503B vendor-vetting checklist for hospital and ASC pharmacy buyers

A practical checklist built from public FDA guidance and published professional guidelines. Use it next to each facility's FDA record in this directory. The boxes work in your browser and nothing is saved or sent.

This is general information, not legal or regulatory advice. Your organization's policies, your state's rules, and current FDA guidance take precedence. Guidance documents get revised, so check the cited source for the current version.

Registration and status

Confirm the facility is on FDA's current registered outsourcing facility list, at the specific address that will supply you. Registration is per geographic location, and a company may run several sites. [2] [1]
Check the most recent registration date. Facilities must re-register each year (Oct 1 – Dec 31) or FDA removes them from the list on January 1. [2]
Note what the facility reported about compounding sterile drugs from bulk drug substances. FDA flags this as self-reported and unverified, so confirm it against the products you plan to buy. [2]
Confirm the facility files product reports with FDA (each June and December) and check the Outsourcing Facility Product Report database for the drugs you need. [1]

Inspection and enforcement history

Read the last inspection date, whether a Form 483 was issued, and FDA's “action based on last inspection” in FDA's table. “Open” means FDA has not decided on further action. [2]
Read every Form 483 and warning letter itself, not just the count. Ask the vendor for its written responses and corrective and preventive actions (CAPA), plus evidence that they were carried out. [3] [7] [9]
Search FDA's Enforcement Report for recalls by the firm, including recall class and reason. Check sister sites under the same ownership too. [6] [3]
Check the home-state board of pharmacy and your own state's board for license status, non-resident licensure where required, and any disciplinary actions. FDA's table does not include state actions. [2] [13] [11]

Quality systems (ask for documentation)

CGMP: outsourcing facilities are subject to CGMP under 21 CFR parts 210 and 211. Ask how the facility handles FDA's 503B CGMP guidance, including quality unit oversight, batch release, stability and beyond-use dating, and reserve samples. [4] [1]
Sterility assurance: ask for media fill (aseptic process simulation) results, environmental and personnel monitoring trends, cleanroom certification, and sterility and endotoxin testing practices. [4] [5] [9]
Use FDA's insanitary conditions guidance as a walkthrough or audit lens, covering facility design, gowning, and aseptic technique. [5]
Ask about staff training, including whether personnel have used FDA's Compounding Quality Center of Excellence training. [8]
Know where your organization's own sterile compounding standards come from (e.g. USP <797>) so you can tell a vendor's CGMP-based program apart from the pharmacy standards your staff work under. [12] [9]

Contracting and ongoing oversight

Use a structured request for information and assessment. ASHP's guidelines list contract provisions such as quality reporting, recall notification, labeling, delivery, and the right to audit. [9] [10]
Write into the contract that the vendor must tell you promptly about new Form 483s, warning letters, recalls, and state actions. [9]
Re-check FDA's sources on a set schedule, for example quarterly and before renewal, and after any reported quality event. [3] [6]
Keep records of your due diligence, including source documents and the dates you reviewed them. [9]

References

References are cited for their public content only. Their inclusion does not imply endorsement of this site by any cited organization, and this site is not affiliated with any of them.