“My wholesaler said, my state board of pharmacy said, my PSAO said, my area president, said…” We’ve been fielding a lot of questions regarding USP <800> compliance for almost a year now, and one thing is for sure, pharmacists are getting mixed messages from various groups.
With so many people getting conflicting answers around when USP <800> goes into effect, who will be enforcing, and even the type of drugs, we wanted to bust the Top 5 Myths.
Fact: USP has postponed <795>, <797> and <825> while an appeal is pending. USP <800> Hazardous Drugs is not subject to any pending appeals and became official on December 1, 2019. This includes the use of Negative Pressure Labs.
Fact: Multiple agencies will are enforcing USP <800>; including your state's environment department/agency, as well as the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Occupational Safety & Health Administration (OSHA).
Fact: USP <800> deals with Hazardous Drugs. It does not deal solely with compounding. If your pharmacy carries any drug found on the NIOSH list, then USP <800> does affect you.
The 3 tables of drugs on the NIOSH List are:
Fact: If you have drugs like Warfarin, any type of birth control, or drugs that treat cancer in your pharmacy, to name a few, you are carrying Hazardous Drugs, and you must comply with USP <800>.
Fact::Birth control falls under Table 2 and Table 3 of the NIOSH list. You must have these drugs segregated, have a completed Assessment of Risk, corresponding Safety Data Sheets, and included on your Hazardous Drug Inventory.
We understand it's hard to keep up with regulations; when they start, what they mean, what needs to be implemented, and when they change. At R.J. Hedges & Associates, we are here to keep you stress-free and in compliance! That's why we have a variety of items to help implement USP <800>, including: