Description
The Minneapolis VA HealthCare System requires 503B compounding facilities for large-batch manufacturing of pre-packaged IV medications and eye injections. The contract will be for a base period of 12 months with options to extend for up to 4 additional 12-month periods. The contractor must provide consistent and high-quality pharmacy and sterile compounding services, including documented or extended Beyond-Use Dating (BUD) and batch-level sterility, potency, and endotoxin testing.
• The contractor must be regulated by the Minnesota State Board of Pharmacy, Federal Drug Administration (FDA), and Drug Enforcement Administration (DEA).
• The contractor must comply with all compounding standards and requirements, including U.S. Pharmacopeial Chapters 795, 797, and 800, and Current Good Manufacturing Practices (CGMP).
• The contractor must provide a description of their formal procedures for conducting recalls and whether there have been recalls of any of its compounded preparations.
• The contractor must provide information related to the delivery process and backup planning when severe or catastrophic events happen.