Lots to tackle before the 12/1/2019 deadline…

By now, we’ve all heard about USP <797>, but have you heard about it’s little brother, USP <800>? If you haven’t heard about USP <800> yet, now’s the time to start thinking about whether you’ll be affected by the United States Pharmacopeial Convention’s (USP) newest document.

What is USP General Chapter <800>?

USP General Chapter <800>, commonly referred to as simply #USP800, provides standards on the safe handling of hazardous drugs. Any healthcare center that hazardous drugs on their formulary is required to abide by the standards of USP <800>.

Am I going to be affected by USP <800>?

If your healthcare facility stocks any drugs on the NIOSH Hazardous Drugs in Healthcare Settings list, you will be affected by this regulation. Not sure if your center has any drugs on this list? Send us a copy of your drug inventory or formulary and we’ll check for you, for FREE!

Some of the most common Hazardous Drugs that will affect our clients include:

· Mitomycin

· Warfarin

· Any pharmaceutical hormone

· Antineoplastic drugs

If you’d like a full list of all hazardous drugs, scroll down on the newsletter to download the NIOSH Hazardous Drugs in Healthcare, 2016 document. NIOSH is currently reviewing proposed additions to the list for a 2018 update (also available for download at the bottom of this newsletter).

I use “black boxes” or yellow “chemo boxes” for disposal of my hazardous waste. I’m already prepared, right?

Actually, no. Hazardous Waste and Hazardous Drugs are two completely separate things, governed by two separate entities. The EPA governs Hazardous Waste, which are the P-List and U-List items that get disposed of in your hazardous waste bin, or “black box”.

USP <800> is more focused on the exposure to the healthcare workers, not how you dispose of the drug.

What will I have to do to be compliant with USP <800>?

USP <800> will affect every aspect of how hazardous drugs are handled at your facility. Considerations will have to be made for:

· Receipt of drugs, delivery, unpacking, preparation, usage/ administration, and disposal

· All staff that handle hazardous drugs will need to receive special training.

· The center will have to perform a risk assessment for all hazardous drugs used at the center.

· Special policies & procedures will need to be approved by the board and adopted into the manual.

· Standard operating procedures for handling hazardous drugs will need to be adopted.

· Special PPE will need to be purchased and used for handling hazardous drugs.

· The center may need to re-consider their drug disposal options.

· Hazardous Drug preparation areas must meet certain standards.

· The center may have to purchase or create signage.

· The center may have to purchase spill kits.

There are many areas to consider for compliance with USP <800>. But don’t worry, WE HAVE A PLAN!


JDJ Consulting will be hosting a FREE webinar to introduce our clients to the finer details of USP <800>. We will begin to explain the document in more detail and explain exactly what will need to be done to ensure compliance.

JDJ Consulting will also offer training and compliance packages that cover all areas of USP <800> preparation, from top to bottom. For more details, see the section of the newsletter that talks about our USP <800> package.

6 N. Synnott Avenue Wenonah, NJ 08090

Tel. (609) 313-7572

JDJ Consulting services and availability may vary by state. Contact us to find out what service are available in your area. Pharmacy operational requirements and regulations are governed by Federal, State, Local, and Tribal law, and if applicable, the facility's accrediting agency. JDJ Consulting will provide recommendations based on the regulatory requirements in your area.

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