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    Drugs and Medical Devices Group is within the Division
    for Regulatory Services
    P. O. Box 149347
    Austin, TX 78714-3947
    512-834-6770


    Contact the Web Director


    External links to other sites are intended to be informational and do not have the endorsement of the Texas Department of State Health Services. These sites may not be accessible to people with disabilities.

Rules and Regulations - Drugs and Medical Devices Group

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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.


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

25 Texas Administrative Code (TAC)

 

Bloodborne Pathogen Control
Sections 96.101 - 96.601 Bloodborne Pathogen Control

 

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Certificates of Free Sale and/or Certificates of Origin

25 TAC (Texas Administrative Code) 

Certificates of Free Sale and/or Certificates of Origin
Section 229.301 Purpose

pdf_logo_sm 50KB

Section 229.302 Definitions
Section 229.303 Minimum Requirements
Section 229.304

Application for Certificate

Section 229.305 Time Frames
Section 229.306 Fees
Section 229.307 Appeal Procedures

Certificate of Free Sale and/or Certificate of Origin Applications

Instructions for applying for Certificate of Free Sale and/or Certificate of Origin

Frequently Asked Questions - Certificates of Free Sale and Certificates of Origin

 

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Cosmetics

25 TAC (Texas Administrative Code)

Cosmetics

Regulation of Cosmetics

Section 229.40 Purpose
Licensing of Wholesale Distributors of Nonprescription Drugs, Including Good Manufacturing Practices 75KB
Section 229.41 Applicable Laws and Regulations

 

25 TAC (Texas Administrative Code)

Cosmetics - TAC
Section 229.261 Assessment of Administrative or Civil Penalties
Sections 229.301 - 229.306 Issuance of Certificates of Free Sale and Sanitation and/or Certificates of Origin

Federal Laws and Regulations Adopted by Reference

Cosmetics - Federal
21 U.S.C. Federal Food, Drug, and Cosmetic Act (FD&C Act)
21CFR Part 700 General
21CFR Part 701 Cosmetic Labeling
21CFR Part 740 Cosmetic Product Warning Statement

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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 (Nonprescription)

25 Texas Administrative Code (TAC), Sections 229.241 - 229.252  - Licensing of Wholesale Distributors of Nonprescription Drugs; Including Good Manufacturing Practices (pdf 141kb)  

Section:

  • 229.241 - Purpose
  • 229.242 - Applicable Laws and Regulations
  • 229.243 - Definitions
  • 229.244 - Sales of Nonprescription Drugs
  • 229.245 - Exemption
  • 229.246 - Licensure Requirements
  • 229.247 - Licensing Procedures
  • 229.248 - Report of Changes
  • 229.249 - Licensure Fees
  • 229.250 - Refusal, Cancellation, Suspension or Revocation of License
  • 229.251 - Minimum Standards for Licensure
  • 229.252 - Enforcement and Penalties 

25 Texas Administrative Code (TAC), Subchapter P - Assessment of Administrative Penalties

Section:

  • 229.261 - Assessment of Administrative or Civil Penalties

25 Texas Administrative Code (TAC), Subchapter R - Issuance of Certificates of Free Sale and Sanitation and/or Certificates of Origin and Sanitation

Section:

Federal Laws and Regulations Adopted by Reference (Nonprescription Drugs)

Federal Food, Drug, and Cosmetic Act (FD&C Act)

9 Code of Federal Regulations (CFR)

21 Code of Federal Regulations (CFR)

  • Part 70 - Color Additives
  • Part 71 - Color Additive Petitions
  • Part 73 - Color Additives Exempt From Certification
  • Part 74 - Color Additives Subject to Certification
  • Part 80 - Color Additive Certification
  • Part 81 - Provisional Color Additives for use in Foods, Drugs, and Cosmetics (General Specifications and General Restrictions)
  • Part 82 - Certified Provisionally Listed Colors and Specifications
  • Part 201 - Labeling
  • Part 206 - Imprinting of Solid Oral Dosage Form Drug Products for Human Use
  • Part 207 - Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
  • Part 299 - Drugs; Official Names and Established Names
  • Part 300 - General
  • Part 310 - New Drugs
  • Part 312 - Investigational New Drug Application
  • Part 314 - Applications for FDA Approval to Market a New Drug or an Antibiotic Drug
  • Part 316 - Orphan Drugs
  • Part 320 - Bioavailability and Bioequivalence Requirements

