DIVISION OF DRUGS, DEVICES AND COSMETICS
PRESCRIPTION DRUG MANUFACTURER
A prescription drug manufacturer permit is required for any person that (i) is a manufacturer of a prescription drug and (ii) manufactures or distributes such prescription drugs in Florida.
What is a “manufacturer”? For purposes of qualifying for this permit, a “manufacturer” of a prescription drug does or is one or more of the following:
- “Manufacture” means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic.
- A person who prepares, derives, manufactures, or produces a drug, device, or cosmetic;
- The holder or holders of a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), a Biologics License Application (BLA), or a New Animal Drug Application (NADA), provided such application has become effective or is otherwise approved consistent with s. 499.023;
- A private label distributor for whom the private label distributor’s prescription drugs are originally manufactured and labeled for the distributor and have not been repackaged;
- A person registered under the federal act as a manufacturer of a prescription drug, who is described in paragraph (a), paragraph (b), or paragraph (c), who has entered into a written agreement with another prescription drug manufacturer that authorizes either manufacturer to distribute the prescription drug identified in the agreement as the manufacturer of that drug consistent with the federal act and its implementing regulations;
- A member of an affiliated group that includes, but is not limited to, persons described in paragraph (a), paragraph (b), paragraph (c), or paragraph (d), which member distributes prescription drugs, whether or not obtaining title to the drugs, only for the manufacturer of the drugs who is also a member of the affiliated group. As used in this paragraph, the term “affiliated group” means an affiliated group as defined in s. 1504 of the Internal Revenue Code of 1986, as amended. The manufacturer must disclose the names of all of its affiliated group members to the department; or
- A person permitted as a third party logistics provider, only while providing warehousing, distribution, or other logistics services on behalf of a person described in paragraph (a), paragraph (b), paragraph (c), paragraph (d), or paragraph (e).
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. Florida law prohibits issuing this permit to an entity holding a Florida pharmacy license, except a nuclear pharmacy license, and then only for purposes of manufacturing prescription drugs used in positron emission tomography or other radiopharmaceuticals.
Pre-Clinical Research & Development: This permit is NOT required for the manufacture of products that are in an FDA approved investigational program and that are NOT manufactured for clinical investigation (for actual use in or on humans or animals).
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.
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 $1,500 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 all prescription drugs 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.
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