2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.411. Minimum Restrictions on Transactions

Sec. 431.411.  MINIMUM RESTRICTIONS ON TRANSACTIONS.  (a)  A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse in accordance with the terms and conditions of the agreement between the wholesale distributor and the pharmacy or pharmacy warehouse.  An expired, damaged, recalled, or otherwise nonsalable prescription drug that is returned to the wholesale distributor may be distributed by the wholesale distributor only to either the original manufacturer or a third-party returns processor.  The returns or exchanges, salable or otherwise, received by the wholesale distributor as provided by this subsection, including any redistribution of returns or exchanges by the wholesale distributor, are not subject to the pedigree requirement under Section 431.412 if the returns or exchanges are exempt from pedigree under:
(1)  Section 4, Prescription Drug Marketing Act of 1987 (21 U.S.C. Section 353(c)(3)(B));
(2)  the regulations adopted by the secretary to administer and enforce that Act; or
(3)  the interpretations of that Act set out in the compliance policy guide of the United States Food and Drug Administration.
(a-1)  Each wholesale distributor and pharmacy shall administer the process of drug returns and exchanges to ensure that the process is secure and does not permit the entry of adulterated or counterfeit drugs into the distribution channel.
(a-2)  Notwithstanding any provision of state or federal law to the contrary, a person that has not otherwise been required to obtain a wholesale license under this subchapter and that is a pharmacy engaging in the sale or transfer of expired, damaged, returned, or recalled prescription drugs to the originating wholesale distributor or manufacturer and pursuant to federal statute, rules, and regulations, including the United States Food and Drug Administration's applicable guidances implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100-293), is exempt from wholesale licensure requirements under this subchapter.
(b)  A manufacturer or wholesale distributor may distribute prescription drugs only to a person licensed by the appropriate state licensing authorities or authorized by federal law to receive the drug.  Before furnishing prescription drugs to a person not known to the manufacturer or wholesale distributor, the manufacturer or wholesale distributor must verify that the person is legally authorized by the appropriate state licensing authority to receive the prescription drugs or authorized by federal law to receive the drugs.
(c)  Except as otherwise provided by this subsection, prescription drugs distributed by a manufacturer or wholesale distributor may be delivered only to the premises listed on the license.  A manufacturer or wholesale distributor may distribute prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if:
(1)  the identity and authorization of the recipient is properly established; and
(2)  delivery is made only to meet the immediate needs of a particular patient of the authorized person.
(d)  Prescription drugs may be distributed to a hospital pharmacy receiving area if a pharmacist or an authorized receiving person signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received.  Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesale distributor not later than the next business day after the date of delivery to the pharmacy receiving area.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 10, eff. September 1, 2007.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1009, eff. April 2, 2015.