Division of Drugs, Devices and Cosmetics – Restricted Prescription Drug Distributor – Health Care Entity

A restricted prescription drug distributor – health care entity permit authorizes (i) the sale of a prescription drug by a health care entity or a group purchasing organization (GPO) to a health care entity member of that GPO for the member’s own use, or (ii) a health care entity to distribute prescription drugs to other health care entities under common control. Definitions:

• “Health care entity”:  A “health care entity” typically refers to a closed pharmacy or any person, organization or business entity that provides diagnostic, medical, surgical, or dental treatment or care, or chronic or rehabilitative care.

• “Closed pharmacy”:  A “closed pharmacy” is licensed under Chapter 465, Florida Statutes and purchases prescription drugs for use by a limited patient population and not for wholesale distribution or sale to the public.

• “Pharmacy”: Under Chapter 499, Florida Statutes, “pharmacy” means an entity licensed under Chapter 465, Florida Statutes.

• “Common control”:  In this context, “common control” means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, by voting rights, by contract or otherwise.

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 Qualifying:

• Locations under Common Control. Applicants must submit a list of the locations under common control receiving distributions under this permit, including the name and address of each facility and the pharmacy or other permit number authorizing that location to possess prescription drugs.

-and/or-

• GPO Agreement. Applicants must provide the Department with a copy of the written contract evidencing GPO membership and a listing of all the locations that will be receiving distributions under this permit because of joint membership in GPO.

Inspection: Passing an onsite inspection is a prerequisite to issuance of this permit. License Term: Restricted Prescription Drug Distributor – Health Care Entity 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.