PART 15. TEXAS STATE BOARD OF PHARMACY

CHAPTER 281. ADMINISTRATIVE PRACTICE AND PROCEDURES

SUBCHAPTER C. DISCIPLINARY GUIDELINES

22 TAC §§281.62 - 281.65

The Texas State Board of Pharmacy proposes amendments to §281.62, concerning Aggravating and Mitigating Factors, §281.63, concerning Considerations for Criminal Offenses, §281.64, concerning Sanctions for Criminal Offenses, and §281.65, concerning Schedule of Administrative Penalties. The proposed amendments, if adopted, clarify disciplinary guidelines to reflect that the Board has given careful consideration to the guidelines and intends the guidelines to reflect the regulatory polices and goals of the Board to protect the public health and safety.

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

Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will ensure that the disciplinary guidelines reflect the regulatory polices of the Board protect the public health and safety. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with the sections.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 21, 2008.

The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§281.62.Aggravating and Mitigating Factors.

The following factors may be considered in determining the disciplinary sanctions imposed by the board if the factors are applicable to the factual situation alleged. The factors are not applicable in situations involving criminal actions (in which case §281.63 of this title (relating to Considerations for Criminal Offenses) applies).

(1) [(a)] Aggravation. The following may be considered as aggravating factors so as to merit more severe or more restrictive action by the board:

(A) [(1)] patient harm and the severity of patient harm;

(B) [(2)] economic harm to any individual, entity, or the environment, and the severity of such harm;

(C) [(3)] increased potential for harm to the public;

(D) [(4)] attempted concealment of the conduct which serves as a basis for disciplinary action under the Act;

(E) [(5)] premeditated conduct which serves as a basis for disciplinary action under the Act;

(F) [(6)] intentional conduct which serves as a basis for disciplinary action under the Act;

(G) [(7)] motive for conduct which serves as a basis for disciplinary action under the Act;

(H) [(8)] prior conduct of a similar or related nature;

(I) [(9)] disciplinary actions taken by any regulatory agency of the federal government or any state;

(J) [(10)] prior written warnings or written admonishments from any government agency or official regarding statutes or regulations pertaining to the conduct which serves as a basis for disciplinary action under the Act;

(K) [(11)] violation of a board order;

(L) [(12)] failure to implement remedial measures to correct or mitigate harm from the conduct which serves as a basis for disciplinary action under the Act;

(M) [(13)] lack of rehabilitative potential or likelihood for future conduct of a similar nature;

(N) [(14)] relevant circumstances increasing the seriousness of the conduct which serves as a basis for disciplinary action under the Act; and

(O) [(15)] circumstances indicating intoxication due to ingestion of alcohol and/or drugs.

(2) [(b)] Extenuation and Mitigation. The following may be considered as extenuating and mitigating factors so as to merit less severe or less restrictive action by the board:

[(1) absence of patient harm;]

[(2) absence of economic harm to any individual or entity;]

(A) [(3)] absence of potential harm to the public;

(B) [(4)] self-reported and voluntary admissions of the conduct which serves as a basis for disciplinary action under the Act;

(C) [(5)] absence of premeditation to commit the conduct which serves as a basis for disciplinary action under the Act;

(D) [(6)] absence of intent to commit the conduct which serves as a basis for disciplinary action under the Act;

[(7) motive;]

(E) [(8)] absence of prior conduct of a similar or related nature;

(F) [(9)] absence of [a] disciplinary actions taken by any regulatory agency of the federal government or any state;

(G) [(10)] implementation of remedial measures to correct or mitigate harm from the conduct which serves as a basis for disciplinary action under the Act;

(H) [(11)] rehabilitative potential;

(I) [(12)] prior community service and present value to the community;

(J) [(13)] relevant circumstances reducing the seriousness of the conduct which serves as a basis for disciplinary action under the Act;

(K) [(14)] relevant circumstances lessening responsibility for the conduct which serves as a basis for disciplinary action under the Act; and

(L) [(15)] treatment and/or monitoring of an impairment.

§281.63.Considerations for Criminal Offenses.

(a) - (h) (No change.)

(i) The board has determined that the following crimes directly relate to duties and responsibilities of board licensees or registrants. The commission of each indicates an inability or a tendency for the person to be unable to perform or to be unfit for licensure or registration, because commission [ violation] of such crimes indicates a lack of integrity and respect for one's fellow human being and the community at large. Even if the commission of these crimes did not occur while the licensee or registrant was on-duty or employed at a pharmacy, the board has determined that the crimes directly relate to the practice of pharmacy based on a lack of integrity and good moral character exhibited by the commission of the crimes. In addition, the direct relationship to a license or registration is presumed when any crime occurs in connection with the practice of pharmacy or the operation of a pharmacy. The crimes are as follows:

(1) practicing or operating a pharmacy without a license or registration and other violations of the Pharmacy Act;

(2) deceptive business practices under the Texas Penal Code;

(3) medicare or medicaid fraud;

(4) a misdemeanor or felony offense under the Texas Penal Code involving:

(A) murder;

(B) assault;

(C) burglary;

(D) robbery;

(E) theft;

(F) sexual assault;

(G) injury to a child;

(H) injury to an elderly person;

(I) child abuse or neglect;

(J) tampering with a governmental record;

(K) forgery;

(L) perjury;

(M) failure to report abuse;

(N) bribery;

(O) harassment;

(P) insurance claim fraud;

(Q) driving while intoxicated;

(R) solicitation of professional employment under the Penal Code §38.12(d) or Occupations Code, Chapter 102;

(S) mail fraud; or

(T) any criminal offense which requires the individual to register with the Department of Public Safety as a sex offender under Chapter 62, Code of Criminal Procedure.

(5) any crime of moral turpitude;

(6) a misdemeanor or felony offense under Chapters 431 and 481 through 486, Health and Safety Code and the Comprehensive Drug Abuse Prevention and Control Act of 1970; or

(7) other misdemeanors or felonies which serve as grounds for discipline under the Act, including violations of the Penal Code, Titles 4, 5, 6, 7, 8, 9, and 10, which indicate an inability or tendency for the person to be unable to perform as a licensee or registrant, or to be unfit for licensure or registration, if action by the board will promote the intent of the Pharmacy Act, board rules including this chapter, and Occupations Code, Chapter 53.

§281.64.Sanctions for Criminal Offenses.

(a) The guidelines for disciplinary sanctions apply to criminal convictions and to deferred adjudication community supervisions or deferred dispositions, as authorized by the Act, for all types of licensees and registrants including applicants for such licenses and registrations issued by the board. The board considers criminal behavior to be highly relevant to an individual's fitness to engage in pharmacy practice and has determined that the sanctions imposed by these guidelines promote the intent of §551.002 of the Act. The "date of disposition," when referring to the number of years used to calculate the application of disciplinary sanctions, refers to the date a conviction, a deferred adjudication, or a deferred disposition is entered by the court. The use of the term "currently on probation" is construed to refer to individuals currently serving community supervision or any other type of probationary term imposed by an order of a court for a conviction, deferred adjudication, or deferred disposition.

(b) (No change.)

