Partner quality is a safety decision.

From a distance, the federal registry of outsourcing facilities looks stable. Up close it isn't. Of the 71 outsourcing facilities registered with the FDA in 2014, only 20 were still registered in 2022, according to KPMG's analysis of FDA data. Over the past decade the number of registered facilities has hovered between roughly 60 and 75, even as at least 97 facilities deregistered or went out of business, according to a presentation hosted by the FDA.

That churn is why we treat choosing a compounding partner as a patient safety decision first and a pricing decision second. Compounded drugs are not FDA-approved products. Their quality depends on the processes of the facility that makes them, and those processes can change faster than a contract renews.

Why the rules exist

The modern rules were written in response to a disaster. In 2012, contaminated steroid injections from the New England Compounding Center in Massachusetts caused a multistate outbreak of fungal meningitis. By early 2013 the CDC had counted more than 700 infections across 20 states and dozens of deaths, and later reporting cited by KPMG suggested the death toll was undercounted.

Congress answered with the Drug Quality and Security Act of 2013, which created the outsourcing facility category and tied it to federal registration, inspection, and manufacturing standards. Pharmacy standards kept tightening, too. The revised USP chapters 795 and 797 became official on November 1, 2023, with chapter 800 on hazardous drugs applying alongside them, as USP's compounding team explained at the time. How strictly each state enforces them is still up to its board of pharmacy.

What to check before you sign

Start with licensure. A 503A pharmacy needs a license in its home state and a nonresident license in every state where your patients live. Ask for the list, then spot-check it on the state boards' license lookups.

For a 503B, pull the facility up on the FDA's registered outsourcing facilities list. The table shows when it first registered, when it was last inspected, whether a Form 483 was issued, and whether it has conducted a recall. One 483 observation isn't disqualifying. A pattern of findings on sterility assurance or environmental monitoring is.

Then ask how the partner actually meets the USP standards: how often its cleanrooms are certified, what its environmental monitoring shows, and who tests its sterile products for potency, sterility, and endotoxins. Certificates of analysis for the lots you receive should be easy to get. If they aren't, that tells you something.

Finally, look at the unglamorous parts: beyond-use dates, cold chain, packaging, delivery windows. They decide what actually arrives at your door.

Five questions for the first call

1. Which states are you licensed in, including nonresident licenses?
2. When were you last inspected, and what did the inspector find?
3. Who tests your sterile products, and can we see certificates of analysis?
4. If an order fails or a lot is recalled, how do we find out, and who calls us?
5. Who manages our account after launch?

Check again next year

Vetting a partner once isn't enough. Registrations lapse, inspections happen, ownership changes. Put a reminder on the calendar to re-verify licenses and registration every year, and read new inspection findings when they post.