Compounding Regulatory Compliance
Compliance reviews, Audits & Gap Analysis
Is your compounding operation cGMP, FDA, DEA, Board of Pharmacy, USP, PCAB, or NABP compliant? Ready for your next regulatory or accreditation audit? Our experts are compounding veterans, having spent their careers in 503A, 503B, and pharmaceutical manufacturing settings. We conduct comprehensive reviews, mock audits, and gap analyses to assess compliance with the applicable pharmacy or outsourcing regulations and accrediting bodies. We outline where the gaps are and if you like, we’ll fix them, too.
Compounding Supplier Audits
The FDA is cracking down on API suppliers. Almost daily, pharmaceutical firms broadcast recall alerts for their FDA approved drug products. The materials you use in your compounding operation can make or break you. Hospitals and pharmacies may not have the time or be well-versed in GMP to conduct an adequate audit of a compounding material supplier. 503B outsourcing facilities may also prefer to sub this work out to a competent GMP auditor so they can focus on mass production. Our consultants have extensive audit and GMP experience. Don’t take time away from your operation. Let us take the guess work out of auditing your critical compounding material suppliers.
Enforcement Responses & Implementation
If your organization has been hit with a FDA Form 483, warning letter, or Board of Pharmacy accusation or plan of correction mandate, you don’t have much time to respond and correct the deficiencies. What you need is a team of experts that have seen it all and can help you respond quickly to a regulator with cost-effective solutions that adequately address the problems. Restore Health Consulting can support you through this difficult time so you can put this in the past quickly and get on with making quality compounded preparations.
Expert Witness & Probation Monitoring
Restore Health Consulting provides litigation support services in matters of 503A pharmacy and 503B outsourcing facility compounding laws and regulations. We provide expert witness depositions, testimony, evidence review and detailed reports for all things compounding and pharmacy law. We also provide pharmacy probation monitoring services and assess compliance with probation agreements at the required frequency. If your compounding operation has been hit with legal issues, our expert witnesses and probationary consultants can help.