Sterile Products Regulatory Compliance (USP <797>, <800>)

PCI works cooperatively with clients to evaluate sterile product compounding and safety.  PCI is experienced in performing quality audits and mock inspection services for healthcare institutions to support USP <797> and USP <800> compliance.  A thorough report will specify actions necessary to remedy any deficiencies identified during the evaluation.

PCI will assess sterile products program processes, including:

  • Clean room design and maintenance
  • Sterile products policy and procedure
  • Employee competency
  • Hazardous drug storage and management
  • Beyond use dating

Our Services

Drug Cost, Utilization and Revenue


Controlled Substances Management

Sterile Products Regulatory Compliance (USP <797>, <800>)

Pharmacy Technology

Pharmacy Strategy for Integrated Delivery Networks

Pharmacy Operations

Infusion and Cancer Centers

Specialty, Retail and Ambulatory Pharmacy Programs

Legal and Litigation Support

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