News & events

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.

USP 797 states “CSPs administered epidurally should have the same endotoxin limit as that of intrathecally administered CSPs.” This new requirement lowers the endotoxin limit for epidural products from parenteral limit calculations to intrathecal limit calculations.

Pyrogens are a group of fever causing substances which can be found in compounded sterile preparations (CSPs) if appropriate actions are not taken to reduce or remove them. One of the most widely known groups of pyrogens are bacterial endotoxins.