Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.429 - Minimum Standards for Licensure
Current through Reg. 50, No. 13; March 28, 2025
(a) General requirements.
(b) Federal establishment registration and drug listing. All persons who operate as prescription drug manufacturers in Texas must meet the requirements in 21 Code of Federal Regulations (CFR) Part 207, titled Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code. New prescription drugs offered for sale by wholesale distributors must meet, if applicable, the requirements of 21 CFR Part 314, Applications for FDA Approval to Market a New Drug.
(c) Good manufacturing practices. Manufacturers of prescription drug products must comply with the applicable requirements in:
(d) Buildings and facilities.
(e) Storage of prescription drugs. All prescription drugs stored by wholesale distributors must be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs.
(f) Minimum restrictions on transactions.
(g) Prescription drug labeling. Prescription drugs sold by wholesale distributors must meet the labeling requirements of the Act and those adopted in § 229.420(a) of this subchapter.
(h) Prescription drugs that are combination products. Any prescription drug that is a combination product as described in § 229.424(c) of this subchapter (relating to Licensure Requirements) is also subject to the applicable requirements in Subchapter X of this chapter (relating to Licensing of Device Distributors and Manufacturers).
(i) Prescription drugs that are also cosmetics. Any prescription drug that is also a cosmetic or component thereof is also subject to the applicable requirements of Subchapter D of this chapter (relating to Regulation of Cosmetics).
(j) Nonprescription drugs. Nonprescription drugs offered for sale by wholesale distributors of prescription drugs must comply with the applicable requirements of Subchapter O of this chapter (relating to Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices).