Mr. Paul Reid, Maitland Labs, 7972 Forest City Road, Orlando, FL 32810, 407-730-7002.; The Petition seeks a formal opinion from the Department for clarification on the requirement to obtain a permit to operate as a prescription drug manufacturer ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that Division of Drugs Devices and Cosmetics has received the petition for declaratory statement from Mr. Paul Reid, Maitland Labs, 7972 Forest City Road, Orlando, FL 32810, [phone]. The petition seeks the agency’s opinion as to the applicability of 499.01(1)(a), F.S., as it applies to the petitioner.

The Petition seeks a formal opinion from the Department for clarification on the requirement to obtain a permit to operate as a prescription drug manufacturer under 499.01(1)(a). Maitland Labs is a newly established FDA registered 503B Outsourcing Facility, a recently created class of manufacturer of prescription compounded drugs under 21 USC 353(b) Outsourcing Facility. As a manufacturer of prescription drugs it is assumed that Maitland Labs must apply for and obtain a manufacturing license from the Division prior to commencing operations.

A copy of the Petition for Declaratory Statement may be obtained by contacting: Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, FL 32399, [e-mail], [phone].

Please refer all comments to: Drew F. Winters, Division Director, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, FL 32399, [e-mail], website http://interredesignalpha/dbpr/ddc_division_notices.html.

Except for good cause shown, motions for leave to intervene or petitions for administrative hearing by persons whose substantial interest may be affected must be filed within 21 days after the publication of this notice.