USP <795> and <797>

USP <795> and USP <797> are standards designed to keep compounded preparations safe. These two standards relate to the preparation of nonsterile and sterile compounded formulations, respectively. Whether these standards are required is determined by state pharmacy boards.

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Regulatory Background: USP <795> and USP <797> Compliance

State pharmacy boards have traditionally provided oversight to compounding pharmacies. The boards require USP <795> and USP <797> compliance.

Here are the key aspects of USP <795> and USP <797> compliance for compounding pharmacies:

  • USP <795> compliance (Pharmaceutical Compounding–Nonsterile Preparations): This chapter outlines the responsibilities of the compounder and provides guidance on compliant practices in the preparation of nonsterile compounded formulations for both human and animal use.

  • USP <797> compliance (Pharmaceutical Compounding–Sterile Preparations): This chapter describes requirements for the preparation of sterile drugs, including radiopharmaceuticals. It describes conditions and practices to avoid harm to patients.

The FDA and USP <795> and USP <797> Compliance

The U.S. Congress passed the Drug Quality and Security Act (H.R. 3204) to amend Section 503A of the Federal Food, Drug, and Cosmetic Act. The bill clarifies the authority of the FDA over compounding pharmacies that act as “outsourcing facilities.”

Under the Drug Quality and Security Act, outsourcing facilities can register with the FDA on a voluntary basis and submit reports twice a year to identify compounded formulations they produce. Companies that register will be subject to inspections, cGMP compliance, labeling, adverse event reporting requirements, and user fees.

Traditional compounding pharmacies are not covered by the Drug Quality and Security Act. They will remain under the jurisdiction of state pharmacy boards. Their key requirement is USP <795> and USP <797> compliance.

How MasterControl can Help with USP <795> and USP <797> Compliance and Future Compliance with the Drug Quality and Security Act

MasterControl, a leading provider of software solutions and consulting services in the FDA and other regulated environments, enables companies to accelerate compliance, reduce costs, and improve efficiency. Here’s how MasterControl can help compounding pharmacies:

MasterControl’s Quality and Compliance Consulting Team: MasterControl can help compounding pharmacies design and establish quality processes such as CAPA, SOP management, audit, training, and customer complaint. It can help companies assess an organization’s needs pertaining to USP <795> and USP <797> compliance.

If your company already has CAPA, audit, and other quality processes, MasterControl can help you improve your existing quality processes by identifying their strengths and weaknesses. MasterControl consultants can help you strengthen your quality management system (QMS) for a holistic approach to USP <795> compliance and USP <797> compliance.

MasterControl Quality and Compliance Software: If your company is using a paper-based or hybrid quality management system for USP <795> and USP <797> compliance, the need to switch to an automated and integrated QMS has never been greater. MasterControl quality and compliance software can serve as an effective platform for your QMS by automating all documents- and forms-based processes, connecting all quality processes, and providing a centralized, web-based location for all documents.

MasterControl will strengthen your USP <795> and USP <797> compliance and inspection readiness in these areas:

  • Document Control: MasterControl Documents can serve as a centerpiece for an effective QMS that will facilitate USP <795> and USP <797> compliance. It will automate routing, review, and approval, as well as tracking and retrieval, of all documents.

  • Issue Review and CAPA Management: Recent Form FDA 483s issued to compounding pharmacies reflect many CAPA-related issues. MasterControl CAPA offers industry best-practice forms that will guide your quality team throughout the CAPA process. For recipients of 483s, it will facilitate USP <795> compliance and USP <797> compliance and show FDA investigators how CAPA issues have been addressed.

  • Training Control: MasterControl Training automates and streamlines the process for routing, tracking, escalation, and approval of training tasks. It gives you the capability to provide online exams and progressive training for automatic sequencing of training tasks.

  • Customer Complaints Management: Customer safety is the overriding concern of the Drug Quality and Security Act, making customer complaints critical. MasterControl will make it easier for you to manage customer complaints information by standardizing and automating the process. It provides best-practice customer complaint forms that are easy to use and track.

  • Audit Management: MasterControl Audit streamlines the audit process, from collection of data to tracking of findings, for accelerated USP <795> and USP <797> compliance. It automates all audit-related tasks, including distribution, tracking, follow-up, escalation, review, and approval of those tasks.

For More Information on MasterControl's solution to help with USP <795> and USP <797> Compliance

To learn more about MasterControl, Contact a MasterControl representative