Sec. 442.053. REQUIREMENTS FOR DONATED PRESCRIPTION DRUGS. (a) A donated prescription drug may be accepted or dispensed under this chapter only if the drug is in its original, unopened, sealed, and tamper-evident unit-dose packaging. A drug packaged in single unit doses may be accepted and dispensed if the outside packaging is opened but the single unit-dose packaging is unopened.
(b) A donated prescription drug may not be accepted or dispensed under this chapter if:
(1) the drug is a controlled substance;
(2) the drug is adulterated or misbranded;
(3) the drug is not stored in compliance with the drug's product label; or
(4) the United States Food and Drug Administration requires the drug to have a risk evaluation or mitigation strategy.
(c) A participating provider shall comply with all applicable provisions of state and federal law relating to the inspection, storage, labeling, and dispensing of prescription drugs.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
Structure Texas Statutes
Title 6 - Food, Drugs, Alcohol, and Hazardous Substances
Subtitle A - Food and Drug Health Regulations
Chapter 442 - Donation of Prescription Drugs
Subchapter B. Donation and Redistribution of Unused Prescription Drugs
Section 442.051. Donation and Redistribution of Prescription Drugs
Section 442.052. Standards for Donation and Redistribution
Section 442.053. Requirements for Donated Prescription Drugs
Section 442.054. Donation Process
Section 442.056. Recipient Form