As you may have read, last month, President Trump issued a memo and Executive Orders (EO) regarding agency publication of guidances and final rules. While on the surface, these appear to directly impact the FDA's work on regulating compounding, it appears that this may or may not be the case. The memo and the EO primarily focus on the promulgation of regulations (rules) and not guidances. Additionally, the documents outline that rules or guidances which directly critical health issues may qualify for a waiver. Lastly, the EOs only apply to "significant" regulations - which the agency could interpret that the EO and memo do not apply to the compounding issues.

Therefore, until we have official word from the FDA that proposed or final guidances or rules have been rescinded or delayed, it is IACPs opinion that all actions by the FDA regarding compounding remain in effect and will continue their current deadlines for comments as originally published.

IACP is keeping a close eye on this issue - if anything changes in regards to the Agency's actions, we will notify our membership via our Member Alert e-mail.