Compounding - Regulation in The United States

Regulation in The United States

In the United States, compounding pharmacies are licensed and regulated by their respective state like all other pharmacies. National standards have been created by Pharmacy Compounding Accreditation Board (PCAB).

Compounding pharmacies were the subject of the United States Supreme Court decision Thompson v. Western States Medical Center (535 U.S. 357, 2002), which held that Congressional attempts to restrict advertising by compounding pharmacies were unconstitutional. However, the same statute (FDAMA, amending the FDCA which establishes the FDA) also contained a provision that largely exempted compounded products from the FDA's control by defining many of them as not being "new drugs" for FDA purposes. Since the Supreme Court did not rule on the issue of how broadly to interpret that provision, nor on the issue of whether that provision was "severable" from the struck provision, there remains today a Circuit-split on both of those questions: As of 2008, the 9th Circuit (binding in several western states) holds that the provisions are not severable, and hence the entire FDAMA is void; on the other hand, the 6th Circuit (binding in several southwestern states) holds that the provisions are severable, and hence the non-struck portions of the FDAMA remain intact (including what it interpreted to be a limited exemption from FDA reach for any compounded drugs that meet the requirements given in the statute).

Meanwhile, in Circuits where the FDAMA is void and thus the FDA retains its original reach, the FDA weighs the following (non-exhaustive) mix of factors in deciding whether to "exercise its discretion" to require approval for a custom-compounded drug product, from its 2002 Compliance Policy Guide on the matter:

1. Compounding in anticipation of receiving prescriptions,
2. Compounding drugs removed from the market for safety reasons,
3. Compounding from bulk ingredients not approved by FDA,
4. Receiving, storing, or using drugs not made in an FDA-registered facility,
5. Receiving, storing, or using drugs' components not determined to meet compendia requirements,
6. Using commercial-scale manufacturing or testing equipment,
7. Compounding for third parties for resale,
8. Compounding drugs that are essentially the same as commercially available products,
9. Failing to operate in conformance with applicable state law.

Hence, making truly patient-customized products with particular drug(s)/dosage(s) upon receiving valid prescriptions from a physician is likely to be acceptable, especially if the ingredients are FDA approved, etc.

Also from the 2002 CPG document, the FDA assures compounding pharmacies that its main concern is those who effectively engage in multi-patient "manufacturing" under the guise of compounding. "FDA recognizes 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."