CPhA releases statement on USP <800> and pending California regulation

By | March 31, 2016

CPhA recently sent out an alert notifying members of upcoming California State Board of Pharmacy adoption of USP <800> guidelines. You can read about it here.

California isn’t planning to adopt the entirety of USP <800>, but what they have decided to adopt will become enforceable on January 1, 2017. “The proposed California BOP regulations adopt certain requirements for engineering controls consistent with USP <800>, but the regulations do not adopt USP<800> in its entirety.  Specifically, the new regulations only apply to antineoplastic agents identified by NIOSH as hazardous.“ That’s interesting. I wish they’d just adopt the whole thing and get it over with. This is going to create a lot of confusion, especially with the proposed date of January 1, 2017. As it stands now, USP <800> isn’t supposed to be enforceable until July of 2018. Guess California has other plans.

However, it’s not all bad. Pharmacies can apply for an exemption if the meet the necessary requirements. From the alert: “… [this is] particularly concerning for compounding pharmacies because the proposed regulations have an effective date of January 1, 2017.  As explained in further detail below, pharmacies compounding hazardous drugs will not be required to comply with the USP <800> provisions on January 1, 2017 … The BOP regulations have a proposed effective date of January 1, 2017, but the BOP included a process for pharmacies to apply for a waiver from the above requirements when compliance requires physical construction or alteration and the pharmacy needs additional time beyond the implementation date to complete the upgrades.  The BOP will require that good cause be demonstrated and it is recommended that pharmacies compounding hazardous drugs develop a plan and begin implementing steps necessary to come into compliance with the above BOP requirements“. There’s always a loophole in there somewhere. So if you have to do construction or any major renovations to comply with USP <800>, you have a bit of a reprieve. Just make sure you apply for the waver.

People are going to be scrambling.

2 thoughts on “CPhA releases statement on USP <800> and pending California regulation

  1. john ortego

    Jerry
    Do you know how one goes about obtaining a waiver? It’s very difficult to find any helpful info on the BOP website.

  2. Pingback: USP Announces Intent to Postpone Official Date of USP Chapter – Jerry Fahrni

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