Variances and Waivers from Martha Harrell Chumbler, Carlton Fields, P.A. on behalf of AmerisourceBergen Drug Corporation, 1300 Morris Drive, Chesterbrook, PA 19087. The petition seeks a variance and waiver of it's administrative rules 61N-1.012(3)...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that on October 3, 2013, the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, received a petition for Variances and Waivers from Martha Harrell Chumbler, Carlton Fields, P.A. on behalf of AmerisourceBergen Drug Corporation, 1300 Morris Drive, Chesterbrook, PA 19087.

The petition seeks a variance and waiver of Florida Administrative Code subparagraph 61N-1.012(3)(a)1, Pedigree Papers. The pedigree papers required by Sections 499.01212, F.S., must include either the proprietary name or the generic name with the name of the manufacturer, repackager, or distributor as reflected on the label of the product; dosage form; strength; container size; quantity by lot number; the name and address of each owner of the prescription drug that is required to be identified on the pedigree paper; the name and address of each location from which it was shipped if different from the owner’s; and the transaction dates. The pedigree paper must clearly identify the invoice to which it relates; however, if an invoice number has not been generated at the time the pedigree is prepared then an alternate reference number that is easily traceable to the invoice number may be used.

Petitioner request a permanent variance from the requirement in Rule that the pedigree paper include the full proprietary or generic name of the drug and requests that, instead, Petitioner be permitted to utilize an abbreviated form of the prescription drug's name, as long as other information sufficient to conclusively identify the drug is also included.

A copy of the Petition for Variance or Waiver may be obtained by contacting: The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, [phone].

Please refer all comments to: Reggie Dixon, Executive Director, Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, website: http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.