Any person that engages in the distribution of a “complimentary drug” (also a “sample”): a human prescription drug that is labeled “sample,” “not to be sold,” “complimentary,” or other words to that effect, that is provided as a courtesy, that is not intended to be sold, and that is intended to promote the sale of the drug.
“Starter packs,” also known as “stock samples,” “trade packages,” “initial dose packs” or “starter stocks,” means human prescription drugs that are generally distributed without charge by manufacturers or distributors to pharmacies to be placed in stock and sold at retail. Although starter packs are generally given without charge to the pharmacy, they are not intended to be a free sample to the consumer nor are they labeled as such. Starter packs are subject to regulation as prescription drugs under the Florida Drug and Cosmetic Act in the same manner as stock shipments of prescription drugs. Starter packs are not drug samples.
Limitations on Activity under This Permit:
- A manufacturer or distributor may not directly or through its agents, employees or independent contractors, hold, distribute or otherwise dispose of any complimentary drugs or drug samples in or into Florida without first obtaining a complimentary drug distributor permit pursuant to this section.
- Complimentary drugs may be distributed in or into Florida only by persons holding this permit, and only in response to a written request from practitioners licensed to prescribe such drugs.
- Complimentary drugs may be provided only to practitioners authorized by law to prescribe such drugs, or at the request of such a practitioner, to hospital pharmacies or other health care entity pharmacies.
Establishments: A manufacturer or distributor of complimentary or sample prescription drugs located outside this state may obtain this permit for its headquarters or home office in lieu of a permit for each establishment from which complimentary prescription drugs are distributed. All establishments located in Florida from which complimentary prescription drugs are distributed must have this permit.
Application: Businesses seeking this permit must complete the Department’s application. Mail or deliver the application and all required attachments to:
Inspection: Passing an onsite inspection is generally a prerequisite to issuance of this permit to establishments in Florida, although the Department may conduct a pre-permit or routine inspection, onsite or otherwise. A person permitted as a Prescription Drug Manufacturer that is applying for a Complimentary Drug Distributor permit at that address does not require another onsite inspection and is not required to pay an initial application/onsite inspection fee when applying for the additional permit.
Resident State Licensure: Applicants must submit a copy of a license or permit to engage authorizing possession of prescription drugs in compliance with laws of the state in which it is a resident. If the issuing agency does not allow photocopying of a license or permit, the applicant may submit a verification of the license or permit from the issuing agency
License Term: Complimentary Drug 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 $500 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.
All requests for publications, documents, forms, applications for licenses, permits and other similar certifications can be obtained by contacting the Customer Contact Center.
Walter Copeland, Division Director
Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047