BILL ANALYSIS

H.B. 4332

By: Klick

Public Health

Committee Report (Unamended)

BACKGROUND AND PURPOSE

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.

CRIMINAL JUSTICE IMPACT

It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.

RULEMAKING AUTHORITY

It is the committee's opinion that rulemaking authority is expressly granted to the Texas State Board of Pharmacy in SECTION 2 of this bill.

ANALYSIS

H.B. 4332 amends the Health and Safety Code to authorize a provider who elects to participate in the collection and redistribution of donated prescription drugs to dispense to a recipient donated prescription drugs that are prepackaged and labeled in accordance with the bill's provisions and rules adopted by the Texas State Board of Pharmacy (TSBP). The bill requires a prepackaged prescription drug that a participating provider dispenses to a recipient to contain a label that includes the following:

· the drug's brand name or generic name and the manufacturer or distributor of the drug;

· the amount of the drug in a given dose;

· the drug's lot number;

· the earliest expiration date of the drug for that drug lot number; and

· the quantity of any drug the provider dispenses in more than one dose.

H.B. 4332 requires a participating provider to maintain a record of each prepackaged prescription drug dispensed to a recipient. The record must include:

· the drug's name, the amount of the drug in a given dose, and the dosage size or frequency;

· the provider's lot number for that drug;

· the drug's manufacturer or distributor;

· the manufacturer's lot number for that drug;

· the expiration dates of the drug from that drug's lot number;

· the quantity of the drug in each prepackaged unit;

· the number of prepackaged units that include the drug;

· the date the drug was prepackaged;

· the name, initials, or written or electronic signature of the individual who prepackaged the drug; and

· the written or electronic signature of the pharmacist responsible for the drug's prepackaging.

The bill defines "prepackage" as 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.

H.B. 4332 requires the TSBP to adopt any rules necessary to implement the bills provisions as soon as practicable after the bill's effective date.  

EFFECTIVE DATE

September 1, 2023.