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.
Recently Adopted Rules
The rules and adopted preambles as published in the Texas Register.
Issuance of Certificates of Free Sale and Sanitation and/or Certificates of Origin and Sanitation (effective October 1, 2010) (PDF 50KB) "Texas Register" publication, September 17, 2010.
Licensure of Tanning Facilities (effective December 27, 2010) (PDF 77KB) "Texas Register" publication, December 24, 2010.
Donation of Unused Drugs and Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices (effective December 9, 2010) (PDF 171KB) "Texas Register" publication, December 3, 2010.
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
25 Texas Administrative Code (TAC)
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Certificates of Free Sale and/or Certificates of Origin
25 TAC (Texas Administrative Code)
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Cosmetics
25 TAC (Texas Administrative Code)
25 TAC (Texas Administrative Code)
21 Code of Federal Regulations
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Dietary Supplements Containing Ephedrine
25 Texas Administrative Code (TAC)
Dietary Supplements Containing Ephedrine
| Sections229.461 - 229.464 |
Regulations to Set Standards for the Formulation, Sale and Distribution of Dietary Supplements Containing Ephedrine from Natural Ephedra Alkaloids and to Restrict the Sale and Distribution of Certain Drug Products Containing Ephedrine |
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Drugs
25 TAC (Texas Administrative Code)
25 TAC (Texas Administrative Code)
Donation of Unused Drugs
Donation of Unused Drugs
|
| Section 229.21 |
Definitions |
 89KB |
| Section 229.22 |
Donation of Drugs to Charitable Medical Clinics |
| Section 229.23 |
Donation of Drugs From Nursing Homes to Foreign Countries |
| Section 229.24 |
Dispensing of Drugs From Charitable Medical Clinics |
| Section 229.25 |
Minimum Requirements for Licensing as a Charitable Drug Donor |
| Section 229.26 |
Enforcement - Refusal, Revocation, or Suspension of License |
25 TAC (Texas Administrative Code)
25 TAC (Texas Administrative Code)
| Sections 229.301 - 229.306 |
Issuance of Certificates of Free Sale and Sanitation and/or Certificates of Origin |
| Section 229.261 |
Assessment of Administrative or Civil Penalties |
Code of Federal Regulations
Code of Federal Regulations
| Part 201 |
Labeling |
| Part 203 |
Prescription Drug Marketing |
| Part 205 |
Guidelines for State Licensing of Wholesale Prescription Drug Distributors |
| Part 210 |
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General |
| Part 211 |
Current Good Manufacturing Practice for Finished Pharmaceuticals |
U.S. Food and Drug Administration
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Limitations on Sales of Products Containing Ephedrine, Pseudoephedrine, and Norpseudoephedrin
25 TAC (Texas Administrative Code)
Limitations on Sales of Products Containing Ephedrine, Pseudoephedrine, and Norpseudoephedrin
| Sections 230.11 - 230.18 |
Limitations on Sales of Products Containing Ephedrine, Pseudoephedrine, and Norpseudoephedrine |
80KB |
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Medical Device Distributors and Manufacturers
25 TAC (Texas Administrative Code)
21 Code of Federal Regulations
21 Code of Federal Regulations
| Part 801 |
Labeling |
| Part 803 |
Medical Device Reporting |
| Part 807 |
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices |
| Part 814 |
Premarket Approval of Medical Devices |
| Part 820 |
Quality System Regulation |
Miscellaneous
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Salvage Brokers and Establishments
25 TAC (Texas Administrative Code)
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Tanning
25 TAC (Texas Administrative Code)
21 Code of Federal Regulations
Tanning 21 Code of Federal Regulations
| Part 801 |
Labeling |
| Part 1010 |
Performance Standards For Electronic Products; General |
| Part 1040, Section 1040.20 |
Performance Standards for Light-Emitting Products: Section 1040.20: Sunlamp products and ultraviolet lamps intended for use in sunlamp products. |
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Tattoo and Body Piercing Studios
25 TAC (Texas Administrative Code)
Tattoo and Body Piercing Studios
| Section 229.261 |
Assessment of Administrative or Civil Penalties |
| Section 229.401- 229.413 |
Minimum Standards for Licensure of Tattoo and Certain Body Piercing Studios |
87KB |
29 Code of Federal Regulations
Tattoo and Body Piercing Studios
| Part 1910.1030 |
Bloodborne Pathogens: Occupational Safety and Health Standards |
67KB |
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