USP 797 is a quality system developed by an independent not-for-profit organization that establishes standards and procedures for compounding sterile drug preparations in pharmacies. The United States Pharmacopeia Convention (USP) develops the standard, which is intended to prevent patient harm and death from microbial contamination, excessive bacterial endotoxins, and incorrect ingredients. While this is not a required standard for a lab, it is a very important validation point and one that our manufacturing partner is validated to conform to.

The FDA enforces cGMP regulations, which set minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing. These regulations ensure the quality of products, and are not required in competing verticals of manufacturing. ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world. It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

Our partner lab is proud to create API in-house with some of the most advanced technology and equipment available to the industry. All stages of manufacturing and products used in the process are hand-picked without any concession to price point, and the end-product quality is evident in the testing results produced and shared with clients. Most raw materials are sourced domestically in the United States, and the ones that are not domestic do come from FDA Registered and vetted facilities.