News

Compounding Records

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.

MFR

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.

USP 51 Testing

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. 

Sterilization Methods

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. Terminal sterilization provides the longest BUDs possible but may not be compatible with the compounded preparation due to the conditions required to sterilize. Ultimately, the appropriate sterilization method for a particular formulation depends on the product, with the allowable BUD a consequence.

Endotoxin Testing

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. 

 

Endotoxin Limits

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.

Therapeutic Peptides

Peptide therapies have become increasingly popular due to the ability to help build lean muscle, shed weight, increase energy, improve skin appearance, amongst other benefits. With the increasing popularity and improvements in peptide production this has allowed compounded preparations to become more readily available. Wider availability has allowed ARL to test a variety of natural and modified peptides that cover multiple therapeutic areas. 

USP Updates

United States Pharmacopeia published the revised <795> and <797> chapters November 1, 2022. These chapters become official November 1, 2023. Revisions to the chapters can be accessed through a subscription to the USP Compounding Compendium.

USP 797 BUD

In JuneJuly , and Augustwe discussed Personnel Qualification, Environmental Monitoring Requirements, and Release Inspections and Testing for Compounded Sterile Preparations (CSPs) for Categories 1, 2, and 3. This month we will discuss beyond use dating. 

USP 797 Release Testing

In June and July we discussed Personnel Qualification and Environmental Monitoring Requirements for Compounded Sterile Preparations (CSPs) for Categories 1, 2, and 3. This month we will discuss Release Inspections and Testing for Categories 2 and 3.