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.
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.
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.
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.
In June, July , and August, we 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.
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.
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.
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.
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.
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>.