Tex. Health & Safety Code Section 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 (Pedigree Required) 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.

Source: Section 431.411 — Minimum Restrictions on Transactions, https://statutes.­capitol.­texas.­gov/Docs/HS/htm/HS.­431.­htm#431.­411 (accessed Nov. 25, 2023).

431.001
Short Title
431.002
Definitions
431.003
Article Misbranded Because of Misleading Labeling or Advertising
431.004
Representation of Drug as Antiseptic
431.005
Provisions Regarding Sale of Food, Drugs, Devices, or Cosmetics
431.006
Certain Combination Products
431.007
Compliance with Other Law
431.008
Applicability of Chapter to Distressed or Reconditioned Merchandise and Certain Licensed Entities
431.009
Applicability of Chapter to Frozen Desserts
431.010
Applicability of Chapter to Milk and Milk Products
431.011
Applicability of Chapter to Consumable Hemp Products and Manufacturers
431.021
Prohibited Acts
431.022
Offense: Transfer of Product Containing Ephedrine
431.023
Limited Exemption for Distressed Food, Drugs, Devices, or Cosmetics
431.041
Definition
431.042
Inspection
431.043
Access to Records
431.044
Access to Records Showing Movement in Commerce
431.045
Emergency Order
431.046
Violation of Rules
431.047
Violation
431.048
Detained or Embargoed Article
431.049
Removal Order for Detained or Embargoed Article
431.050
Condemnation
431.051
Destruction of Article
431.052
Correction by Proper Labeling or Processing
431.053
Condemnation of Perishable Articles
431.054
Administrative Penalty
431.055
Administrative Penalty Assessment Procedure
431.056
Payment of Administrative Penalty
431.057
Refund of Administrative Penalty
431.058
Recovery of Administrative Penalty by Attorney General
431.059
Criminal Penalty
431.060
Initiation of Proceedings
431.061
Minor Violation
431.081
Adulterated Food
431.082
Misbranded Food
431.083
Food Labeling Exemptions
431.084
Emergency Permits for Foods Contaminated with Microorganisms
431.111
Adulterated Drug or Device
431.112
Misbranded Drug or Device
431.113
Exemption for Certain Drugs and Devices
431.114
New Drugs
431.115
New Animal Drugs
431.116
Average Manufacturer Price
431.117
Priority for Health Care Providers in Distribution of Influenza Vaccine
431.141
Adulterated Cosmetic
431.142
Misbranded Cosmetic
431.161
Poisonous or Deleterious Substances
431.171
Designation of Consumer Commodity as Abusable Synthetic Substance
431.172
Applicability of Chapter to Abusable Synthetic Substance
431.181
Fair Packaging and Labeling
431.182
False Advertisement
431.183
False Advertisement of Drug or Device
431.201
Definitions
431.202
License Required
431.203
Contents of License Statement
431.204
Fees
431.206
Change of Location of Place of Business
431.207
Refusal to License
431.208
Reporting of Purchase Price
431.0211
Exception
431.221
Definitions
431.222
License Required
431.223
Contents of License Application
431.224
Fees
431.225
Expiration Date
431.226
Refusal to Grant License
431.227
Food Safety Best Practice Education Program
431.241
Rulemaking Authority
431.242
Contested Case Hearings and Appeals
431.244
Federal Regulations Adopted as State Rules
431.245
Definition or Standard of Identity, Quality, or Fill of Container
431.246
Removal of Adulterated Item from Stores
431.247
Delegation of Powers or Duties
431.248
Memorandum of Understanding with Department of Agriculture
431.249
Dissemination of Information
431.250
Public Comments for Federal Grants and Contracts
431.271
Definitions
431.272
License Required
431.273
Exemption from Licensing
431.274
License Application
431.276
Fees
431.278
Change of Location of Place of Business
431.279
Refusal to License
431.321
Definitions
431.322
Donation of Unused Drugs to Charitable Medical Clinic
431.323
Circumstances Under Which Donated Drugs May Be Accepted and Dispensed
431.324
Rules
431.325
Limitation on Liability
431.401
Definitions
431.402
License Required
431.403
Exemption from Licensing
431.404
License Application
431.405
Qualifications for License
431.406
Effect of Operation in Other Jurisdictions
431.407
Criminal History Record Information
431.409
Fees
431.410
Change of Location of Place of Business
431.411
Minimum Restrictions on Transactions
431.412
Pedigree Required
431.413
Pedigree Contents
431.414
Refusal to License
431.415
Order to Cease Distribution
431.0495
Recall Orders
431.0585
Civil Penalty
431.0805
Definitions
431.2011
Applicability of Subchapter
431.2031
Effect of Operation in Other Jurisdictions
431.2211
Application of Subchapter
431.2245
Processing of Licensing Fees
431.2251
Change in Location of Place of Business
431.4011
Ongoing Relationship
431.4012
Applicability of Subchapter
431.4031
Exemption from Certain Provisions for Certain Wholesale Distributors
431.4045
Inspection Required
431.4095
Renewal Notification

Accessed:
Nov. 25, 2023

§ 431.411’s source at texas​.gov