Prescription Drug Manufacturer

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:

• Prepares, derives, manufactures, or produces the drug;
• Holds an approved New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), a Biologics License Application (BLA), or a New Animal Drug Application (NADA);
• A private label distributor for whom non-repackaged prescription drugs are originally manufactured and labeled;
• A person registered under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (federal act), as a manufacturer of a prescription drug, who is described in paragraphs 1. through 3. above, who has entered 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; or
• A member of an affiliated group with multiple prescription drug manufacturer members (the applicant and at least one other prescription drug manufacturer) - provided that the permittee distributes prescription drugs only for members of that affiliated group.
• An "affiliated group" in this context means an affiliated group as defined in s. 1504 of the Internal Revenue Code of 1986, as amended.

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: Complete the application by clicking on the "Printable Application" link at the bottom of the page.

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.