Does registration with FDA mean a facility is approved?

No. FDA says registration means only that it has received the information required to register the facility, and that drugs made by compounders, including those made at outsourcing facilities, are not FDA-approved. Registration and inspections are facility specific, and facilities under common ownership are inspected individually. FDA updates the list weekly, so read the list on FDA’s own site rather than a saved copy.

What does a Form FDA 483 on the list mean?

A Form FDA 483 lists the investigators’ observations at an inspection. FDA says it is issued when investigators observe any significant objectionable conditions, and that it does not constitute a final agency determination. On the list, the inspection date is the date the Form 483 was issued; if none was issued, the date is the last day of the inspection. “Open” next to an inspection means FDA has not determined whether further action will be taken; “Closed” means the inspection was closed without further action.

How often does a facility re-register with FDA?

Annually. The registration period runs from October 1 to December 31, and FDA removes a facility from the list on January 1 if it did not re-register. A facility can sit on a printed list and be off the current one, so date-stamp what you check.

Is checking FDA’s list enough before a clinic buys?

No. FDA’s list does not include state board of pharmacy actions, so also check the board of pharmacy for the state the facility is located in, and any state it ships to. For enforcement, FDA lists compounding actions by facility, each marked 503A or 503B, and its Warning Letter Database is searchable. FDA also notes that some columns on the list are the facility’s own statements at registration and have not been verified by FDA, and that an inspection is just a snapshot in time.

How to check a 503B outsourcing facility

In short. FDA publishes a list of registered outsourcing facilities, updated weekly, with each facility’s registration date, its last inspection, and any Form FDA 483 observations. Read it on FDA’s own site, read the dates, and then check the state board of pharmacy too — FDA’s list does not include state board actions.

What the list is, and is not

An outsourcing facility is a compounder that registers with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act. FDA keeps a public list of every registered facility. FDA is clear about what the list says: “Registration means only that FDA has received the information required to register the facility.” It is not an approval, and drugs made by compounders, including at outsourcing facilities, are not FDA-approved. FDA also says it inspects facilities on a risk-based schedule, and that “FDA inspections are just a snapshot in time. Conditions at the facility can change at any time.”

One more caveat FDA puts on its own list: some columns are what the facility reported at registration and “has not been verified by FDA.” Registration and inspections are facility specific, so a sibling facility under the same ownership does not inherit another facility’s record.

Reading a facility’s row, step by step

Is it on the current list? FDA updates the list weekly. A saved or printed copy can be stale — check the list on FDA’s own page.
The registration date. The “initial date of registration” is the date the facility was first registered: the day FDA found its registration information complete and the fee paid in full.
The last inspection date. FDA states the date shown “is the date a Form FDA 483 listing the investigators’ observations was issued. If no FDA Form 483 was issued, the date is the last day of the inspection.”
Any observations, and whether they are open. “Open” means FDA has not determined whether further action will be taken; “Closed” means closed without further action. Possible actions FDA names include a warning letter, seizure or injunction.
What it compounds. At registration a facility indicates whether it compounds from bulk drug substances and whether it compounds sterile drugs from them. Facilities also report the drugs they compounded in the previous six months at registration and each June and December.
Re-registration. Facilities must re-register annually, in the window from October 1 to December 31. FDA removes a facility from the list on January 1 if it did not re-register, so check the date you read the list.

What a Form FDA 483 means, and what it does not

A Form FDA 483 lists the investigators’ observations. FDA says it “is issued when investigators observe any significant objectionable conditions” and “does not constitute a final agency determination.” An open observation is a question FDA has not finished with; a closed one is closed without further action. Neither is, by itself, FDA’s final determination about the facility — and a clean row with no Form 483 is a snapshot from one inspection, not a continuous audit.

Where to look up enforcement

Beyond the list, FDA publishes compounding enforcement actions by facility — letters, warning letters and Form 483s — each marked 503A or 503B, and its Warning Letter Database is searchable by firm. Reading the letter itself tells you what the agency actually objected to.

Why to also check the state board

FDA’s list “does not include State Board of Pharmacy actions,” so a facility can hold a federal registration while its state board has a different record. An outsourcing facility is not required to be a licensed pharmacy, which makes the state’s own licence and inspection record worth reading on the board’s own lookup. NABP keeps a list of every state board of pharmacy.

Where TrueRoute fits

TrueRoute is ordering software, not a pharmacy, and never prescribes. Orders are filled by licensed pharmacies in our network. A patient prescription and an office-use purchase are separate orders in TrueRoute; office-use purchasing is available once your account’s program is set up. Prescribers on the account are NPI-validated and clinic-attested, and every order keeps its status, payment and fulfillment on one append-only record — including which pharmacy filled it and when.

The pharmacy network · The office-use path