DIVISION OF DRUGS, DEVICES AND COSMETICS
A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in Florida.
What is a “cosmetic”? A cosmetic is an article, with the exception of soap, that is: (a) intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance; or (b) intended for use as a component of any such article.
What is “manufacturing”? In this context, the term includes the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any cosmetic.
What is “repackaging”? The term includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the product. 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 1-liter bottles into 10-milliliter bottles.
- Relabeling, if the process involves opening the manufacturer’s sealed container. Relabeling, without opening such a sealed container, does NOT require this permit.
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 cosmetics – only the manufacturing or repackaging. However, cosmetic distributors must keep and maintain sales and other distribution records records.
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 also holds an Over-the-Counter Drug Manufacturer or Prescription Drug Manufacturer permit at the same address.
License Term: Cosmetic 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 unless the applicant also holds an Over-the-Counter Drug Manufacturer or Prescription Drug Manufacturer permit at the same address. Make checks payable to DBPR. The inspection fee applies only to new permits.
Product Registration: Florida law requires that all cosmetics manufactured in this state must be registered with the department before sale. Product registration is NOT a prerequisite to issuance of this permit.
If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.
Application Currently Unavailable Using Online Services