Division of Drugs, Devices and Cosmetics – Restricted Prescription Drug Distributor – Government Programs

This permit is required for a state or local government agency, or any entity eligible to purchase prescription drugs at public health services prices pursuant to section 602, Public Law 102-585, the Veterans Health Care Act of 1992, codified as Section 340B of the Public Health Service Act (a “covered entity”) to distribute its prescription drugs to a contract provider or its subcontractor for administering or dispensing to eligible patients of the covered entity under the eligible program.

Important Limitation: A prescription drug distributed under this permit may not be sold or transferred for reimbursement or payment of any kind.

Requirements:

Application: Businesses seeking this permit must complete the Department’s application.  Mail or deliver the application and all required attachments to:

Florida Department of Business and Professional Regulation

Drugs, Devices and Cosmetics Program

2601 Blair Stone Road

Tallahassee, FL  32399-1047

Public Health Improvement Plan:  The applicant for a new permit must submit to the department a detailed plan justifying the necessity for this permit which demonstrates that the transfer of a prescription drug under this subsection will enhance the public’s health by improving access, quality, or safety because current drug delivery systems to reach patients of the entity are inadequate.

Contractors and Subcontractor Recipients:  The applicant must submit a list of the intended contractors and subcontractors that will receive the entity’s prescription drugs under this permit and the permit numbers that authorize each of them to administer or to dispense.

Contracts:  The applicant must provide copies of all contracts with the intended contractors and subcontractors receiving the entity’s prescription drugs under this permit.

Inspection: The Department may elect to conduct an inspection before issuing new permits.

License Term: Restricted Prescription Drug Distributor – Government Programs 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 $600 for a two-year permit. Make checks payable to DBPR.  No inspection fee will be assessed.