Compounding Pharmacy Due Diligence: A Checklist for Medical Practices

Choosing a compounding supplier is not just a procurement decision — it is a compliance decision. The compounding pharmacy you work with becomes part of your compliance infrastructure. If they have problems, those problems can become your problems.

This checklist covers everything a medical practice should verify before establishing a relationship with a compounding supplier.

• Verify the pharmacy holds a valid pharmacy license in its home state
• Confirm the license is current and in good standing (not suspended, revoked, or on probation)
• Check the license expiration date

How to verify: State board of pharmacy websites have license lookup tools. Search by pharmacy name or license number.

• Verify the pharmacy holds a non-resident pharmacy license in YOUR state
• Confirm the license is current and in good standing
• Verify the license covers the type of compounding you need (sterile, non-sterile, etc.)

Why this matters: A pharmacy that ships to your state without a non-resident license is operating illegally under your state's law. Products from an unlicensed source create significant liability.

• If the supplier claims 503B status, verify FDA registration at fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities
• Confirm the registration is current
• Check for any FDA enforcement actions against the facility

• Request a sample COA for a product you intend to order
• Verify the COA is from an independent third-party laboratory (not the compounder's own lab)
• Confirm the COA includes: identity testing, potency/assay, purity, endotoxin (for sterile preparations), and sterility (for sterile preparations)
• Verify the COA references the specific lot number

• Ask what BUD dates the supplier assigns to their products
• Request the stability data supporting those BUD dates
• Verify the stability data is from appropriate testing (not just USP defaults if claiming extended BUD dates)

• Ask for a summary of their quality system
• Verify they have written SOPs for compounding, quality control, and release testing
• Ask about their out-of-specification (OOS) investigation process

• Search the FDA warning letter database at fda.gov for the supplier's name
• Review any warning letters for the nature and severity of violations
• If warning letters exist, ask the supplier what corrective actions were taken

• Check the supplier's home state board of pharmacy for any disciplinary actions
• Check your state's board for any actions against the supplier's non-resident license

• Review FDA inspection records for 503B facilities (available at fda.gov)
• Check for any Form 483 observations (inspection findings)
• Assess the severity and resolution of any findings

• Confirm the supplier is licensed to ship to all states where your patients are located
• If you operate in multiple states, verify coverage for each

• Confirm the supplier carries the specific products you need
• Ask about typical lead times for in-stock items
• Ask about availability of custom formulations

• Confirm overnight shipping capability for temperature-sensitive products
• Ask about cold-chain packaging (cold packs, insulated containers)
• Ask about their process for handling shipping delays or temperature excursions

• Understand minimum order requirements
• Get pricing for your expected volume
• Understand pricing for custom orders

• Can you reach a knowledgeable person directly (not just a call center)?
• Is 24/7 support available for urgent issues?
• Who is your primary contact for compliance questions?

• Will the supplier notify you proactively of regulatory changes affecting your supply?
• Will they notify you of supply issues before you run out?
• Do they have a process for communicating product recalls or quality issues?

• Does the supplier have legal or regulatory expertise on staff?
• Can they explain the regulatory basis for their compounding?
• Do they track FDA and state regulatory developments?

• Has the supplier or its principals been involved in pharmaceutical litigation?
• Do they understand the litigation risk landscape for compounded medications?

Walk away from a supplier that:

• Cannot produce a COA on demand
• Cannot verify their state pharmacy license or FDA registration
• Has unresolved FDA warning letters
• Cannot explain the regulatory basis for their compounding
• Routes all communication through a call center with no direct access
• Offers prices that seem too good to be true
• Cannot confirm overnight shipping capability for temperature-sensitive products

We welcome due diligence inquiries from prospective clients. We can provide:

• Licensing documentation for all relevant states
• Sample COAs
• Stability data summaries
• Regulatory history (clean record)
• Direct access to our team for compliance questions

Contact us to begin due diligence →

For licensed medical providers only. This checklist is for informational purposes and does not constitute legal advice.