When a clinic sources compounded medications, it is not just buying a product — it is taking on a degree of responsibility for the quality and compliance of that product. If a compounded preparation causes an adverse event, regulators will look at both the pharmacy that made it and the clinic that administered it.

That is why due diligence on your pharmacy partners is not optional. It is a core part of operating a compliant clinic. This post walks through exactly how to verify that a compounding pharmacy meets the standards you need before you source from them.

Every compounding pharmacy must be licensed by the state board of pharmacy in the state where it is located. If the pharmacy ships to your state, it may also need to be licensed in your state (non-resident pharmacy license).

How to verify:

• Check your state board of pharmacy's online license verification database
• Search for the pharmacy by name or license number
• Confirm the license is active and in good standing
• Check for any disciplinary actions, suspensions, or conditions on the license

State board of pharmacy websites are publicly accessible and license lookups are typically free. This should be the first step in any pharmacy due diligence process.

If you are sourcing from a 503B outsourcing facility, the facility must be registered with the FDA. The FDA maintains a public database of registered outsourcing facilities.

How to verify:

• Go to the FDA's outsourcing facility registration database (available on FDA.gov)
• Search for the facility by name or location
• Confirm the facility is currently registered
• Note the registration date and any gaps in registration history

A facility that claims to be a 503B outsourcing facility but is not in the FDA's database is not a legitimate 503B facility. Do not source from unregistered facilities claiming 503B status.

The FDA inspects 503B outsourcing facilities and publishes the results of those inspections. This is publicly available information that every clinic should review before sourcing from a 503B facility.

What to look for:

• Warning letters: A warning letter indicates the FDA found significant violations. Review the letter to understand the nature of the violations and whether they have been corrected.
• Form 483 observations: These are observations made during an inspection. Some observations are minor; others indicate significant quality system deficiencies. Ask the facility how they responded to any observations.
• Import alerts: An import alert can restrict a facility's ability to import materials. This may affect the quality of their supply chain.
• Voluntary recalls: Check the FDA's recall database for any recalls involving the facility's products.

Where to find this information:

• FDA Warning Letters database (FDA.gov)
• FDA Establishment Inspection Reports (available via FOIA request)
• FDA Recall database (FDA.gov)

A facility with a recent warning letter or significant unresolved 483 observations is a higher-risk supplier. This does not necessarily mean you cannot source from them, but it means you should ask more questions and monitor the situation.

A reputable compounding pharmacy should be able to provide quality documentation for the preparations you source. Request the following before placing your first order:

Certificate of Analysis (CoA): A CoA for each lot should include:

• Product name and lot number
• Manufacturing date and BUD
• Test results for potency, purity, sterility, endotoxins, and particulate matter
• Pass/fail determination for each test
• Signature of the quality control reviewer

Sterility test results: Confirm that sterility testing is performed on each lot before release, not just periodically.

Stability data: Ask for a summary of the stability data supporting the assigned BUD. A reputable facility will have this data and will share a summary.

API sourcing documentation: Ask where the active pharmaceutical ingredient (API) comes from. The API should be sourced from an FDA-registered supplier with a Certificate of Analysis.

If a pharmacy cannot or will not provide this documentation, that is a significant red flag.

Several accreditation organizations evaluate compounding pharmacies against quality standards. Accreditation is voluntary but indicates the pharmacy has undergone an independent quality assessment.

PCAB (Pharmacy Compounding Accreditation Board): The most widely recognized accreditation for compounding pharmacies. PCAB accreditation indicates the pharmacy has met standards for quality, safety, and compliance.

ACHC (Accreditation Commission for Health Care): Another accreditation body that evaluates compounding pharmacies.

ISO certification: Some facilities hold ISO 9001 or ISO 13485 certification, which indicates a quality management system meeting international standards.

Accreditation is not a guarantee of quality, but it is a positive indicator. Check the accrediting organization's website to verify current accreditation status.

For clinics that source large volumes from a single pharmacy partner, a facility audit may be appropriate. This involves visiting the facility (or hiring a third-party auditor) to assess:

• Physical facility and cleanroom conditions
• Quality management system documentation
• Personnel training records
• Equipment calibration and maintenance records
• Batch records and release procedures
• Environmental monitoring data

A facility audit provides the most comprehensive picture of a pharmacy's quality systems, but it is resource-intensive. It is most appropriate for high-volume, long-term supply relationships.

Due diligence is not a one-time event. Establish a process for ongoing monitoring of your pharmacy partners:

• Annual re-verification: Re-check state licensure and FDA registration annually
• CoA review: Review the CoA for each lot received before use
• FDA database monitoring: Periodically check the FDA's warning letter and recall databases for your pharmacy partners
• Adverse event tracking: Track any adverse events or quality complaints related to compounded preparations and report them as required

Be cautious of pharmacy partners that:

• Cannot provide a CoA for each lot
• Assign BUDs that seem unusually long without supporting stability data
• Are not licensed in your state or registered with the FDA (for 503B claims)
• Have recent warning letters or significant unresolved 483 observations
• Cannot identify the source of their API
• Offer unusually low prices that seem inconsistent with quality manufacturing costs
• Are unwilling to answer questions about their quality systems

1. U.S. Food and Drug Administration. Registered Outsourcing Facilities. FDA database, accessed 2026.
2. U.S. Food and Drug Administration. Warning Letters — Compounding. FDA database, accessed 2026.
3. Pharmacy Compounding Accreditation Board. PCAB Accreditation Standards. PCAB, 2023.
4. National Association of Boards of Pharmacy. Compounding Pharmacy Regulation. NABP, 2023.
5. United States Pharmacopeia. USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations. 2023 Revision.

MedClinic Partners connects licensed clinics with vetted 503B supply partners that have been evaluated for compliance and quality. Questions about pharmacy due diligence? Use the Get Connected form to reach our team.