USP <800> Myth Busters!
Jenny Schell
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Thu, Nov 14, 2019
“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.
Myth: USP has put everything on hold, so we don't need to do anything right now.
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.
Myth: My state board isn't implementing USP <800>, so I don't have anything to worry about.
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).
Myth: My pharmacy doesn't do any type of compounding, so USP <800> doesn't apply to me.
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:
- Antineoplastic drugs
- Non-antineoplastic drugs that meet 1 or more of the NIOSH criteria for an HD
- Non-antineoplastic drugs that primarily have adverse reproductive effects
Myth: My pharmacy doesn't carry any Hazardous Drugs.
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>.
Myth: My pharmacy carries birth control, but it is all in manufacturer packaging, so we don't need to do anything.
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:
- Hazardous Drug Program for Retail & LTC Pharmacies- complete with Policies & Procedures and all the support documents needed for implementation.
- Pharmacy & Hazardous Drug Spill Kit- a ready for use for USP<800> compliance and any bodily fluid clean-ups that may occur.
- Completed Assessments of Risk- customized and ready for review and signatures for the top 100+ Hazardous Drugs.
- Hazardous Drug Labels-to help alert staff and TLC facilities of HDs.
