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

This permit is required for persons engaged in the handling, processing and removal of expired or otherwise adulterated or unsuitable prescription drugs on behalf of licensed pharmacies, practitioners, wholesalers, or other persons authorized to possess prescription drugs, for return to the manufacturer or source of the prescription drug or for destruction. This permit authorizes the reverse distribution of prescription drugs removed from the owner establishment to the manufacturer or source or to a person authorized to arrange for destruction of prescription drugs.

Licensing Exceptions:

• This permit is not required if a person only performs the service of processing prescription drugs (such as preparing the inventory) for return or destruction and does not physically remove any prescription drugs from the owner establishment.
• Holders of this permit who also receive, handle and process prescription drugs for purposes of arranging the destruction of those drugs do NOT need the Restricted Prescription Drug Distributor Permit – Destruction permit.

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

Inspection: Passing an onsite inspection is a prerequisite to issuance of this permit.

License Term: Restricted Prescription Drug Distributor – Reverse 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 $600 for a two-year permit, plus a one-time pre-permit inspection fee of $150. Make checks payable to DBPR. The inspection fee applies only to new permits.