Texas Administrative Code › Title 22 - EXAMINING BOARDS › Part 15 - TEXAS STATE BOARD OF PHARMACY › Chapter 291 - PHARMACIES › Subchapter A - ALL CLASSES OF PHARMACIES › Section 291.8 - Return of Prescription Drugs

Current through Reg. 49, No. 28; July 12, 2024
(a) General
				  prohibition on return of prescription drugs. A pharmacist may not accept an
				  unused prescription or drug, in whole or in part, for the purpose of resale or
				  re-dispensing to any person, after the prescription or drug has been originally
				  dispensed or sold, except as provided in subsection (b) of this section or
				  Subchapter M, Chapter
				  431, Health
				  and Safety Code, or Chapter
				  442, Health
				  and Safety Code.
(b) Return of
				  prescription drugs from health care facilities.
(1) Purpose. The purpose of this subsection
				  is to outline procedures for the return of unused drugs from a health care
				  facility or a penal institution to a dispensing pharmacy as specified in the
				  §
											562.1085 of the
				  Occupations Code. Nothing in this section shall require a consultant
				  pharmacist, health care facility, penal institution, or pharmacy to participate
				  in the return of unused drugs.
(2)
				  Definitions. The following words and terms, when used in this section, shall
				  have the following meanings, unless the context clearly indicates otherwise.
(A) Consultant pharmacist--A pharmacist who
				  practices in or serves as a consultant for a health care facility in this
				  state.
(B) Health care facility--A
				  facility regulated under Chapter
				  242, Health
				  and Safety Code.
(C) Licensed
				  health care professional--A person licensed by the Texas Medical Board, Texas
				  Board of Nursing, or the Texas State Board of Pharmacy.
(D) Penal institution--A place designated by
				  law for confinement of persons arrested for, charged with, or convicted of an
				  offense. A penal institution includes a city, county, or state jail or
				  prison.
(3)
				  Responsibilities. A licensed health care professional in a penal institution or
				  a consultant pharmacist may return to a pharmacy certain unused drugs, other
				  than a controlled substance as defined by Chapter
				  481, Health
				  and Safety Code, purchased from the pharmacy.
(A) The unused drugs must:
(i) be approved by the federal Food and Drug
				  Administration and be:
(I) sealed in unopened
				  tamper-evident packaging and either individually packaged or packaged in
				  unit-dose packaging;
(II) oral or
				  parenteral medication in sealed single-dose containers approved by the federal
				  Food and Drug Administration;
(III)
				  topical or inhalant drugs in sealed unit-of-use containers approved by the
				  federal Food and Drug Administration; or
(IV) parenteral medications in sealed
				  multiple-dose containers approved by the federal Food and Drug Administration
				  from which doses have not been withdrawn.
(ii) not be the subject of a mandatory recall
				  by a state or federal agency or a voluntary recall by a drug seller or
				  manufacturer; and
(iii) have not
				  been in the physical possession of the person for whom it was
				  prescribed.
(B) A
				  healthcare facility or penal institution may not return any drug product that:
(i) has been compounded;
(ii) appears on inspection to be
				  adulterated;
(iii) requires
				  refrigeration; or
(iv) has less
				  than 120 days until the expiration date or end of the shelf life.
(C) The consultant pharmacist or
				  licensed health care professional in a penal institution shall be responsible
				  for assuring an inventory of the drugs to be returned to a pharmacy is
				  completed. The following information shall be included on this inventory:
(i) name and address of the facility or
				  institution;
(ii) name and
				  pharmacist license number of the consultant pharmacist or name and license
				  number of the licensed health care professional;
(iii) date of return;
(iv) date the prescription was
				  dispensed;
(v) unique
				  identification number assigned to the prescription by the pharmacy;
(vi) name of dispensing pharmacy;
(vii) name, strength, and quantity of
				  drug;
(viii) signature of
				  consultant pharmacist or licensed healthcare professional responsible for the
				  administration of drugs in a penal institution.
(D) The health care facility/penal
				  institution shall send a copy of the inventory specified in subparagraph (C) of
				  this paragraph to:
(i) the pharmacy with the
				  drugs returned; and
(ii) the Health
				  and Human Services Commission.
(4) Dispensing/Receiving pharmacy
				  responsibilities. If a pharmacy accepts the return of unused drugs from a
				  health care facility/penal institution, the following is applicable.
(A) A pharmacist employed by the pharmacy
				  shall examine the drugs to ensure the integrity of the drug product.
(B) The pharmacy shall reimburse or credit
				  the entity that paid for the drug including the state Medicaid program for an
				  unused drug returned to the pharmacy. The pharmacy shall maintain a record of
				  the credit or reimbursement containing the following information:
(i) name and address of the facility or
				  institution which returned the drugs;
(ii) date and amount of the credit or
				  reimbursement was issued;
(iii)
				  name of the person or entity to whom the credit or reimbursement was
				  issued;
(iv) date the prescription
				  was dispensed;
(v) unique
				  identification number assigned to the prescription by the pharmacy;
(vi) name, strength, and quantity of
				  drug;
(vii) signature of the
				  pharmacist responsible for issuing the credit.
(C) After the pharmacy has issued credit or
				  reimbursement, the pharmacy may restock and re-dispense the unused drugs
				  returned under this section.
(5) Limitation on Liability.
(A) A pharmacy that returns unused drugs and
				  a manufacturer that accepts the unused drugs under §
												562.1085,
				  Occupations Code, and the employees of the pharmacy or manufacturer are not
				  liable for harm caused by the accepting, dispensing, or administering of drugs
				  returned in strict compliance with §
												562.1085,
				  Occupations Code, unless the harm is caused by:
(i) wilful or wanton acts of
				  negligence;
(ii) conscious
				  indifference or reckless disregard for the safety of others; or
(iii) intentional conduct.
(B) This section does not limit,
				  or in any way affect or diminish, the liability of a drug seller or
				  manufacturer under Chapter
				  82,
				  Civil Practice and Remedies Code.
(C) This section does not apply if harm
				  results from the failure to fully and completely comply with the requirements
				  of §
												562.1085,
				  Occupations Code.
(D) This section
				  does not apply to a pharmacy or manufacturer that fails to comply with the
				  insurance provisions of Chapter
				  84,
				  Civil Practice and Remedies Code.