Drug access and affordability

Dermatologists have a long history of safely administering compounded medications. However, new regulations on compounding have had the unintended consequence of making it more difficult for physicians to stock and administer commonly used medications.

Most notably, the FDA has issued rules on compounding by traditional compounding pharmacies and physicians who compound in office. Also, the USP (US Pharmacopeia) has issued standards that may be adopted at the state level.

The Academy advocates against restrictions on dermatologists’ ability to prepare, administer, and prescribe compounded medications.

The FDA no longer allows traditional compounding pharmacies to distribute office-use compounded medications to physician offices without a patient-specific prescription. If you wish to order office-use compounded medication without a prescription, you must order from designated outsourcing facilities, listed under Section 503B on the FDA Registered Outsourcing Facilities page.

These changes make it more difficult for physicians to stock and administer commonly used medications such as cantharidin.

In-office preparations

The FDA regulates the medications that physicians prepare in their offices that fall under the definition of compounding. Examples are buffered lidocaine and reconstituted botulinum toxins when the label is not followed. As a result, dermatologists could be held to the same strict guidelines as large compounding pharmacies. Dermatologists may continue to compound in the clinical setting but should be aware of FDA’s restriction on compounding, allowing for up to a 30-day supply based on previous use, as well as any relevant state law restrictions.

Section 503A bulk drug substances list

Section 503A of the Food Drug and Cosmetics Act (FDCA) directs the FDA to develop a list of bulk drug substances that can be compounded by physicians and pharmacists. As a result of this process, the FDA Pharmacy Compounding Advisory Committee (PCAC) considers nominations and public input and then votes on whether a bulk drug substance should be added to the list. The FDA ultimately has the final decision.