(CN) - The Food and Drug Administration cannot bar a Florida pharmacy from using bulk active ingredients to compound drugs for animals that don't produce food, a federal judge ruled.
Ocala-based pharmacy chain Franck's Lab had faced an unprecedented lawsuit alleging that it violated the Food, Drug and Cosmetic Act of 1938 by engaging in bulk compounding of animal drugs.
The chain's founder, Paul Franck, opened his first pharmacy in Archer, Fla., in 1983 and added several more over the next few years.
Franck's Ocala location started compounding and selling medication for humans and non-food-producing animals in 1985.
With almost 40,000 veterinary prescriptions filled every year, Franck's compounds most of its animal drugs from raw chemical materials - a procedure known as bulk compounding that accounted for about 40 percent of Franck's business at the time the FDA filed suit.
The FDA inspected Franck's compounding facilities on several occasions, expressing concerns that the chain was manufacturing medication and eluding the FDA's new-drug approval process. FDA officials questioned Franck's practice of compounding veterinary drugs from bulk active ingredients, especially where an approved drug would adequately treat the animal.
After receiving a warning letter from the FDA in January 2005, Franck's assured the agency that it was compounding animal drugs within the limits established by the FDA. Franck's asserted that it engaged in traditional pharmacy compounding for individual animal patients, based on valid veterinary prescriptions, not in drug manufacturing.
But the FDA renewed its suspicions in 2009 when Franck's supplied a compounded injectable drug for the Venezuelan national polo team horses. A mathematical error in the conversion of an ingredient had made Franck's medication too strong, which proved fatal to 21 polo horses. The Florida Board of Pharmacy investigated Franck's but allowed it to continue compounding without restriction.
That year, however, the FDA re-inspected Franck's facilities three times and expressed concerns about quality assurance and training issues.
Though it acknowledged that a mathematical error, not Franck's bulk compounding, had killed the polo horses, the FDA sued the chain in April 2010 to enjoin it from compounding veterinarian-prescribed drugs from bulk ingredients.
Franck's countered, however, that its status as a traditional compounding pharmacy, not a drug manufacturer, should lead the court to dismiss.
The practice of compounding - by which a pharmacist combines, mixes or alters ingredients to create drugs tailored to the specific needs of a patient - is a long-standing and traditional part of the pharmacy business. Like the practice of pharmacy in general, compounding is regulated by the states. Florida law allows for the compounding of drugs from bulk substances, which has become preferred among veterinarians, because bulk ingredients, unlike finished drug products, ensure that the compounded medication is of the expected purity, potency and quality. Bulk-compounded drugs are sometimes the only alternative to medication that is not commercially available or is unsuitable for a particular patient's condition or allergies. Such is the case for non-food-producing animals, whose size, species or intolerance to some active ingredients often make mass-produced drugs inadequate.
Since the 1990s, the FDA has addressed bulk compounding in several compliance policy guides, out of concern that retail pharmacies may manufacture and sell unapproved drugs under the guise of compounding, in contravention of the FDA's new-drug requirements.