USP 800 seeks to address the situation in which millions of healthcare workers are exposed to hazardous medications on a daily basis in hospitals, pharmacies and other related facilities.
Hundreds of hazardous drugs (HDs) are compounded on a daily basis. Studies show a variety of health risks for hazardous drug-exposed workers including headaches, eye issues, rashes, hair loss, reproductive issues, and increased risks of forming cancer. USP 800 was created to provide guidelines for safe handling and compounding of these types of pharmaceuticals.
USP Chapter 797, addressed safe handling of pharmaceuticals but did not adequately address the handling of hazardous drugs. USP 800 offers guidance to safely work with these hazardous drugs from receipt of the HDs to compounding to proper disposal.
Key Points for USP 800 Compliance
Below are some of the main points to study in USP Chapter 800 along with a brief explanation to help protect your workers handling hazardous drugs. See a detailed USP 800 Compliance Checklist.
USP 800 Compliant PPE
UPS 800 gives guidelines and quality standards for the proper personal protective equipment (PPE) and supplies to be used for USP 800 compliance for both sterile and non-sterile compounding facilities. The guideline advises on materials and styles of products like chemo gloves, chemo gowns, bouffant, face masks, shoe covers, and more.
Very important PPE characteristics for USP 800 compliance:
- USP 800 cleanroom apparel must meet the ASTM D6978-05 testing requirement which deals with permeation of chemotherapy drugs. There can be no permeation at any seam and the material itself must pass these strict quality tests.
- Double-gloving is required for workers handling chemotherapy. Read more about the ASTM testing guidelines and worker recommendations such as regularly changing chemo-rated gloves.
- ASTM D6978-05 certified gowns must be worn when administering any type of hazardous drug via injection.
- HD-handling cleanroom workers must be trained on how to gown with proper protective apparel to ensure complete safe management of any hazardous situations including spills.
Managing HD Spills
Standard operating procedures (SOP) must be created both to prevent accidental spills and to contain hazardous drugs if there is a spill. Key SOP components:
- Implement training for cleanroom or lab workers to show proper technique to clean up spills. It is important that HD handlers in your cleanrooms understand the different components of chemo/HD spill kits used.
- Address different sizes of spills and situations where a spill can occur.
- Designate who is responsible for handling the cleanup and the proper PPE required for cleanup activities.
Selecting a Compounding Supervisor
Section 4 of USP 800 requires each facility to appoint a compounding supervisor who is specifically trained in all areas of handling hazardous drugs. The person in this position must fully understand all of the proper procedures and risks of working with hazardous pharmaceuticals as well as how to maintain compliance in their pharmacy. It is a high-responsibility job and a full-time oversight job that includes:
- verifying all procedures
- making sure all personnel are properly donning PPE for and performing their duties.
Properly Receiving & Unpacking HDs
Hazardous drugs and the ingredients to compound hazardous drugs must be removed from the original packaging in a specially constructed neutral or negative pressure room. This ensures no airborne particles are introduced into the cleanroom or lab that could:
- expose workers
- or escape outside of the pharmacy area.
It is vital that unpacking of HD or HD components is not done in sterile compounding areas or positive pressure areas as this can spread hazardous airborne particles. Cleanroom workers should be trained to eliminate chemo contamination using products such as WipeDown 1-2-3.
USP 800 Compliance Assistance
Cleanroom Connection is the leading supplier of PPE for USP 800 compliance. USP-compliant pharmacy cleanroom design, staff training, and overall USP 800 compliance consulting is available through Cleanroom Connection. We work with some of the nation’s pioneer veteran pharmacists and industry leaders to ensure compliance in the largest, most complex healthcare environments.
Our trained staff can take the mystery out of selecting the right PPE for USP 800 compliance. We help premier hospitals and healthcare facilities across the country with USP 800 and other regulatory compliance. In addition to our experience, our free samples and best-price guarantee make Cleanroom Connection the perfect asset to have on your team.
To speak with one of our USP 800 cleanroom experts about your facility’s requirements, email or call.