STATE | ASPS responds to new compounding regulations and guidelines
Food & Drug Administration
The FDA released its 2018 compounding policy priorities, which identify the need for new guidance on "insanitary" conditions and violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The influence of the house of medicine is evident, as the outline states that, "This guidance will address concerns raised by some providers who compound small quantities of drugs in their offices for patient use, and as part of their routine clinical practice. This came up in the setting of certain dermatological procedures, for example." The full outline can be found here. ASPS will look for opportunities to shape the in-office compounding guidelines produced by the FDA during upcoming comment periods.
Ohio Medical Board
Following the promulgation of regulations last year, the State of Ohio Medical Board has revisited compounding again in 2018. One of the key points of contention with the previous rules was the fact that physicians were forced to obtain a Terminal Distributor of Dangerous Drugs (TDDD) license in order to possess, have custody or control of, and distribute controlled substances. Unfortunately, the new proposal would exempt a very limited number of physicians from the TDDD requirement. ASPS joined a coalition led by the Ohio State Medical Association (OSMA), which commented on the proposal and emphasized the need to wait for the FDA to revise the aforementioned United States Pharmacopeia-National Formulary guidance documents before implementing state policies.
Federation of State Medical Boards
The Federation of State Medical Boards (FSMB) released a draft position statement on physician compounding. While the draft is a positive development, several clauses warranted response in order to better represent plastic surgery's use of in-office compounds. Notably, the FSMB included recommendations that would potentially lead to unnecessary restrictions if adopted by state medical boards. These include recommendations to: (1) establish relationships with pharmacies or other entities that have registered as outsourcing facilities with the FDA in instances where patients require medications in forms that are different from those commercially available; and (2) limit compounding activity to nonsterile preparations. ASPS crafted comments and is working closely with ASPS member Sarvam TerKonda, MD who sits on the FSMB Committee on Ethics and Professionalism in order to ensure that plastic surgery's voice is heard.