Compounding Pharmacy

The audit confirms you need help. Certification confirms you have prevailed. Few options exist to address the critical period in between.

ValSource conducts the audit, identifies the issues and develops the solution, assisting achievement of certification.

Providing parenteral and high potency products prepared for patients’ while simultaneously needs is a challenging yet crucial mandate. As pharmacy compounding grows, it is also receiving more attention from Federal regulators (US FDA) and state pharmacy boards.

The Approach.

Leveraging a unique combination of people with clinical/retail pharmacy, regulatory, and manufacturing experiences, ValSource tailors risk-based approaches to hospital pharmacies and compounding centers.

We assist compounders seeking compliance with new requirements of USP <797> and <800>, and also expectations of FD&C Act 503B.

Services include:

  • USP <800> guidance, facility/ operational review, and design
  • USP <797> guidance, facility/ operational review and design
  • Project management
  • Quality system development
  • Compliance remediation