Larry Roth, Counsel for Hill Dermaceuticals, Inc, 2650 South Mellonville Avenue, Sanford, FL 32773; Hill Dermaceuticals, Inc., currently possesses a Florida Prescription Drug Manufacturer Permit with the Division. Hill Dermaceuticals, Inc., is ...

 

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 Larry Roth, Counsel for Hill Dermaceuticals, Inc., 2650 South Mellonville Avenue, Sanford, FL 32773. The petition seeks the agency's opinion as to the applicability of subsection 61N-1.015(2), F.A.C., Sections 499.003(18), 499.0121(6)(e), F.S. and sub-paragraph 61N-1.012(6)(b)2., F.A.C. as they apply to the petitioner.

Hill Dermaceuticals, Inc., currently possesses a Florida Prescription Drug Manufacturer Permit with the Division. Hill Dermaceuticals, Inc., is petitioning to amend the Prescription Drug Manufacturer permit to include the address of the second building to the permit. Hill respectfully believes that the second building qualifies as part of the Establishment, as defined in Section 499.003(18), F.S. due to its close proximity to the first building (only 2,000 feet) with a intervening thoroughfare.

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 interests may be affected must be filed within 21 days after the publication of this notice.