DIVISION OF DRUGS, DEVICES AND COSMETICS
LIMITED PRESCRIPTION DRUG VETERINARY WHOLESALE DISTRIBUTOR
A limited prescription drug veterinary wholesale distributor engages in the distribution in or into this state of veterinary prescription drugs and, within certain parameters, human-use prescription drugs.
Limitations on Activity Under This Permit:
- Authorizes distribution of human-use prescription drugs and veterinary prescription drugs ONLY to customers: (i) holding licenses in, and practicing full-time, veterinary medicine; (ii) engaging in regular and lawful veterinary medicine instruction; (iii) engaging in regular and lawful law enforcement activities; (iv) conducting research not involving clinical use; (v) conducting chemical analysis or physical testing; or (v) engaged in the instruction of law enforcement activities, research or testing.
- No more than 30 percent of total annual prescription drug sales may be human-use prescription drugs.
- May not distribute in any jurisdiction human-use prescription drugs to any person who is authorized to sell, distribute, purchase, trade or use these drugs on or for humans.
Intracompany Transactions – Limited Exemption from Licensure: This permit IS NOT required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed to engage in the wholesale distribution of prescription drugs in its state of residence to a licensed limited prescription drug veterinary wholesale distributor in this state, if both wholesale distributors conduct wholesale distributions of prescription drugs under the same business name.
- Note: Certain Florida-specific recordkeeping requirements, set forth in Sections 499.0121(6) and 499.01212, Florida Statutes still apply to these transactions.
Application: Businesses seeking this permit must complete the Department’s application. Mail or deliver the application and all required attachments to:
Tallahassee, FL 32399-1047
Surety Bond: All applicants and permittees must post a $20,000 surety bond or provide other equivalent means of security acceptable to the Department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Florida Drugs, Devices and Cosmetics Trust Fund.
Resident State Licensure: Applicants and permittees must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with laws of the state in which it is a resident. Holding this permit fulfills this requirement for Florida establishments.
Inspection: Passing an onsite inspection is a prerequisite to issuance of this permit to an establishment located in Florida, although the Department may conduct a pre-permit or routine inspection, onsite or otherwise, of any establishment outside the state.
License Term: Limited Prescription Drug Veterinary Wholesale Distributor permits are valid through the last day of the initial issuance month in the second year of licensure. Example: A permit issued on September 12, 2011 would be valid through September 30, 2013.
Fee: The application and permitting fee is $1,000 for a two-year permit, plus a one-time pre-permit inspection fee of $150 for establishments in Florida. Make checks payable to DBPR. The inspection fee applies only to new permits issued to establishments in Florida.
If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.
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