DIVISION OF DRUGS, DEVICES AND COSMETICS

NONRESIDENT PRESCRIPTION DRUG MANUFACTURER

A nonresident prescription drug manufacturer permit is required for any person that is a manufacturer of prescription drugs located outside of this state or outside the United States, and that engages in the wholesale distribution of such prescription drugs into Florida.

Requirements:

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), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), or 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.

What activities do NOT require this permit?

• Pre-Clinical Research & Development:  Manufacturing and distributing 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).

• Active Pharmaceutical Ingredient – “Limited Quantities” Exception: An unlicensed manufacturer may distribute (i) a prescription drug active pharmaceutical ingredient (not a finished dosage form), (ii) that it manufactures, (iii) to a prescription drug manufacturer permitted in this state, and (iv) in limited quantities intended for research and development and not for resale, or human use other than lawful clinical trials and biostudies authorized and regulated by federal law.  Some recordkeeping requirements do apply, per Section 499.01(2)(c)3., Florida Statutes.

Domestic Compliance: The applicant must comply with the licensing or permitting requirements of the jurisdiction in which the establishment is located and the federal act.  Application must attach copies of all permits or licenses issued to the applicant’s address which authorize the manufacture or possession of prescription drugs at that address, regardless of the issuing agency. If the issuing agency prohibits photocopying the permit or license, the applicant may submit official verification of any permits or licenses issued to the applicant’s address.

FDA-Approval and Imported Prescription Drugs: If a person intends to import prescription drugs from a foreign country into this state, the nonresident prescription drug manufacturer must provide to the department a list identifying each prescription drug it intends to import and document approval by the United States Food and Drug Administration for such importation.

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

Drugs, Devices and Cosmetics Program

1940 North Monroe Street

Tallahassee, FL  32399-0783

License Term: Nonresident 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.

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.

Fee: The application and permitting fee is $1,000 for a two-year permit. Make checks payable to DBPR.

If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.