Selecting a compounding pharmacy partner is a significant clinical and compliance decision. The questions below are organized into five categories and are designed to help you conduct a thorough due diligence process before establishing a pharmacy relationship. Use these questions in initial conversations with pharmacy representatives, and document the responses for your compliance records.
1Licensure and Accreditation
Are you licensed in [my state] and in all states where my patients are located?
Are you PCAB-accredited or ACHC-accredited? If not, what quality standards do you follow?
Are you registered with the FDA as a 503B outsourcing facility?
Have you received any FDA warning letters or state board disciplinary actions in the past five years?
Are you listed in the NABP e-Profile system?
2Quality and Testing
Do you provide certificates of analysis (COA) for each lot of compounded preparations?
What quality testing do you perform on finished preparations (sterility, potency, endotoxin)?
Who performs your quality testing — in-house or an independent laboratory?
Where do you source your APIs, and how do you qualify your suppliers?
What is your process for handling out-of-specification results?
3Sterile Compounding
Are you USP <797> compliant for sterile preparations?
What ISO classification are your cleanrooms?
How frequently do you perform environmental monitoring?
What are your beyond-use dating policies for sterile preparations?
Do you have cold-chain shipping capabilities for temperature-sensitive sterile compounds?
4Formulary and Clinical Support
What is your current formulary for [hormone therapy / peptides / GLP-1 / other relevant category]?
Can you prepare [specific dosage form or strength] for my patients?
Do you have a clinical pharmacist available for consultation?
How do you handle formulary changes or discontinuations?
Do you offer e-prescribing integration or a provider portal?
5Operations and Compliance
What is your typical turnaround time for [specific preparation type]?
What is your process for prescription verification and clarification?
How do you handle recalls or quality failures?
What are your pricing and partnership program options for practices?
What documentation do you provide to support provider compliance requirements?
How to Use This Checklist
Schedule a formal introductory call with the pharmacy's provider relations or account management team
Request written responses to quality and compliance questions for your records
Ask for references from other practices in your specialty
Request sample certificates of analysis for preparations you commonly prescribe
Verify all licensure and accreditation claims independently through official sources
Document your due diligence process and retain records for compliance purposes