“A Dangerous Idea” Revisited
This article builds upon my May 22 column, entitled A Dangerous Idea: Two Drug Manufacturing Pathways, One Regulated, One Not.[1][2]
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Recently Novo Nordisk dropped out of its arrangement with Hims and Hers because the latter continued to sell compounded GLP-1 weight-loss products that are no longer legal (except in extremely limited situations).
The resulting commentaries and comments on Linked-In have run hot and heavy. Some of the comments are little more than flaming tirades against the pharmaceutical industry, but others reflect thoughtful concerns about access, price, cost, quality, and safety. It is easy to get lost trying to figure out who’s right and for what reasons.
However, if you step back and look beyond just GLP-1’s, it turns out to be simple: the narrow exceptions that compounders want to expand would cross critical boundaries that FDA needs to preserve.
There is so much that feels special about GLP-1 products that we tend to forget that, from a regulatory perspective, they are just another class of regulated drug products. There cannot be one set of rules for GLP-1’s and another set of rules for other drug products.
A short history of GLP-1 compounding
Given the anticipation for any new weight loss drug and the sterling results from the GLP-1 obesity clinical trials, it is no mystery why demand for GLP-1 drugs was so large. GLP-1 drugs were quickly the “go to” drugs for weight loss. As a result, the initial manufacturing capacity of Novo Nordisk and Lilly were insufficient, and FDA declared a shortage until the commercially available supply could catch up to demand.
In March 2025, FDA declared the shortage ended. Compounding was to cease no later than May 22. As we now know, many compounders stopped, but many didn’t.
Those who continue to compound GLP-1’s have shifted their justification from “shortage compounding” (no longer legal) to “special needs compounding” (the only other exception recognized by law).
That is problematic because “special needs” is an extremely limited category that requires a specific physician to establish that a specific patient has “special needs” that cannot be met by commercially available products. Special needs compounding was never intended to be a landing place for shortage compounders to go once a shortage ended.
“Special needs” might come into play with a Parkinson’s patient who can’t swallow pills or a child who needs special dosing to take a medicine normally intended for adults.
“Special needs” is not, for example, mass-compounding of GLP-1’s with vitamin B-12 added. Both products are commercially available, there is no clinical rationale, and it is not plausible that that all or most of a company’s GLP-1 patients have the exact same special need.
Compounding lacks important consumer protections under the FDCA.
Among other things, the Food, Drug, and Cosmetics Act (FDCA) provides for the regulation of biopharmaceutical products--approval, manufacture, distribution, and labeling. While certainly not perfect, it is a comprehensive set of rules that protect consumers from products that are unsafe or ineffective and that guide appropriate use through labeling.
Compounding sits outside those FDCA consumer protections. FDA does not approve the compounded product, it does not review whether the compounding is done under Current Good Manufacturing Practices (cGMP), it does not inspect compounding facilities, and there is no requirement for labeling.
A consumer has no way of knowing if the compounded product is the same as the approved one. Maybe it is just as good, but that is unproven and, in most instances, unknowable.
For that reason, compounding is allowed in only two instances--shortages and special needs--where the additional risk is justified by the circumstances.
If GLP-1 “special needs” compounding is broadly allowed, then it is precedent for any drug that can be compounded.
If trivial adjustments to a commercially-available product qualifies as “special needs,” then the shift from regulated manufacturers to unregulated compounders will expand to many additional drug products beyond GLP-1’s. Compounding would then be far beyond what the law was intended to permit, and far from the consumer protections we now enjoy.
FDA urgently needs to address the permissible scope of special needs compounding or risk the creation of an alternative pharmaceutical market that operates outside the safeguards and consumer protections provided by the Food Drug and Cosmetics Act.
Beyond consumer protection, an alternative unregulated pharmaceutical market will adversely impact drug development.
Traditional companies will be less interested in investing in research and development of any product that could be readily compounded by others. Likewise, a generic company will have less incentive to gain FDA approval of their product if the target market is already eroded by compounding.
For a pharmacist’s perspective—along with illustrations of compounder pitches and commentary on the problems they create: From the FDA to Instagram: How Ozempic Got Hijacked by Compounders by Alec Ginsberg.
For an overview of the compound-related marketing practices of telehealth companies: https://sherwood.news/business/the-controversial-rise-of-franken-pills-telehealth-companies-push-to-mix/