This goes beyond preparation and administration all the way through packaging, transportation and disposal.

Because USP <800> may carry a heavy burden in cost, this resolution has not been met with popular support.¹ But more than 264 drugs are classified as hazardous by NIOSH,² which means the issue is impossible for the industry to avoid.

The Difference Between USP <797> and <800>

Published in 2004, USP <797> focused on patient safety in sterile compounding pharmacies. Many stakeholders across the industry quietly resented the regulation and some discouraged its discussion. But in 2012, 64 people died and 800 were injured by substandard aseptic compounding practices by a single facility—the New England Compounding Pharmacy. This engendered a sea change of attitude and USP <797> enforcement.³

USP <800>, on the other hand, focuses on a far narrower population and pharmaceutical focus—healthcare professionals and best practices for handling HDs. Bearing in mind that the consequences of HD exposure typically manifest in the long term and are far more difficult to attribute with certainty, there is a lack of urgency behind USP <800> and many feel its burdens exceed the benefits.

What Does USP <800> Entail?

From a broad perspective, an overhaul of the engineering controls for preparing, packaging and unpacking HDs. For example, facilities may continue to use biological safety cabinets (BSCs) and compounding aseptic containment isolators (CACIs) for preparing HDs, but permissible conditions will change.^{4, 5} The “low volume exception” that allowed a Class II BSC or CACI to be used for both sterile and non-sterile HD prep will be eliminated, requiring a dedicated control. More importantly in terms of infrastructure, HD preparation must occur in a negative pressure environment. This necessitates building either an ISO cleanroom or a containment segregated compounding area (C-SCA) with exterior ventilation and strict air change requirements.⁶

It will also require a far more disciplined approach for training the personnel involved with HDs. Employers will have to provide all the appropriate HD safety training for each employee’s position with yearly reassessments and documentation of competency. Additionally, facilities will need to designate a supervisor for HD practices and create a detailed quality assurance program. .⁷

Why USP <800> Makes Sense

It is true that USP <800> will likely not provide safeguards against a dramatic, made-for-TV tragedy like the meningitis outbreak of 2012. But it will help protect healthcare organizations involved with HDs and their employees.

A study in 1999 prompted today’s HD regulations when it showed that women who handled HDs while pregnant had a 40% higher risk for catastrophic pregnancy outcomes.⁸ Current studies have proven that even under existing regulations, healthcare workers who handle antineoplastic drugs in the workplace are significantly more likely to suffer genetic abnormalities than those who do not.^{9, 10, 11}

Considering that Johnson & Johnson was recently ordered to pay $4.69 billion to 22 women who allegedly developed ovarian cancer from its famous baby powder,¹² protecting the 8 million healthcare workers who handle HDs is in everyone’s best interest.¹³

Will USP <800> Be Legally Enforced on December 1, 2019?

That depends on your facility. If you accept Medicaid and Medicare funding then you are obligated to follow all USP chapters under <1,000>, which will include USP <800>.¹⁴ But the FDA has not formally adopted USP <800> standards, so it won’t be federally mandated—at least in the beginning.

Otherwise, it depends on your state pharmacy board. Although many have chosen to pass on enforcing USP <800> compliance and your state may be among them, that doesn’t mean you shouldn’t adopt the standards. In fact, it is much safer for you to do so regardless of the initial enforcement status in your locale.

Why You Shouldn’t Wait to Adopt USP <800> Regardless of Enforcement

First, it will help protect your staff from hazards and safeguard your organization from future legal liabilities. There is a proven HD safety gap in the industry. According to OSHA, 9-13% of pharmacists and nurses who handle HDs never received specialized safety training. Even more troubling, staff members who prepare HDs reportedly fail to wear basic protective equipment such as gowns up to 36% of the time.^{15, 16} Secondly, USP <800> will require significant changes to the engineering controls of many facilities. Some may even need to undertake major infrastructure upgrades. Having as much lead time as possible will be key to making these improvements without derailing operations.

From a human perspective, protecting your employees from cancer, genetic defects and other job-related maladies is a moral imperative. The dangers from prolonged HD exposure, in particular, antineoplastic drugs, is scientifically proven.

From a business perspective, predicting changes in your industry and acting before you are forced to react is the best way to get ahead. Adopting USP <800> standards in advance may offer a competitive advantage over competitors who do not.

Final Thoughts

USP <800> represents a major departure from current HD handling practices. If you are conducting a gap analysis, determining cleaning protocols for new engineering controls, or investigating sampling and quality control programs, then reach out to FG Clean Wipes. With more than 50 years in cleanroom and critical environment cleaning, we have experience with numerous facilities that meet USP <800> standards. We can help you get up to speed.