As a 503B outsourcing facility, we adhere to the FDA’s Current Good Manufacturing Practice (cGMP) regulations set forth in Title 21 of the Code of Federal Regulations parts 210 and 211. The cGMP regulations contain requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of medications. These regulations help ensure that medications are safe for use and that they have the ingredients and strengths they claim to have.
We also comply with the United States Pharmacopeia (USP) for our sterile and non-sterile medications. USP standards are recognized in various provisions of the Federal Food, Drug, and Cosmetic Act and in laws, regulations, and policies promulgated by states. These standards are enforced by the FDA, state boards of pharmacy, and other regulatory bodies.