USP 795 and USP 797 Standards

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.

Automating Document Control Processes to Comply With FDA and ISO Requirements

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Key Aspects for Pharmacy Compliance

Compounding pharmacies that prepare both sterile and nonsterile drugs must follow standards and regulations to ensure their preparations aren’t sub-potent, super potent, or contaminated. As with any highly-regulated industry, compounding pharmacies must effectively implement compliant practices and be able to prove that those practices have been implemented. The best way to do this is through pharmacy compliance software which documents and tracks a pharmacy’s quality assurance practices.

MasterControl Features

  • Document control: MasterControl Documents™ automates routing, review, approval, tracking, and retrieval of all documents related to compliance.
  • CAPA management: MasterControl CAPA™ guides compounding pharmacies through the CAPA process and tracks CAPA efforts to show how issues have been addressed.
  • Customer complaints: MasterControl Complaints™ makes it easy for compounding pharmacies to standardize and automate their process for addressing customer complaints.
  • Audit management: MasterControl Audit™ streamlines the audit process, from collection of data to tracking of findings, for accelerated compliance.

FDA Compliance

In the U.S., the Drug Quality and Security Act amended Section 503A of the Federal Food, Drug, and Cosmetic Act and clarified the authority of the U.S. Food and Drug Administration (FDA) over compounding pharmacies that act as “outsourcing facilities.” The FDA’s guidance applies to sterile compounding pharmacies and nonsterile ones equally. Traditional compounding pharmacies are still regulated at the state level.

Guidelines for Complying With USP <797>

  • The type of controls that must be in place are determined by whether the products being manufactured have a low, medium, or high-risk factor.
  • Based on the risk factor, a gap analysis of the compounding process must be performed.
  • In areas where the compounding pharmacy falls short, the organization must develop a corrective action plan.
  • To be fully compliant, a compounding pharmacy must track its efforts and be able to provide documentation showing its progress.

MasterControl Can Help With USP <795> and <797>

MasterControl can help compounding pharmacies design and establish quality processes such as CAPA, SOP management, audit, training, and customer complaint. For companies that already have these processes, MasterControl can help improve them by identifying weaknesses and strengthening the quality management system (QMS). If the QMS is a paper-based or hybrid system, MasterControl provides a QMS that automates all documents- and forms-based processes and provides a centralized web-based location for all documents.

MasterControl & The FDA

Organizations all over the world use MasterControl software solutions to ensure compliance – including organizations that enforce compliance. The U.S. Food and Drug Administration (FDA) became a MasterControl customer in 2009. Since then, the FDA has expanded its use and now multiple divisions of the agency use MasterControl software solutions.

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