On September 12, 2011, the U.S. District Court for the Middle District of Florida in United States v. Franck's Lab, Inc. denied a request by the U.S. Food and Drug Administration ("FDA") for an injunction and summary judgment against a compounding pharmacy, Franck's, and firmly rejected the FDA's contention that it had per se authority to regulate pharmacies compounding drugs for animal use. This landmark case is likely to have broad implications for the future of compounding pharmacies, and serves as the latest round in a long-standing debate between the FDA and compounding pharmacies over the scope—if any—of the FDA's authority in this area. Despite this recent victory for the compounding industry, this area of the law remains obscure at best. Pharmacies that have questions or receive inquiries from the FDA or their respective state boards related to compounding activities should consider seeking legal counsel.
Franck's is a national pharmacy chain based in Florida, which distributes and compounds drugs for both animal and human use. The Franck's case began when, in 2004 and 2005, the FDA inspected Paul Franck's—Franck's CEO, owner and a duly licensed Florida pharmacist—compounding facilities, citing concerns that Franck's was impermissibly manufacturing drugs; compounding drugs outside a valid veterinarian-client-patient relationship; and compounding drugs when approved drugs were otherwise available. After Franck's initial response to this inquiry, the FDA did not approach Franck's until 2009, when Franck's was investigated and reprimanded by the Florida Board of Pharmacy for a misfilled prescription. This incident prompted the FDA to reinspect Franck's facilities and issue an FDA Form 483. Then, in April 2010, the FDA sought a preliminary injunction to enjoin Franck's from distributing animal drugs compounded from bulk substances, asserting that it was a per se violation of the federal Food, Drug and Cosmetic Act ("FDCA") to compound animal medications from bulk substances. In essence, the FDA's contention was that "th[e] traditional compounding practice implicate[d] the same concerns under the FDCA as the mass-production, mass-marketing, and mass-distribution of unapproved animal drugs by an unlicensed manufacturer."1 In contrast, Florida law permits pharmacists to compound animal medications from bulk substances, as does the law in many other states.2
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