How Will USP 800 Impact Your Business?
Posted by Emily Thompson on Sep 2nd 2020
Are you one of the approximately 8 million U.S. healthcare personnel who are exposed to Hazardous Drugs each year? If any part of your job description involves direct or indirect contact with Hazardous Drugs (HDs), you’ve no doubt heard of USP 800 –a new proposal designed to protect health care professionals and the environment in the handling of HDs. Of course, with increased protection comes increased standards and potentially big changes for your pharmacy.
While your inbox is probably packed to the gills with updates and changes in regulations, as the spotlight turns more and more toward compounding, we want to make sure that you are aware and stay informed of these changes before they impact your business.
Here’s a brief rundown of who the proposal will affect and what to expect.
Who does it apply to?
USP 800 is for anyone who is involved with HDs, but not limited to, healthcare practitioners and their staff, occupational health and safety specialists, and their human resource providers.
What does the USP 800 address?
- New standards for all physical locations where HDs are prepared, stored, transported, and administered (including ventilation equipment and room setup)
- How both sterile and nonsterile preparations should be received, stored, compounded, dispensed, administered, and disposed of
- Any physical altering of HDs to include counting, crushing, and pouring
Which drugs are considered “Hazardous”?
By using the most current NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, which can be found here, you can see what’s currently affected. Still, companies should be mindful that future updates to this list are possible.
How can I submit a Public Comment?
USP 800 is still in drafting, which means you can submit your comments and opinions to this proposal through July 31st by emailing CompoundingSL@USP.org .
When submitting reviews, be sure to indicate the line number(s) corresponding to your comments. (General Chapter with line number available here: www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf)
You can also view the USP 800 in its entirety at ttps://www.usp.org/usp-nf/notices/compounding-notice.
Our door is always open. Be sure to contact our compounding advisor by calling 800-878-2822 x115 if we can answer any questions!