Published on: 8076334. Rule Hearing requested on Proposed Amended Rule 64F-12.012 F.A.C., Records of Drugs, Cosmetics and Devices. This hearing is intended to be the final rule hearing on the amendment of Rule 64F-12.012 F.A.C.; January 7, 2010, 10:00 a.m. (EST); Conference Call: 1(888)808-6959, Conference Code: 9766152#
Published on: 8013284. 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 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.
Published on: 7953338. Rule Hearing requested on Proposed Amended Rule 64F-12.012, F.A.C., Records of Drugs, Cosmetics and Devices.; December 15, 2009, 10:00 a.m. – 12:00 Noon (EST); Teleconference: 1(888)808-6959, Conference Code: 9766152#
Published on: 7824522. The Department proposes to revise the rule language regarding pedigree requirements to be compliant with Chapter 499 F.S. and to delete language that is no longer relevant to pedigrees because of statutory changes. The department proposes to amend the audit trail and pedigree requirements for wholesale distributions of prescription drugs, to the extent necessary to protect the public health safety and welfare.
Published on: 7335545. The Department proposes to review this section for possible revisions to all records and recordkeeping requirements for Drugs, Devices and Cosmetics. This review includes but is not limited to pedigree requirements for prescription drug distributions.