Florida/Georgia Personal Injury & Workers Compensation

...Bio-Med Plus acquired prescription drugs from persons not authorized under the Florida Drug and Cosmetic Act, Chapter 499, F.S., to distribute prescription drugs to Bio-Med Plus. As a result, Bio-Med Plus acquired and resold or otherwise distributed prescription drugs that were adulterated, as defined in s. 499.006, F.S., in violation of s....

...uspension order." Daube v. Dep't of Health, 897 So.2d 493, 495 (Fla. 1st DCA 2005). While the Department does allege that Bio-Med's blood products have been " per se adulterated" because they were distributed by parties not authorized to do so under section 499.006(10), [2] the ESO contains no factual allegations that Bio-Med's plasma-derivative products were in any way counterfeited, altered, expired, or mislabeled; and no factual allegations to support a conclusion that the safety or welfare of the public is being threatened at present....

...Regulation, 363 So.2d 1162, 1165 (Fla. 1st DCA 1978); Garcia v. Dep't of Prof'l Regulation, 581 So.2d 960 (Fla. 3d DCA 1991). This court has previously granted Bio-Med's emergency motion for stay of the ESO pending final disposition of this proceeding. [2] Section 499.006(10), Florida Statutes (2004), provides that a drug is adulterated if it "has been purchased, held, sold or distributed at any time by a person not authorized under federal or state law to do so." [3] Bio-Med alleges, without contradic...

...(b) Knowingly adulterating a drug that is intended for further distribution. Section 499.003(37), Florida Statutes (2003) 2 , defines “repackage” as including *157 “repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug....” (emphasis added). Section 499.006, Florida Statutes (2003), provides, in relevant part, as follows: A drug or device is adulterated: [[Image here]] (2) If it has been produced, prepared, packed, or held under conditions whereby it could have been contaminated with fil...

...njurious to health; if the facility or the methods used at the facility to hold, process or package the drugs do not conform with the requirements of section 499.001-.081; or held or distributed by a person not authorized under federal or state law. § 499.006....

...ithout review by a physician, without the supervision of a pharmacist, unsecured and left in containers for distribution without any labels, clearly constitutes conditions where the drugs could have been contaminated or rendered injurious to health, § 499.006(2). These facts demonstrate that the facilities and methods used did not conform to the requirements of section 499.001-.081, § 499.006(3), and the facts detailed earlier show the drugs were being held and distributed by individuals not authorized to do so under federal or state law, § 499.006(10)....

...Despite this enforcement relaxation, the staff director testified that the Department’s definition of an “adulterated” prescription drug remained static. In July 2003, following the collapse of the Carlow enterprise, the Florida Legislature amended section 499.006, Florida Statutes, to define an “adulterated drug or device” as drugs either sold without pedigree papers or “purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so.” I...