Division of Drugs, Devices and Cosmetics – Restricted Prescription Drug Distributor – Charitable Organization

This permit is required for a charitable organization described in Section 501(c)(3) of the Internal Revenue Code of 1986 to engage in the sale, purchase or trade of a prescription drug to a nonprofit affiliate of the organization.  This permit is required for a charitable organization to authorize the possession or transfer of prescription drugs, including prescription drug samples.

Exceptions and Limitations:

• A charitable institution which is otherwise licensed to use, administer, or dispense prescription drugs and which does not distribute or transfer prescription drugs is not required to obtain this permit.
• Transfers authorized by this permit are limited to nonprofit affiliates of the permittee authorized to possess prescription drugs, exports to charitable organizations in other countries in compliance with applicable federal and state exportation laws, and the daily transfer to a Florida licensed practitioner authorized to administer or dispense for the purpose of administering or dispensing the prescription drug to patients of the charitable organization with the daily return by the practitioner to the charitable organization permittee of the unused prescription drugs.
• A permittee may only receive a donated prescription drug in its original, unopened packaging with its labeling intact.

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

Proof of Nonprofit Status: Applicants must submit proof of the charitable organization designation under Section 501(c)(3) of the Internal Revenue Code of 1986.

FDA Enrollment: If the applicant is participating in or the product of an FDA-initiated enrollment program, submit the FDA central file number of the applicant.

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

License Term: Restricted Prescription Drug Distributor – Charitable Organization 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.