RULES AND REGULATIONS

This page provides links to rules and regulations for the regulated communities served by the Drugs and Medical Devices Group.

Links to sites outside the Texas Department of State Health Services are intended to be informational and do not necessarily imply any official endorsement. Staff associated with the Drugs and Medical Devices Group routinely review the links, but we cannot guarantee the validity of information provided at outside sites.

Draft Rules and/or Proposed Rules

CURRENT RULES AND REGULATIONS

Below is a list of the rules and regulations that govern drug distributors and manufacturers. Click on the title of the rule, regulation, or law that you would like view. The links below will send you an official site for the rule OR, if available, there is a link provided to the rule in PDF format.

• Bloodborne Pathogen Control
• Cosmetics
• Dietary Supplements Containing Ephedrine
• Drugs
• Limitations on Sales of Products Containing Ephedrine, Pseudoephedrine, and Norpseudoephedrine
• Medical Device Distributors and Manufacturers
• Salvage Brokers and Establishments
• Tanning
• Tattoo and Body Piercing Studios

Bloodborne Pathogen Control

25 Texas Administrative Code (TAC)

Cosmetics

25 TAC (Texas Administrative Code)

Regulation of Cosmetics
Section 229.40	Purpose	75KB
Section 229.41	Applicable Laws and Regulations

25 TAC (Texas Administrative Code)

21 Code of Federal Regulations

Dietary Supplements Containing Ephedrine

25 Texas Administrative Code (TAC)

Drugs

25 TAC (Texas Administrative Code)

Licensing of Wholesale Distributors of Nonprescription Drugs; Including Good Manufacturing Practices
Section 229.241	Purpose	131KB
Section 229.242	Applicable Laws and Regulations
Section 229.243	Definitions
Section 229.244	Sale of Nonprescription Drugs
Section 229.245	Exemption
Section 229.246	Licensure Requirements
Section 229.247	Licensing Procedures
Section 229.248	Report of Changes
Section 229.249	Licensure Fees
Section 229.250	Refusal, Cancellation, Suspension or Revocation of License
Section 229.251	Minimum Standards for Licensure
Section 229.252	Enforcement and Penalties

25 TAC (Texas Administrative Code)

Licensing of Wholesale Distributors of Prescription Drugs; Including Good Manufacturing Practices
Section 229.419	Purpose	149KB
Section 229.420	Applicable Laws and Regulations
Section 229.421	Definitions
Section 229.422	Sale of Prescription Drugs
Section 229.423	Exemptions
Section 229.424	Licensure Requirements
Section 229.425	Licensing Procedures
Section 229.426	Report of Changes
Section 229.427	Licensure Fees
Section 229.428	Refusal, Cancellation, Suspension or Revocation of License
Section 229.429	Minimum Standards for Licensure
Section 229.430	Enforcement and Penalties

25 TAC (Texas Administrative Code)

Code of Federal Regulations

U.S. Food and Drug Administration

Limitations on Sales of Products Containing Ephedrine, Pseudoephedrine, and Norpseudoephedrin

25 TAC (Texas Administrative Code)

Sections 230.11 - 230.16

Limitations on Sales of Products Containing Ephedrine, Pseudoephedrine, and Norpseudoephedrine

48KB

Medical Device Distributors and Manufacturers

25 TAC (Texas Administrative Code)

Sections 229.431 - 229.444	Licensing of Device Distributors and Manufacturers	136KB
Section 229.261	Assessment of Administrative or Civil Penalties
Section 229.444	Device Distributors and Manufacturers Advisory Committee

21 Code of Federal Regulations

Miscellaneous

Salvage Brokers and Establishments

25 TAC (Texas Administrative Code)

Section 229.261	Assessment of Administrative or Civil Penalties
Sections 229.571-229.584	Regulation of Drug Salvage Establishments and Brokers	87KB
Sections 229.601-229.614	Regulation of Device Salvage Establishments and Brokers	75KB
Sections 229.631-229.644	Regulation of Cosmetic Salvage Establishments and Brokers	74KB

Tanning

25 TAC (Texas Administrative Code)

Section 229.341 - 229.357	Licensure of Tanning Facilities	75KB
Section 229.261	Assessment of Administrative or Civil Penalties

21 Code of Federal Regulations

Tattoo and Body Piercing Studios

25 TAC (Texas Administrative Code)

29 Code of Federal Regulations