variance or waiver from rule 64F-12.015(6)(d)(1)(b)(iii). The petitioner is Organon API Inc., 2136 South Wolf Road, Des Plaines, IL 60018, Contact Person: Fred Figa, Senior Legal Counsel, Organon USA Inc., Phone: [phone], Fax: [phone]. ...

 

DEPARTMENT OF HEALTH
Division of Family Health Services

RULE NO: RULE TITLE
64F-12.015: Licensing, Application, Permitting

NOTICE IS HEREBY GIVEN THAT on November 6, 2007, the Department of Health, received a petition for variance or waiver from sub-sub-subparagraph 64F-12.015(6)(d), (1), (b) (iii), F.A.C. The petitioner is Organon API, Inc., 2136 South Wolf Road, Des Plaines, IL 60018, Contact Person: Fred Figa, Senior Legal Counsel, Organon USA, Inc., [phone], Fax: [phone].

Organon API Inc. requests a variance from sub-sub-subparagraph 64F-12.015(6)(d), (1), (b)(iii), F.A.C. That section provides that a company may be licensed by the state as a non-resident manufacturer of prescription drugs if it is “a private label distributor and the private label distributor’s prescription drugs are originally manufactured and labeled for the distributor and have not been repackaged.” It is Organon API Inc.’s understanding that the Board of Pharmacy has interpreted this provision as requiring that the private label distributor’s name appear on the product labels. Organon API Inc.’s name does not appear on the labels of the products manufactured for it and, therefore, Organon API Inc. requests a variance from this code requirement.

A copy of the Petition for Variance or Waiver may be obtained by contacting: Rebecca R. Poston, R.Ph., Executive Director, Board of Pharmacy and Drugs, Devices, and Cosmetics Program, 4052 Bald Cypress Way, Bin C-04, Tallahassee, FL 32399-3254, telephone: [phone].