FDA Again Exceeds its Jurisdictional Authority
HOUSTON, Nov. 11, 2011 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration (FDA) appealed the September 2011 U.S. District Court for the Middle District of Florida ruling in US vs. Franck's Lab, Inc., which had decided in favor of pharmacy compounding for veterinary patients. This lawsuit, brought by the Food & Drug Administration against Paul Franck, R.Ph., FIACP of Franck's Lab in Ocala, Fla., alleged that the use of active pharmaceutical ingredients (APIs) in compounding veterinary preparations for non-food producing animals was illegal.
In this landmark pharmacy compounding court decision, Judge Timothy Corrigan had ruled that:
- The FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy so long as the pharmacy's activities are not manufacturing. That rests with individual state Boards of Pharmacy.
- Congress did not give FDA jurisdictional authority when it enacted the FDCA in 1938 to take enforcement action against a pharmacy that is engaged in the traditional practice of compounding.
- The FDA cannot use its CPG for veterinary compounding issued in 2003 as the basis for enforcement action.
- The regulations enacted by the FDA based upon AMDUCA are in error – AMDUCA did not give FDA authority to prohibit the use of bulk APIs in veterinary compounding.
- Size and scope of compounding does not mean a pharmacy is a manufacturer.
- The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food producing animals is an illogical position for the FDA to take and contraindicated by its own actions over the past 50+ years.
IACP Response on FDA's Appeal Today
"Despite Judge Corrigan's clear ruling that the FDA once again attempted to exceed its jurisdictional authority, the agency seems determined to waste taxpayers' money with another lengthy and unnecessary legal case," said IACP President John Herr, R.Ph., FIACP. "Given its track record with other cases affecting compounding pharmacists, the FDA again refuses to recognize that both the U.S. Constitution and the U.S. Congress limits its role in the state governed practice of medicine and pharmacy – a practice rightfully regulated by the state Boards of Pharmacy."
"For seven years, IACP and members of Congress continued to send a clear and simple message to the FDA… 'Fix the Veterinary Compounding Compliance Policy Guidance document.' Had the FDA fulfilled its commitment to do so in 2004, this case would never have been brought to the courts in the first place. Think of all the money wasted by the FDA prosecuting a case which they have now lost twice, all the money wasted by Community Pharmacist Paul Franck in defending his business, all the money that will be spent on appeals and defense of appeals… simply because a government agency refused to solve a problem of their own creation. Despite rulings in other cases in addition to the recent US v. Franck Labs, Inc. and in language accompanying each of its own documents, the FDA appears unable to accept that its Compliance Policy Guidelines are not enforceable documents," says, IACP Executive Vice President & CEO David G. Miller, R.Ph.
The International Academy of Compounding Pharmacists (IACP) is a professional association founded in 1991 to protect, promote and advance personalized medication solutions. The association represents more than 2,100 pharmacists and pharmacist technicians located throughout North America, South America, Europe, Australia and Asia, who are committed to the safe and ethical practice of pharmacy compounding. In addition, IACP represents more than 159,527 patients, physicians, veterinarians and nurse practitioners through its ally grassroots organization, Patients & Professionals for Customized Care (P2C2). IACP is committed to ensuring the rights of practitioners to prescribe, of pharmacists to prepare, and of patients to take personalized medication solutions that meet their unique, individual health needs. www.iacprx.org.
IACP Director of Communications
[email protected], 281/933-8400.
David G. Miller, R.Ph.
IACP Executive Vice President & CEO, [email protected], 215/778-5128
SOURCE International Academy of Compounding Pharmacists (IACP)