(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.
A guide issued in 1992 listed several activities that the FDA believed would cross the line between compounding and manufacturing, requiring the FDA to initiate federal enforcement action. Bulk compounding based on valid prescriptions for individual patients did not make the list of prohibited activities.
A 1996 guide also allowed bulk compounding based on a legitimate medical need, so long as the dose was appropriate for the individual patient’s species, age, size and medical condition. It also stipulated that there could not be an approved drug available to adequately treat the condition. Neither guide listed bulk compounding of drugs for non-food-producing animals as an area the FDA would regulate.
In 2002 and 2003 guides, the FDA asserted that compounded human and animal drugs were not exempt from the new-drug approval. The guides assured pharmacists that the FDA would only take enforcement action against pharmacies that crossed the line between traditional compounding and drug manufacturing. Nonetheless, according to a June 2005 letter by 26 senators and 72 congressmen who pushed for revision of the guides, the FDA increased inspection and enforcement activities against compounding pharmacies based on the new guides.
Despite congressional pressure triggered by pharmacists’ and veterinarians’ complaints that the FDA’s restrictive guidelines would deprive animal patients of much-needed medication, the FDA failed to revise its latest guides or open them for public review and comment.
In 2006, a coalition of compounding pharmacies challenged the FDA’s new assertion of authority over the compounding process and sought to prevent it from enforcing the 2003 guide. The pharmacists claimed that drugs compounded by licensed pharmacists for non-food-producing animals were not new drugs under the Food, Drug and Cosmetic Act (FDCA). A federal judge agreed, finding that the FDCA’s provisions did not apply to drugs resulting from bulk compounding. Franck’s was one of five pharmacies that filed an amicus brief in support of the plaintiff pharmacies.
Ultimately, the 5th Circuit reversed the decision, finding that compounded drugs were subject to the FDCA’s new-drug approval requirements.
In its 2010 complaint against Franck’s, the FDA asserted that traditional compounding raised the same concerns as the mass production and distribution of unapproved animal drugs by unlicensed manufacturers, and therefore fell under the incidence of the FDCA. It added that, once the FDA could prove a violation of the statute, it had the authority to enforce the new-drug approval scheme.
According to the complaint, Franck’s bulk compounding creates “new animal drugs,” as broadly defined by the FDCA.
Franck’s countered that Congress never intended in passing the FDCA to let the agency regulate or prohibit bulk compounding as practiced by state-licensed pharmacists, based on individual prescriptions for non-food-producing animals.
U.S. District Judge Timothy Corrigan addressed the parties’ arguments in a lengthy order that called the FDA’s attempt to control state-licensed bulk compounding of animal drugs a “‘maximalist’ interpretation of its authority.”
The court found that the FDA had failed to prove that Franck’s engaged in drug manufacturing.
“Although the FDA’s complaint and declarations contain allegations that Franck’s has engaged in conduct indicative of a ‘manufacturer’ of drugs, such as compounding commercially available drugs or compounding drugs in advance of a valid prescription, it has provided no factual support for such claims and ultimately does not rely on them to maintain this action,” Corrigan wrote.
He added that the FDA did not assert that Franck’s compounded drugs were unsafe or inadequate for animal consumption, noting that the killed polo horses were irrelevant to Franck’s bulk-compounding practice.
Corrigan also rejected the FDA’s argument that traditional pharmacy compounding is subject to the same requirements as new drugs manufactured and distributed in interstate commerce. He noted that it seemed unlikely that Congress had intended to subject small-scale compounding to the same kind of safety and efficacy testing as mass-produced drugs, which would not be economically feasible.
“Likewise, despite the literal language of the statute, this court cannot find that Congress has ‘directly and plainly’ said that traditional pharmacy compounding of animal drugs must meet the requirements of the FDCA’s new drug approval provisions,” according to the 80-page ruling.
What’s more, under the 1962 amendments to the FDCA, state-regulated pharmacies that dispense drugs in response to veterinary prescriptions and do not compound drugs for sale outside the traditional patient-veterinarian-pharmacist relationship are exempt from certain FDA registration and inspection requirements, the order states.
The court recognized the FDA’s right and duty to control manufacturers masquerading as pharmacy compounders, but noted that the agency must do so without restricting the state-regulated practice of compounding.
“What the Supreme Court recognized is that Congress delegated to the FDA the authority to draw a line distinguishing between compounded drugs that must undergo the new drug approval process because they bear the attributes of having been ‘manufactured’ and ‘compounded drugs created to meet the unique needs of individual patients,’ because it ‘would not make sense’ for the latter ‘to undergo the testing required for the new drug approval process,'” Corrigan wrote.
Florida clearly distinguishes manufacturers that make drugs for resale from licensed compounding pharmacists subject to state regulations, according to the ruling.
Though the FDA has the authority to draw a regulatory line between manufacturers and traditional compounding pharmacies, it failed to do so, Corrigan added.
“The FDA is certainly statutorily authorized to draw clear distinctions between manufacturing and compounding generally,” the ruling states. “However, what the FDA seeks to do here is reinterpret the FDCA to allow it to eradicate the line between manufacturing and traditional compounding of animal medications. Its wholesale assertion of authority over traditional pharmacy compounding in the context of a pharmacist-veterinarian-patient relationship is contrary to congressional intent.”
Corrigan denied the FDA’s request for a preliminary injunction, finding that the agency’s attempt to expand its statutory authority over traditional bulk compounding could “destabilize the pharmacy profession and leave many animal patients without necessary medication.”