Current Good Manufacturing Practice:

  • Part 210 - Manufacturing, Processing, Packing, or Holding of Drugs; General  
  • Part 211 - Finished Pharmaceuticals
  • Part 225 - Medicated Feeds
  • Part 226 - Type A Medicated Articles
  • Part 250 - Special Requirements For Specific Human Drugs

Over-The-Counter (OTC) Human Use:

  • Part 328 - Drug Products Intended for Oral Ingestion that Contain Alcohol
  • Part 330 - Human Drugs Which are Generally Recognized as Safe, Effective, & Not Misbranded
  • Part 331 - Antacid Products
  • Part 332 - Antiflatulent Products
  • Part 333 - Topical Antimicrobial Drug Products
  • Part 335 - Antidiarrheal Drug Products
  • Part 336 - Antiemetic Drug Products
  • Part 338 - Nighttime Sleep-aid Drug Products
  • Part 340 - Stimulant Drug Products
  • Part 341 - Cold, Cough, Allergy, Bronchodilator, and Anti-asthmatic Drug Products
  • Part 343 - Internal Analgesic, Antipyretic, and Antirheumatic Drug Products
  • Part 344 - Topical OTIC Drug Products
  • Part 346 - Anorectal Drug Products
  • Part 347 - Skin Protectant Drug Products
  • Part 348 - External Analgesic Drug Products
  • Part 349 - Ophthalmic Drug Products
  • Part 350 - Antiperspirant Drug Products
  • Part 352 - Sunscreen Drug Products
  • Part 355 - Anticaries Drug Products
  • Part 357 - Miscellaneous Internal Drug Products
  • Part 358 - Miscellaneous External Drug Products
  • Part 369 - Interpretive Statements Re: Warnings on Drugs and Devices for Sales

Drugs (Prescription)

25 Texas Administrative Code (TAC), Sections 229.419 - 229.430 - Licensing of Wholesale Distributors of Prescription Drugs; Including Good Manufacturing Practices (pdf 121kb)

Section:

25 Texas Administrative Code (TAC), Subchapter B - Donation of Unused Drugs (pdf 89kb):

Section: 

  • 229.21 - Definitions
  • 229.22 - Donation of Drugs to Charitable Medical Clinics
  • 229.23 - Donation of Drugs From Nursing Homes to Foreign Countries
  • 229.24 - Dispensing of Drugs From Charitable Medical Clinics
  • 229.25 - Minimum Requirements for Licensing as a Charitable Drug Donor
  • 229.26 - Enforcement - Refusal, Revocation, or Suspension of License

25 Texas Administrative Code (TAC), Subchapter P - Assessment of Administrative Penalties

Section:

  • 229.261 - Assessment of Administrative or Civil Penalties

25 Texas Administrative Code (TAC), Subchapter R - Issuance of Certificates of Free Sale and Sanitation and/or Certificates of Origin and Sanitation

Section:

Federal Laws and Regulations Adopted by Reference (Prescription Drugs)

Federal Food, Drug, and Cosmetic Act, 21 United States Code (U.S.C), §301 et seq.

