H.B. No. 4332
AN ACT
relating to the redistribution of donated prepackaged prescription
drugs.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 442.001, Health and Safety Code, is
amended by adding Subdivision (6-a) to read as follows:
(6-a) "Prepackage" means the act of repackaging and
relabeling varying quantities of prescription drugs from a
manufacturer's original commercial container into a prescription
container, unit-dose packaging, or a multi-compartment container
for a pharmacist to dispense to a consumer.
SECTION 2. Subchapter B, Chapter 442, Health and Safety
Code, is amended by adding Section 442.0515 to read as follows:
Sec. 442.0515. REDISTRIBUTION OF DONATED PREPACKAGED
PRESCRIPTION DRUGS. (a) A participating provider may dispense to a
recipient donated prescription drugs that are prepackaged and
labeled in accordance with this section and rules adopted by the
Texas State Board of Pharmacy.
(b) A prepackaged prescription drug a participating
provider dispenses to a recipient must contain a label that
includes:
(1) the drug's brand name or, for a generic version of
the drug, the drug's generic name and the manufacturer or
distributor of the drug;
(2) the amount of the drug in a given dose;
(3) the drug's lot number;
(4) the earliest expiration date of the drug for that
drug lot number; and
(5) the quantity of any drug the provider dispenses in
more than one dose.
(c) A participating provider shall maintain a record of each
prepackaged prescription drug dispensed to a recipient. The record
must include:
(1) the drug's name, the amount of the drug in a given
dose, and the dosage size or frequency;
(2) the provider's lot number for that drug;
(3) the drug's manufacturer or distributor;
(4) the manufacturer's lot number for that drug;
(5) the expiration dates of the drug from that drug's
lot number;
(6) the quantity of the drug in each prepackaged unit;
(7) the number of prepackaged units that include the
drug;
(8) the date the drug was prepackaged;
(9) the name, initials, or written or electronic
signature of the individual who prepackaged the drug; and
(10) the written or electronic signature of the
pharmacist responsible for the drug's prepackaging.
SECTION 3. As soon as practicable after the effective date
of this Act, the Texas State Board of Pharmacy shall adopt any rules
necessary to implement the changes in law made by this Act.
SECTION 4. This Act takes effect September 1, 2023.
______________________________ ______________________________
President of the Senate Speaker of the House
I certify that H.B. No. 4332 was passed by the House on April
28, 2023, by the following vote: Yeas 140, Nays 4, 2 present, not
voting.
______________________________
Chief Clerk of the House
I certify that H.B. No. 4332 was passed by the Senate on May
17, 2023, by the following vote: Yeas 31, Nays 0.
______________________________
Secretary of the Senate
APPROVED: _____________________
Date
_____________________
Governor