(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which doses have not been withdrawn.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.
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Source Note: The provisions of this §291.8 adopted to be effective December 23, 2003, 28 TexReg 11261; amended to be effective September 18, 2007, 32 TexReg 6318; amended to be effective December 6, 2009, 34 TexReg 8690; amended to be effective December 6, 2022, 47 TexReg 8041; amended to be effective December 4, 2023, 48 TexReg 7048 |