Clinical and Legal Considerations in Pharmaceutical Compounding

It is not uncommon for dermatologists to utilize compounded drug formulations to address specific patient needs that cannot be met using commercially available drugs. Some dermatology practices may derive certain economic benefits and convenience for their patients by compounding formulations in-house. Compounded drugs are considered off-label; thus, they are not approved by the United States Food and Drug Administration (FDA). Oversight of compounding pharmacies and in-clinic compounding varies by state, although the FDA has issued guidance on compounding pharmacies and regulates outsourcing and 503(B) pharmacies. Dermatologists should be aware of the legal and regulatory issues of pharmaceutical compounding, as well as safety issues and penalties associated with compounding violations. Some controversies in compounding include the use of drug moieties that have been recalled by the FDA, compounding commercially available drugs for economic reasons (cheaper than brand names), or compounding drugs when reasonable alternatives are available commercially. This article reviews the regulatory, legal, and clinical considerations of pharmaceutical compounding in the field of dermatology.