Kenneth L. McCall, PharmD, published a study in the Journal of the American Pharmacists Association on August 31, 2026, documenting that the FDA inspected only 11 of 48 recently registered 503B outsourcing facilities. The Partnership for Safe Medicines summarized the data the same day. [The study, authored by PSM board member Kenneth L.
McCall, PharmD, examined the inspection reports of 48 facilities that were registered with the FDA between January 1, 2020 and April 30, 2025](https://www.safemedicines.org/2026/09/august-31-2026.html).
Only 23 percent of the 48 facilities underwent FDA inspection. The mean interval from initial registration to the first inspection exceeded 2.2 years. A facility registered at the beginning of the study operated for more than two years before the agency examined its production controls.
All 11 inspected facilities carried at least two significant violations in their inspection reports. No facility in the study cohort passed an initial inspection without multiple objectionable findings. The study identifies delayed and infrequent inspections as a structural condition of current 503B outsourcing oversight.
The statutory framework under Section 503B of the Federal Food, Drug, and Cosmetic Act grants outsourcing facilities exemptions from premarket approval requirements. Those exemptions depend on compliance with current good manufacturing practice standards. The 2.2-year inspection lag establishes the enforcement baseline for any facility entering the 503B register.
For 503B operators, the data quantify inspection probability and violation frequency. A new outsourcing facility can expect a 23 percent chance of FDA inspection within the first two years of registration. An inspection, when it occurs, will identify multiple deficiencies. This baseline determines the liability profile for every sterile drug produced during the uninspected .
The enforcement deficit extends beyond domestic 503B operations into cross-border supply chains for active pharmaceutical ingredients. The Partnership for Safe Medicines reviewed May and June 2026 pharmaceutical import data and found that 23 percent of peptide shipments originated from facilities identified as illegitimate manufacturers. Only 4 percent of those shipments were refused entry.
A 503B facility sourcing an active pharmaceutical ingredient from an unregistered supplier forfeits its statutory exemptions. The compounded product then requires full new drug approval, labeling, and Drug Supply Chain Security Act pedigree tracking. The distinction between compounding and manufacturing narrows when the inspection record fails to establish compliance.
The McCall study concludes that these oversight gaps pose risks for sterile drug production. It recommends increased FDA funding for inspection frequency, mandatory corrective actions, and enhanced staff training. The recommendations target the inspection lag rather than the conduct of individual facilities.
Regulatory affairs managers and quality assurance directors at 503B outsourcing facilities must evaluate their exposure against these figures. The study does not name the 48 facilities. It does not categorize the specific objectionable findings beyond the minimum count of two per site. It does not record an FDA enforcement response to the findings.
The data leave the baseline enforcement exposure defined. Every compounded sterile product shipped during an uninspected carries the legal exposure of an unapproved drug. The 2.2-year mean gap between registration and first inspection remains the central finding.
Broader regulatory shifts in peptide oversight intersect with these inspection metrics as pet owners inject dogs with 'wolverine stack' as fda panel vote fuels uncertainty. The same compounding vote that reshaped bulk substance lists also accelerated demand, as dog owners inject bpc-157 and tb-500 as fda compounding vote fuels a pet peptide surge.
Downstream purchasers evaluating supply chain liability must determine if their facilities meet the statutory threshold for exemption or if they should verify whether are research peptides safe before procurement.
The Partnership for Safe Medicines reported the McCall study and the import data findings on September 1, 2026.
