USP <800> Update -- The Impact on Pharmacy Owners

As pharmacy owners know, USP <800> took effect in December 2019, but there have been some changes since then. We spoke to USP <800> expert, Jeff Hedges, to bring RxSafe customers up to speed on the latest developments. 

Is Anyone Enforcing USP <800>?

When it first came out, many state pharmacy boards were refusing to enforce USP <800> due to the appeals surrounding USP <795> and <797> . Many pharmacy owners were left feeling unsure about the next steps needed to comply. 

“This matter was resolved on March 12, 2020 when USP came back and said that they were going to remand this back to the committee and use previous versions,” says Jeff. “That left USP standing by itself, and that's when it became totally effective.”

What does this mean for pharmacy owners? 

“Up until the COVID-19 outbreak there were states enforcing USP <800> at retail and long term care pharmacies,” says Hedges. Although there has been a pause in enforcement due to the pandemic, Hedges believes pharmacists should immediately prepare to comply.  

“Start now, the regulations are in effect. Regulators are not going to inspect during the COVID-19 emergency, but when this is over, you can expect these inspections to start at all levels nationwide,” says Hedges. 

What Does it Mean for Independent Pharmacy?

Independent pharmacies can expect to see a new guideline to help track all hazardous drugs. “Retail pharmacists will have to create a document called an Assessment of Risk, and that document has to be completed on every hazardous drug,” says Hedges. 

“There are specific elements in the document, and it needs to be signed by the hazardous drug designee, and renewed every year,” adds Hedges. In addition to the hazardous drugs tracking system, USP <800> specifies which drugs are allowed to be processed through an automation system.

A major factor that pharmacy owners should prepare for is the decontamination of a hazardous drug. “Pharmacies should already have some type of spill kit in place to deal with bio-hazards. That would include a solidifier, a scoop bag, gloves, disinfectants, and other items like that. And it should be sent off to be disposed of as a bio waste,” says Hedges. rxsafe1800multiind-200x300-1

The Impact on RxSafe Customers

For RxSafe 1800 owners, there are no new changes. The RxSafe does not violate the dispensing guidelines of USP <800>. Each medication remains in the original packaging that it arrives in, which is then stored inside the RxSafe 1800. When a medication is needed, a staff member inputs the correct information into the system. The RxSafe 1800 then retrieves the appropriate medication, and dispenses the entire stock bottle. 

The RxSafe does not open any stock bottle within the machine, eliminating the risk of cross contamination. This means that both hazardous and regular medications can be stored within the RxSafe 1800. 

If you would like to learn more about the compliance of the RxSafe 1800 or the RapidPakRx with USP <800>, please call us at (877) 754-1285.


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