The FDA's reliance on the compliance policy guide as a basis for the need for a patient-specific prescription is also noteworthy.

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date against compounding pharmacies on the issue of patient-specific prescriptions. The FDA stated that the receipt of a valid prescription for an individually identified patient prior to the distribution of compounded drugs is "relevant" to Section 503A (21 U.S.C. 353a) of the Food and Drug Administration Modernization Act (FDAMA) and the compliance policy guide FDA issued on compounding issued in 2002 (CPG). Based on Medi-Fare Drug's alleged lack of patient specific prescriptions, the FDA also stated the compounds were unapproved new drugs that had not been through the drug approval process.

The FDA's use of FDAMA is noteworthy in light of a circuit split that created conflicting decisions regarding FDAMA. An amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), FDAMA regulates compounds. FDAMA exempts compounds from certain FDCA requirements if the compounds, among other things, are prepared "on prescription order for [an] individual patient."¹ FDAMA also contained an advertising ban, which the United States Supreme Court struck down as unconstitutional in Western States.² The Ninth Circuit in Western States found the advertising provision could not be severed from the remainder of FDAMA, and therefore found the entire statute unconstitutional.³ In 2008, the Fifth Circuit disagreed with the Ninth Circuit, finding FDAMA's advertising provision could be severed, thereby resurrecting the remainder of FDAMA and declaring it good law.⁴ Since that time, the FDA has applied FDAMA in the Fifth Circuit and to the pharmacies who were plaintiffs in the suit. The FDA has not applied FDAMA to the remainder of the country.

Medi-Fare Drug is located in South Carolina, which is not in the Fifth Circuit, and Medi-Fare Drug was not a plaintiff in the Fifth Circuit suit. By basing its claim that individually identified patients prescriptions are required partly on FDAMA, the FDA is applying FDAMA requirements to a pharmacy that is not located in the district where it is the law.

The FDA's reliance on the CPG as a basis for the need for a patient-specific prescription is also noteworthy. The CPG sets out nine factors that the FDA states will raise concerns that a compounding pharmacy is acting as a manufacturer.⁵ None of these nine factors contains discussion that a prescription must be patient-specific. The CPG identifies compounding in anticipation of receiving prescriptions as raising concerns, but does not discuss this concern in the context of any patient-specific requirement.

About Duane Morris

Duane Morris attorneys counsel clients in the pharmaceutical and medical device industries on virtually all aspects of their business and at all stages of the client’s lifecycle, from bringing new products to market materials, price reporting, adverse event reporting, import and export issues, manufacturing questions, to conducting self-evaluative audits and designing corrective action plans. Duane Morris also regularly assists clients in dealing with governmental regulatory agencies, including the FDA, DEA, CMS, OIG, HHS, DOJ, the FDA Office of Criminal Investigations, and state regulatory authorities; in matters involving regulatory enforcement actions, False Claims Act litigation, internal investigations, fraud and abuse, off-label promotion, and federal and state anti-kickback statutes.

For Further Information

If you have any questions about this Alert or would like more information, please contact Rachael G. Pontikes, Elinor L. Hart, any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy & Food group or the attorney in the firm with whom you are regularly in contact.

Notes

1. 21 U.S.C. 353a (West 2013).
2. Western States Med. Ctr. v. Shalala, 535 U.S. 357 (2002).
3. Western States Med. Ctr. v. Shalala, 238 F.3d 1090 (9th Cir. 2001) aff'd 535 U.S. 357.
4. Med. Ctr. Pharmacy v. Mukasey, 536 F.3d 383 (5th Cir. 2008).
5. Dep't of Health & Human Servs., Food & Drug Admin., Compliance Policy Guidance for FDA Staff and Industry Sec. 460.200 Pharmacy Compounding (May 29, 2002), available here.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.