Opinion ID: 2340795
Heading Depth: 1
Heading Rank: 5

Heading: Frequently Asked Questions General Pharmacy Law

Text: . . . . 8. Does an entity have to be licensed as a pharmacy to sell veterinary legend drugs to the consumer/owner of the animal(s)? Yes. Veterinary legend drugs may only be sold based on the order/prescription of a veterinarian. An entity may not sell veterinary legend drugs directly to the consumer (owner of animal) based on a prescription without being licensed as a pharmacy. If an entity sells veterinary legend drugs to veterinarians or other wholesalers, the entity would have to be licensed as either a pharmacy or a drug distributor. Pharmacies are limited to 5% of their gross pharmaceutical sales before licensure as a drug distributor is required. State law allows a licensed veterinarian to dispense veterinary prescription drugs to clients with whom he has an established relationship. The board denies that the FAQ was a rule. The board did not comply with the rulemaking requirements of section 536.021 concerning this FAQ. Pharmacal brought this action for declaratory judgment stating in its petition: 22. On information and belief, in 2001, the Board of Pharmacy adopted a rule, applicable to all sellers of federal veterinary legend drugs to consumers, requiring those entities to have licensed pharmacists present when such sales take place and to obtain a license to operate a pharmacy to conduct such sales. . . . . 28. The Board of Pharmacy's rules requiring sellers of federal veterinary legend drugs to consumers to comply with licensure and regulatory requirements as a licensed pharmacy and to have a licensed pharmacist on duty when such sales take place fall outside of the delegation of authority to the Board of Pharmacy by the General Assembly, and were promulgated without notice and hearing. Said rules are, therefore, unlawful, illegal and void under the applicable statutory provisions and all other pertinent law. The board of pharmacy was the only defendant named in the declaratory judgment suit.