The USP 797 chapter on "Pharmaceutical Compounding - Sterile Preparations" provides for enforceable guidelines, procedures and compliance requirements for compounding sterile preparations. Issued by the U.S. Pharmacopeia (USP), these standards include the proper facility design, environmental monitoring, handling and storage of sterile compounds to prevent serious illness or fatalities caused by accidental contamination of these materials.

USP 797 guidelines are designed to prevent the improper handling and contamination of sterile compounds for certain drugs or biologic preparations. These items include:
  • - Baths for live tissues and organs
  • - Tissue implants
  • - Aqueous nasal and bronchial inhalations
  • - Irrigating solutions
  • - Opthalmics
  • - Parenterals

EMSL Analytical offers a wide range of testing services to support USP 797 requirements. These services are available to those impacted by USP 797, including those involved with compounded sterile preparations (CSPs), healthcare professionals and providers, manufacturers, industry and government agencies.

Years of experience and utilizing advanced analytical techniques have made EMSL one of the world's leading USP 797 testing providers. This allows EMSL to provide customers with rapid results based on proven scientific techniques.