1. What is a Certificate of Free Sale?A certificate of free sale is a document evidencing that goods such as drugs, cosmetics, or medical devices are legally sold or distributed in the open market and approved by the regulatory authorities in the country of origin.
  1. Where can I obtain a Certificate of Free Sale (COFS)?
  1. Drugs – The Division is authorized to issue a COFS to Florida permitted prescription drug manufacturers, prescription drug repackagers, and over-the-counter manufacturers for any product that they have registered with the Division.
  1. Cosmetics – Effective July 1, 2017, the Division will no longer be authorized to issue a COFS for cosmetic products, including those products that are currently registered with the Division and the registration’s expiration date is July 1, 2017, or later.
  1. To assist you in your efforts to obtain a COFS, the following resources have been identified as entities who have indicated the ability to issue certificates of free sale and certificates of origin:

U.S. Food and Drug Administration

For information, visit the FDA website.

Fees/Requirements:

  • $10 fee for food, food additives, seafood, dietary supplements and cosmetics
  • $175 maximum fee for human or animal drugs and biologics (fees vary on product type but will not exceed $175)
  • FDA website offers FDA point of contact broken out by product and step-by-step instructions for obtaining a certificate online.

Enterprise Florida

For information, call (305) 808-3660 or download thePDFflyer[ ].

Fees/requirements:

  • $30 per document (includes certification and notarization)
  • Completed Certificate of Free Sale
  • Manufacturer’s declaration stating products are manufactured in the United States
  • Copy of recently paid invoice to substantiate products freely sold in United States

Florida Chamber of Commerce

For information, call (850) 521-1200, email , or visit the Florida Chamber of Commerce website.

Fees/requirements:

Regular processing (up to two weeks)

  • Member rate: $60 per certificate
  • Non-member rate: $80 per certificate

Apostille

  • $25 additional per certificate (allow for extra processing time)

Expedited processing (1-2 days for processing; call to confirm availability)

  • Member rate: $150
  • Non-member rate: $175

All fees must be paid in advance and are non-refundable.Each certificate covers the first 100 products; orders exceeding this amount will be charged $25 for each additional certificate.Bulk users (requiring more than 25 certificates a month) will be charged a flat rate. Please contact the Florida Chamber Miami International Trade Office for information on how to qualify.

  • Completed U.S. Certificate of Origin form available on the UPS website.
  • Must take the completed certificate into the Chamber Office to be notarized.

The Division of Drugs, Devices, and Cosmetics neither endorses these resources nor approves of links to external sources. External links are made available for the convenience of the Internet user. The State of Florida takes no responsibility for a link's operation or content. The links that are shown are not an exclusive listing of organizations available within the State.