An over-the-counter (OTC) drug manufacturer engages in the manufacturing or repackaging of an OTC drug in Florida.
What is “manufacturing”? In this context, the term means the preparation, deriving, compounding, propagation, processing, producing or fabrication of any OTC drug.
What is “repackaging”? The term includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the OTC drug. A few examples:
- Altering a packaging component that is or may be in direct contact with the drug, device, or cosmetic. For example, repackaging from bottles of 1000 to bottles of 100.
- Altering a manufacturer’s package for sale under a label different from the manufacturer. For example, a kit that contains an injectable vaccine from manufacturer A; a syringe from manufacturer B; alcohol from manufacturer C; and sterile gauze from manufacturer D packaged together and marketed as an immunization kit under a label of manufacturer Z.
- Altering a package of multiple-units, which the manufacturer intended to be distributed as one unit, for sale or transfer to a person engaged in the further distribution of the product. This does not include:
- Selling or transferring an individual unit which is a fully labeled self-contained package that is shipped by the manufacturer in multiple units, or
- Selling or transferring a fully labeled individual unit, by adding the package insert, by a person authorized to distribute prescription drugs to an institutional pharmacy permit, health care practitioner or emergency medical service provider for the purpose of administration and not for dispensing or further distribution.
What is NOT a “manufacturer”? A Florida-licensed pharmacy operating in compliance with pharmacy practice standards under the Florida Pharmacy Act, Chapter 465, Florida Statutes.
Distributors – No Permit Required: Florida law does NOT require any permit for the distribution of OTC drugs – only the manufacturing. However, OTC drug distributors must keep and maintain sales and other distribution records.
FDA Establishment Registration: The applicant must have an FDA establishment registration number, or provide documentation supporting an exemption from FDA registration.
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 a prerequisite to issuance of this permit, unless the applicant holds a Prescription Drug Manufacturer permit for the establishment.
License Term: Prescription Drug Manufacturer 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 $800 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.
Product Registration: Florida law requires that any person who manufacturers, packages, repackages, labels, or relabels a drug or device in the State of Florida must register such drug or device biennially with the department, pay a fee and comply with section 499.015, Florida Statutes (F.S.). You may want to review 499.015(1)(a), F.S. and 499.015(3), F.S.
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