RULE NO: RULE TITLE
64F-12.012: Records of Drugs, Cosmetics and Devices
NOTICE IS HEREBY GIVEN THAT on November 17, 2009, the Department of Health, Drugs, Devices and Cosmetics Program has received the petition for declaratory statement from Henry Schein, Inc., 135 Duryea Road, Melville, New York 11747, (631)843-5546; Medline Industries, Inc., One Medline Place, Mundelein, Illinois 60060, (847)837-2759; and, Cardinal Health, Inc., 700 Cardinal Place, Dublin, Ohio 43017, (614)757-5000.The petition seeks the agency's opinion as to the applicability of Section 499.01(2)(t), Florida Statutes and Rule 64F-12.012, Florida Administrative Code, as it applies to the petitioner.
The petition seeks a Declaratory Statement from the Department of Health, Drugs Devices and Cosmetics Program regarding the responsibilities of a licensed prescription drug wholesale distributor regarding the Health Care Clinic Establishment (HCCE) Permit as required by Section 499.01(2)(t), Florida Statutes and Rule 64F-12.012, Florida Administrative Code. The Petition seeks the Department’s guidance on how a distributor can make an accurate determination whether the distributor is selling a prescription drug to a business establishment or to an individual employed at the establishment. The petition seeks guidance on the level of inquiry a distributor should resort to in making this determination, in order to ensure the sale is to a person authorized to purchase prescription drugs in Florida. The petition also seeks guidance on the audit trail requirements for prescription drug sales to health care clinic establishments.
A copy of the Petition for Declaratory Statement may be obtained by contacting: Rebecca Poston, R.Ph., Executive Director, Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, Mail Bin #C-04, Tallahassee, Florida 32399, (850)245-4294.