The Safety Net Under Compounded Drugs Has Some Large Holes

The argument for moving peptides into compounding pharmacies rests on a single assumption: that a pharmacy is a supervised environment and an anonymous website is not.

A study published in the Journal of the American Pharmacists Association, by Kenneth L. McCall, PharmD, went and measured the supervision. The findings are not reassuring.

What the study found

Looking at 48 recently registered outsourcing facilities between January 2020 and April 2025:

• Only 11 of the 48, about 23 percent, were inspected at all during that period.
• The average time from registration to first inspection was more than two years.
• Of the 11 that were inspected, every single one had at least two significant violations recorded.

The authors describe critical gaps in oversight, with particular concern about sterile drug production.

What an outsourcing facility is

Worth a moment on the categories, because they get used interchangeably and are not the same.

A 503A pharmacy is traditional compounding. It prepares a medicine for an individual patient against a specific prescription. The July advisory vote we covered, which recommended six peptides, concerned this list.

A 503B outsourcing facility is the larger tier. It makes batches rather than one-off preparations, can supply clinics without a patient-specific prescription, registers with the FDA, and is expected to follow manufacturing quality standards and submit to inspection.

The important part: 503B is the more heavily regulated tier. It is the one with the higher expectations and the formal inspection regime. This study is describing the stricter side of compounding.

Reading the 100 percent figure fairly

A finding that every inspected facility was in violation invites overreaction, so two caveats are worth stating.

First, inspections tend to find something almost anywhere. Regulatory inspections of any manufacturing operation frequently record deviations, and a violation on a report is not the same as a product that harmed someone.

Second, the FDA is likely to prioritize facilities it has reason to worry about. If limited inspection capacity gets pointed at the higher-risk end, a high hit rate among those inspected is partly by design.

Neither caveat helps with the other two numbers. A two-year average wait before a first inspection, and three quarters of newly registered facilities never inspected at all in a five-year window, are not artifacts of how you select inspections. They are measures of how much of this sector is operating unobserved.

Why this lands on peptides

Two connections make this more than a general pharmacy story.

The first is sterile production, which the study singles out. That is precisely what failed in August, when a compounding pharmacy recalled three lots of injectable peptide over endotoxin contamination. A study warning about sterile production oversight and a recall caused by a sterile production failure are the same story told from two ends.

The second is direction of travel. If the FDA follows July's advice, six peptides move onto the 503A list. Most preparation would then happen in traditional pharmacies, which sit in the tier with lighter oversight than the one this study examined. The problem described here is upstream of where peptides are heading, not downstream.

What it does and does not change

It does not reverse the harm-reduction argument. A licensed pharmacy with a pharmacist accountable for the preparation remains a better source than an offshore vendor with a forged certificate, and this year has supplied ample evidence of what the alternative looks like, including a vendor sentenced to six years.

What it does is put a number on how much better. The word "regulated" carries an implication of continuous watchfulness. In this corner of the system it appears to mean a registration form and, on average, a wait of over two years before anyone checks.

For anyone weighing a compounded peptide, the practical version is that the pharmacy matters as an individual business rather than as a category. Being registered is a much weaker signal than it sounds, and asking which facility prepared a product, and whether it has been inspected, is a more useful question than asking whether compounding is legal.

Source: Partnership for Safe Medicines on the Journal of the American Pharmacists Association study of 503B oversight.