Dr. Makary has indicated that the FDA will take an aggressive enforcement stance on GLP-1 compounded products as well as action on misleading advertising for such products.  He has also indicated that the FDA will take decisive action against compounders that produce copies of approved drug products that do not have a required clinical difference.  FDA regulations allow for compounding of a product to occur without enforcement action when an approved drug is in shortage or if there is a specific need for an individual patient (i.e., when an approved product contains an inactive ingredient that a specific patient might be allergic to, or if a person cannot swallow a solid oral dosage form and there is need for an oral solution or suspension).  However, the FDA is currently facing situations where compounding for certain products falls outside the established bounds of individual patient prescriptions for 503A compounders or they are being mass-produced by 503B compounders and are clearly copies of FDA-approved drug products.  Some telemarketers also make misleading statements regarding FDA approval or that the products are equivalent to the approved, listed drug.

A comprehensive article on this issue was published yesterday on McDermott Will & Schulte’s website (here); it outlines the current “ying and yang” between approved drug products and compounded drug products, and how that squares with the FDA’s views and existing guidance and regulation.  We have written on this topic extensively (here, here, here, here, here, here, here, and here), particularly about the issue of compounding during drug shortages as well as the issues with compounding duplicate versions of approved drug products.  The FDA is now expressing a growing concern with such products as well as the increasing prevalence of reports of adverse events from compounded products.  One article, reported by MSN and written by Karl Hille of the Baltimore Sun (here), stated that some 8,000 patients were sickened by compounded versions of GLP-1 products.

The problems with this practice are myriad—the use of unregistered sources of the active pharmaceutical ingredients for the some of the compounded products, the products are being produced outside the bounds of FDA guidance and regulation, and/or the entities making the claims in Direct-To-Consumer (DTC) ads are misleading the public—and all cause the products to be considered misbranded, unapproved new drugs under FDA regulations.  There are also an infinite number of quality and efficacy questions raised regarding the manufacturing practices and compounding of these mass-produced products.  However, this is not primarily why I’m writing this blog.  The key takeaway today is that the latest FDA “CDER Guidance Agenda New and Revised Draft Guidances Planned for Publication in Calendar Year 2026” (here) shows that the Agency is actively involved in writing guidance documents to try to reign in compounding for both 503A and 503B compounders.  According to this document, in 2026, we can expect the following FDA guidances to be published to address the compounding space:

  • Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft
  • Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised Draft
  • Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Considerations Related to Drug Shortages
  • Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act
  • Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
  • Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft
  • Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug and Cosmetic Act; Revised Draft
  • Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Outsourcing Facilities Under Section 503B of the FD&C Act

As you can see, many of the existing guidances referenced above are being revised.  It’s generally believed that we’ll see the FDA tighten the compounding guardrails in these revised guidances, when issued, to comport more closely with current FDA thinking as well as the statutory and regulatory landscape.  It will also likely establish a new storyline for the FDA’s evolving enforcement position.  We’re seeing strong words come out of the Agency and a multitude of warning letters being issued to firms, including telemarketers, 503B compounders, and 503A compounders, for quality, efficacy, and advertising issues relating to compounded products.  How aggressive will the Agency be?  If its current stance is pursued, it appears that the FDA will be very aggressive.  But in any case, prepare for swift FDA action and the changes that are coming down the road, not just to GLP-1 compounding.