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.