)

[ (54) ] Unusable drugs--Drugs or devices that are unusable for reasons, such as they are adulterated, misbranded, expired, defective, or recalled.

(57)

[ (55) ] Written protocol--A physician's 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 (Texas Civil Statutes, Article 4495b).

§291.73.Personnel.

(a)

Requirements for pharmacist services.

(1)

A Class C pharmacy in a facility licensed for 101 beds or more shall be under the continuous on-site supervision of a pharmacist during the time it is open for pharmacy services; provided, however, that pharmacy technicians [ supportive personnel ] may distribute prepackaged and prelabeled drugs from a satellite pharmacy in the absence of on-site supervision of a pharmacist, under the following conditions:

(A)-(B)

(No change.)

(2)-(3)

(No change.)

(b)

Pharmacist-in-charge.

(1)

General.

(A)-(B)

(No change.)

(C)

The pharmacist-in-charge shall be assisted by additional pharmacists and pharmacy pharmacy technicians [ supportive personnel ] commensurate with the scope of services provided.

(D)

(No change.)

(2)

(No change.)

(c)

(No change.)

(d)

Pharmacists.

(1)

General.

(A)-(B)

(No change.)

(C)

All pharmacists shall be responsible for any delegated act performed by pharmacy technicians [ supportive personnel ] under his or her supervision.

(D)-(E)

(No change.)

(2)

(No change.)

(e)

Pharmacy technicians. [ Supportive personnel/Pharmacy technicians. ]

(1)

Qualifications.

(A)

General.

(i)

All pharmacy technicians [ supportive personnel ] shall:

(I)

[ (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)

[ (ii) ] complete a structured didactic and experiential training program, which provides instruction and experience in the areas listed in paragraph (4) of this subsection.

[ (B)

Supportive personnel employed in a pharmacy before March 1, 1996, are not required to comply with the education requirements listed in subparagraph (A)(i) of this paragraph but must complete the training program specified in subparagraph (A)(ii) of this paragraph by January 1, 1997, or cease performing the duties of a supportive person. ]

[ (C)

All supportive personnel employed in a pharmacy on or after March 1, 1996, must meet the education requirements listed in subparagraph (A)(i) of this paragraph and complete the training program specified in subparagraph (A)(ii) of this paragraph by January 1, 1997, or cease performing the duties of a supportive person. ]

(III)

[ (D) ] Effective January 1, 2001, all pharmacy technicians [ supportive personnel ] must have taken and passed the National Pharmacy Technician Certification Exam or be a pharmacy technician trainee .

(ii)

[ (E) ] For the purpose of this section, pharmacy technicians [ supportive personnel ] are those persons who perform nonjudgmental technical duties associated with the distribution of a medication drug order.

(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.

(ii)

A person may be designated a pharmacy technician trainee for no more than one year or until the trainee fails, or fails to take, the next regularly-scheduled exam to become a certified pharmacy technician after completion of training.

(C)

Certified Pharmacy Technicians. All certified pharmacy technicians shall have taken and passed the National Pharmacy Technician Certification Exam and maintain a current certification with the Pharmacy Technician Certification Board.

(2)

Duties.

(A)

General. Duties may include, but need not be limited to, the following functions under the direct supervision of and responsible to a pharmacist:

(i)

[ (A) ] pre-packing and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her signature (first initial and last name or full signature) or electronic signature to the appropriate quality control records;

(ii)

[ (B) ] preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders, provided a pharmacist supervises and checks the preparation;

[ (C)

compounding sterile pharmaceuticals pursuant to medication orders providing a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy); ]

(iii)

[ (D) ] bulk compounding or batch preparation provided a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the appropriate quality control records;

(iv)

[ (E) ] distributing routine orders for stock supplies to patient care areas;

(v)

[ (F) ] entering medication order and drug distribution information into a data processing system, provided judgmental decisions are not required and a pharmacist checks the accuracy of the information entered into the system prior to releasing the order or in compliance with the absence of pharmacist requirements contained in §291.74(e) of this title (relating to Operational Standards); and

(vi)

[ (G) ] loading bulk unlabeled drugs into an automated compounding or drug dispensing system provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her signature (first initial and last name or full signature) or electronic signature to the appropriate quality control records.

(B)

Sterile pharmaceuticals.

(i)

Only pharmacy technicians who have completed the training specified in subsection (f) of this section may compound sterile pharmaceuticals pursuant to medication orders providing a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy).

(ii)

effective January 1, 2001, only certified pharmacy technicians who have completed the training specified in subsection (f) of this section may compound sterile pharmaceuticals pursuant to medication orders providing a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy).

(3)

Procedures.

(A)

pharmacy technicians [ Supportive personnel ] shall handle medication orders in accordance with standard, written procedures and guidelines.

(B)

pharmacy technicians [ Supportive personnel ] shall handle prescription drug orders in the same manner as those working in a Class A pharmacy.

(4)

Training.

(A)

pharmacy technicians [ Supportive personnel ] shall complete initial training as outlined by the pharmacist-in-charge in a training manual, prior to the regular performance of their duties. 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 [ supportive person ] works certifies that the pharmacy technician [ supportive person ] 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 effective January 1, 2001, compound sterile pharmaceuticals; and

(ii)

may be designated a pharmacy technician trainee for no longer than one year.

(C)

[ (B) ]The pharmacist-in-charge shall assure the continuing competency of pharmacy technicians [ supportive personnel ] through in-service education and training to supplement initial training.

(D)

[ (C) ] The pharmacist-in-charge shall document the completion of the training program and certify the competency of pharmacy technicians [ supportive personnel ] completing the training. A written record of initial and in-service training of pharmacy technicians [ supportive personnel ] shall be maintained and contain the following information:

(i)-(iii)

(No change.)

(iv)

a statement or statements that certifies that the pharmacy technician [ supportive person ] is competent to perform the duties assigned;

(v)

name of the person supervising the training; and

(vi)

signature of the pharmacy technician [ supportive person ] 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 [ supportive personnel ].

(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 technicians [ Supportive personnel ] 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 [ supportive personnel ]. Such procedures and guidelines shall:

(i)

specify the manner in which the pharmacist responsible for the supervision of pharmacy technicians [ supportive personnel ] 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 [ supportive personnel ]; and

(B)

instruction in the following areas and any additional areas appropriate to the duties of pharmacy technicians [ supportive personnel ] in the pharmacy:

(i)-(xi)

(No change.)

(xii)

Written policy and guidelines for use of and supervision of pharmacy technicians [ supportive personnel ].

(f)

Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile pharmaceuticals.

(1)

General.

(A)-(B)

(No change.)

(C)

Although process validation may be incorporated into the experiential portion of a training program, process validation must be conducted at each pharmacy where an individual compounds sterile 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 compound sterile pharmaceuticals and supervise pharmacy technicians [ supportive personnel ] compounding sterile pharmaceuticals without process validation provided the pharmacist:

(i)-(ii)

(No change.)

(D)-(E)

(No change.)

(2)

Pharmacists.

(A)

All pharmacists who compound sterile pharmaceuticals or supervise pharmacy technicians [ supportive personnel ] compounding sterile pharmaceuticals shall:

(i)

[ effective March 1, 1996, ] complete through a single course, a minimum 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may be evidenced by either:

(I)-(II)

(No change.)

(ii)

(No change.)

(B)

[ Pharmacists shall discontinue preparation of sterile pharmaceuticals if the training specified in subparagraph (A) of this paragraph is not completed by March 1, 1996. Such pharmacists may continue to compound sterile pharmaceuticals and supervise supportive personnel compounding sterile pharmaceuticals until March 1, 1996, if they comply with the previous requirements of these rules and maintain documentation of completion of 20 hours of on-the-job training in the preparation, sterilization, and admixture of sterile pharmaceuticals. ]

[ (C) ]

The required experiential portion of the training programs specified in this paragraph must be supervised by an individual who has already completed training as specified in paragraph (2) or (3) of this subsection.

(3)

Pharmacy technicians. [ Supportive personnel/pharmacy technicians. ] In addition to the qualifications and training outlined in subsection (e) of this section, all pharmacy technicians [ supportive personnel ] who compound sterile pharmaceuticals shall:

(A)

have a high school or equivalent education;

(B)

either:

(i)

(No change.)

(ii)

complete a training program which is accredited by the American Society of Health-System Pharmacists (formerly the American Society of Hospital Pharmacists). Individuals enrolled in training programs accredited by the American Society of Health-System Pharmacists may compound sterile pharmaceuticals in a licensed pharmacy provided:

(I)

(No change.)

(II)

the individual is under the direct supervision of and responsible to a pharmacist who has completed training as specified in paragraph (2) of this subsection [ this subparagraph of this paragraph ]; and

(III)

the supervising pharmacist conducts in-process and final checks; and

(C)

shall discontinue preparation of sterile pharmaceuticals if they have not taken and passed the National Pharmacy Technician Certification Exam by January 1, 2001. 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 subparagraph (B) of this paragraph.

(D)

[ (C) ] acquire the required experiential portion of the training programs specified in this paragraph under the supervision of an individual who has already completed training as specified in this paragraph or paragraph (2) of this subsection.

[ (D)

discontinue preparation of sterile pharmaceuticals if the training specified in subparagraphs (A) and (B) of this paragraph is not completed by March 1, 1996. Such supportive personnel may continue to compound sterile pharmaceuticals during the interim between the effective date of these rules and March 1, 1996, if they comply with the previous requirements of these rules and maintain documentation of completion of 40 hours of on-the-job training in the preparation, sterilization, and admixture of sterile pharmaceuticals.]

(4)

(No change.)

(g)

Identification of pharmacy personnel. All pharmacy personnel shall wear an identification tag or badge which bears the person's name and identifies him or her by title or function as follows:

(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.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 24, 1999.

TRD-9903771

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: August 8, 1999

For further information, please call: (512) 305-8028

Part XXIV. Texas Board of Veterinary Medical Examiners

Chapter 573. Rules of Professional Conduct

Subchapter F. Records Keeping

22 TAC §573.52

The Texas Board of Veterinary Medical Examiners proposes amendments to §573.52, concerning Patient Record Keeping. The amendments clarify what information is required to be maintained in patient records, including a notation identifying the person who treated the animal. Other amendments require practitioners to furnish clients with a copy of their animal's patient records within 15 business days of request. The cost for furnishing the records is the client's responsibility.

Mr. Ron Allen, Executive Director, has determined that for the first five-year period the amendments are in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the amendments.

Mr. Allen also has determined that for the first five years the amendments are in effect that the public benefit anticipated as a result of enforcing the amendments will be better enforcement of the act since who performed what treatment can be specifically identified by the Board. The amendments will also give clients guidelines on how to obtain copies of patient records.

The additional information required to be recorded will take such a small amount of time that the time required could not be quantified. Therefore no economic costs can be established for persons who are required to comply with the amendments, including small businesses. Comments are solicited if a cost of compliance can be established. There will be no economic costs to practitioners who are required to furnish patient records because the practitioner is reimbursed under these amendments for any costs.

Written comments on the proposal may be submitted in writing to Mr. Chris Kloeris, Texas Board of Veterinary Medical Examiners, 333 Guadalupe, Suite 2-330, Austin, Texas 78701-3998, phone: (512) 305-7555, and must be received by September 15, 1999.

The amendments are proposed under the authority of the Veterinary Licensing Act, Texas Civil Statutes, article 8890, §8(a) which grants the Board the authority to amend rules of professional conduct in order to establish a high standard of integrity in the practice of veterinary medicine.

The amendments affect the Veterinary Licensing Act, article 8890, §14(a)(5) which allows the Board to discipline licensees for engaging in conduct violative of the rules of professional conduct.

§573.52.Patient Record Keeping.

(a)

Individual records will be maintained at the veterinarian's place of business and include, but are not limited to:

(1)

name and address of client;

(2)

patient identity[ , ];

(3)

patient history[ , ];

(4)

dates of visits[ , ];

(5)

any immunization records[ , ];

(6)

weight [ (estimate if necessary), ] if required for diagnosis or treatment. Weight may be estimated if actual weight is difficult to obtain;

(7)

temperature if required for diagnosis or treatment [ ( ]except when treating a herd, [ or ] flock or a species that is difficult to temperature[ ), ];

(8)

any laboratory analysis[ , ];

(9)

any radiographs[ , ];

(10)

names, dosages, concentration, and routes of administration of each drug prescribed, [ anesthetics and other medications ] administered and/or dispensed;[ , and ]

(11)

other details necessary to substantiate the examination, diagnosis, and treatment provided, and/or surgical procedure performed [ conducted ].

(12)

any signed acknowledgment required by §§573.12, 573.14, 573.15, and 573.16 of this title (relating to Supervision of Personnel). Each entry in the patient record shall identify the veterinarian who performed or supervised the procedure recorded.

(b)

Patient records shall be current and maintained on the business premises for a period of three years and are the responsibility and property of the veterinarian or veterinarians who own the veterinary practice, provided however, the client is entitled to a copy of the patient records pertaining to his/her animals.

(c)

Upon the request of the client or his/her authorized representative, the veterinarian shall furnish a copy of the patient records, including a copy of any radiographs requested, within 15 business days of the request, unless a longer period is reasonably required to duplicate the records. The veterinarian may charge a reasonable fee for this service, including actual costs for mailing, shipping or delivery. A veterinarian may not refuse a request for copies because payment in full for veterinary care has not been received from the client.

(d)

[ (c) ] When appropriate, licensees may substitute the words "herd", "flock" or other collective term in place of the word "patient" in subsections (a) and (b) of this section. Records to be maintained on these animals may be kept in a daily log, or the billing records, provided that the treatment information that is entered is adequate to substantiate the identification of these animals and the medical care provided. In no case does this eliminate the requirement to maintain drug records as specified by state and federal law and Board rules.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 21, 1999.

TRD-9903694

Ron Allen

Executive Director

Texas Board of Veterinary Medical Examiners

Proposed date of adoption: October 7, 1999

For further information, please call: (512) 305-7555

Subchapter G. Other Provisions

22 TAC §573.64

The Texas Board of Veterinary Medical Examiners proposes amendments to §573.64, concerning Continuing Education Requirements. The amendments allow practitioners obtaining continuing education hours in excess of the 15 required for license renewal, to carry the balance over and apply them to the next year's license renewal period. The carry over is limited to 15 hours each year.

Mr. Ron Allen, Executive Director, has determined that for the first five- year period the amendments are in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the amendments.

Mr. Allen also has determined that for the first five years the amendments are in effect that the public benefit anticipated as a result of enforcing the amendments will be the improvement of practitioner skills through encouraging attendance at complex and comprehensive continuing education courses by allowing a practitioner to receive credit for more of the hours of attendance.

There are no additional costs imposed on the practitioner and therefore no adverse economic effects on small businesses. In some cases, there will be a cost benefit to practitioners who have previously not been able to count all the continuing education hours received.

Written comments on the proposal may be submitted in writing to Mr. Chris Kloeris, Texas Board of Veterinary Medical Examiners, 333 Guadalupe, Suite 2-330, Austin, Texas 78701-3998, phone: (512) 305-7555, and must be received by September 15, 1999.

The amendments are proposed under the authority of the Veterinary Licensing Act, Texas Civil Statutes, article 8890, §13(g) which requires the Board to establish a minimum number of hours of continuing education required to renew a license under this Act, and §8(a) which grants the Board the authority to amend rules of professional conduct in order to establish a high standard of integrity in the practice of veterinary medicine.

The amendments affect the Veterinary Licensing Act, article 8890, §14(a)(5) which allows the Board to discipline licensees for engaging in conduct violative of the rules of professional conduct.

§573.64.Continuing Education Requirements.

(a)

Requirements.

(1)

Fifteen (15) hours of acceptable continuing education shall be required annually for renewal of all types of Texas licenses except as provided in subsection (e) of this section. Licensees who successfully complete the Texas State Board Examination shall be allowed to substitute the examination for the continuing education requirements of their examination year.

(A)

A licensee shall obtain the required fifteen hours of acceptable continuing education during the calendar year immediately preceding the licensee's application for license renewal. Should a licensee obtain acceptable continuing education hours during the year in excess of the required 15 hours, the licensee may carry over and apply the excess hours to the requirement for the next year. A maximum of 15 hours may be carried over each year.

(B)

Effective Date. Beginning with the continuing education requirement for license renewal in 2000, licensees may carry over acceptable continuing education hours pursuant to subsection (a)(1)(A) of this section. For example, acceptable continuing education hours obtained in 1999 which are in excess of the 15 hours required for renewal in 2000, may be carried over and applied to the continuing education requirement for renewal in 2001, subject to the provisions of subsection (a)(1)(A).

[ (2)

Required continuing education hours must be obtained during the calendar year immediately preceding the submission for license renewal. Continuing education hours may be used for only one renewal period.]

(2)

[ (3) ] Hardship extensions may be granted by appeal to the Executive Director of the Board. The executive director shall only consider requests for a hardship extension from licensees who were prevented from completing the required continuing education hours due to circumstances beyond the licensee's control. Requests for a hardship extension must be received in the Board offices by December 15. Should such extension be granted, thirty (30) hours of continuing education shall be obtained in the two-year period of time that includes the year of insufficiency and the year of extension. Licensees receiving a hardship extension shall maintain records of the thirty (30) hours of continuing education obtained and shall file copies of these records with the Board by attaching the records to the license renewal application submitted following the extension year.

(b)

Proof of Continuing Education. The licensee shall be required to sign a statement on the license renewal form attesting to the fact that the required continuing education hours have been obtained. It shall be the responsibility of the licensee to maintain records which support the sworn statements. Such records [ may ] include continuing education certificates, attendance records signed by the presenter, and/or receipts for meeting registration fees. These documents must be maintained for the last 3 complete renewal cycles and shall be provided for inspection to Board investigators upon request.

(c)

Acceptable Continuing Education. Acceptable continuing education hours shall be hours earned by attending meetings sponsored or co-sponsored by the American Veterinary Medical Association (AVMA), AVMA's affiliated state veterinary medical associations and/or their continuing education organizations, AVMA recognized specialty groups, regional veterinary medical associations, local veterinary medical associations, and veterinary medical colleges. The Executive Director and a licensed veterinarian Board member appointed by the Board President may approve hours earned by alternative methods.

(d)

Distribution of Continuing Education Hours. Of the required fifteen (15) hours of continuing education, no more than five (5) may be derived from either:

(1)

correspondence courses; or

(2)

practice management courses. Continuing Education obtained as part of a disciplinary action is acceptable.

(e)

Exemption from Continuing Education Requirements. A licensee is not required to obtain or report continuing education hours, provided that the licensee submits to the Board sufficient proof that during the preceding year the licensee was:

(1)

in retired status,

(2)

a veterinary intern or resident, or

(3)

out-of-country on charitable or special government assignments for at least 9 months or

(4)

on inactive status. Licensees on inactive status may voluntarily acquire continuing education for purposes of reinstating his/her license to regular status.

(f)

Disciplinary Action for Non-Compliance. Failure to complete the required hours without obtaining a hardship extension from the executive director, failure to maintain required records, falsifying records, or intentionally misrepresenting programs for continuing education credit shall be grounds for disciplinary action by the Board.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 21, 1999.

TRD-9903693

Ron Allen

Executive Director

Texas Board of Veterinary Medical Examiners

Proposed date of adoption: October 7, 1999

For further information, please call: (512) 305-7555

Chapter 577. General Administrative Duties

Subchapter B. Staff and Miscellaneous

22 TAC §577.15

The Texas Board of Veterinary Medical Examiners proposes amendments to §577.15, concerning Fee Schedule. The amendments raise the license renewal and corresponding late fees by $11 in order to provide funding for the appropriations made by the 76th Legislature.

Ron Allen, Executive Director, has determined that for the first five-year period the amendments are in effect there will be no fiscal implications for local government as a result of enforcing or administering the amendments. For state government, there will be increased revenue OF $121,011 for each biennium that the amended license fee amounts are in effect.

Mr. Allen also has determined that for the first five years the amendments are in effect, that the public benefit anticipated as a result of enforcing the amendments will be the funding of those programs the 76th Legislature found appropriate to fund. The economic costs for persons who are required to comply with the amendments, including small businesses, will be an additional license fee of $11 for each license holder. No disparate effect is foreseen on small businesses as the fee is imposed on individual professionals regardless the size of any business. Comments are solicited if a cost of compliance can be established.

Written comments on the proposal may be submitted in writing to Mr. Chris Kloeris, Texas Board of Veterinary Medical Examiners, 333 Guadalupe, Suite 2-330, Austin, Texas 78701-3998, phone: (512) 305-7555, and must be received by September 15, 1999.

The amendments are proposed under the authority of the Veterinary Licensing Act, Texas Civil Statutes, Article 8890, §19 which grants the Board the authority to establish by rule reasonable and necessary fees to cover the costs of administering the act.

The amendments affect the Veterinary Licensing Act, Article 8890, §19 which places limits on the Board's authority to set fees.

§577.15.Fee Schedule.

The Board shall establish fee amounts in accordance with Section 19(a), (b), and (c) of the Veterinary Licensing Act, art. 8890.

Figure: 22 TAC §577.15

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 21, 1999.

TRD-9903691

Ron Allen

Executive Director

Texas Board of Veterinary Medical Examiners

Earliest possible date of adoption: October 7, 1999

For further information, please call: (512) 305-7555