(c) The board has determined that the nature and seriousness of certain crimes outweigh other factors to be considered in §281.63(g) of this title (relating to Considerations for Criminal Offenses) and necessitate the disciplinary action listed below. The following sanctions apply to individuals with the criminal offenses as described below:

(1) Criminal offenses which require the individual to register with the Department of Public Safety as a sex offender under Chapter 62, Code of Criminal Procedure--denial;

(2) Felony offenses:

(A) Drug-related offenses, such as those listed in Chapter 481 or 483, Health and Safety Code:

(i) Offenses involving manufacture, delivery, or possession with intent to deliver, fraud, or theft of drugs:

(I) Currently on probation--denial or revocation;

(II) 0 - 5 years since date of disposition--denial or revocation;

(III) 6 - 10 years since date of disposition--denial or revocation;

(IV) 11 - 20 years since date of disposition--denial or revocation;

(V) Over 20 years since date of disposition--5 years probation;

(ii) Offenses involving possession of drugs:

(I) Currently on probation--denial, revocation, or suspension; [ or revocation;]

(II) 0 - 5 years since date of disposition--evaluation by a mental health professional indicating the individual is safe to engage in pharmacy practice and 5 years probation;

(III) 6 - 10 years since date of disposition--evaluation by a mental health professional indicating the individual is safe to engage in pharmacy practice and 3 years probation;

(IV) 11 - 20 years since date of disposition--2 years probation;

(V) Over 20 years since date of disposition--1 year probation;

(B) Offenses involving sexual contact or violent acts, or offenses considered to be felonies of the first degree under the Texas Penal Code:

(i) Currently on probation--denial or revocation;

(ii) 0-5 years since date of disposition--denial or revocation;

(iii) 6-10 years since date of disposition--denial or revocation;

(iv) 11-20 years since date of disposition--5 years probation;

(v) Over 20 years since date of disposition--1 year probation;

(C) Other felony offenses:

(i) Currently on probation--denial, revocation, or suspension; [ or revocation;]

(ii) 0 - 5 years since date of disposition--5 years probation;

(iii) 6 - 10 years since date of disposition--3 years probation;

(iv) 11 - 20 years since date of disposition--1 year probation;

(3) Misdemeanor offenses:

(A) Drug-related offenses, such as those listed in Chapter 481 or 483, Health and Safety Code:

(i) Offenses involving manufacture, delivery, or possession with intent to deliver, fraud, or theft of drugs:

(I) Currently on probation--denial or revocation;

(II) 0-10 years since date of disposition--5 years probation;

(III) Over 10 years since date of disposition--3 years probation;

(ii) Offenses involving possession of drugs:

(I) Pharmacists:

(-a-) 0 - 5 years since date of disposition--evaluation by a mental health professional indicating the individual is safe to engage in pharmacy practice and 5 years probation;

(-b-) 6 - 10 years since date of disposition--evaluation by a mental health professional indicating the individual is safe to engage in pharmacy practice and 3 years probation;

(II) Pharmacy Technicians and Pharmacy Technician Trainees:

(-a-) 0 - 5 years since date of disposition and determined to have a drug or alcohol dependency--5 years probation;

(-b-) 0 - 5 years since date of disposition and not determined to have a drug or alcohol dependency--1 year probation;

(-c-) 6 - 10 years since date of disposition and determined to have a drug or alcohol dependency--3 years probation;

(B) Intoxication and alcoholic beverage offenses as defined in the Texas Penal Code, if two such offenses occurred in the previous ten years:

(i) Pharmacists:

(I) 0-5 years since date of disposition--evaluation by a mental health professional indicating the individual is safe to engage in pharmacy practice and 5 years probation;

(II) 6-10 years since date of disposition--evaluation by a mental health professional indicating the individual is safe to engage in pharmacy practice and 3 years probation;

(ii) Pharmacy Technicians and Pharmacy Technician Trainees: 0- 5 years since date of disposition and determined to have a drug or alcohol dependency--5 years probation;

(C) Other misdemeanor offenses involving moral turpitude: 0 - 5 years since date of disposition--reprimand.

(d) - (e) (No change.)

§281.65.Schedule of Administrative Penalties [ administrative penalties ].

The board has determined that the assessment of an administrative penalty promotes the intent of §551.002 of the Act. In disciplinary matters, the board may assess an administrative penalty in addition to any other disciplinary action in the circumstances and amounts as follows:

(1) (No change.)

(2) The following violations by a pharmacy may be appropriate for disposition with an administrative penalty with or without additional sanctions or restrictions:

(A) failure to provide patient counseling: $1,500;

(B) failure to conduct a drug regimen review or inappropriate drug regimen reviews provided by §291.33(c)(2)(A) of this title (relating to Operational Standards): $1,500;

(C) failure to clarify a prescription with the prescriber: $1,500;

(D) failure to properly supervise or improperly delegating a duty to a pharmacy technician: $1,500;

(E) failure to identify the dispensing pharmacist on required pharmacy records: $500;

(F) failure to maintain records of prescriptions: $500;

(G) failure to provide or providing false or fraudulent information on any application, notification, or other document required under this Act, the Dangerous Drug Act, or Controlled Substances Act, or rules adopted pursuant to those Acts: $1,000;

(H) shortages of prescription drugs following an accountability audit: up to $5,000;

(I) dispensing a prescription drug pursuant to a forged, altered, or fraudulent prescription: up to $5,000;

(J) dispensing unauthorized prescriptions: up to $5,000;

(K) dispensing controlled substances or dangerous drugs to an individual or individuals in quantities, dosages, or for periods of time which grossly exceed standards of practice, approved labeling of the federal Food and Drug Administration, or the guidelines published in professional literature: up to $5,000;

(L) violating the reporting provisions of an Order of the Board: $1,000 - $5,000;

(M) failure to report or to assure the report of a malpractice claim: up to $1,000;

(N) failure to respond within the time specified on a warning notice to such warning notice issued as a result of a compliance inspection or responding to a warning notice as a result of a compliance inspection in a manner that is false or misleading: up to $1,000;

(O) allowing a pharmacist to practicing pharmacy with a delinquent license: $250 - $1,000;

(P) operating a pharmacy with a delinquent license: $1,000 - $5,000;

(Q) allowing an individual to perform the duties of a pharmacy technician without a valid registration: $250 - $1500; [$250 - $1,000;]

(R) failure to comply with the requirements of the Official Prescription Program: up to $1,000;

(S) aiding and abetting the unlicensed practice of pharmacy, if an employee of the pharmacy knew or reasonably should have known that the person engaging in the practice of pharmacy was unlicensed at the time: up to $5,000;

(T) a conviction or deferred adjudication for a misdemeanor or felony which serves as a ground for discipline under the Act: up to $5,000;

(U) unauthorized substitutions: $1,000;

(V) false or fraudulent claims to third parties for reimbursement of pharmacy services: up to $5,000;

(W) possessing or engaging in the sale, purchase, or trade or the offer to sell, purchase, or trade of misbranded prescription drugs or prescription drugs beyond the manufacturer's expiration date: up to $1,000;

(X) possessing or engaging in the sale, purchase, or trade or the offer to sell, purchase, or trade of prescription drug samples as provided by §281.8(b)(2) of this title (relating to Grounds for Discipline for a Pharmacy License): up to $1,000;

(Y) failure to keep, maintain or furnish an annual inventory as required by §291.17 of this title (relating to Inventory Requirements): $1,000;

(Z) failure to obtain training on the preparation of sterile pharmaceutical compounding: $1,500;

(AA) failure to maintain the confidentiality of prescription records: $1,000 - $5,000;

(BB) failure to inform the board of any notification or information required to be reported by the Act or rules: $250 - $500.

(3) - (6) (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 9, 2008.

