With new FDA enforcement priorities and USP updates, 2025 has become the year of accountability for compounding pharmacies.
Whether you’re a patient filling a personalized prescription or a clinician partnering with a new facility, verifying safety and compliance has never been more important.
Why Compounding Verification Matters More Than Ever
Compounding pharmacies play a vital role in modern healthcare, they bridge the gap when commercial medications are unavailable, discontinued, or not suitable for a specific patient.
But as more online and mail-order providers enter the market, not all are following the same rules.
Recent FDA alerts highlight unlicensed operations, mislabeled GLP-1 injections, and falsified batch testing as growing concerns.
(Reference: FDA – Concerns about Unapproved GLP-1 Drugs Used for Weight Loss)
Step 1, Verify Licensing and Accreditation
Start with the basics. A legitimate compounding pharmacy will:
- Be licensed by your state board of pharmacy (check via official board websites).
- Disclose its license number publicly or upon request.
- Maintain NABP or PCAB accreditation for sterile operations (if applicable).
- Specify whether it operates under Section 503A (patient-specific) or 503B (outsourcing for clinics).
“Transparency is a pharmacy’s first credential,” says a regulatory consultant at the Alliance for Pharmacy Compounding.
Step 2, Ask About Testing and Documentation
A compliant pharmacy should provide Certificates of Analysis (CoAs) for each compounded medication, showing test results for:
- Identity (correct ingredient)
- Potency (dose accuracy)
- Sterility and endotoxins (for injectables)
- Beyond-use dating (BUD) validation
(OutSourceWoRx, part of the AllMedRx network, provides CoAs and batch validation for every sterile product.)
Step 3, Review Their Ingredient Sources
Ensure all active pharmaceutical ingredients (APIs) come from FDA-registered suppliers and are accompanied by lot traceability.
If a provider says they use “research-grade” or “semaglutide salts,” that’s a red flag, it’s not pharmaceutical-grade material.
(See also Reuters — FDA warns of risks linked to sulfite-containing compounded drugs).
Step 4, Evaluate Communication and Clinical Support
Reputable pharmacies don’t just dispense, they educate.
Before filling a prescription, pharmacists should explain:
- The difference between compounded vs. commercial products
- Proper storage and administration
- Possible side effects and interactions
- When to contact the provider or pharmacy for follow-up
If you can’t reach a pharmacist for questions, that’s a sign to look elsewhere.
Step 5, Confirm Alignment with USP <797> and <800> Standards
These U.S. Pharmacopeia chapters define national best practices for sterile compounding and hazardous drug handling.
Hospitals and clinics should ensure their pharmacy partners maintain:
- Routine environmental monitoring
- ISO-classified cleanrooms
- Trained staff with annual competency testing
- Written procedures for documentation and deviations
(Learn more in AllMedRx’s Future of Compounding: How AI and Automation Are Transforming Pharmacy Operations in 2025).
Step 6, Review Digital and Data Transparency
Ask how the pharmacy stores and shares information:
- Do they use electronic CoAs?
- Can you access temperature logs or audit data?
- How are recalls or corrective actions communicated?
A robust digital documentation system demonstrates operational maturity and audit readiness.
(Capital Worx’s Why Transparency Is the New Currency in Healthcare Investment explains why data integrity drives both safety and value.)
Step 7, Look for Red Flags
⚠ “Too good to be true” pricing
⚠ Missing physical address or license number
⚠ No pharmacist contact listed
⚠ No mention of USP or FDA alignment
⚠ Generic marketing claims like “FDA-approved compounding” (which is false by definition)
When in doubt, verify credentials before trusting your health or your patient’s health to an unverified source.
Final Takeaway
Vetting a compounding pharmacy doesn’t require insider knowledge, just the right checklist.
A responsible provider will never hesitate to show their credentials, testing, or documentation. At AllMedRx, transparency isn’t a slogan, it’s a standard.
Every prescription is compounded with care, tested for safety, and backed by open communication, because trust is the foundation of personalized medicine.