Before placing an order with a compounding pharmacy, collect evidence about the exact facility, product, and ordering arrangement. A price sheet and a logo are not enough to establish whether that pharmacy fits your practice.
FDA explains that compounded drugs are not FDA-approved. The agency does not verify their safety, effectiveness, or quality before they are marketed. Supplier diligence helps your team assess evidence and identify unanswered questions. It does not replace FDA approval or the prescribing clinician's judgment.
Use these ten questions as a written questionnaire. Keep the responses, supporting documents, verification dates, and reviewer in one file for each facility.
1. Verify the facility and its licenses
Ask for the legal entity, physical address, resident-state license, and relevant nonresident licenses. Match the records to the facility that will fill your orders, rather than relying on the parent company's name.
For a section 503B outsourcing facility, check the FDA registration directory as well as applicable state requirements. Federal registration and state licensing answer different questions. Neither establishes that every product in a catalog is eligible for your intended use.
A claim of nationwide coverage should come with current destination-specific evidence.
2. Check accreditation and other credentials
Ask which accreditation or certification programs cover the facility, what each credential covers, and when it expires. Verify claimed credentials with the issuing organization.
Programs such as PCAB accreditation and other third-party reviews have different scopes. A credential for nonsterile compounding does not establish sterile-compounding capability. A parent company's certificate may not cover the facility supplying your order.
Accreditation is one part of the review. It does not replace license checks, product review, or lot documentation.
3. Confirm ingredient source and chemical form
Ask where the active pharmaceutical ingredient comes from, how the pharmacy qualifies its supplier, and how the ingredient can be traced to a lot. Request the exact chemical form and supporting identity and quality documentation.
Similar names can conceal different substances. Confirm that the exact ingredient and chemical form are eligible for compounding under current law. See FDA's concerns with unapproved GLP-1 drugs.
A catalog listing or supplier assurance is not enough to resolve an ingredient-eligibility question.
4. Understand the certificate of analysis
Ask which certificates and test results are available for the ingredients and finished preparation. Check whether the document applies to the actual lot, formulation, concentration, and container you will receive.
A useful review identifies:
- The facility or laboratory that performed the test.
- The product and lot number.
- The method, specification, and result.
- The testing date and authorized approval.
- Whether the document covers an ingredient or the finished preparation.
A sample certificate can explain a format. It cannot establish the result for a different lot.
5. Review the testing and release process
For sterile products, ask how the pharmacy addresses sterility, bacterial endotoxins, potency, and other applicable quality requirements. Have a qualified pharmacy reviewer assess the testing and release process for the facility type and preparation.
Identify who performs the tests, how methods are qualified, what sampling is used, and what happens when a result fails. Independent laboratory work can provide useful evidence, but an outside laboratory alone does not establish that a testing program is sufficient. In-house testing is not automatically disqualifying.
Ask how results connect to lot traceability and the decision to release a preparation. See FDA's compounding oversight resources.
6. Check shipping and temperature controls
For temperature-sensitive medication, request the storage requirements, qualified packaging configuration, supported transit window, and process for a delayed or damaged shipment.
Ask who evaluates a reported temperature excursion and how the practice or patient should hold the medication while awaiting instructions. Agree on the contact route and replacement process before an incident occurs.
A claim of cold-chain shipping should be supported by a defined packaging and handling process.
7. Confirm the prescription and purchasing model
State whether the order is for an identified patient's prescription or for eligible office stock. Ask the pharmacy to confirm the applicable pathway in writing.
A named patient's medication delivered to a practice remains patient-specific. Delivery to a practice address does not turn it into general inventory. A 503B designation also does not establish that every preparation may be supplied for office use in every jurisdiction.
Review the 503A and 503B comparison with your clinical and pharmacy leads when the purchasing model is unclear.
8. Review inspection and enforcement history
Request relevant inspection reports, FDA Form 483 observations, warning letters, recalls, and state board actions. Check public records and ask the facility to explain its response and any unresolved issues.
A Form 483 records investigator observations. It is not a final agency determination. Evaluate the finding, the response, subsequent inspections, and whether the issue affects the preparation or facility you plan to use.
Use FDA's compounding inspection, recall, and action records alongside state board records.
9. Establish recall and adverse-event contacts
Ask how the pharmacy receives, investigates, and responds to product complaints and adverse-event reports. Identify the responsible contact and the information needed to trace a report to a product and lot.
Confirm how the pharmacy will notify your practice about a recall, how affected patients will be identified, and who coordinates the response. Record the responsibilities of the practice and pharmacy before the first order.
10. Confirm availability and turnaround
Use your actual formulations and destinations when asking about capacity. Separate the time to accept an order, the time to prepare it, and carrier transit time.
Ask when availability was last confirmed, which products require additional lead time, and how the pharmacy communicates a stockout or delay. A current formulary is useful, but it is not a promise of immediate availability.
Compare those commitments with actual order outcomes after onboarding.
Keep the supplier file current
Keep one file per facility with the responses, supporting evidence, open questions, and decision record. Assign an owner for updates.
Set review dates around license and credential expirations, contractual requirements, and the risks of the products you use. Reassess after material changes such as a new facility, ownership change, formulation change, recall, or serious fulfillment issue. An annual review can be part of the process; it is not a substitute for responding to an event that matters today.
When using a marketplace, establish which evidence the platform maintains and what your practice must obtain. Confirm document availability for each pharmacy rather than assuming every profile includes the same records.
When to pause an order
Pause and investigate when the facility identity does not match its records, the ingredient or formulation is unclear, an office-stock proposal conflicts with the patient-specific pathway, or the pharmacy cannot explain a quality concern affecting the intended preparation.
Ask qualified clinical, pharmacy, or legal reviewers to resolve the question. A lower price does not compensate for an unresolved eligibility or quality issue.
This checklist is an operational reference. Requirements depend on the preparation, facility, transaction, and jurisdiction. It does not authorize prescribing, compounding, or dispensing.