BILL ANALYSIS

Senate Research Center	H.B. 4332
88R3067 JG-D	By: Klick (Sparks)
	Health & Human Services
	5/5/2023
	Engrossed

AUTHOR'S / SPONSOR'S STATEMENT OF INTENT

There have been calls to enable broader participation and utilization of prescription drug donation programs by facilitating the redistribution of donated prepackaged prescription drugs in Texas. Under current law, it is difficult for health care providers to redistribute prescription drugs that have been donated but are not in their original packaging, even if they are still safe and effective. H.B. 4332 seeks to increase access to affordable medication by authorizing providers who participate in the collection and redistribution of donated prescription drugs to dispense donated prescription drugs that are prepackaged in accordance with requirements for labeling and recordkeeping provided by the bill.

H.B. 4332 amends current law relating to the redistribution of donated prepackaged prescription drugs.

RULEMAKING AUTHORITY

Rulemaking authority is expressly granted to the Texas State Board of Pharmacy in SECTION 3 of this bill.

SECTION BY SECTION ANALYSIS

SECTION 1. Amends Section 442.001, Health and Safety Code, by adding Subdivision (6-a) to define "prepackage."

SECTION 2. Amends Subchapter B, Chapter 442, Health and Safety Code, by adding Section 442.0515, as follows:

Sec. 442.0515. REDISTRIBUTION OF DONATED PREPACKAGED PRESCRIPTION DRUGS. (a) Authorizes a participating provider to 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 (TSBP).

(b) Requires that a prepackaged prescription drug a participating provider dispenses to a recipient 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) Requires a participating provider to maintain a record of each prepackaged prescription drug dispensed to a recipient. Requires that the record 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. Requires TSBP, as soon as practicable after the effective date of this Act, to adopt any rules necessary to implement the changes in law made by this Act.

SECTION 4. Effective date: September 1, 2023.