USP <800> Delivers Standardization

July 2016 : Hazardous Drug Handling - Vol. 13 No. 7 - Page #1

Historically, the approach to hazardous drug (HD) issues has varied greatly among regulatory bodies. Some state boards took an aggressive stance pursuant to HD compliance, while others demonstrated less interest. Given this, among the more strident benefits of USP <800> Hazardous Drugs—Safe Handing in Healthcare Settings is that it establishes a single, clear standard, to which health systems nationwide will be accountable. State boards of pharmacy are in the process of being trained extensively on this regulation and we can expect their inspections will reflect their commitment to this standard moving forward.

The deadline of July 1, 2018 for implementation of USP <800> may seem a ways off, but the time to prepare is now. Approaching compliance in a thoughtful and progressive fashion will reap significant benefits come the Summer of 2018. Keep in mind that CMS recently added USP <797>—in its entirety—to the conditions of participation. As such, we can project that the same is likely to occur with USP <800>. In turn, both CMS and the various accrediting bodies also will be inspecting hospitals with a commitment to ensuring compliant HD practices.

While the first step in any compliance plan should be conducting a gap analysis to identify areas that require improvement, pursuing the low-hanging fruit is also an effective approach. USP <800> requires the use of CSTDs during HD administration. If you have not implemented these safety devices, now is the time. And while CSTDs may only be recommended—not required—for HD compounding, there is really no way to justify adding this protection to one class of employees (nursing) while denying it to another class (pharmacy).

Pharmacy Purchasing & Products will continue to cover the myriad topics related to HD handling and compounding, and in the meantime, please review the contents of this supplement with an eye toward your adoption of USP <800>.

All the best,
R. Mitchell Halvorsen


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