Updated September 2026
The short answer: To choose a compounding pharmacy or 503B outsourcing facility, match the lane to the use (503A for patient-specific prescriptions, 503B for office stock). Then verify licenses in the home state and in every state the product ships to, check FDA's registered outsourcing facility list and inspection record, search warning letters and recalls, and get the pharmacy's quality documents in writing.
Knowing how to choose a compounding pharmacy protects your patients and your license. Compounded drugs aren't FDA-approved, so the pharmacy's licensing, inspection history and quality systems are much of the assurance you have. The 12 checks below rely on public records and on documents a reputable pharmacy should be willing to share.
First, 503A or 503B?
Federal law creates two lanes for compounded drugs:
- 503A pharmacies compound for an identified patient on a valid prescription. They may compound ahead only in limited quantities: no more than a 30-day supply, based on their own prescription history. They're licensed by states, aren't required to follow federal CGMP, and aren't federally required to report adverse events to FDA.
- 503B outsourcing facilities register with FDA, compound under CGMP, are inspected on a risk-based schedule and must report adverse events. They may supply clinics and practitioners with non-patient-specific office stock.
Neither lane makes a compounded drug FDA-approved. FDA's 503A prescription-requirement guidance directs clinics that want office stock to 503B facilities. Some states allow limited 503A office use under state law: MedGrid's research finds 23 jurisdictions that don't allow it, 17 that allow it with limits, and 11 not yet confirmed. See the office-use map.
How to choose a compounding pharmacy: the 12-point checklist
Compounding pharmacy license verification
1. The lane matches your order. Patient-specific prescriptions go to a 503A pharmacy; office stock comes from a 503B outsourcing facility. If a 503A pharmacy offers you office stock, ask which provision of your state's law allows it.
2. The home-state license is active. Look the pharmacy up on its home-state board of pharmacy website and note the license type, status, expiration date and any discipline. FDA's advice to health care professionals is to know your source and verify that your supplier is licensed by the state.
Out-of-state licensing: the nonresident pharmacy license and 503B permits
3. It holds a nonresident pharmacy license in every state it ships to. MedGrid's research found that all 50 states and DC require an out-of-state pharmacy to hold a license or registration before shipping prescriptions to patients there. Several add requirements for sterile compounding:
- California requires a separate nonresident sterile compounding license (Cal. Bus. & Prof. Code §4127.2).
- Florida requires a nonresident sterile compounding permit (Fla. Stat. §465.0158).
- Maryland requires a USP <797> inspection report, done within 90 days before applying, from pharmacies that will dispense compounded sterile preparations to Maryland patients (Md. Code, Health Occ. §12-403).
Check each state on the nonresident pharmacy license map.
4. For 503B: it's licensed where you practice. Being on FDA's list doesn't settle state licensing. MedGrid's research finds 41 jurisdictions that require an out-of-state 503B to hold a state license or registration, 5 where it depends and 5 not yet confirmed:
| State | Answer | What the research found |
|---|---|---|
| Connecticut | Depends | A Department of Consumer Protection manufacturer registration, or a copy of the FDA registration for FDA-registered out-of-state manufacturers; out-of-state sterile compounders shipping non-patient-specific product must register. |
| Florida | Depends | A nonresident sterile compounding permit to ship compounded sterile products; drug-manufacturer permits may also apply. |
| Hawaii | Depends | No outsourcing-facility license; a Board "miscellaneous permit" is needed to ship prescription drugs in as an out-of-state pharmacy. |
| Pennsylvania | Depends | No outsourcing-facility license; nonresident pharmacy registration only for patient-specific prescriptions, plus Department of Health registration or listing of in-state representatives. |
| Texas | Depends | No Board of Pharmacy license for 503Bs; a Texas pharmacy license only to dispense patient-specific prescriptions; non-patient-specific distribution appears to fall under state health department (DSHS) distributor or manufacturer licensing. |
| Indiana | Not confirmed | No outsourcing-facility license; whether a wholesale distributor license or nonresident pharmacy registration is needed wasn't confirmed. |
| Louisiana | Not confirmed | Whether a Board of Drug and Device Distributors license is needed couldn't be verified. |
| Montana | Not confirmed | No outsourcing-facility license yet; a pending Board rule would require an outsourcing endorsement plus a wholesale or mail-order license. |
| Nebraska | Not confirmed | No outsourcing-facility category; the state health department (DHHS) asks entities to contact it. |
| Wisconsin | Not confirmed | Statutes and DSPS materials don't say which credential applies; check with DSPS. |
The full, sourced map for all 51 jurisdictions is on the 503B state licensing page.
