Articles — regulation

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of pharmaceuticals, biologics, and much more. It is one of the leading regulatory and compliance agencies that a compounding pharmacy will work alongside while developing products. The FDA is responsible for routine inspections, which many manufacturers know all too well! But, three little numbers - 483 - can come from the inspections, and they mean serious business. But there are two different types of terms associated with these numbers: "Observations" and "Warning Letters." Today, we'll look at the difference between...

  In 2019, revisions were published to the USP General Chapter 797 Pharmaceutical Compounding – Sterile Preparations, by the Compounding Expert Committee of the US Pharmacopeia Convention, on compounding nonsterile and sterile preparations, along with advanced standards for compounding radiopharmaceutical drugs. This is one of the first changes to the original regulation set of sterile compounding practice standards given by the United States Pharmacopeia (USP). The updates advocate for change in both structure and content, forcing processes to broaden and to increasingly become more effective. Below outlines the significant details that will most influence sterilization and depyrogenation. Compounded Sterile Preparation...