Division of Drugs, Devices and Cosmetics – Non Resident Prescription Drug Repackager

Requirements:

A nonresident prescription drug repackager permit is required for any person, located outside of Florida, that is a repackager of a prescription drug and that distributes such prescription drug into Florida. A person engaging in activity for which a nonresident prescription drug repackager permit is required, must file an application on form number DBPR-DDC-237

What is “repackaging”? The term includes repacking or otherwise changing the container, wrapper or labeling to further the distribution of the drug, device, or cosmetic.

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 1,000 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.

FDA Establishment Registration. The applicant must have a 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:

Florida Department of Business and Professional Regulation
Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047

Inspection: : Passing an onsite inspection is not a prerequisite to issuance of this permit, although the department may conduct a pre-permit or routine inspection of an out-of-state establishment.

License Term: Non Resident Prescription Drug Repackager 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 $1,500 for a two-year permit, Make checks payable to DBPR.

Product Registration: Florida law requires that all prescription drugs repackaged in this state must be registered with the department before sale. Product registration is NOT a prerequisite to issuance of this permit.