Compounding exception for allergy

The Federation of State Medical Boards (FSMB) recently published, for comment, a draft position statement on physician compounding. The draft states that physicians are encouraged to limit compounding to non-sterile preparations but specifically notes, as an exception, the allergy and immunology specialty, stating that:

  • “accepted practice regularly includes the preparation of sterile compounds by or under the supervision of a specially trained physician for their individual patients”
  • “physicians should follow aseptic technique, as well as the protocols developed by their specialty and set forth in applicable published practice parameters.” 

This draft position statement takes a more flexible position than a 2016 position statement that was never finalized. The Advocacy Council had submitted lengthy comments to the FSMB in response to the 2016 draft and representatives of the FSMB attended the USP Roundtable last year along with representative from the Advocacy Council and the AAAAI. We believe the acknowledgement of the special nature of allergy and immunology in the new version is a direct result of the College’s and Academy’s effective advocacy on this issue. In fact, the FSMB has incorporated some of our recommended language verbatim. We have provided the FSMB additional feedback on the new draft position statement.

We believe this signals a better and more nuanced approach by the FSMB on physician compounding and, in particular, allergen extract preparation. We will keep you posted as to developments in this area.

Advocacy Issue: 
Mixing Allergen Extracts