Update on USP 797 and FDA Compounding Guidance

As we start a new year, we thought this to be a good time to update you on the status of our efforts to preserve in-office compounding of allergen extracts. The Advocacy Council continues to be very engaged in this issue on several fronts. 

Advocacy Council representatives serve on the Steering Committee that is organizing a USP Roundtable Discussion scheduled in early February on the specific issue of compounding of allergen extracts. This will be an opportunity for allergists to meet face-to-face with USP representatives related to the proposed changes to USP 797.

We are also actively monitoring the Food and Drug Administration’s (FDA’s) release of new guidance documents. Shortly before the end of 2016, the FDA released a guidance on prescription requirements for compounded products. This is not the guidance on Insanitary Conditions in Compounding Pharmacies that the allergy specialty has been concerned about. That guidance is still pending. Rather, the year-end guidance focuses on prescription requirements for compounded drugs, addresses anticipatory compounding by pharmacies, and clarifies that in the office setting, a prescription may consist of a notation in the patient’s chart.

We also continue to monitor activities in Congress that may impact compounding by allergists, as well as initiatives at the state level including activities of state Boards of Pharmacy and state legislatures. We are also continuing to stay in contact with the Federation of State Medical Boards which is studying the issue.

We feel strongly that in order to do a good job, all of these areas must continually be monitored; this takes a significant number of man-hours and resources that are not part of our operating budget. Once again, we are asking you to look to the future – to the future of allergy; to the future of medicine – and support these efforts by contributing to our Defend Allergy SHots (DASH) Campaign.

Extracts