503A or 503B
Start by asking the pharmacy which section of the Federal Food, Drug, and Cosmetic Act it compounds under. The FDA's pages describe the two this way.
On section 503A, the FDA says: "One of these conditions is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions."
On section 503B: "Unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements, and they may distribute compounded drugs either pursuant to a patient-specific prescription or in response to an order from a health care provider, such as a hospital, that is not for an identified individual patient (e.g., for office stock)."
On who oversees each: "Generally, state boards of pharmacy have primary responsibility for the day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities." And: "Facilities that register with FDA as outsourcing facilities under section 503B are primarily overseen by FDA and inspected by FDA according to a risk-based schedule."
| Question | 503A pharmacy | 503B outsourcing facility |
|---|---|---|
| Prescriptions | Compounds on a prescription for a named patient | A prescription for a named patient, or an order from a health care provider that is not for an identified patient |
| CGMP requirements | Not subject to them when it meets the conditions of section 503A | Subject to them |
| Day-to-day oversight | The state board of pharmacy | The FDA, on a risk-based inspection schedule |
| Where to look it up | The state board's license lookup | The FDA's table of registered outsourcing facilities |
The table restates the four quotations above. Record the pharmacy's answer and the source you checked it against.
Licensure in every ship-to state
Ask the pharmacy for its license in its home state and for the license or registration it holds in each state your patients live in. Then look each one up yourself, on that state board's own lookup.
We read one state's statute for this page. It is an example and not a survey, so read the rule of each state you ship to.
California, nonresident pharmacies. Business and Professions Code section 4112: "(a) Any pharmacy located outside this state that is involved in the preparation, dispensing, shipping, mailing, or delivery, in any manner, of controlled substances, dangerous drugs, or dangerous devices into this state shall be considered a nonresident pharmacy. (b) A person shall not act as a nonresident pharmacy unless the person has obtained a license from the board."
California, sterile compounding. Section 4127.2(a): "A nonresident pharmacy shall not compound sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable."
NABP keeps a page that lists the boards, with each board's phone number and website. In NABP's words: "We partner with our members, the state boards of pharmacy, to protect public health." We use the page as a directory and go to the board's own site for the lookup.
NABP also runs an inspection program, the Verified Pharmacy Program, described on its own page. Where a pharmacy has a report from that program, we ask for a copy. That request is our practice and not a statement of what NABP or any board asks of a pharmacy.
For each license, we record the state, the license number, the license type, the expiration date and the status exactly as the board's lookup shows them, with the date we looked.
The FDA's table of registered outsourcing facilities
This step applies when the pharmacy says it is a 503B outsourcing facility. The FDA's definition: "The law defines an outsourcing facility as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B."
The FDA publishes the registered facilities in a table and says what the table is: "This 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."
Each row carries nine columns:
- Facility
- Contact
- Initial Registration Date
- Most Recent Registration Date
- Last Inspection
- Form 483 Issued?
- Recall Conducted?
- Action Based on Last Inspection
- Intends to Compound Sterile Drugs From Bulk Substances
Registration is per facility, at one address. Match the address on the row with the address the pharmacy ships from, and save a dated capture of the row with the table's "Updated as of" date in view.
Inspection history
Four public sources carry inspection records for compounders. Read each for what it says and the date it carries.
The FDA's compounding actions page. An A to Z list of compounders. Each entry is labeled "503A Facility" or "503B Facility" and carries dated items such as "483 Issued", "Warning Letter" and "State Referral Letter". See Compounding: Inspections, Recalls, and other Actions.
The FDA Data Dashboard. Inspection records, searchable by firm name or FEI number. Its glossary lists three classifications: No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI). The FDA notes: "The datasets are updated weekly and only include final actions." See the dashboard.
The outsourcing facilities table. For a 503B facility, the row described in the section above gives the last inspection date, whether a Form 483 was issued and the action based on that inspection.
The state board. The FDA says its table "does not include State Board of Pharmacy actions, if any", and adds: "Some states post disciplinary or other actions on their web sites." We ask the pharmacy for its most recent board inspection report and its written response.
Read a Form 483 the way the FDA describes it: "A Form FDA 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations."
The FDA does inspect 503A pharmacies. Its questions and answers page says: "FDA does conduct surveillance and for-cause inspections of state-licensed pharmacies that are not registered as outsourcing facilities."
A gap between inspections is not a finding. Writing about human drug manufacturing establishments, the FDA's inspections page says: "Time between surveillance inspections should not be interpreted as a measure of facility or product quality (i.e., not having been inspected in several years does not mean there should be less confidence in the facility or its products)."
Documents to ask the pharmacy for
This list is ours. It does not restate a rule, and it is not a statement of what any accreditor asks for.
- Licenses
A copy of the home-state license and of the license or registration for each state you ship to.
- Inspection report
The most recent state board report, and the FDA's where there is one, with the pharmacy's written response.
- Supplier qualification file
One for each API supplier. The supplier qualification guide lists what we keep in it.
- The COA for each lot
The certificate that arrived with the lot of API in the preparations your patients receive. COA requirements by source quotes what each source says about it.
- Testing records
For sterile preparations, the sterility, endotoxin and potency results the pharmacy holds for the batches it ships to your patients.
- The recall procedure
The written procedure, and the name of the person at the pharmacy who calls you.
Ask for the documents themselves. A summary letter tells you a document exists, and the document tells you what it says.
What a per-lot record gives you
A check at onboarding describes the pharmacy on the day you looked. Licenses renew, suppliers change and every new lot of API arrives with its own certificate.
A per-lot record ties each lot the pharmacy used to the documents behind it: the COA, the manufacturer's registration capture and the pharmacist's signed decision on the lot. When a patient, a board or your own clinical lead asks about a preparation, the answer is a dated record and not a recollection.
This is how we read it, and it is the work Veritura does. Our page for telehealth platforms shows quality oversight for every pharmacy that fills under your name, with each item marked Verified, Not verified or Decision owed.
Sources
Every source below was opened and read for this page. Last reviewed: November 11, 2026.
- Human Drug Compounding Laws. The FDA. Content current as of December 17, 2024.
- Compounding and the FDA: Questions and Answers. The FDA. Content current as of September 16, 2025.
- Information for Outsourcing Facilities. The FDA.
- Registered Outsourcing Facilities. The FDA's table, updated weekly.
- Compounding: Inspections, Recalls, and other Actions. The FDA's list of compounders and dated actions. Content current as of October 22, 2026.
- FDA Data Dashboard. The FDA's public inspection and enforcement data.
- FDA Data Dashboard, glossary. Defines the FEI and the inspection classifications.
- FDA Data Dashboard, inspections. The inspections dataset and the FDA's notes on reading it.
- California Business and Professions Code sections 4112 and 4127.2. Read in the California State Board of Pharmacy's 2026 Lawbook for Pharmacy (Rev 7/2026), pages 125 to 127 and 171. PDF.
- Boards of Pharmacy. NABP's list of the state boards, with each board's phone number and website.
- Verified Pharmacy Program. NABP's page about its inspection program.
We read documents. We do not test material.