Texas State Board of Pharmacy Proposed Amendments

SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
22 TAC §291.131, §291.133
The Texas State Board of Pharmacy proposes amendments to §291.131, concerning Pharmacies Compounding Non-Sterile Preparations, and §291.133, concerning Pharmacies Compounding Sterile Preparations. The proposed amendments, if adopted, clarify the requirements for the recall of compounded preparations.
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 that the proper recall procedures are being practiced by pharmacies that are compounding sterile and non-sterile preparations. There is no fiscal impact for individuals, small or large businesses, or to other entities which are required to comply with these 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) 305-8008. Comments must be received by 5:00 p.m., July 31, 2012.
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 these amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.131.Pharmacies Compounding Non-Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (6) (No change.)
(7) Drugs, components, and materials used in non-sterile compounding.
(A) - (H) (No change.)
(I) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [Food and Drug Administration ] list of drug products withdrawn or removed from the market for safety reasons.
(8) - (10) (No change.)
(e) - (f) (No change.)
(g) Recall Procedures.
(1) The pharmacy shall have written procedures for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to the requirements as specified in paragraph (3) of this subsection.
(2) The pharmacy shall immediately initiate a recall of any non-sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient.
(3) If the pharmacy identifies a potential or confirmed harm to a patient, the pharmacist-in-charge shall ensure that:
(A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall;
(B) each patient to whom the preparation was dispensed is notified, in writing, of the recall;
(C) if the preparation is prepared as a batch, the board is notified of the recall, in writing;
(D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing;
(E) the preparation is quarantined; and
(F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures.
[(1) The pharmacy shall have written procedure for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or to a pharmacy for administration. The recall procedures shall require:]
[(A) notification to each practitioner, facility, and/or pharmacy to which the preparation was distributed;]
[(B) notification to each patient to whom the preparation was dispensed;]
[(C) quarantine of the product if there is a suspicion of harm to a patient; and]
[(D) a recall if there is probable or confirmed harm to a patient.]
[(2) If the pharmacy identifies a suspicion of, probable, or confirmed harm to a patient, the pharmacy shall immediately notify and provide information as required by the board to the following:]
[(A) the Texas Department of State Health Services, Drugs and Medical Devices Group, if the preparation is distributed for office use; and]
[(B) the board.]
(4) [(3)] The board may require a pharmacy to initiate [institute ] a recall if there is potential for [probable ] or confirmed harm to a patient.
§291.133.Pharmacies Compounding Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (9) (No change.)
(10) Drugs, components, and materials used in sterile compounding.
(A) - (G) (No change.)
(H) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [Food and Drug Administration ] list of drug products withdrawn or removed from the market for safety reasons.
(11) - (13) (No change.)
(e) - (f) (No change.)

(g) Recall Procedures.
(1) The pharmacy shall have written procedures for the recall of any compounded sterile preparation provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to the requirements as specified in paragraph (3) of this subsection.
(2) The pharmacy shall immediately initiate a recall of any sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient.
(3) If the pharmacy identifies a potential or confirmed harm to a patient, the pharmacist-in-charge shall ensure that:
(A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall;
(B) each patient to whom the preparation was dispensed is notified, in writing, of the recall;
(C) if the preparation is prepared as a batch, the board is notified of the recall, in writing;
(D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing;
(E) the preparation is quarantined; and
(F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures.
[(1) The pharmacy shall have written procedure for the recall of any compounded sterile preparations provided to a patient, to a practitioner for office use, or to a pharmacy for administration. The recall procedures shall require:]
[(A) notification to each practitioner, facility, and/or pharmacy to which the preparation was distributed;]
[(B) notification to each patient to whom the preparation was dispensed;]
[(C) quarantine of the product if there is a suspicion of harm to a patient; and]
[(D) a recall if there is probable or confirmed harm to a patient.]
[(2) If the pharmacy identifies a suspicion of, probable, or confirmed harm to a patient, the pharmacy shall immediately notify and provide information as required by the board to the following:]
[(A) the Texas Department of State Health Services, Drugs and Medical Devices Group, if the preparation is distributed for office use; and]
[(B) the board.]
(4) [(3)] The board may require a pharmacy to initiate [institute] recall if there is potential for [probable] or confirmed harm to a patient.
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 7, 2012.
TRD-201202900
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 22, 2012
For further information, please call: (512) 305-8028