Licensing Requirements for Drug Manufacturers and Distributors

Licensing Requirements for Drug Manufacturers and Distributors 

 Review licensing requirements, licensing verification instructions, and search recommendations below.  

Drug Manufacturers 

Drug manufacturers may apply for a license by completing and returning a license application form. Licenses are valid for two years unless amended, suspended or revoked. For assistance in completing applications, call 512-834-6727. 

 

“Manufacturer” means a person who manufactures, prepares, propagates, compounds, processes, packages or repackages drugs, or a person who changes the container, wrapper or labeling of any drug package. A person licensed or approved by the United States Food and Drug Administration to engage in the manufacture of drugs consistent with the federal agency's definition of "manufacturer" under the agency's regulations and guidance implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293). The term does not include a pharmacist engaged in compounding that is done within the practice of pharmacy and pursuant to a prescription drug order or initiative from a practitioner for a patient or prepackaging that is done in accordance with Occupations Code, §562.154. 

 

Drug Distributors

Drug distributors may apply for a license by completing and returning a license application form. Licenses are valid for two years unless amended, suspended or revoked. For assistance in completing applications, call 512-834-6727. 

“Distributor” means a person engaged in the wholesale distribution of prescription drugs, including, but not limited to, a distributor, wholesaler, own-label distributor, private-label distributor, jobber, broker, manufacturer warehouse, distributor warehouse, or other warehouse, manufacturer's exclusive distributor, authorized distributor of record, independent wholesale drug trader, specialty wholesale distributor, third-party logistics provider, retail pharmacy that conducts wholesale distribution, and a pharmacy warehouse that conducts wholesale distribution. 

Multiple Products

You may be eligible for a Multiple Products License if your firm distributes two or more of the following products: food, nonprescription drugs, compressed medical gases, and medical devices. A separate license is required if you are distributing prescription drugs (other than compressed medical gases). 

Late Fees 

A person who files a renewal application after the expiration date must pay an additional $100 as a delinquency fee.