FDA May Not Prevent Pharmacists from Promoting Compounded Drugs

By Melanie R. Margolis

On April 29, 2002, the U. S. Supreme Court handed down its decision in Thompson v. Western States Medical Center, available on the Internet at http://supct.law.cornell.edu/supct/html/01-344.ZO.html.  In this case, the Supreme Court considered whether certain provisions of federal law concerning the advertisement of compounded drugs unconstitutionally restricted commercial speech. Drug compounding is the process by which pharmacists mix ingredients together to create medications specific to the needs of a particular individual. Compounding is a traditional part of pharmacy practice. Compounding is taught in pharmacy school, and many states regulate compounding within their pharmacy regulations. See, e.g., 22 Tex. Admin. Code § 291.36 (2002).

The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) regulates the manufacturing, marketing, and distribution of drugs, and provides that “new drugs” must receive Food and Drug Administration (FDA) approval.  Regulation of compounding was left largely to the states, but the FDA was concerned that some pharmacists were circumventing the “new drug” requirements by producing commercial quantities of compounded drugs, which without FDA approval, could cause public harm.

In 1997, the FDA Modernization Act (FDAMA) specifically exempted compounded drugs from “new drug” requirements, provided that certain criteria were met. The most pertinent of the criteria was that the prescriptions for compounded drugs had to be “unsolicited.” Pharmacies, licensed pharmacists, and licensed physicians could advertise and promote the fact that they provided compounding services, but they could not specifically advertise and promote a particular compounded drug or class of drugs.

This case was initiated by a group of pharmacies seeking an injunction in district court against enforcement of the limitation on advertising and promoting compounded drugs. The district court sided with the pharmacists, invalidating the relevant provisions of federal law. The Ninth Circuit Court of Appeals agreed with the district court that the provisions were unconstitutional.

The Supreme Court in turn upheld the Ninth Circuit’s determination that the provisions were unconstitutional restrictions on commercial speech. The Supreme Court held that the prohibition on soliciting prescriptions for compounded drugs and advertising compounded drugs violated the First Amendment.

Like the federal law in question, Texas regulations provide that pharmacies and pharmacists may advertise and promote their compounding services, but they are prohibited from soliciting business "by promoting [their ability] to compound specific drug products.”  22 TAC § 291.33 (2002). In light of this Supreme Court decision, this Texas provision will have to be revisited.

08/30/02