Question? What is USP 797?
Answer: The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP sets standards for the quality of drug products and works with healthcare providers to help them meet the standards. Chapter 797 will affect anyone or any facility that handles injectables and other products that require sterility. This includes injections, aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants. USP 797 went through its final revision approval in December. The new standard becomes official June 1, 2008.
Please contact JDJ Consulting for assistance in meeting these standards.