What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?

Are there 503B outsourcing facilities compounding medicines without ever being inspected by the FDA?

Yes.

Outsourcing facilities must report the products they have produced to the FDA biannually. You can look up the products made by each facility in the FDA’s Outsourcing Facility Product Report Search tool. See appendices one and two to see reports from June and December. June 2025 product reports are not yet available on FDA’s website.

In June and December of 2024, several 503B registered facilities that have never been inspected by the FDA filed biannual reports listing their compounded products:

Bennett Pharmaceuticals of America, LLC: June and December 2024 filings (see appendices) reported that the company created tetracaine hydrochloride, bupivacaine hydrochloride, and phenylephrine hydrochloride in spray bottles, jars, and glass bottles—likely for topical dental anesthetic. Initially registered on April 19, 2022, it has never been inspected by the FDA.

McGuff Pharmaceuticals, Inc dba McGuff Outsourcing Solutions: McGuff operated a 503A compounding pharmacy until the company surrendered their license in response to a complaint by the California Board of Pharmacy in December 2022. FDA’s list indicates that the company registered as a 503B outsourcing facility in January 2023, but it has never been inspected. A June 2024 report (see appendices) declared that they produced glutathione, methionine, methylcobalamin, and procaine; sodium metabisulfite in vials. We presume these are for injection, which requires sterility.

BSO, LLC: There are two 503B registrations under the name BSO, one in Lakewood, CO and the other in Golden, CO. One was inspected (and received a Form 483 in 2024) and the other has never been inspected. However, both have filed production reports, and it isn’t clear which is which, though you can see both in the appendix. June and December 2024 filings reported that both sites made sterile estradiol pellets, which are implantable pellets used in hormone replacement therapy. (Since initial publication, the second facility of BSO LLC was inspected June 27th, 2025. It received a 483 warning letter.)

Sterile implantable hormone therapy pellets are not FDA-approved. In 2019 FDA raised concerns about their safety and related adverse events reported. Because they are implanted, they must be sterile, and one of the concerns listed in the FDA’s warning letter is that BSO’s sterilization validation studies are inadequate.

 A fourth facility, F.H. Investments, Inc. (dba Asteria Health) filed production reports for testosterone and estradiol pellets between 2019 and February 2024, and was inspected by the FDA at the end of October 2024. It seems to have closed when a Texas company purchased it last year, however, and is now on FDA’s registration list as “not yet inspected.” We have not included it in our count.

When will the FDA inspect the 39 uninspected 503B outsourcing facilities?

We are not aware of any way for a 503B to demand that the FDA inspect them, so the timing of an inspection is not entirely in an outsourcing facility’s control. We agree that if a 503B is truly not in operation, it would be a poor use of resources to inspect them until they are ready to compound medicine. However, the regulatory guidance is that FDA expects to inspect newly registered outsourcing facilities that have not previously been inspected within two months of registration.

We studied the registered outsourcing facilities list and found that 39 of them have never been inspected by the FDA.

We also scrutinized their websites to see what they advertised as capabilities. Although 23 of them advertised sterile injectables or the ability to make sterile injectables, including nine that advertised making GLP-1s, we could not find evidence that as of the reporting period ending December 2024, that any of the uninspected facilities had been making GLP-1s.

The fact that only three uninspected facilities filed product reports with the FDA for the last half of 2024, but 24 have websites promoting products, leaves us with a few possibilities:

• These 24 have websites but are not in operation making compounded medicine.
• These 24 have websites, started operation after the December 2024 filing deadline, and will file June 2025 product reports about what they made.
• These 24 are state-licensed and operating as 503A compounding pharmacies already and not operating under their 503B registration.
• Some of these 24 were producing products in 2024 and did not file required reports.

Why are sterile injectables a concern for patient safety?

Sterile injectables are a particular concern for patient safety, since potential contamination can have very serious medical consequences. As FDA stated in a November 2024 warning to the public about potentially non-sterile semaglutide and tirzepatide injections, “[a]dministration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis.” In fact, patient harm caused by contaminated spinal injections made by NECC was the impetus to create the 503B statute in the first place.

Are these 39 facilities operating entirely without oversight?

The fact that the FDA hasn’t yet inspected these facilities doesn’t mean a complete lack of oversight. We were able to confirm that 11 of the 39 are licensed state pharmacies that are presumably expanding their existing compounding facilities into higher volume 503B outsourcing facilities. Another 15 hold state manufacturer or distributor licenses, though these requirements vary from state to state. Of the remaining 13 businesses, several are clearly not in operation; the status of others is less clear.

The problem of regulating these mass compounders is exactly the problem Congress tried to solve in the wake of the New England Compounding Center scandal. By falling behind on their pipeline of inspections, the FDA has returned us to that undesirable state.

What are other issues that we didn’t include in this analysis?

We assume that all 503Bs that are required to report products have done so. It’s possible that some 503Bs are making products and not reporting them. We’ve seen that previously in a warning letter to Annovex Pharma:

Your facility failed to submit a report to FDA in June 2024 identifying the drug products that you compounded during the previous 6-month period, including Heparin 4 units/mL in 0.9% Sodium Chloride (b)(4) IV bag, Phenylephrine 100 mcg/ml in 0.9% Sodium Chloride Solution 10ml syringe, and Phenylephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL Bag.

There is no way to know whether a 503B launched production in 2025 until we see the June 2025 production report filings. We’ll revisit this article after the June outsourcing facilities filings become public, which is generally not until August.