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Administration ] list of drug products withdrawn or removed from the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.)