TRD-200802976

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 20, 2008

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

SUBCHAPTER A. ALL CLASSES OF PHARMACIES

22 TAC §291.15

The Texas State Board of Pharmacy proposes new §291.15, concerning Storage of Drugs. The proposed new rule, if adopted, provides the storage requirements for drugs in all classes of pharmacies.

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 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 to ensure that the storage of drugs is consistent between the different classes of pharmacies and USP guidelines. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.

Comments on the proposed new rule may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 21, 2008.

The new rule is proposed under §551.002, and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§291.15.Storage of Drugs.

All drugs shall be stored at the proper temperature and conditions as defined by the following terms:

(1) Freezer--A place in which the temperature is maintained thermostatically between minus 25 degrees Celsius and minus 10 degrees Celsius (minus 13 degrees Fahrenheit and 14 degrees Fahrenheit).

(2) Cold--Any temperature not exceeding 8 degrees Celsius (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 degrees Celsius and 8 degrees Celsius (36 degrees Fahrenheit and 46 degrees Fahrenheit).

(3) Cool--Any temperature between 8 degrees Celsius and 15 degrees Celsius (46 degrees Fahrenheit and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.

(4) Room temperature--The temperature prevailing in a working area.

(5) Controlled room temperature--A temperature maintained thermostatically between 15 degrees Celsius and 30 degrees Celsius (59 degrees Fahrenheit and 86 degrees Fahrenheit).

(6) Warm--Any temperature between 30 degrees Celsius and 40 degrees Celsius (86 degrees Fahrenheit and 104 degrees Fahrenheit).

(7) Excessive heat--Any temperature above 40 degrees Celsius (104 degrees Fahrenheit).

(8) Protection from freezing--Where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.

(9) Dry place--A place that does not exceed 40% average relative humidity at controlled room temperature or the equivalent water vapor pressure at other temperatures.

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 9, 2008.

TRD-200802977

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 20, 2008

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

22 TAC §§291.72 - 291.74

The Texas State Board of Pharmacy proposes amendments to §291.72, concerning Definitions, §291.73, concerning Personnel, and §291.74, concerning Operational Standards. The proposed amendments to §291.72, if adopted, define physically present supervision and electronic supervision. The proposed amendments to §291.73, if adopted, require the pharmacy to document the identity of each pharmacist involved in a specific portion of the distribution process if the pharmacy's data processing system is capable of recording such information and outline the duties for pharmacy technicians and pharmacy technician trainees that must be performed under the physically present supervision of a pharmacist and duties that may be performed under the electronic supervision of a pharmacist. The proposed amendments to §291.74, if adopted, remove the storage of drugs requirements and locate the requirements in new §291.15 proposed elsewhere in this issue of the Texas Register, and replace the term substitute with the term interchange.

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

Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will be to ensure pharmacy technicians and pharmacy technician trainees working in Class C pharmacies are appropriately supervised by a pharmacist, ensure the storage of drugs is consistent with other classes of pharmacy and USP guidelines, and clarify the rules regarding formularies in hospitals. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with the sections.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 21, 2008.

The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§291.72.Definitions.

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

(1) - (43) (No change.)

(44) Supervision--

(A) Physically present supervision--In a Class C pharmacy, a pharmacist shall be physically present to directly supervise pharmacy technicians or pharmacy technician trainees.

(B) Electronic supervision--In a Class C pharmacy in a facility licensed for 100 beds or less, a pharmacist licensed in Texas may electronically supervise pharmacy technicians or pharmacy technician trainees to perform the duties specified in §291.73(e)(2) of this title (relating to Personnel) provided:

(i) the pharmacy uses a system that monitors the data entry of medication orders and the filling of such orders by an electronic method that shall include the use of one or more the following types of technology:

(I) digital interactive video, audio, or data transmission;

(II) data transmission using computer imaging by way of still-image capture and store and forward; and

(III) other technology that facilitates access to pharmacy services;

(ii) the pharmacy establishes controls to protect the privacy and security of confidential records;

(iii) the pharmacist responsible for the duties performed by a pharmacy technician or pharmacy technician trainee verifies:

(I) the data entry; and

(II) the accuracy of the filled orders prior to release of the order; and

(iv) the pharmacy keeps permanent digital records of duties electronically supervised and data transmissions associated with electronically supervised duties for a period of two years.

(C) If the conditions of subparagraph (B) of this paragraph are met, electronic supervision shall be considered the equivalent of direct supervision for the purposes of the Act.

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

(46) [(45)] 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.

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

(48) [(47)] Written protocol--A physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Texas Medical Board under the Texas Medical Practice Act Subtitle B, Chapter 157, Occupations Code.

§291.73.Personnel.

(a) - (c) (No change.)

(d) Pharmacists.

(1) General.

(A) - (D) (No change.)

(E) A distributing pharmacist shall be responsible for and ensure that the drug is prepared for distribution safely, and accurately as prescribed unless the pharmacy's data processing system can record the identity of each pharmacist involved in a specific portion of the preparation of medication orders for distribution, in which case each pharmacist involved in the preparation of medication orders shall be responsible for and ensure that the portion of the process the pharmacist is performing results in the safe and accurate distribution and delivery of the drug as ordered. [In addition, if multiple pharmacists participate in the preparation of medication orders for distribution, each pharmacist shall ensure the safety and accuracy of the portion of the process the pharmacist is performing.] The preparation and distribution process for medication orders shall include, but not be limited to, drug regimen review, and verification of accurate medication order data entry, preparation, and distribution, and performance of the final check of the prepared medication.

(2) - (3) (No change.)

(e) Pharmacy technicians and pharmacy technician trainees.

(1) General. All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).

(2) Duties. Duties may include, but need not be limited to, the following functions under the [direct] supervision of and responsible to a pharmacist:

(A) Facilities licensed for 101 beds or more. The following functions must be performed under the physically present supervision of a pharmacist:

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

(iii) 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) distributing routine orders for stock supplies to patient care areas;

(v) 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;

(vi) loading bulk unlabeled drugs into an automated compounding or counting device 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;

(vii) accessing automated medication supply systems after proper training on the use of the automated medication supply system and demonstration of comprehensive knowledge of the written policies and procedures for its operation;

(viii) compounding non-sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees have completed the training specified in §291.131 of this title; and

(ix) compounding sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(I) have completed the training specified in §291.133 of this title; and

(II) are supervised by a pharmacist who has completed the training specified in §291.133 of this title and who conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy.)

(B) Facilities licensed for 100 beds or less.

(i) Physically present supervision. The following functions must be performed under the physically present supervision of a pharmacist:

(I) 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) 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;

(III) loading bulk unlabeled drugs into an automated compounding or counting device 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; and

(IV) compounding medium-risk and high-risk sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(-a-) have completed the training specified in §291.133 of this title; and

(-b-) are supervised by a pharmacist who has completed the training specified in §291.133 of this title, and who conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy.)

(ii) Electronic supervision or physically present supervision. The following functions may be performed under the electronic supervision or physically present supervision of a pharmacist:

(I) preparing, packaging, or labeling prescription drugs pursuant to medication orders, provided a pharmacist checks the preparation;

(II) distributing routine orders for stock supplies to patient care areas;

(III) 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;

(IV) accessing automated medication supply systems after proper training on the use of the automated medication supply system and demonstration of comprehensive knowledge of the written polices and procedures for its operation;

(V) compounding non-sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees have completed the training specified in §291.131 of this title; and

(VI) compounding low-risk sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(-a-) have completed the training specified in §291.133 of this title; and

(-b-) are supervised by a pharmacist who has completed the training specified in §291.133 of this title, and who conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy.)

