• Loading...

    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

Loading...

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

 

Back to Rules List


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

 

Back to Rules List


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

21 Code of Federal Regulations 

Cosmetics - Federal
Part 700 General
Part 701 Cosmetic Labeling
Part 740 Cosmetic Product Warning Statement

Back to Rules List


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

Back to Rules List


Drugs

25 TAC (Texas Administrative Code)

Drugs

Licensing of Wholesale Distributors of Nonprescription Drugs; Including Good Manufacturing Practices

Section 229.241 Purpose
Licensing of Wholesale Distributors of Nonprescription Drugs, Including Good Manufacturing Practices 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

Licensing of Wholesale Distributors of Prescription Drugs; Including Good Manufacturing Practices 

Section 229.419 Purpose
Licensing of Wholesale Distributors of Prescription Drugs, Including Good Manufacturing Practices 121KB
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

 

Donation of Unused Drugs

Donation of Unused Drugs

Section 229.21 Definitions
pdf_logo_sm 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

U.S. Food and Drug Administration
Compressed Medical Gases Medical Gases Are Drugs, Too

Back to Rules List


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 pdf icon   80KB

Back to Rules List


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 icon 136KB
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
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

Miscellaneous
Important Notice for Device Distributors and Manufacturers   (PDF 79KB)
Medical Device Quality Systems Manual: A Small Entity Compliance Guide

Back to Rules List


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

Back to Rules List


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.

  

Back to Rules List


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

Back to Rules List

 

 

 

 

  • Loading...
Last updated January 24, 2013