Due diligence
How to read FDA’s registered-outsourcing-facilities list
FDA publishes a table of the facilities that have registered under section 503B, rebuilt weekly against a data-lock date, and a prescriber can read it directly without the supplier’s cooperation. Read the whole row rather than the presence of the name: the table carries registration dates, a last-inspection date, a Form 483 column, a recall column and an action column. Registration is an election to be regulated as an outsourcing facility, not an approval, an endorsement, or a licence — and it settles the federal half of the question and nothing about your own state.
What is this table, and what does appearing on it establish?
It is FDA's own register of the facilities that have elected to be regulated under section 503B, and appearing on it establishes that election and very little else.
FDA's page states the scope in its own words: the table "lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table." That is a statement about paperwork completeness as of a cutoff, not a judgement about the facility.
What the election means is substantive, though. A facility registered under section 503B compounds under current good manufacturing practice requirements, reports the products it compounds to FDA, and is subject to FDA inspection on a risk-based schedule — none of which applies to a 503A pharmacy, which is exempt from those CGMP requirements. That is the real content of a registration, and it is worth confirming directly rather than taking on trust.
Is registration the same as approval?
No, and FDA has said so in enforcement correspondence in almost these words.
FDA's guidance for telehealth companies lists, among the promotional practices it identifies as false or misleading, any claim that a compounded drug is sourced from a facility FDA has approved or licensed — and then states the reason flatly: "FDA does not approve or license any facility."
Three consequences follow for how you read a supplier's claim. FDA does not approve, endorse or vouch for a registered facility or anything it compounds. Compounded preparations are not FDA-approved drugs. And registration does not make a facility a pharmacy — an outsourcing facility is registered with FDA rather than licensed as a pharmacy at all, which is why attaching the word registered to the word pharmacy gets the regulator and the credential wrong in the same breath. The only accurate construction is registered with FDA as an outsourcing facility under section 503B.
What are the columns?
Nine of them, and the ones people never read are the ones carrying the information.
The columns FDA publishes are, in order: Facility, Contact, the two registration-date columns, Last Inspection, and then the four described below.
| Column | What it tells you |
|---|---|
| Initial / Most Recent Registration Date | When the facility first registered, and when it last did. A registration that lapses does so quietly |
| Last Inspection | Whether FDA has inspected at all, and when — not whether the outcome was good |
| The Form 483 Issued? column | Whether inspectional observations were issued at the last inspection |
| The Recall Conducted? column | Whether a recall is recorded against the facility |
| The Action Based on Last Inspection column | What followed the inspection, sometimes with several actions stacked in one cell |
| Intends to Compound Sterile Drugs From Bulk Substances | The facility's own stated intent, which bears directly on whether it can make what you are asking for |
The last column is the one worth pausing on, because a stated intent to compound from bulk substances only matters where a lawful bulk route exists — and for an outsourcing facility there are just two, the 503B bulks list and a current shortage listing. What that means when a shortage ends is at what happens when a drug comes off the FDA shortage list.
Check the table on the day you are deciding rather than trusting a screenshot, a badge, or a supplier's PDF.
Should an entry in the observations column worry you?
Almost certainly not by itself, and this is the single most useful thing to know before reading the table.
Of the 97 registered locations published as of 2026-08-28, 40 read "Not yet inspected." Of the 57 that had been inspected, the published Form 483 Issued? column read yes for 55 and no for 2. An entry in that column is therefore close to the ordinary case, not an outlier, and treating its presence as disqualifying would exclude almost every facility FDA has actually visited while leaving the never-inspected ones looking cleaner than they have been shown to be.
The corollary matters as much. An empty inspection column is not a good sign; it is an absence of evidence, and on this table it is the most common state of affairs. A prescriber comparing an inspected facility carrying observations against an uninspected facility carrying none is not comparing better with worse — they are comparing a facility FDA has examined with one it has not.
What about the recall column?
On the retrieval date it was doing no work at all, which is itself worth knowing.
Across all 97 rows as of 2026-08-28, the published Recall Conducted? column carried no "Yes" at all: 54 read "No" and 43 read "N/A". A column that separates nothing cannot be used to separate suppliers, and a reader who takes an empty recall column as a positive finding has read reassurance into a field that had none to give on that date.
Note also that "N/A" and "never inspected" are not the same thing on this table. Three rows carried an inspection date alongside "N/A" in the recall column, so the value cannot be interpreted as shorthand for an absent inspection. What FDA intends by "N/A" here we did not establish, and we are not going to guess at it.
How consistent are the values themselves?
Less than a machine-readable table suggests, which is a reason to read cells rather than filter them.
The Form 483 column took four distinct values across the 97 rows as of 2026-08-28 — "Yes" on 50, "N/A" on 40, the bare string "483" on 5, and "No" on 2. Five rows say "483" where every other row says "Yes." At least one action cell contained an evident typographical error. FDA also stacks history inside a single action cell, pipe-delimited, so one cell can carry both a warning letter and a later closeout.
The action column's observed vocabulary, again as of 2026-08-28, ran to seven recognisable forms plus one malformed value: "N/A" on 40 rows, "Open" on 34, and the remainder spread across regulatory meetings, warning letters, FMD-145 letters, untitled letters, and warning-letter closeouts, each carrying a date. We verified that these strings appear. We did not find FDA's definitions of them, and no page should tell you what "Open" or "FMD-145 Letter" signifies on the strength of the string alone.
Are you checking a company or an address?
An address — and conflating the two is how a check quietly verifies the wrong thing.
Registration attaches to a geographic location. As of 2026-08-28 the 97 registrations were held across 92 distinct company names, with five companies holding two registrations each for separate sites. Eleven rows carried a legal entity together with a separate trading name, and in at least one case two different legal entities operated under the same trading name.
So the check is: find the row for the specific facility your product ships from, under the legal entity on your invoice. A company being "on the list" is not the same as the site filling your order being on it, and a brand being on it is not the same as the registrant behind that brand being the one you contracted with.
What does this table not settle?
Your own state, which is the half that decides whether the shipment is lawful.
Section 353b is an exemption from specified federal requirements. It preempts no state licensing scheme and it regulates the facility rather than the facility's customer. In every state whose receiving side we have read from primary sources, an outsourcing facility must also hold that state's own credential before it may ship compounded office stock in — and in several of them that credential is issued by an agency other than the board of pharmacy. A facility that satisfies section 353b in full and holds nothing in your state is federally clean and state-exposed.
How to run that half of the check is at how to verify a compounding pharmacy’s state licence.
Where do the enforcement records themselves live?
On separate FDA pages, and reading them is a different exercise from reading the register.
FDA publishes compounding-specific inspections, recalls and other actions on its own page, and publishes warning letters individually. The register tells you a letter exists; the letter tells you what FDA actually found, which is the part that bears on whether the finding touches the preparation you are buying. What those letters say, and the pattern running through the compounding ones, is at what FDA’s compounding warning letters actually say.
For the distribution of registered facilities by jurisdiction — and why that count is not the number that decides whether one can ship to you — see where FDA-registered 503B outsourcing facilities are. The wider diligence sequence is at how to vet a compounding pharmacy, and what separates the two federal pathways is at 503A vs 503B.
To have a supplier's pathway and your own state's requirements mapped before you commit, you can apply for an account.