FDA States Policy on Pharmacy Compounding
The agency published its guidance on FDA's Web site on June 4.
Although effective from the date of publication in the Federal Register, the guide will be open for public comment, according to an agency spokeswoman.
Joseph H. Deffenbaugh, professional affairs associate for the American Society of Health-System Pharmacists (ASHP), participated in the June 3 teleconference. He said that FDA plans to develop the Bush adminstration's proposal for legislation in response to a recent U.S. Supreme Court decision that invalidated the compounding provisions contained in the FDA Modernization Act (FDAMA) of 1997.
"FDA is considering the implications of [the Supreme Court's] decision and determining how it intends to regulate pharmacy compounding in the long-term," the agency's guidance manual states. "However, FDA recognizes the need for immediate guidance on what types of compounding might be subject to enforcement action under current law."
Supreme decision. The high court, in a 5-to-4 decision, upheld a ruling by the 9th U.S. Circuit Court of Appeals that declared the compounding provisions invalid because they contained unconstitutional restrictions on commercial speech.
Those provisions exempted compounded drug products from FDA's standard drug-approval requirements under the federal Food, Drug, and Cosmetic Act as long as the providers of the compounded products abided by several restrictions. Among these restrictions was one that barred pharmacists and others from advertising or promoting that they compounded any particular drug or type of drug. Under the provisions, a prescription for a compounded product has to be unsolicited.
A group of pharmacies that specialize in compounding sued the government, arguing that the provisions violated the right to free speech under the First Amendment.
The pharmacies won the case initially in a U.S. District Court in Nevada, which, in 1999, invalidated the restrictions on advertising but let the other compounding provisions stand.
From there, the government appealed, bringing the case to the circuit court. That court, in 2001, agreed with the pharmacies and upheld the district court's ruling that FDAMA's restrictions on advertising were unconstitutional (see April 15, 2001, AJHP News).
However, the appeals court found that the provisions pertaining to advertising could not be severed from the rest of the compounding provisions.
The government appealed the case to the Supreme Court but challenged only the constitutional question about free speech (see April 1, 2002, AJHP News).
When the high court affirmed the lower court's decision, which included the finding that the advertising provisions could not be severed from the other provisions, the justices invalidated the compounding provisions entirely.
What next? Carmen A. Catizone, executive director of the National Association of Boards of Pharmacy, participated in the teleconference. He said that, while the high court's ruling has created some confusion among pharmacists, including himself, FDA's new compliance policy guidelines "may add more confusion."
"There's a lot of uncertainty because, for one, there's not been a commissioner appointed," Catizone said. "No one has articulated the mission or what purpose the FDA is going to have within the administration. So without that central leadership, people just don't know. We haven't heard very many policy stances out of the FDA on other issues."
According to the new document, FDA will continue to defer to state authorities regarding "less significant violations" related to pharmacy compounding: "FDA anticipates that, in such cases, cooperative efforts between the states and the agency will result in coordinated investigations, referrals, and follow-up actions by the states."
But FDA will "seriously consider enforcement action" when it suspects a pharmacy of "manufacturing and distributing unapproved new drugs in a manner that is clearly outside the bounds of traditional pharmacy practice" and violates federal law.
FDA identified nine factors that it will use to determine whether to initiate action against a pharmacy.
Those factors, said ASHP's Deffenbaugh, seem to modify a compliance policy guide issued in 1992 and the regulations established under FDAMA.
FDA may use "other factors" when considering a particular case, according to the new guide. The agency has other guidance documents that interpret or define its positions on compounding in settings other than community pharmacies.
The United States Pharmacopeia (USP) has proposed a new chapter containing compounding guidelines for its next edition of The United States Pharmacopeia and The National Formulary. USP has also proposed revisions to other chapters that pertain to pharmacy compounding. The chapters are open for comment, according to a USP spokesman.
USP declined to comment on the Supreme Court's decision that invalidated the compounding provisions.
Meaning of the court decision. Randy P. Juhl, dean of the University of Pittsburgh's School of Pharmacy and a former chair of FDA's Pharmacy Compounding Advisory Committee, said there are some "bright sides" to the Supreme Court's decision.
FDA's requests to the Supreme Court, Juhl said, acknowledged that the agency wants to preserve the availability of compounded drugs for patients.
"This is a noteworthy statement because, at times, organized pharmacy has gotten the impression that FDA wants no compounding of anything, anytime, anywhere, any place, by anyone," he said. "But they have recognized the value of preserving the availability of compounded drugs for patients who, for particular medical reasons, cannot use commercial products."
Indeed, FDA says in its new guidance document that "pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of human drugs upon receipt of a valid prescription for an individually identified patient from a licensed practitioner. This traditional activity is not the subject of this guidance."
Juhl also said the justices' majority opinion statement noted that compounding is a traditional practice for pharmacists.
The justices "seem to acknowledge that it is part of the art and science of pharmacy...and in a way give credence to compounding as a valuable component of the practice of pharmacy," he said. "There was concern amongst pharmacists that the court would say something that could be taken as basis for the complete ban of compounding. And quite the contrary, the court seems to have recognized the value of pharmacy compounding."
Juhl said the Supreme Court's decision supplies FDA with guidance to develop new legislative proposals about compounding.
"The court seems to be using the volume of drugs produced as a differentiation from manufacturing and compounding," he said. "That is wording the FDA can use in its pursuit of further legislation and that we all should use, because that is what the Supreme Court has said. The court goes on to say that there are several nonspeech-related ways of drawing that line between compounding and manufacturing."
There are provisions of the original legislation that ought to be preserved, Juhl said.
It would be in the best interest of all parties, including FDA, the pharmaceutical industry, and pharmacy organizations, to agree on legislation and "go to Congress together," he said. "Because to do so otherwise would just invite a fight."