News

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. 

USP 797 Category 3 Drugs

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

Microbial Tests

USP <795> states that pharmacists performing non-sterile compounding must ensure that the finished preparation has its accepted potency, purity, quality, and characteristics.  This article discusses the tests described in USP <61> and USP <62> that are used to determine if non-sterile products meet quality requirements.  These tests can also be used by sterile compounders for qualifying raw materials and performing in-process quality control testing.  

T3/T4 Formulations

Liothyronine Sodium (T3) and Levothyroxine Sodium (T4) are iodonated amino acids and are typically formulated in microgram concentrations. These active pharmaceutical ingredients (APIs) contain water: up to 4% in the T3 powder and up to 11% in the T4 powder. The primary reasons for the difficulty in preparing formulations containing T3 and/or T4 arise from these 3 issues: microgram concentrations, iodination of the compound, and water.

GMP vs. non-GMP testing

ARL offers two potency test options, non-cGMP and cGMP, for determining the concentration of the active pharmaceutical ingredient (API) in compounded preparations.

Test Specifications

USP <797> states compounders must ensure products maintain labeled strength within monograph limits. The difficulty with determining limits (specifications) for compounded preparations is that there may not be a monograph to reference. In these cases, ARL assigns the specification by choosing them from a monograph that is closest to the product being tested. When there is not a monograph for a similar product, ARL defaults to 90%-110% per <797>.

Potency Test Results

For potency testing with respect to HPLC, IC and/or GC methodologies, ARL verifies by way of system suitability that we are capable of performing the analysis. The verification focuses on:

1. Multiple injections of the reference standard for calculation of %CV

2. Verification of retention time of the standard and the sample

 

 

USP 797

Now is the time to prepare for proposed changes to USP <797>.

Over the next few newsletters, we will highlight proposed changes to sterile compounding testing requirements and how ARL can help your pharmacy meet USP standards. 

We begin with Personnel Qualification and Environmental Monitoring Requirements for Compounded Sterile Preparations (CSPs) Categories 1 and 2.