New USP Regulations to be Implemented by November 2023

HP Environmental Now Offering Analytical Services to Help Clients Meet New USP Requirements and Regulations

The Unites States Pharmacopeia (USP) has issued new testing requirements for facilities falling under General Chapter 797.  In response, HP Environmental is now offering supplies, media, and incubation and identification services for those who need assistance in adopting or meeting the new requirements.

The new regulatory requirement must be fully implemented by November 1, 2023, to ensure that facilities compounding sterile products for human or animal use do so in an aseptic manner and clean environment. 

The revisions include updates to the beyond-use dates (BUDs), as well as new information to reflect advancements in science and clinical practice and to clarify topics that were not consistently understood in previous chapters.  The regulatory updates are intended to help ensure quality compounded preparations, promote public health, and protect both patients and healthcare workers.

General Chapter 797 applies to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared for human and animal patients.  This includes, but is not limited to the following:

• Pharmacists
• Technicians
• Nurses
• Physicians
• Veterinarians
• Dentists
• Naturopaths
• Chiropractors

Additionally, relevant facilities include but are not limited to:

• Hospitals and other healthcare institutions
• Medical and surgical patient treatment sites
• Infusion facilities
• Pharmacies
• Physicians’ or veterinarian practice sites

To help clients meet the new requirements, HP Environmental is now offering supplies and testing kits available for purchase, as well as incubation of samples for those who do not have the needed laboratory equipment or proper storage.  Clients interested in surface testing, glove fingertip and thumb testing, or simply addressing media testing needs, should contact HPE for further information.  HPE’s Director of Microbiology, Jonathon Hall, can be reached at jhall@hpenviron.com or by calling our offices during business hours at 703-471-4200. 

Please do not hesitate to contact HP Environmental if you should have any questions about the latest USP regulation updates or meeting the requirements outlined in General Chapter 797. 

HPE offers a range of microbiological testing services including biological assessment profiles that identify fungi and bacteria from air, bulk, water, and wipe samples.  Please see our full product list for more details.

For those who are impacted by these changes or for facilities who are meeting regulatory requirements for the first time, please review the document in its entirety. The following topics are covered in the FAQ document:

• Personnel training and evaluation
• Personnel hygiene and garbing
• Facilities and engineering controls (HEPA filtration, pressure measuring devices, sinks, etc.) Microbiological air and surface monitoring
• Cleaning, disinfecting, and applying sporicidal disinfectants and 70% IPA
• Equipment, supplies, and components
• Sterilization and depyrogenation
• Master formulation and compounding records
• Release inspections and testing
• Establishing beyond-use dates (BUD)
• Use of conventionally manufactured products as components
• Use of compounded sterile products as components
• QA and QC
• Compounded sterile preparation (CSP) handling, storage packaging shipping and transport

A full overview of HPE’s Microbiology and laboratory services can be viewed here.  If you have further questions or require guidance, please feel free to reach out to our HPE Microbiology experts for assistance.