[(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;]

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

[(C) 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;]

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

[(E) 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);]

[(F) loading bulk unlabeled drugs into an automated compounding or counting device 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; and]

[(G) may be allowed access to automated medication supply systems after proper training on the use of the automated medication supply system and demonstration of comprehensive knowledge of the written policies and procedures for its operation.]

[(H) compounding sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:]

[(i) have completed the training specified in §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations); and]

[(ii) are supervised by a pharmacist who has completed the training specified in §291.133 of this title and who conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy.)]

[(3) Special requirements for compounding.]

[(A) Non-Sterile Preparations. All pharmacy technicians and pharmacy technician trainees engaged in compounding non-sterile preparations shall meet the training requirements specified in §291.131 of this title.]

[(B) Sterile Preparations. Pharmacy technicians and pharmacy technician trainees engaged in compounding sterile preparations shall meet the training requirements specified in §291.133 of this title.]

(3) [(4)] Procedures.

(A) Pharmacy [pharmacy] technicians and pharmacy technician trainees shall handle medication orders in accordance with standard, written procedures and guidelines.

(B) Pharmacy [pharmacy] technicians and pharmacy technician trainees shall handle prescription drug orders in the same manner as those working in a Class A pharmacy.

(f) - (g) (No change.)

§291.74.Operational Standards.

(a) - (e) (No change.)

(f) Drugs.

(1) Procurement, preparation and storage.

(A) - (C) (No change.)

(D) All drugs shall be stored at the proper temperatures, as defined in the USP/NF and in §291.15 of this title (relating to Storage of Drugs) [by the following].

[(i) Cold--Any temperature not exceeding 8 degrees Centigrade (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 and 8 degrees Centigrade (36 and 46 degrees Fahrenheit). A freezer is a cold place in which the temperature is maintained thermostatically between -20 and -10 degrees Centigrade (-4 and 14 degrees Fahrenheit).]

[(ii) Cool--Any temperature between 8 and 15 degrees Centigrade (46 and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator unless otherwise specified in the labeling.]

[(iii) Room temperature--The temperature prevailing in a working area. Controlled room temperature is a temperature thermostatically between 15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit).]

[(iv) Warm--Any temperature between 30 and 40 degrees Centigrade (86 and 104 degrees Fahrenheit).]

[(v) Excessive heat--Any temperature above 40 degrees Centigrade (104 degrees Fahrenheit).]

[(vi) Protection from freezing where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.]

(E) Any drug bearing an expiration date may not be distributed beyond the expiration date of the drug.

(F) Outdated and other unusable drugs shall be removed from stock and shall be quarantined together until such drugs are disposed of properly.

(2) Formulary.

(A) A formulary shall be developed by the facility committee performing the pharmacy and therapeutics function for the facility. For the purpose of this section, a formulary is a compilation of pharmaceuticals that reflects the current clinical judgment of a facility's medical staff.

(B) The pharmacist-in-charge or pharmacist designated by the pharmacist-in-charge shall be a full voting member of the committee performing the pharmacy and therapeutics function for the facility, when such committee is performing the pharmacy and therapeutics function.

(C) A practitioner may grant approval for pharmacists at the facility to interchange [substitute], in accordance with the facility's formulary, for the prescribed drugs on the practitioner's medication orders provided:

(i) the pharmacy and therapeutics committee has developed a formulary;

(ii) the formulary has been approved by the medical staff committee of the facility;

(iii) there is a reasonable method for the practitioner to override any interchange [substitution]; and

(iv) the practitioner authorizes pharmacists in the facility to interchange [substitute] on his/her medication orders in accordance with the facility's formulary through his/her written agreement to abide by the policies and procedures of the medical staff and facility.

(3) - (5) (No change.)

(g) - (j) (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 9, 2008.

TRD-200802978

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 20, 2008

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

22 TAC §§291.91 - 291.94

The Texas State Board of Pharmacy proposes amendments to §291.91, concerning Definitions, §291.92, concerning Personnel, §291.93, concerning Operational Standards, and §291.94, concerning Records. The amendments, if adopted, incorporate the recommendations of the Task Force on Clinic Pharmacies (Class D). Specifically, the amendments, if adopted, update the definition of "practitioner" to be consistent with the Texas Pharmacy Act; update formulary requirements to allow Class D pharmacies with expanded formularies to have antipsychotic drugs; prohibit Class D pharmacies from having Carisoprodal or drugs used to treat erectile dysfunction; allow Class D pharmacies with expanded formularies including drugs requiring special monitoring to submit policies and procedures regarding the provision of such drugs; clarify that Class D pharmacies wishing to add drugs to an expanded formulary must make such a request in writing to the Board prior to adding the drugs; require pharmacists to conduct retrospective drug reviews on a quarterly basis in Class D pharmacies with expanded formularies; require an initial order by a physician for antipsychotic drugs provided in a Class D pharmacy, followed by monitored therapy and at least yearly physical exams by the physician; and require a licensed nurse or practitioner to provide verbal and written information to the patient.

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

Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will be to ensure patients receiving medications at Class D pharmacies are appropriate and safe. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with the sections.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 21, 2008.

The amendments are proposed under §551.002, and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by the amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§291.91.Definitions.

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

(1) - (15) (No change.)

(16) Practitioner--

(A) a person licensed or registered to prescribe, distribute, administer, or dispense a prescription drug or device in the course of professional practice in this state, including a physician, dentist, podiatrist, or veterinarian but excluding a person licensed under the Act;

(B) a person licensed by another state, Canada, or the United Mexican States in a health field in which, under the law of this state, a license holder in this state may legally prescribe a dangerous drug;

(C) a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration registration number and who may legally prescribe a Schedule II, III, IV, or V controlled substance, as specified under Chapter 481, Health and Safety Code, in that other state; or

(D) an advanced practice nurse or physician assistant to whom a physician has delegated the authority to carry out or sign prescription drug orders under §§157.0511, 157.052, 157.053, 157.054, 157.0541, or 157.0542, Occupations Code.

[(16) Practitioner--]

[(A) a physician, dentist, podiatrist, veterinarian, or other person licensed or registered to distribute 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 Act.]

(17) - (22) (No change.)

§291.92.Personnel.

(a) Pharmacist-in-charge.

(1) (No change.)

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

(A) continuous supervision of registered nurses, licensed vocational nurses, physician assistants, pharmacy technicians , pharmacy technician trainees, and assistants carrying out the pharmacy related aspects of provision;

(B) documented periodic on-site visits as specified in §291.93(h) and §291.94(b) [§291.94(a)] of this title (relating to Operational Standards and Records), either personally or by the consultant pharmacist or staff pharmacist, to insure that the clinic is following set policies and procedures; documentation shall be as specified in §291.94(b) [§291.94(a) ] of this title;

(C) development of a formulary for the clinic, in conjunction with the clinic's pharmacy and therapeutics committee, consisting of drugs and/or devices needed to meet the objectives of the clinic;

(D) procurement and storage of drugs and/or devices, but he or she may receive input from other appropriate staff of the clinic;

(E) determining specifications of all drugs and/or devices procured by the clinic;

(F) maintenance of records of all transactions of the pharmacy as may be required by applicable law and as may be necessary to maintain accurate control over and accountability for all drugs and/or devices;

(G) development and at least annual [periodic ] review of a policy and procedure manual for the pharmacy in conjunction with the clinic's pharmacy and therapeutics committee;

(H) meeting inspection and other requirements of the Texas Pharmacy Act and these sections;

(I) dispensing of prescription orders; and

(J) conducting inservice training at least annually for supportive personnel who provide drugs; such training shall be related to actions, contraindications, adverse reactions, and pharmacology of drugs contained in the formulary.

