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USP 800 Compliancy Is Around the Corner. Are You Ready?

DOP’s, risk managers, and pharmacy technicians should by now all be aware of the procedures implementing USP <800> protocols.

hourglass with cleanroom technicians in background

Bottom line

If your hospital has not yet become compliant, time is not on your side and you may have to act quickly. It is estimated that nearly 30,000 locations throughout the U.S. will require compliancy towards the new USP standards by December 1, 2019 as a multidisciplinary initiative in promoting the safe use, preparation, and administration of hazardous drugs.

Potential effects of shortage

Realistic predictions pose a problem for hospitals applying too late, due to the shortage of suppliers delivering compliancy on time. Assuming there is a shortage of supply by the deadline, there is also an additional risk that hospitals may have to dash out even more money than they initially budgeted for.

Permanent installation or modular cleanroom. Which is best?

Here's a comparison chart comparing stick built installations vs. adaptable cleanroom installations for controlled environments and contamination control.

Cleanroom build comparison chart

Reference source

Prolonging the inevitable

On September 29, 2017 the United States Pharmacopeial Convention (USP) released a notification of intent to revise the official date of USP General Chapter 800 to December 1, 2019, to be aligned with the next revision of USP 797. Their explanation for the postponement is the intent to provide a unified approach to quality compounding.

Still, much speculation surrounds the account for the new release date; one being the stress compounding facilities and hospitals are feeling, having realized the high risk of not meeting the original deadline set for July 2018. This is primarily due to the known short supply of compliant secondary engineering control environments that would be available for delivery and installation in time. Failure for facilities to meet these deadlines could mean stiff fines, and/or being forced to close down their operations.

Knowing the inevitable, the CFO and DOP can make an early, calculated decision and avoid many financial and regulatory problems down the road; not to mention unnecessary interruptions in their processes.

Who enforces USP regulations?
To clear up a misconception, USP does not enforce regulations. It only sets standards. State/federal agencies and officials enforce regulations. Some states already have enforcement laws around the current practice.

Choosing a cleanroom solution

A modular cleanroom will help you transform your existing pharmacy environment into a fully compliant, USP 797/800 certified environment. These cleanrooms are highly adaptable and cost effective. They can be rented or purchased depending on different budget situations.

About QleanAir Scandinavia

With more than 25 years experience, QleanAir Scandinavia’s innovative approach and technology provides businesses with solutions that promote health for their people and customers by controlling their indoor environments and air quality.

QleanSpace – More than just modular

QleanAir Scandinavia’s “QleanSpace” is a turn-key cleanroom with guaranteed functionality, offering highly adaptable solutions with short installation time; providing a safe and efficient environment for pharmacy operations.

Want more information?

Reach out to one of our cleanroom specialists and someone will get back in touch with you shortly to help you evaluate your facility's compliance preparation.

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