The FDA record: using the 503B outsourcing facility list
5. It's on FDA's list. FDA publishes a list of registered outsourcing facilities that it updates weekly (content current as of September 8, 2026). Facilities must re-register and pay the annual fee between October 1 and December 31, and FDA removes those that don't, so check again early each year.
6. The inspection history is clean, or explained. The list shows each facility's last inspection, whether FDA issued a Form 483 (inspectional observations), and other actions such as warning letters, untitled letters or regulatory meetings. FDA notes that a Form 483 isn't a final agency determination, so ask the facility for the 483 and its response.
7. No unexplained warning letters, recalls or risk alerts. Search FDA's warning letter database for the company name, check FDA's recall enforcement reports, and read FDA's compounding risk alerts. In August 2026, for example, FDA reminded compounders not to use dietary-supplement-grade glutathione in injectables. For 503A pharmacies, also check state board discipline.
8. Adverse events get reported. 503B facilities must report adverse events to FDA, including 15-day reports of serious, unexpected events. 503A pharmacies aren't federally required to. Ask any pharmacy how it handles complaints and adverse events. You can also report problems yourself through FDA's MedWatch program.
Product and process
9. Its ingredients are eligible. A 503A pharmacy may compound from a bulk ingredient only if it has a USP or NF monograph, is a component of an FDA-approved drug, or is on the 503A bulks list; FDA also tolerates interim "Category 1" substances. A 503B facility compounding from bulk is limited to the 503B bulks list, FDA's interim Category 1, or drugs in shortage. Licensed biologics, such as hCG and tesamorelin, can't be compounded in either lane. As of September 2026, peptides such as BPC-157 and TB-500 are neither on the 503A bulks list nor in Category 1. FDA's advisory committee voted on several peptides in July 2026, and FDA hasn't yet acted on those votes. See FDA's 503A bulk drug substances page.
10. It isn't compounding copies of approved drugs. Compounded drugs that are "essentially copies" of commercially available products are restricted. For a 503A prescription, the prescriber must document a significant difference for that patient, and price doesn't count. A 503B facility can't compound a copy of an approved drug unless the drug is in shortage. The tirzepatide and semaglutide shortages ended in October 2024 and February 2025, so ask how any compounded GLP-1 offer meets these rules.
11. It shares its quality documents. Ask for the latest home-state or FDA inspection report, any accreditation certificates, certificates of analysis for active ingredients, and its beyond-use-date and testing policies. Several states require sterile compounders to follow USP <797>, and some accept accreditation in place of an inspection report: Michigan, for example, accepts sterile-compounding reports or certificates from Board-approved programs including PCAB, ACHC and NABP's Verified Pharmacy Program.
12. The product comes straight from the source, with records. Section 503B bars anyone other than the outsourcing facility from selling or transferring its compounded drugs, and FDA's draft guidance on 503B wholesaling says the drug should go from the facility to the entity that administers or dispenses it. So a clinic shouldn't resell or transfer 503B product to another clinic. Confirm cold-chain packaging, lot numbers on every unit, and how you'll be told about recalls.
How MedGrid handles pharmacy vendor diligence
On MedGrid, pharmacy and outsourcing vendors clear document diligence for each category before they list, and their licences and documents are shown on product pages, marked verified by MedGrid, so you can review them before you order. In the doctor portal, 503A prescriptions are routed to pharmacies licensed for the patient's state, and 503B products are listed for office use. You can see participating pharmacies on MedGrid, and the regulations research tool includes live FDA lookups. None of this replaces your own review, so keep copies of the documents you rely on.
This article is general information, not legal advice. Pharmacy rules change often; confirm requirements with the relevant state board of pharmacy, as of September 2026.
Frequently asked questions
How do I verify a compounding pharmacy's license?
