Ioana Maties, Compliance Manager, Spectrum Chemical Mfg. Corp, 14422 S. San Pedro St., Gardena, CA 90248, 1-310-516-8000 ext, 5601. Filed January 26, 2018.; The Petition seeks a formal opinion from the Department as to whether the Petitioner needs ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that The Division of Drugs, Devices and Cosmetics has received the petition for declaratory statement from Ioana Maties, Compliance Manager, Spectrum Chemical Mfg. Corp, 14422 S. San Pedro St., Gardena, CA 90248, 1(310)516-8000, ext, 5601. Filed January 26, 2018.The petition seeks the agency's opinion as to the applicability of 499.003,(40), F.S., as it applies to the petitioner.

The Petition seeks a formal opinion from the Department as to whether the Petitioner needs additional licensing. The petitioner wants clarification on if a cosmetic manufacturer and OTC manufacturer located in Florida, would also require a prescription drug permit for an API labeled RX ONLY, that will be incorporated into a cosmetic product that does not require prescription? Adenosine is a prescription API but is also a cosmetic ingredient used as wrinkle relaxer. Except for good cause shown, motions for leave to intervene or petitions for administrative hearing by persons whose substantial interests may be affected must be filed within 21 days after the publication of this notice.

A copy of the Petition for Declaratory Statement may be obtained by contacting: Dinah Greene, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, FL 32399-1047, [e-mail], [phone].

Please refer all comments to: Drew Winters, Director, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, FL 32399-1047, [e-mail], website: http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.