Methodology, sources and disclaimers

What this is

503B Docket is an independent, informational directory of every facility on FDA's list of registered human drug compounding outsourcing facilities (section 503B of the FD&C Act). It pulls together what FDA has published about each facility (registration, inspections, Form 483s, warning letters and other letters, and recalls) so that hospital and surgery-center pharmacy buyers can begin vendor due diligence in one place, then confirm everything at the source.

We do not score, grade, rank, endorse, or recommend any facility. A Form 483 lists investigators' observations and, as FDA notes, is not a final agency determination of a violation.

Sources

1. FDA: Registered Outsourcing Facilities: the facility list and every registration field (city/state, contact phone, registration dates, last inspection, Form 483 issued, recall conducted, action based on last inspection, intent to compound sterile drugs from bulk substances). Current snapshot: table “updated as of” Sep 30, 2026; page content current as of Oct 13, 2026. We do not publish individual contact names.
2. FDA: Compounding Inspections, Recalls, and other Actions: Form 483 PDFs, warning letters, close-outs, untitled letters, FMD-145 letters, state referral letters and regulatory meetings (380 firm entries parsed). The live page covers actions from 2019 on. FDA keeps older items in an archive, which we do not parse.
3. openFDA drug enforcement API (api.fda.gov/drug/enforcement.json): recall records with classification, status and reason, grouped by recall event. Dataset last updated Oct 7, 2026. openFDA states its data should be treated as unvalidated.
4. State boards of pharmacy: each facility page links to the license lookup (or the board's site, where a direct lookup URL could not be confirmed) for the state in its FDA listing. We do not list license numbers or license status.

Matching rules

FDA's registration table is treated as authoritative for each facility. Records from the actions page and openFDA are attached by name and location:

• FDA table The item comes straight from that facility's row in FDA's registration table.
• Matched The normalized firm name (legal name, d/b/a name, or former name as FDA lists it) is identical, and the city and state are identical. Normalization ignores case, punctuation and corporate suffixes such as LLC or Inc.
• Uncertain match The name matches but the city differs (often another site of the same company), the city matches but the state differs (often a typo in one source), or the name is only similar once generic words like “pharmacy” or “pharma” are dropped. These items are shown, each with the reason, but are not counted and do not trigger the 3-year flag.
• Anything else is not attached. Firms with very different legal names, unlisted d/b/a names, or recall records filed under a parent company may be missed.

Duplicates (the same document type on the same date from more than one source) are collapsed, keeping the FDA-table version.

Definitions

• Last inspection and “Form 483 issued?” are shown exactly as FDA's table lists them. Per FDA, the inspection date is the date the 483 was issued, or the last day of the inspection if no 483 was issued.
• Form 483 records count dated 483 issuances (including amended 483s) found in the sources. Firm responses are listed but not counted.
• Warning letters count warning letter issuances. Close-outs and responses are listed but not counted.
• Recall events count openFDA recall events (one event can cover many products). Class shown is FDA's classification (Class I, II, or III).
• “Has warning letter or recall in last 3 years”: at least one counted warning letter or recall event dated on or after Oct 16, 2023 (3 years before the build date). Recalls are dated by recall initiation date.
• Sterile from bulk: FDA's column “Intends to compound sterile drugs from bulk substances,” self-reported and unverified by FDA. All outsourcing facilities compound sterile drugs by statutory definition.

Current totals

98 facilities; 147 Form 483 records, 28 warning letters and 126 recall events attached (FDA table or exact matches); 71 uncertain-match items shown but not counted.

Known limitations

• FDA's table lists only city and state, not street addresses. Location matching is at the city level.
• Some FDA listings contain apparent typos (for example, a city or state that doesn't match other FDA records for the same firm). We reproduce FDA's listing as published and mark affected matches uncertain instead of correcting them.
• Records before 2019, records under unrelated parent or prior owners, and state board actions may not appear.
• Data is refreshed periodically, not in real time. Check the “as of” dates.

Disclaimers

503B Docket is independent and is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration, any state board of pharmacy, ASHP, A4PC, NABP, USP, or any listed facility. Content is informational only and is not medical, legal, regulatory, or purchasing advice. Records may be incomplete, delayed, or mismatched despite our care. Always verify with the official sources linked on each page before making any decision. Product and company names belong to their respective owners.

Corrections: if you find a transcription or matching error, a correction request process will be announced on the claim page.

— The 503B Docket team