Complying with USP <800>

USP <800>

The last thing anyone wants to have to focus on is regulatory compliance. It often feels nearly impossible to maneuver around all the already existing red tape while staying focused on the work at hand, let alone figuring out how to implement new standards. By the same token, the rules put in place are vitally important to ensuring the safety of everyone working directly with hazardous drugs and even help keep the community at large stay safe from potential danger if there are any mistakes. However you feel about regulations, the fact remains that every facility must do everything possible to maintain compliance.

The United States Pharmacopeia (USP) officially implemented General Chapter <800> on December 1, 2019. As of that date, state boards of pharmacy were able to require compliance within their respective states. Due to some technicalities, since USP <800> is not mentioned in another official chapter of USP, it is not yet federally enforceable. But even if your state is not enforcing USP <800> yet, that does not mean your facility should overlook it. Patricia C. Kienle, MPA, RPh, BCSCP, FASHP, director of accreditation and medication safety at Cardinal Health, points out, “the whole point of <800> is protection for us as health care employees. So, you want to incorporate all those things that you can. Once <795> or <797> become official, that will trigger <800> to be [federally] enforceable as well.” So even if it is not federal law yet, it likely will be in the near future.

What Does USP <800> Address?

USP <800> is specifically designed to address healthcare professionals who handle hazardous drugs and any entity that stores, prepares, transports, or administers hazardous drugs. This may include pharmacies, healthcare institutions, patient treatment clinics, physicians' practice facilities, and veterinarians' offices, among others. Section 1 of USP <800> describes some of what is meant by “handling drugs,” as including, but not being limited to, “the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations.” The National Institute for Occupational Safety and Health (NIOSH) defines hazardous drugs as those which pose the risk of “carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous.”

While USP <800> covers a wide range of responsibilities allotted to those facilities that handle hazardous drugs, AirClean Systems focuses on helping you fulfill obligations regarding the proper enclosures to use. USP has stated that containment primary engineering controls (C-PECs) used for procedures such as weighing and mixing must have “redundant–HEPA filters in series and must provide personnel and environmental protection, such as a Class I BSC or Containment Ventilated Enclosure (CVE),” if they are not externally vented. Any ductless enclosure used to handle hazardous drugs must employ two HEPA filters, back to back, to ensure that the air released into the room is entirely free of any harmful contaminants. These enclosures are designed to protect the operator and the environment from the dangers associated with these threatening substances.

Products That Meet USP <800> Requirements

Fortunately, AirClean Systems provides a wide array of standard and custom enclosures that meet the new USP <800> requirements and keep you safe. Some of the most popular units which are easy to integrate into your facility’s workflow are our Powdersafe™ Type A, Type B, and Type C Enclosures. These each implement the redundant HEPA filtration required by USP <800> and give you the option to customize filtration further depending on your specific application. And all, of course, come equipped with AirClean Systems’ proprietary AirSafe® Automatic Safety Controller, a user-friendly interface that provides airflow control, filtration monitoring, gas detection capabilities, a lab timer, and more. In addition to these offerings, AirClean Systems also offers Polypropylene E-Series Free-Standing Enclosures, Polypropylene Horizontal Laminar Flow Clean Bench, Vertical Laminar Flow Workstation, and Polypropylene Vertical Laminar Flow Enclosure, which are all compatible with the requirements of USP <800>.

While it may often seem like regulations are just another hindrance to getting things done, it is essential to remember the role they play in keeping yourself, your co-workers, and your community safe from the harmful effects of hazardous drugs. For a more in-depth look at the requirements of USP <800>, AirClean Systems has a page dedicated to explaining and helping you navigate this new regulation and its requirements. By putting forth a little effort at the front end to do your homework and ensure your continued compliance, you help to make your workplace and your community a better and safer place.