(b) - (c) (No change.)

(d) Supportive personnel.

(1) Qualifications.

(A) Supportive personnel shall possess education and training necessary to carry out their responsibilities.

(B) Supportive personnel shall be qualified to perform the pharmacy tasks assigned to them.

(2) Duties. Duties may include:

[(A) provision of drugs and/or devices under the continuous supervision of a pharmacist according to standing delegation orders or standing medical orders and in accordance with written policies and procedures and completion of the label as specified in §291.93(e)(6)(F) of this title (relating to Operational Standards);]

(A) [(B)] prepackaging and labeling unit of use packages, under the direct supervision of a pharmacist with the pharmacist conducting in-process and final checks and affixing his or her signature to the appropriate quality control records;

(B) [(C)] maintaining inventories of drugs and/or devices; and

(C) [(D)] maintaining pharmacy records.

(3) Absence of the pharmacist. The pharmacist-in-charge shall designate from among the supportive personnel a person to supervise the day-to-day pharmacy-related operations of the clinic.

(e) Owner. The owner of a Class D pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:

(1) - (4) (No change.)

§291.93.Operational Standards.

(a) Registration.

(1) General requirements.

(A) - (G) (No change.)

(H) A clinic [Class D (clinic)] pharmacy shall notify the board in writing of any change in name or location within 10 days.

(I) - (K) (No change.)

(2) (No change.)

(b) Environment.

(1) (No change.)

(2) Security.

(A) Only authorized personnel may have access to storage areas for dangerous drugs and/or devices.

(B) All storage areas for dangerous drugs and/or devices shall be locked by key, [or] combination, or other mechanical or electronic means, so as to prohibit access by unauthorized individuals [ so as to prevent access by unauthorized personnel].

(C) The pharmacist-in-charge shall be responsible for the security of all storage areas for dangerous drugs and/or devices including provisions for adequate safeguards against theft or diversion of dangerous drugs and devices, and records for such drugs and devices.

(D) The pharmacist-in-charge shall consult with clinic personnel with respect to security of the pharmacy, including provisions for adequate safeguards against theft or diversion of dangerous drugs and/or devices, and records for such drugs and/or devices.

(E) Housekeeping and maintenance duties shall be carried out in the pharmacy, while the pharmacist-in-charge, consultant pharmacist, staff pharmacist, or supportive personnel is on the premises.

(c) (No change.)

(d) Library. A reference library shall be maintained which includes the following in hard copy or electronic format:

(1) current copies of the following [laws]:

(A) Texas Pharmacy Act and rules; and

(B) Texas Dangerous Drug Act [Law];

(2) current copies of at least two of the following references:

(A) Facts and Comparisons with current supplements;

(B) AHFS Drug Information;

(C) United States Pharmacopeia Dispensing Information (USPDI);

(D) Physician's Desk Reference (PDR);

(E) American Drug Index;

(F) a reference text on drug interactions, such as Drug Interaction Facts. A separate reference is not required if other references maintained by the pharmacy contain drug interaction information including information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken; [ Hansten's and Horn's Drug Interactions Analysis and Management;]

(G) reference texts in any of the following subjects: toxicology, pharmacology, or drug interactions; or

(H) reference texts pertinent to the major function(s) of the clinic.

(e) Drugs and devices.

(1) Formulary.

(A) Each Class D pharmacy shall have a formulary which lists all drugs and devices that are administered, dispensed, or provided by the Class D pharmacy.

(B) The formulary shall be limited to the following types of drugs and [and/or] devices, exclusive of injectable drugs for administration in the clinic and nonprescription drugs, except as provided in subparagraph (D) of this paragraph:

(i) - (vi) (No change.)

(C) The formulary shall not contain the following drugs or types of drugs:

(i) Nalbuphine (Nubain);

(ii) Carisoprodal (Soma); [antipsychotics; and]

(iii) drugs used to treat erectile dysfunction; and

(iv) [(iii)] Schedule I-V controlled substances.

(D) Clinics with a patient population which consists of at least 80% indigent patients may petition the board to operate with a formulary which includes types of drugs and [and/or ] devices, other than those listed in subparagraph (B) of this paragraph based upon documented objectives of the clinic, under the following conditions.

(i) Such petition shall contain an affidavit with the notarized signatures of the medical director, the pharmacist-in-charge, and the owner/chief executive officer of the clinic, and include the following documentation:

(I) the objectives of the clinic;

(II) the total number of patients served by the clinic during the previous fiscal year or calendar year;

(III) the total number of indigent patients served by the clinic during the previous fiscal year or calendar year;

(IV) the percentage of clinic patients who are indigent, based upon the patient population during the previous fiscal year or calendar year; [and]

(V) the proposed formulary and the need for additional types of drugs based upon objectives of the clinic; and [.]

(VI) if the provision of any drugs on the proposed formulary require special monitoring, the clinic pharmacy shall submit relevant sections of the clinic's policy and procedure manual regarding the provision of drugs that require special monitoring.

(ii) Such petition shall be resubmitted every two years in conjunction with the application for renewal of the pharmacy license.

(I) Such renewal petition shall contain the documentation required in clause (i) of this subparagraph.

(II) If at the time of renewal of the pharmacy license, the patient population for the previous fiscal year or calendar year is below 80% indigent patients, the clinic shall be required to submit an application for a Class A pharmacy license or shall limit the clinic formulary to those types of drugs and [and/or] devices listed in subparagraph [subparagraphs] (B) [and (C)] of this paragraph.

(iii) If a clinic pharmacy wishes to add additional drugs to the expanded formulary, the pharmacy shall petition the board in writing prior to adding such drugs to the formulary. The petition shall identify drugs to be added and the need for the additional drugs based upon objectives of the clinic as specified in clause (i) of this subparagraph.

(iv) [(iii)] The following additional requirements shall be satisfied for clinic pharmacies with expanded formularies.

(I) Supportive personnel who are providing drugs shall be licensed nurses or practitioners [physician assistants].

(II) The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall make on-site visits to the clinic at least monthly.

(III) If the pharmacy provides drugs which require special monitoring (i.e., drugs which require follow-up laboratory work or drugs which should not be discontinued abruptly), the pharmacy shall have policies and procedures for the provision of the prescription drugs to patients and the monitoring of patients who receive such drugs.

(IV) The pharmacist-in-charge, consultant pharmacists, or staff pharmacists shall conduct retrospective drug regimen reviews of a random sample of patients of the clinic on at least a quarterly basis. The pharmacist-in-charge shall be responsible for ensuring that a report regarding the drug regimen review, including the number of patients reviewed, is submitted to the clinic's medical director and the pharmacy and therapeutics committee of the clinic.

(V) If a pharmacy provides antipsychotic drugs:

(-a-) a physician of the clinic shall initiate the therapy;

(-b-) a practitioner shall monitor and order ongoing therapy; and

(-c-) the patient shall be physically examined by the physician at least on a yearly basis.

(v) [(iv)] The board may consider the following items in approving or disapproving a petition for an expanded formulary:

(I) the degree of compliance on past compliance inspections;

(II) the size of the patient population of the clinic;

(III) the number and types of drugs contained in the formulary; and

(IV) the objectives of the clinic.

(2) Storage.

(A) Drugs and/or devices which bear the words "Caution, Federal Law Prohibits Dispensing without prescription" or "Rx only" shall be stored in secured storage areas.

(B) All drugs shall be stored at the proper temperatures, as defined in §291.15 of this title (relating to Storage of Drugs). [by the following terms.]

[(i) Cold--Any temperature not exceeding 8 degrees Centigrade (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 degrees and 8 degrees Centigrade (36 degrees and 46 degrees Fahrenheit). A freezer is a cold place in which the temperature is maintained thermostatically between -20 degrees and -10 degrees Centigrade (-4 degrees and 14 degrees Fahrenheit).]

[(ii) Cool--Any temperature between 8 degrees and 15 degrees Centigrade (46 degrees and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator, unless otherwise specified in the individual monograph.]

[(iii) Room temperature--The temperature prevailing in a working area. Controlled room temperature is a temperature maintained thermostatically between 15 degrees and 30 degrees Centigrade (59 degrees and 86 degrees Fahrenheit).]

[(iv) Warm--Any temperature between 30 degrees and 40 degrees Centigrade (86 degrees and 104 degrees Fahrenheit).]

[(v) Excessive heat--Temperature above 40 degrees Centigrade (104 degrees Fahrenheit).]

[(vi) Protection from freezing--Where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.]

(C) Any drug or [and/or] device bearing an expiration date may not be provided, dispensed, or administered beyond the expiration date of the drug or [and/or] device.

(D) Outdated drugs or [and/or] devices shall be removed from stock and shall be quarantined together until such drugs or [and/or] devices are disposed.

(E) Controlled substances may not be stored at the clinic pharmacy.

(3) Drug samples.

(A) Drug samples of drugs listed on the clinic pharmacy's formulary and supplied by manufacturers shall be properly stored, labeled, provided, or dispensed by the clinic pharmacy in the same manner as prescribed by these sections for dangerous drugs.

(B) Samples of controlled substances may not be stored, provided, or dispensed in the clinic pharmacy.

(4) Prepackaging and labeling for provision.

(A) Drugs may be prepackaged and labeled for provision in the clinic pharmacy. Such prepackaging shall be performed by a pharmacist or supportive personnel under the direct supervision of a pharmacist and shall be for the internal use of the clinic.

(B) Drugs must be prepackaged in suitable containers.

(C) The label of the prepackaged unit shall bear:

(i) the name, address, and telephone number [ and address] of the clinic;

(ii) directions for use, which may include incomplete directions for use provided:

(I) labeling with incomplete directions for use has been authorized by the pharmacy and therapeutics committee;

(II) precise requirements for completion of the directions for use are developed by the pharmacy and therapeutics committee and maintained in the pharmacy policy and procedure manual; and

(III) the directions for use are completed by practitioners, pharmacists, licensed nurses or physician assistants in accordance with the precise requirements developed under subclause (II) of this clause;

(iii) name and strength of the drug--if generic name, the name of the manufacturer or distributor of the drug;

(iv) quantity;

(v) lot number and expiration date; and

(vi) appropriate ancillary label(s).

(D) Records of prepackaging shall be maintained according to §291.94(c) of this title (relating to Records).

(5) Labeling for provision of drugs and/or devices in an original manufacturer's container.

(A) Drugs and/or devices in an original manufacturer's container shall be labeled prior to provision with the information set out in paragraph (4)(C) of this subsection.

(B) Drugs and/or devices in an original manufacturer's container may be labeled by:

(i) a pharmacist in a pharmacy licensed by the board; or

(ii) supportive personnel in a Class D pharmacy, provided the drugs and/or devices and control records required by §291.94(d) of this title, are quarantined together until checked and released by a pharmacist.

(C) Records of labeling for provision of drugs and/or devices in an original manufacturer's container shall be maintained according to §291.94(d) of this title.

(6) Provision.

(A) Drugs and [and/or] devices may only be provided to patients of the clinic.

(B) At the time of provision, a licensed nurse or practitioner shall provide verbal and written information to the patient or patient's agent on side effects, interactions, and precautions concerning the drug or device provided. [the patient shall be provided verbal and/or written information on side effects, interactions, and precautions concerning the drug and/or device provided.]

(C) The provision of drugs or devices shall be under the continuous supervision of a pharmacist according to standing delegation orders or standing medical orders and in accordance with written policies and procedures and completion of the label as specified in subparagraph (G) of this paragraph.

(D) [(C)] Drugs and/or devices may only be provided in accordance with the system of control and accountability for drugs and/or devices provided by the clinic; such system shall be developed and supervised by the pharmacist-in-charge.

(E) [(D)] Only drugs and/or devices listed in the clinic formulary may be provided.

(F) [(E)] Drugs and/or devices may only be provided in prepackaged quantities in suitable containers and/or original manufacturer's containers which are appropriately labeled as set out in paragraphs (4) and (5) of this subsection.

(G) [(F)] Such drugs and/or devices shall be labeled by a pharmacist licensed by the board; however, when drugs and/or devices are provided under the supervision of a physician according to standing delegation orders or standing medical orders, supportive personnel may at the time of provision print on the label the following information:

(i) patient's name;

(ii) any information necessary to complete the directions for use in accordance with paragraph (4)(C)(ii) of this subsection;

(iii) date of provision; and

(iv) practitioner's name.

(H) [(G)] Records of provision shall be maintained according to §291.94(e) of this title.

(I) [(H)] Controlled substances may not be provided or dispensed.

(J) Non-sterile and sterile preparations may only be provided by the clinic pharmacy in accordance with §291.131 and §291.133 of this title (relating to Pharmacies Compounding Non-sterile Preparations and Pharmacies Compounding Sterile Preparations).

(7) Dispensing. Dangerous drugs may only be dispensed by a pharmacist pursuant to a prescription order in accordance with §§291.31 - 291.35 of this title (relating to Community Pharmacy (Class A)) and §291.131 and §291.133 of this title. [ §§291.31 - 291.36 of this title (relating to Community Class A Pharmacy).]

(f) Pharmacy and therapeutics committee.

(1) The clinic pharmacy shall have a pharmacy and therapeutics committee, which [pharmacy and therapeutics committee] shall be composed of at least three persons and shall include the pharmacist-in-charge, the medical director of the clinic, and a person who is responsible for provision of drugs and [and/or] devices.

(2) The pharmacy and therapeutics committee shall develop the policy and procedure manual.

(3) The pharmacy and therapeutics committee shall meet at least annually to: [review and update the policy and procedure manual.]

(A) review and update the policy and procedure manual; and

(B) review the retrospective drug utilization review reports submitted by the pharmacist-in-charge if the clinic pharmacy has an expanded formulary.

(g) Policies and procedures.

(1) Written policies and procedures shall be developed by the pharmacy and therapeutics committee and implemented by the pharmacist-in-charge.

(2) The policy and procedure manual shall include, but not be limited to, the following:

(A) a current list of the names [and addresses] of the pharmacist-in-charge, consultant-pharmacist, staff pharmacist(s), supportive personnel designated to provide drugs or [and/or ] devices, and the supportive personnel designated to supervise the day-to-day pharmacy related operations of the clinic in the absence of the pharmacist;

(B) functions of the pharmacist-in-charge, consultant pharmacist, staff pharmacist(s), and supportive personnel;

(C) objectives of the clinic;

(D) formulary;

(E) a copy of written agreement between the pharmacist-in-charge and the clinic;

(F) date of last review/revision of policy and procedure manual; and

(G) policies and procedures for:

(i) security;

(ii) equipment;

(iii) sanitation;

(iv) licensing;

(v) reference materials;

(vi) storage;

(vii) packaging-repackaging;

(viii) dispensing;

(ix) provision;

(x) retrospective drug regimen review;

(xi) [(x)] supervision;

(xii) [(xi)] labeling-relabeling;

(xiii) [(xii)] samples;

(xiv) [(xiii)] drug destruction and returns;

(xv) [(xiv)] drug and [and/or ] device procuring;

(xvi) [(xv)] receiving of drugs and [ and/or] devices;

(xvii) [(xvi)] delivery of drugs and [ and/or] devices;

(xviii) [(xvii)] recordkeeping; and

(xix) [(xviii)] inspection.

(h) Supervision. The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall personally visit the clinic on at least a monthly basis to ensure that the clinic is following established policies and procedures. However, clinics operated by state or local governments and clinics funded by government sources money may petition the board for an alternative visitation schedule under the following conditions:

[(1) The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall be in contact with the clinic on at least a monthly basis, either through written memos, documented telephonic conferences, or on-site visits.]

[(2) The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall personally visit the clinic every three months to ensure that the clinic is following set policies and procedures, provided, however, that clinics who are operated by state or local governments and clinics who are funded by public money may petition the board for an alternative visitation schedule under the following conditions.]

(1) [(A)] Such petition shall contain an affidavit with the notarized signatures of the medical director, the pharmacist-in-charge, and the owner/chief executive officer of the clinic, which states that the clinic has a current policy and procedure manual on file, has adequate security to prevent diversion of dangerous drugs, and is in compliance with all rules governing Class D pharmacies.

(2) [(B)] The board may consider the following items in determining an alternative schedule:

(A) [(i)] the degree of compliance on past compliance inspections;

(B) [(ii)] the size of the patient population of the clinic;

(C) [(iii)] the number and types of drugs contained in the formulary; and

(D) [(iv)] the objectives of the clinic.

(3) [(C)] Such petition shall be resubmitted every two years in conjunction with the application for renewal of the pharmacy license.

§291.94.Records.

(a) Maintenance of records.

(1) Every inventory or other record required to be kept under the provisions of §291.91 of this title (relating to Definitions), §291.92 of this title (relating to Personnel), §291.93 of this title (relating to Operational Standards), and §291.94 of this title (relating to Records), contained in Clinic Pharmacy (Class D) shall be:

(A) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and

(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.

(2) Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

(A) the records maintained in the alternative system contain all of the information required on the manual record; and

(B) the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

(3) Invoices and records of receipt may be kept at a location other than the pharmacy. Any such records not kept at the pharmacy shall be supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy.

(b) [(a)] On-site visits. A record of on-site visits by the pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall be maintained and include the following information:

(1) date of the visit;

(2) pharmacist's evaluation of findings; and

(3) signature of the visiting pharmacist.

[(b) Invoices or records of receipt.]

[(1) Each Class D pharmacy shall maintain invoices and/or records of procurement in accordance with the requirements of the Texas Dangerous Drug Law and the Texas Pharmacy Act and rules.]

[(2) Invoices and records of receipt may be kept at a location other than the pharmacy. Any such records not kept at the pharmacy shall be available for inspection, upon request, within two business days.]

(c) Prepackaging. Records of prepackaging shall include the following:

(1) name, strength, and dosage form [and strength ] of drug;

(2) name of the manufacturer;

(3) manufacturer's lot number;

(4) [manufacturer's] expiration date;

(5) facility's lot number;

(6) [(5)] quantity per package and number of packages;

(7) [(6)] date packaged;

(8) [(7)] name(s), signatures, or electronic signatures of the supportive personnel who prepackages the drug under direct supervision of a pharmacist; and

(9) [(8)] name, signature, or electronic signature of the pharmacist who prepackages the drug or supervises the prepackaging and checks and releases the drug.

(d) Labeling. Records of labeling of drugs or [and/or ] devices in original manufacturer's containers shall include the following:

(1) name and strength of the drug or device labeled;

(2) name of the manufacturer;

(3) manufacturer's lot number;

(4) manufacturer's expiration date;

(5) quantity per package and number of packages;

(6) date labeled;

(7) name of the supportive personnel affixing the label; and

(8) the signature of the pharmacist who checks and releases the drug.

(e) Provision. Records of drugs and/or devices provided shall include logs, patient records, or other acceptable methods for documentation. Documentation shall include:

(1) patient name;

(2) name, signature, or electronic signature of the person who provides the drug or device;

(3) date provided; and

(4) the name of the drug or device and quantity provided.

(f) Dispensing. Record-keeping requirements for dangerous drugs dispensed by a pharmacist are the same as for a Class A pharmacy as set out in §291.34 of this title (relating to Records).

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 9, 2008.

TRD-200802979

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 20, 2008

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

22 TAC §291.133

The Texas State Board of Pharmacy proposes amendments to §291.133, concerning Pharmacies Compounding Sterile Preparations. The amendments, if adopted, remove the storage of drugs requirements from this section and locate the requirements in new §291.15 proposed elsewhere in this issue of the Texas Register.

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 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 to ensure that the storage of drugs is consistent with other classes of pharmacies and USP guidelines. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 21, 2008.

The amendments are proposed under §551.002, and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by the amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§291.133Pharmacies Compounding Sterile Preparations.

(a) - (c) (No change.)

(d) Operational Standards.

(1) - (4) (No change.)

(5) Environment. Compounding facilities shall be physically designed and environmentally controlled to minimize airborne contamination of critical sites.

(A) - (G) (No change.)

(H) Storage requirements and beyond-use dating.

(i) Storage requirements. All drugs shall be stored at the proper temperature and conditions, as defined in the USP/NF and in §291.15 of this title (relating to Storage of Drugs). [ The most commonly used definitions are as follows:]

[(I) freezer--A place where the temperature is maintained thermostatically between minus 25 degrees and minus 10 degrees Celsius (minus 13 degrees Fahrenheit and 14 degrees Fahrenheit).]

[(II) cold temperature--A temperature not exceeding 8 degrees Celsius (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature maintained thermostatically between 2 degrees and 8 degrees Celsius (36 degrees and 46 degrees Fahrenheit);]

[(III) cool--A temperature between 8 degrees and 15 degrees Celsius (46 degrees and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator unless otherwise specified on the labeling; and]

[(IV) controlled room temperature--A temperature maintained thermostatically between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit).]

(ii) Beyond-use dating.

(I) Beyond-use dates for compounded sterile preparations shall be assigned based on professional experience, which shall include careful interpretation of appropriate information sources for the same or similar formulations.

(II) Beyond-use dates for compounded sterile preparations that are prepared strictly in accordance with manufacturers' product labeling must be those specified in that labeling, or from appropriate literature sources or direct testing.

(III) Beyond-use dates for compounded sterile preparations that lack justification from either appropriate literature sources or by direct testing evidence must be assigned as described in Chapter 797, Pharmaceutical Compounding--Sterile Preparations of the USP/NF.

(6) - (13) (No change.)

(e) - (g) (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 9, 2008.

TRD-200802980

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 20, 2008

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

22 TAC §305.2

The Texas State Board of Pharmacy proposes amendments to §305.2, concerning Pharmacy Technician Training Programs. The amendments, if adopted, clarify that individuals enrolled in pharmacy technician training programs must be registered with the Board prior to working in a pharmacy as part of the experiential component of the training program.

