FDA Revised Draft Insanitary Conditions Guidance

The Food and Drug Administration (FDA) states, in a revised draft guidance released this week, that it does not intend to enforce the “insanitary conditions” provision of the Food, Drug and Cosmetic Act against physicians that compound or mix in their own offices for their own patients. In the 2016 draft guidance, allergists that prepared allergen immunotherapy in their offices would have been subject to the same stringent environmental and engineering controls and sterility testing requirements applicable to compounding facilities that make high risk sterile preparations intended for intravenous, spinal, or other systemic means of administration. It is important to note that this revised guidance is a draft, and the FDA can change its position.

The AAOA, AAAAI, and ACAAI, along with the AMA and others, submitted comments and testimony concerning patient access to care and a lack of evidence of adverse events from sterility problems in physician in-office compounding. We shared with the FDA our concern that patients face a greater risk of anaphylactic reaction to allergen extract mixed outside the watchful control of allergists’ offices.