RULE NO: RULE TITLE
64B16-28.108: All Permits - Labels and Labeling of Medicinal Drugs
NOTICE IS HEREBY GIVEN THAT on May 25, 2010, the Board of Pharmacy has issued an order disposing of the petition for declaratory statement filed by Gary G. Koesten, B. Pharm, M.S., C.Ph. on December 02, 2009. The following is a summary of the agency's disposition of the petition:
The Notice of Petition for Declaratory Statement published on December 24, 2009, in Vol. 35, No. 51, of the Florida Administrative Weekly. Petitioner sought the Board’s interpretation of paragraph 64B16-28.108(2)(d), Florida Administrative Code, entitled “All Permits – Labels and Labeling of Medicinal Drugs, and Section 465.016(1)(l), F.S., entitled “Disciplinary Actions” concerning administering donated medications to animals. The Board of Pharmacy considered the Petition at its meeting held on February 10, 2010, in Jacksonville, Florida. The Board’s Order found that pursuant to Section 499.005(27), F.S., expressly prohibits the distribution of a “prescription drug that was previously dispensed by a licensed pharmacy, unless such distribution was authorized in Chapter 465, Florida Statutes, or rules adopted under Chapter 465, Florida Statutes.” The Board found that there was no exemption from that provision in Chapter 465, Florida Statutes, or the rules promulgated by the Board, therefore the Petition for Declaratory Statement was denied.
A copy of the Order Disposing of the Petition for Declaratory Statement may be obtained by contacting: Rebecca Poston, R.Ph., Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254.