One of the most common questions healthcare providers ask when evaluating a compounding pharmacy is: "Is this pharmacy FDA approved?" The answer is more nuanced than you might expect — and understanding the distinction between "FDA approved" and "FDA registered" is essential for making informed decisions about your compounding partners.
This guide walks you through exactly how to verify a compounding pharmacy's credentials, what to look for, and what red flags should prompt additional scrutiny.
FDA Approved vs. FDA Registered: An Important Distinction
Before searching any databases, it is important to understand a critical distinction that many people miss:
FDA Approved
FDA approval applies to specific drug products, not pharmacies. When the FDA "approves" a drug, it means the agency has reviewed the drug's safety, efficacy, and manufacturing quality through the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) process.
Compounding pharmacies — both 503A and 503B — do not receive FDA approval for their compounded products. Compounded drugs are not FDA-approved drugs. This is a fundamental aspect of compounding regulation.
FDA Registered
FDA registration is what applies to 503B outsourcing facilities. Under Section 503B of the Federal Food, Drug, and Cosmetic Act, outsourcing facilities must:
- Register with the FDA as an outsourcing facility
- Report the drugs they compound to the FDA
- Comply with current Good Manufacturing Practice (cGMP) regulations
- Submit to FDA inspections
- Report adverse events
So when someone asks "Is [pharmacy name] FDA approved?" what they usually mean is: "Is this facility FDA registered as a 503B outsourcing facility, and is it in good standing?"
Step-by-Step: How to Verify a Compounding Pharmacy
Step 1: Check the FDA's Registered Outsourcing Facilities List
The fastest way to verify a 503B facility's registration is the FDA's official list:
- Go to the FDA Registered Outsourcing Facilities page
- Download or search the current list of registered facilities
- Look for the facility by name and location
- Confirm the facility's registration status is current
As of early 2026, approximately 93 facilities are on this list. You can also search our 503B pharmacy directory which pulls from this same FDA data and adds additional compliance information.
Step 2: Review the Facility's Inspection History
Registration alone does not tell you about a facility's quality. The next step is to check its FDA inspection record:
- Search the FDA Inspection Database for the facility name
- Look for any Form 483 observations — these document conditions that may violate federal law
- Check whether the facility has received any warning letters — these indicate more serious violations
- Review the dates of inspections — recent inspections are more relevant than older ones
For context on what Form 483 observations mean, see our guide: Understanding FDA Form 483 for 503B Facilities.
Step 3: Check for Warning Letters
Warning letters represent a higher level of FDA enforcement concern:
- Search the FDA Warning Letters Database
- Filter by "Compounding" or search for the facility name
- Read any warning letters carefully — they detail the specific violations found
- Check whether the facility has responded and resolved the issues
A facility with an outstanding (unresolved) warning letter should be evaluated with significantly more scrutiny.
Step 4: Verify State Licensing
In addition to FDA registration, compounding pharmacies must hold valid state pharmacy licenses:
- Check with the relevant state board of pharmacy for the state where the facility is located
- Some states also require out-of-state compounding pharmacies to register if they ship products into the state
- Verify that the pharmacy license is current and in good standing
- Check for any state-level disciplinary actions
Step 5: Check for PCAB Accreditation
PCAB (Pharmacy Compounding Accreditation Board) accreditation is a voluntary quality standard that goes beyond FDA registration:
- PCAB-accredited pharmacies undergo rigorous quality assessments
- Accreditation covers both sterile and non-sterile compounding
- Fewer than 100 pharmacies nationwide hold PCAB accreditation
- While not required, PCAB accreditation is a strong quality signal
Note: PCAB accreditation applies to both 503A and 503B pharmacies.
Red Flags to Watch For
When verifying a compounding pharmacy, these warning signs should prompt additional investigation:
Serious Red Flags
- Not on the FDA's registered list: If a facility claims to be a 503B outsourcing facility but is not on the FDA's list, do not use it
- Outstanding warning letters: Unresolved warning letters indicate the FDA has found significant violations that have not been corrected
- Consent decree: A consent decree is the most serious FDA enforcement action short of a facility closure. It means the FDA went to court to mandate compliance
- Repeat Form 483 observations: The same issues appearing across multiple inspections suggest systemic quality problems
Yellow Flags
- No recent inspection: If a facility has not been inspected in over two years, the FDA may not have gotten to it yet — this is not the same as a clean record
- Recent Form 483 with pending response: A new Form 483 is not automatically disqualifying, but you should follow up on the facility's response
- Recently registered: New 503B facilities may not yet have an inspection history, so there is less data to evaluate
- Revoked or lapsed state license: Check that all state-level credentials are current
Using Our Directory to Verify Facilities
Our 503B pharmacy directory makes verification faster by consolidating information in one place:
- Search by name or state to find any registered 503B facility
- View the facility profile which includes FDA registration status, inspection dates, and compliance history
- Browse by state using our 503B Pharmacies by State page
- Check inspection results on our FDA Inspection Results page
Each facility profile links directly to the relevant FDA records so you can verify the primary source.
Frequently Asked Questions
Are compounding pharmacies FDA approved?
No. Compounding pharmacies are not "FDA approved" — their compounded products are exempt from the FDA approval process. However, 503B outsourcing facilities are FDA-registered and subject to FDA inspection under cGMP standards. This registration and oversight provides a layer of quality assurance that traditional 503A compounding pharmacies do not have at the federal level.
How do I know if a 503B pharmacy is legitimate?
Verify the facility appears on the FDA's registered outsourcing facilities list, review its inspection history for any Form 483 observations or warning letters, confirm its state pharmacy license is current, and check for voluntary accreditations like PCAB.
What is the difference between a 503A and 503B pharmacy?
503A pharmacies are traditional compounding pharmacies regulated primarily by state boards of pharmacy. They compound medications based on individual patient prescriptions. 503B outsourcing facilities are federally registered with the FDA, follow cGMP manufacturing standards, and can compound without patient-specific prescriptions for distribution to healthcare facilities. For a full comparison, see our 503A vs 503B guide.
Is [specific pharmacy name] FDA approved?
Search for any specific facility in our 503B pharmacy directory or check the FDA's registered outsourcing facilities list directly. Remember: the correct question is whether the facility is "FDA registered" as a 503B outsourcing facility, not "FDA approved."
Can I trust a compounding pharmacy that has received a Form 483?
A Form 483 alone is not disqualifying — most 503B facilities receive observations at some point during inspections. What matters is the nature of the observations, how promptly and thoroughly the facility responded, and whether the same issues recur across multiple inspections. See our Form 483 guide for a detailed explanation.
Stay Informed
The regulatory landscape for compounding pharmacies continues to evolve. Use the following resources to stay current: