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Rules and Regulations - Drug Manufacturers and Distributors


Table of Contents


Drugs (Nonprescription)

Texas Administrative Code: Licensing of Wholesale Distributors of Nonprescription Drugs - including Good Manufacturing Practices

25 Texas Administrative Code (TAC), §§229.241 – 229.252 (PDF, 140KB)

Section:

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

Section:

  • 229.261 - Assessment of Administrative or Civil Penalties

Federal Laws and Regulations Adopted by Reference

For a complete list of regulations adopted by reference, please see the federal regulations page.


Drugs (Prescription)

Texas Administrative Code: Licensing of Wholesale Distributors of Prescription Drugs - including Good Manufacturing Practices

25 Texas Administrative Code (TAC), §§229.419 – 229.430 (PDF, 121KB)

Section:

25 Texas Administrative Code (TAC), Subchapter B - Donation of Unused Drugs

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

Federal Laws and Regulations Adopted by Reference

For a complete list of regulations adopted by reference, see the federal regulations page.


Dietary Supplements Containing Ephedrine

25 Texas Administrative Code (TAC) - Regulations to Prohibit the Sale of Dietary Supplements Containing Ephedrine

  • 229.461 - Prohibited Sale and Distribution of Dietary Supplements Containing Ephedrine Group Alkaloids
  • 229.464 - Restricted Sale and Distribution of Certain Drug Products Containing Ephedrine