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Educational Article

New USP 800 Compliance White Paper

Whitepaper: Considerations on Facility and Engineering Controls in the Wake of USP 800

New white paper explores the facilities challenges of USP 800 compliance and provides considerations to overcome them

Simplex Isolation Systems has announced a new white paper that explores the challenges imposed by USP 800 Section 5: Facilities and Engineering Controls. The white paper was developed to help healthcare institutions understand the necessary upgrades and modifications required of their facilities to achieve USP 800 compliance. Additionally, the white paper provides these organizations ways in which they can leverage their current facility layout and infrastructure to keep modifications within budget.

The US Pharmacopeial Convention (USP), a non-profit organization that sets health care activity standards enforceable by the Food and Drug Administration (FDA), adopted the USP General Chapter 800 regulation in February 2016 to address concerns over the handling of hazardous drugs. The regulation identifies the requirements for the receipt, storage, compounding, dispensing and administration of hazardous drugs to protect the patient, healthcare personnel and environment. It includes both non-sterile and sterile products and preparations and the standard applies to all personnel who compound these drug preparations and all places where they are prepared, stored, transported and administered.

This white paper provides an overview of USP 800 Section 5: Facilities and Engineering Controls.

Key topics that are discussed include:

  • USP 800-compliant space configurations for receipt, unpacking, storage and compounding of hazardous drugs.

  • Optimal space layouts for non-sterile and sterile hazardous drug compounding rooms.

  • Modular versus traditional stick-built secondary engineering control rooms.

  • Typical facility infrastructure challenges and potential solutions recommended for compliance.

“Since the publishing of USP General Chapter 800 in 2016, we have seen a trend in the configuration, building and infrastructure challenges that our customers have been faced with,” stated Darren McKinnon, Critical Environment Specialist at Simplex and key contributor to the white paper. “Our goal for the whitepaper was to define all potential difficulties from a building design standpoint in one educational piece that healthcare institutions can reference when planning for USP 800 compliance.