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 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 to ensure that pharmacy technicians and pharmacy technician trainees are registered with the Board prior to working in a pharmacy. There is no fiscal impact for individuals if the individual is registering as a pharmacy technician trainee. Individuals registering as pharmacy technicians are required to pay an initial registration fee of $59. The effect on large, small or micro-businesses (pharmacies) will be the same as the economic cost to an individual, if the pharmacy chooses to pay the individual fee.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 21, 2008.

The amendments are proposed under §§551.002, 554.002, and 554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.002 as authorizing the agency to adopt rules regarding the training, qualifications, and employment of pharmacy technicians. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by the amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§305.2.Pharmacy Technician Training Programs.

(a) - (b) (No change.)

(c) Students enrolled in a Board-approved pharmacy technician training programs. A student enrolled in a Board-approved pharmacy technician training program must be registered as a pharmacy technician trainee or pharmacy technician prior to [may be a pharmacy technician trainee for the duration of their enrollment when] working in a pharmacy as part of the experiential component of the Board-approved pharmacy technician training program.

(d) - (e) (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 9, 2008.

TRD-200802981

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 20, 2008

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

22 TAC §309.1, §309.3

The Texas State Board of Pharmacy proposes amendments to §309.1, concerning Objective, and §309.3, concerning Generic Substitution. The amendments, if adopted, establish the procedures for practitioners to prohibit substitution based on the manufacturer of the brand or generic product.

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

Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will be to provide procedures for practitioners to prohibit substitution based on the manufacturer of the brand or generic product. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with the sections.

A public hearing to receive comments on the proposed amendments will be held at 9:00 a.m. on Tuesday, August 5, 2008, at the Health Professions Council Board Room, William P. Hobby Building, 333 Guadalupe Street, Tower II, Room 225, Austin, Texas 78701. Persons planning to present comments to the Board are asked to provide a written copy of their comments prior to the hearing or bring 20 copies to the hearing. Written comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 21, 2008.

The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by the amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§309.1.Objective.

These sections: [govern the substitution of lower-priced generically equivalent drug products for certain brand name drug products.]

(1) govern the substitution of lower-priced generically equivalent drug products for certain brand name drug products; and

(2) establish the procedures for practitioners to prohibit substitution based on the manufacturer of the brand or generic product.

§309.3.Generic Substitution.

(a) General requirements. In accordance with Chapter 562 of the Act, a pharmacist may dispense a generically equivalent drug product if:

[(1) In accordance with Chapter 562 of the Act, a pharmacist may dispense a generically equivalent drug product if:]

(1) [(A)] the generic product costs the patient less than the prescribed drug product;

(2) [(B) ] the patient does not refuse the substitution; and

(3) [(C)] the practitioner does not certify on the prescription form that a specific prescribed brand is medically necessary as specified in a dispensing directive described in subsection (c) of this section.

[(2) If the practitioner has prohibited substitution through a dispensing directive in compliance with subsection (c) of this section, a pharmacist shall not substitute a generically equivalent drug product unless the pharmacist obtains verbal or written authorization from the practitioner and notes such authorization on the original prescription drug order.]

(b) (No change.)

(c) Dispensing directive.

(1) General requirements. The following is applicable to dispensing directives outlines in this subsection.

(A) When a prescription is issued for a brand name product that has no generic equivalent product, the pharmacist must dispense the brand name product. If a generic equivalent product becomes available, a pharmacist may substitute the generically equivalent product unless the practitioner has specified that the on the initial prescription that the brand name product is medically necessary.

(B) If a practitioner issues a prescription for a generic drug and specifies a particular manufacturer or that the same manufacturer always be dispensed, the pharmacist may not refill the prescription with another manufacturer's product without authorization, from the prescribing practitioner.

(C) If the practitioner has prohibited substitution through a dispensing directive in compliance with this subsection, a pharmacist shall not substitute a generically equivalent drug product unless the pharmacist obtains verbal or written authorization from the practitioner, notes such authorization on the original prescription drug order, and notifies the patient in accordance with §309.4 of this title (relating to Patient Notification).

(2) [(1)] Written prescriptions.

(A) A practitioner may prohibit the substitution of a generically equivalent drug product for a brand name drug product by writing across the face of the written prescription, in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary."

(B) The dispensing directive shall:

(i) be in a format that protects confidentiality as required by the Health Insurance Portability and Accountability Act of 1996 (29 U.S.C. Section 1181 et seq.) and its subsequent amendments; and

(ii) comply with federal and state law, including rules, with regard to formatting and security requirements.

(C) The dispensing directive specified in this paragraph may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.

(D) A practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this paragraph. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate "substitution instructions" are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.

(3) [(2)] Verbal Prescriptions.

(A) If a prescription drug order is transmitted to a pharmacist orally, the practitioner or practitioner's agent shall prohibit substitution by specifying "brand necessary" or "brand medically necessary." The pharmacists shall note any substitution instructions by the practitioner or practitioner's agent, on the file copy of the prescription drug order. Such file copy may follow the one-line format indicated in subsection (b)(1) of this section, or any other format that clearly indicates the substitution instructions.

(B) If the practitioner's or practitioner's agent does not clearly indicate that the brand name is medically necessary, the pharmacist may substitute a generically equivalent drug product.

(C) To prohibit substitution on a verbal prescription reimbursed through the medical assistance program specified in 42 C.F.R., §447.331:

(i) the practitioner or the practitioner's agent shall verbally indicate that the brand is medically necessary; and

(ii) the practitioner shall mail or fax a written prescription to the pharmacy which complies with the dispensing directive for written prescriptions specified in paragraph (1) of this subsection within 30 days.

(4) [(3)] Electronic prescription drug orders.

(A) To prohibit substitution, the practitioner or practitioner's agent shall note "brand necessary" or "brand medically necessary" in the electronic prescription drug order.

(B) If the practitioner or practitioner's agent does not clearly indicate in the electronic prescription drug order that the brand is medically necessary, the pharmacist may substitute a generically equivalent drug product.

(C) To prohibit substitution on an electronic prescription drug order reimbursed through the medical assistance program specified in 42 C.F.R., §447.331, the practitioner shall fax a copy of the original prescription drug order which complies with the requirements of a written prescription drug order specified in paragraph (1) of this subsection within 30 days.

(5) [(4)] Prescriptions issued by out-of-state, Mexican, Canadian, or federal facility practitioners.

(A) The dispensing directive specified in this subsection does not apply to the following types of prescription drug orders:

(i) prescription drug orders issued by a practitioner in a state other than Texas;

(ii) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or

(iii) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.

(B) A pharmacist may not substitute on prescription drug orders identified in subparagraph (A) of this paragraph unless the practitioner has authorized substitution on the prescription drug order. If the practitioner has not authorized substitution on the written prescription drug order, a pharmacist shall not substitute a generically equivalent drug product unless:

(i) the pharmacist obtains verbal or written authorization from the practitioner (such authorization shall be noted on the original prescription drug order); or

(ii) the pharmacist obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas, in which the prescription drug order was issued. The following is applicable concerning this documentation.

(I) The documentation shall state that a pharmacist may substitute on a prescription drug order issued in such other state unless the practitioner prohibits substitution on the original prescription drug order.

(II) The pharmacist shall note on the original prescription drug order the fact that documentation from such other state board of pharmacy is on file.

(III) Such documentation shall be updated yearly.

(d) - (e) (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 9, 2008.

TRD-200802982

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 20, 2008

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