FDA Clarifies Compounding Policies as National GLP-1 Supply Stabilizes, Including the Essentially a Copy Standard

On April 1, 2026, the FDA updated its statement titled FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. The update reminded compounders of the conditions for the section 503A and 503B exemptions from the standard drug approval requirements.

A key part of the update explains when a compounded product counts as essentially a copy of a commercially available drug. The FDA used a semaglutide plus vitamin B12 combination as its example of how that standard applies in practice.

The update also noted a factual point that decides many compounding questions: tirzepatide and semaglutide appear on neither the 503B bulks list nor the FDA drug shortage list. Listing status on those two lists is central to whether the 503A and 503B exemptions can apply at all.

This was a clarification of existing policy, not a new rule, and it changed no product approval. FDA approval continues to belong only to a specific approved drug product and its labeled indication, while compounded products remain unapproved products governed by the exemption conditions the statement describes.