Look the pharmacy up on its home-state board of pharmacy website, then confirm it holds a nonresident license or registration in each state it ships to. MedGrid's research found that all 50 states and DC require one. For 503B outsourcing facilities, also confirm the facility is on FDA's registered list.
Where can I find FDA's 503B outsourcing facility list?
FDA publishes it on its Registered Outsourcing Facilities page and updates it weekly. For each facility the list shows the last inspection, whether a Form 483 was issued, and other actions such as warning letters. Facilities that don't re-register between October 1 and December 31 are removed.
What is a nonresident pharmacy license?
It's the license or registration an out-of-state pharmacy needs before shipping prescriptions to patients in a state. Some states add separate permits for sterile compounding, such as California's nonresident sterile compounding license and Florida's nonresident sterile compounding permit.
Can a 503A compounding pharmacy supply office-use stock?
FDA's position is that 503A compounding requires a prescription for an identified patient, and that clinics wanting office stock should use 503B outsourcing facilities. Some states allow limited 503A office use under state law. MedGrid's research finds 23 jurisdictions that don't allow it, 17 that allow it with limits, and 11 not yet confirmed.
Are drugs from a 503B outsourcing facility FDA-approved?
No. 503B facilities are FDA-registered, follow CGMP and are inspected, but neither 503A nor 503B compounding makes a drug FDA-approved.
Do compounding pharmacies have to report adverse events?
503B outsourcing facilities must report adverse events to FDA. Federal law doesn't require 503A pharmacies to, so ask how a pharmacy handles complaints. Clinicians can report problems to FDA's MedWatch program.
Sources
- U.S. Food and Drug Administration, Prescription Requirement Under Section 503A of the FD&C Act — Guidance for Industry (December 1, 2016)
- U.S. Food and Drug Administration, Know Your Source: Protecting Patients from Unsafe Drugs (April 25, 2018)
- U.S. Food and Drug Administration, Registered Outsourcing Facilities (September 8, 2026)
- U.S. Food and Drug Administration, Warning Letters (searchable database) (accessed September 23, 2026)
- U.S. Food and Drug Administration, Compounding Risk Alerts (accessed September 23, 2026)
- U.S. Food and Drug Administration, MedWatch: The FDA Safety Information and Adverse Event Reporting Program (September 21, 2026)
- U.S. Food and Drug Administration, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (May 14, 2026)
- U.S. Food and Drug Administration, Prohibition on Wholesaling Under Section 503B of the FD&C Act — Draft Guidance for Industry (June 27, 2023)
- U.S. Food and Drug Administration, Adverse Event Reporting for Outsourcing Facilities Under Section 503B — Guidance for Industry (www.fda.gov), October 1, 2015
- U.S. Food and Drug Administration, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1–3) (www.fda.gov/media/94155/download), May 14, 2026
- U.S. Food and Drug Administration, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (www.fda.gov), August 6, 2026
- U.S. Food and Drug Administration, Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B — Guidance for Industry (www.fda.gov/media/98964/download), January 1, 2018
- U.S. Food and Drug Administration, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (www.fda.gov), April 1, 2026
- U.S. Food and Drug Administration, FDA reminds compounders not to use dietary supplement grade glutathione for injectables (www.fda.gov), August 27, 2026
- California Legislative Information, Cal. Bus. & Prof. Code §4127.2 — Nonresident sterile compounding license (leginfo.legislature.ca.gov), July 1, 2014
- The Florida Legislature, Fla. Stat. §465.0158 — Nonresident sterile compounding permit (www.leg.state.fl.us), September 23, 2026
- Maryland General Assembly, Md. Code, Health Occupations §12-403 (mgaleg.maryland.gov), September 23, 2026
- Michigan Legislature, MCL 333.17748a — Compounding services for sterile pharmaceuticals; accreditation (www.legislature.mi.gov/Laws/MCL?objectName=mcl-333-17748a), September 23, 2026
- Texas Department of State Health Services, Licensing Requirements for Drug Manufacturers and Distributors (www.dshs.texas.gov), June 2, 2025
- Connecticut General Assembly, Conn. Gen. Stat. Chapter 400j — Pharmacy (www.cga.ct.gov/current/pub/chap_400j.htm), September 23, 2026
Check before you order: See pharmacy licensing rules for your state → Or verify your NPI to order from vendors whose documents MedGrid has checked.