9 Code of Federal Regulations (CFR)

21 Code of Federal Regulations (CFR)

  • Part 70 - Color Additives
  • Part 71 - Color Additive Petitions
  • Part 73 - Listing of Color Additives Exempt From Certification
  • Part 74 - Listing of Color Additives Subject to Certification
  • Part 80 - Color Additive Certification
  • Part 81 - General Specifications & Restrictions for Provisional Color Additives for use in Foods, Drugs, & Cosmetics
  • Part 82 - Listing of Certified Provisionally Listed Colors and Specifications
  • Part 200 - General
  • Part 201 - Labeling
  • Part 202 - Prescription Drug Advertising
  • Part 203 - Prescription Drug Marketing
  • Part 205 - Guidelines for State Licensing of Wholesale Prescription Drug Distributors
  • Part 206 - Imprinting of Solid Oral Dosage Form Drug Products for Human Use
  • Part 207 - Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
  • Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
  • Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
  • Part 216 - Pharmacy Compounding
  • Part 225 - Current Good Manufacturing Practice for Medicated Feeds
  • Part 226 - Current Good Manufacturing Practice for Type A Medicated Articles
  • Part 250 - Special Requirements For Specific Human Drugs
  • Part 290 - Controlled Drugs
  • Part 299 - Drugs; Official & Established Names
  • Part 300 - General
  • Part 310 - New Drugs
  • Part 312 - Investigational New Drug Application
  • Part 314 - Applications for FDA Approval to Market a New Drug or an Antibiotic Drug
  • Part 315 - Diagnostic Radiopharmaceuticals
  • Part 316 - Orphan Drugs
  • Part 320 - Bioavailability and Bioequivalence Requirements
  • Part 361 - Prescription Drugs for Human Use Generally Recognized as Safe, Effective, & Not Misbranded: Used In Research
  • Part 500 - General
  • Part 510 - New Animal Drugs
  • Part 511 - New Animal Drugs for Investigational Use
  • Part 514 - New Animal Drug Applications
  • Part 515 - Medicated Feed Mill License
  • Part 520 - Oral Dosage Form New Animal Drugs
  • Part 522 - Implantation or Injectable Dosage Form New Animal Drugs
  • Part 524 - Opthalmic and Topical Dosage Form New Animal Drugs
  • Part 526 - Intramammary Dosage Forms
  • Part 529 - Certain Other Dosage Form New Animal Drugs
  • Part 530 - Extralabel Drug Use in Animals
  • Part 556 - Tolerances for Residues of New Animal Drugs in Food
  • Part 558 - New Animal Drugs for Use in Animal Feeds
  • Part 589 - Substances Prohibited From Use in Animal Food or Feed
  • Part 600 - Biological Products: General
  • Part 601 - Licensing
  • Part 610 - General Biological Products Standards
  • Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests
  • Part 680 - Additional Standards for Miscellaneous Products
  • Part 1300 - Definitions
  • Part 1301 - Registration of Manufacturers, Distributors, & Dispensers of Controlled Substances
  • Part 1302 - Labeling & Packaging Requirements For Controlled Substances
  • Part 1304 - Records & Reports of Registrants
  • Part 1305 - Orders for Schedule I & II Controlled Substances
  • Part 1306 - Prescriptions
  • Part 1307 - Miscellaneous

U.S. Food and Drug Administration

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

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 pdf icon   80KB

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Medical Device Distributors and Manufacturers

25 TAC (Texas Administrative Code)

Medical Device Distributors and Manufacturers
Sections 229.431 - 229.444 Licensing of Device Distributors and Manufacturers PDF format 161KB
Section 229.261 Assessment of Administrative or Civil Penalties
Section 229.444 Device Distributors and Manufacturers Advisory Committee

21 Code of Federal Regulations

21 Code of Federal Regulations
21 CFR Subchapter J Radiological Health
21 CFR 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
21 CFR Part 820 Quality System Regulation

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Salvage Brokers and Establishments

25 TAC (Texas Administrative Code)

Salvage Brokers and Establishments

Section 229.261

Assessment of Administrative or Civil Penalties

Sections 229.571-229.584 Regulation of Drug Salvage Establishments and Brokers pdf icon 87KB
Sections 229.601-229.614 Regulation of Device Salvage Establishments and Brokers pdf icon 75KB
Sections 229.631-229.644 Regulation of Cosmetic Salvage Establishments and Brokers pdf icon 74KB

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Laws and Regulations Adopted by Reference

 

Salvage
21 U.S.C. Federal Food, Drug, and Cosmetic Act (FD&C Act) 
15 U.S.C. Fair Packaging and Labeling Act
21 CFR Part 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors
21 CFR Part 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21CFR Part 701 Cosmetic Labeling
21 CFR Part 740 Cosmetic Product Warning Statements
21 CFR Part 801 Labeling
21 CFR Subchapter J Radiological Health
21 CFR Part 820 Quality System Regulation


Tanning

25 TAC (Texas Administrative Code)  

Tanning
Section 229.341 - 229.357 Licensure of Tanning Facilities

pdf icon 75KB

Section 229.261 Assessment of Administrative or Civil Penalties

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 pdf icon87KB

29 Code of Federal Regulations

Tattoo and Body Piercing Studios
Part 1910.1030 Bloodborne Pathogens: Occupational Safety and Health Standards pdf icon67KB

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Last updated February 10, 2015