Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product.
The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) regulates drug manufacturing, marketing, and distribution, providing that no person may sell any new drug unless approved by the Food and Drug Administration (FDA). The Food and Drug Administration Modernization Act of 1997 (FDAMA), which amends the FDCA, exempts compounded drugs from the FDCA's requirements provided the drugs satisfy a number of restrictions, including that the prescription must be "unsolicited," and the provider compounding the drug may "not advertise or promote the compounding of any particular drug, class of drug, or type of drug." The provider, however, may "advertise and promote the compounding service."
A group of licensed pharmacies that specialize in drug compounding challenged the FDAMA's requirement that they refrain from advertising and promoting their products if they wish to continue compounding on the basis that it violates the Free Speech Clause of the First Amendment. What test should the court apply in determining the validity of the FDAMA.