How to Verify a Compounding Pharmacy's Compliance: A 10-Point Checklist for Clinics
Before ordering from any compounding pharmacy, clinics should verify compliance across 10 key areas. This checklist covers everything from state licensure to COA documentation to FDA registration status.
How to Verify a Compounding Pharmacy's Compliance: A 10-Point Checklist for Clinics
Choosing a compounding pharmacy partner is one of the most consequential compliance decisions a clinic makes. A non-compliant pharmacy can expose your practice to regulatory risk, product quality issues, and patient safety concerns.
Here is a 10-point checklist for evaluating any compounding pharmacy before you order.
The 10-Point Compliance Checklist
1. State Pharmacy Board Licensure
Verify the pharmacy holds a current, active license from the state pharmacy board in the state where they are located — and in your state if they are shipping to you. You can verify most state pharmacy licenses through the NABP (National Association of Boards of Pharmacy) database.
2. USP <797> Compliance (Sterile Compounding)
For injectable medications like semaglutide, tirzepatide, and NAD+, the pharmacy must comply with USP <797> standards for sterile compounding. Ask for their most recent USP <797> compliance documentation or inspection report.
3. USP <800> Compliance (Hazardous Drugs)
If the pharmacy handles hazardous drugs, USP <800> compliance is required. Ask for documentation.
4. Certificate of Analysis (COA) on Every Lot
A compliant compounding pharmacy provides a Certificate of Analysis for every lot of medication they produce. The COA should include potency testing, sterility testing, and endotoxin testing results. If a pharmacy cannot provide a COA, do not order from them.
5. Beyond-Use Date (BUD) Documentation
The pharmacy should provide clear BUD dating for every preparation, supported by stability data. Extended BUDs (beyond the default USP limits) require supporting stability studies. Ask to see the basis for any extended BUD claims.
6. FDA 503B Registration (if applicable)
If you are ordering from a 503B outsourcing facility, verify their FDA registration status at the FDA's outsourcing facility database (fda.gov). Unregistered facilities claiming 503B status are a significant red flag.
7. Accreditation (PCAB or equivalent)
Pharmacy Compounding Accreditation Board (PCAB) accreditation is voluntary but indicates a higher standard of quality. Not all compliant pharmacies are PCAB-accredited, but accreditation is a positive signal.
8. Recall History
Check the FDA's drug recall database for any recalls involving the pharmacy. A history of recalls — especially Class I recalls — is a serious concern.
9. Responsive Compliance Support
A compliant pharmacy should be able to answer your compliance questions promptly and provide documentation on request. If a pharmacy is evasive about compliance documentation, that is a red flag.
10. Legal and Regulatory Monitoring
Ask whether the pharmacy has legal counsel or a compliance team that monitors FDA 503A/503B guidance, USP updates, and state board requirements. Proactive compliance monitoring is a sign of a serious operation.
How MedClinic Partners Vets Pharmacies
MedClinic Partners vets all partner pharmacies against these standards before connecting them with our provider network. Our team — which includes attorneys with pharmaceutical regulatory backgrounds — monitors FDA guidance and state board requirements in real time.
Apply for portal access — access our pre-vetted pharmacy network in 60 seconds.
Related reading: Compliance Standards · 503A vs 503B Explained · How Onboarding Works
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Written by
Samantha J.
Marketing & Content — MedClinic Partners
Samantha covers healthcare marketing, practice growth, and patient engagement for MedClinic Partners. She writes about the business side of running a compounding-dependent practice — from patient recapture strategies to understanding the regulatory landscape for clinic operators.
Editorial standards: All content on medclinicpartners.com is reviewed by licensed medical operators and compounding compliance specialists before publication. Articles are updated when regulatory guidance changes. This content is for licensed healthcare providers only and does not constitute medical advice.
