Distributors | Manufacturers | Cosmetics
Drug and Cosmetic Rules
This program is responsible for ensuring that human and animal drugs; biologicals; and cosmetics are safe, properly labeled, do not contain harmful additives and do not make any unsubstantiated or fraudulent claims. Businesses engaged in the distribution or manufacture of an over-the-counter (OTC) drug or a prescription drug are required to license with the Texas Department of State Health Services (DSHS).
See Guidance Documents and Forms for more information.
We require all businesses that distribute drugs to anyone other than the consumer or patient to license with the Texas Department of State Health Services (DSHS). We routinely inspect wholesale drug distributors to determine compliance with state and federal laws governing the distribution of drugs. Examples of drug distributors:
Warehouses that supply OTC and/or prescription drugs to hospitals, clinics, pharmacies, retail stores, and other licensed wholesalers.
Veterinary supply businesses that supply OTC and/or prescription drugs to veterinary hospitals, clinic, veterinarians, retail stores, or other wholesalers.
Welding supply businesses, durable medical equipment (DME) businesses, or home health care (HHC) agencies that provide medical oxygen cylinders to other home health care agencies, welding supplies, or home-bound patients.
Any business, including manufacturers within another state that distribute drugs into the state of Texas, is required to license with DSHS. This process allows DSHS to track the interstate movement of the drugs between the states.
We also have businesses in the state of Texas that distribute more than one type of product. In May of 1997, the Drugs and Medical Devices Group in coordination with the Foods Group, adopted a mulitple product license. The rules allow DSHS to standardize its licensure procedures for food, drug, and device distributors, and increase the efficiency of administering and enforcing these sections. The rule establishes a multi-product licensure fee for those firms distributing more than one product, thereby reducing licensure cost for the regulated industry.
We require any business that manufactures, prepares, propagates, compounds, processes, packages, repackages, or changes the container, wrapper, or labeling of any drug product to license with us. Once licensed, these businesses are routinely inspected to ensure the drug products comply with the federal good manufacturing practices and state regulations. Examples of drug manufacturers:
- Manufacturers of cold medications, sunscreens, dandruff shampoos, anti-cavity products, and other OTC medications, as well as, the drugs you may have filled at your local pharmacy.
- Manufacturers of veterinary drugs and biologics (e.g. vaccines, blood products).
- Welding supply companies or home health care agencies that transfill medical gas cylinders or liquid oxygen vessels.
Cosmetic manufacturers and wholesale distributors are not required to license with DSHS, nor are they required to register with the U.S. Food and Drug Administration. However, we ensure that cosmetics are properly labeled and do not contain harmful additives. We also ensure that the manufacturers and distributors of cosmetics do not make unsubstantiated or fraudulent claims about their products.