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USP 800 is a quality standard that promotes patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs). It applies to all healthcare personnel who handle HDs, and all entities that store, prepare, transport, and administer HDs.

USP <797> sets minimum standards for compounded sterile preparations to prevent exposure to particulate matter that may cause patient harm.

Particulate matter is the unwanted solid material in solutions for injection that can come from different sources. It’s important pharmacies identify the source so they can implement preventive measures to manage particulate matter throughout the product lifecycle.

A Compounding Record (CR) is a document that records the preparation of a compounded medication. It is important to maintain compounding records to demonstrate compliance with USP standards.

A Master Formulation Record (MFR) is a detailed record of procedures that describes how the drug product is to be prepared. This documentation is an important component of regulatory compliance and effective process control.

Antimicrobial preservatives are excipients added to aqueous pharmaceutical products.

Nonsterile dosage forms may have preservatives added to protect them from the growth of microorganisms inadvertently introduced during or after the compounding process.

In the upcoming version of USP <797> Pharmaceutical Compounding – Sterile Preparations, the method of sterilization has a significant impact on the maximum allowable Beyond-Use date (BUD) a compounded preparation may be assigned. The two approaches to sterilization in the chapter are aseptic processing and terminal sterilization.