The United States Pharmacopeia announced on September 29, 2017, the delay of the compliance with USP 800. Due to the delay with the approval of USP 797 Pharmaceutical Compounding – Sterile Preparations chapter and the conflicting information between the currently approved 2008 version of USP 797 with the proposed USP 800, the delay is necessary. Within USP 800, the chapter refers to both USP 797 and USP 795 for guidance on key sections for compliance. Without USP 797 and USP 800 being in sync, this will lead to issues especially with states that have fully adopted USP 797, but not USP 800.

This delay is not a time to sit back and wait, the changes to the proposed USP 797 is completely redlined. With USP 800 continually referencing USP 797 for guidance, it is expected sites trying to meet full compliance with USP 800 will be complicated by the uncertain changes proposed for USP 797. The additional time availed with the delay should be used to prepare for proposed USP 800 compliance with continuous review of proposed revisions to sterile compounding.

To complicate the compliance process, USP is currently looking to revise the severely outdated USP 795 Pharmaceutical Compounding – Non-Sterile Preparations general chapter. With the prospect of both USP 795 and USP 797 being updated and improved places greater emphasis on sites to prepare for better practice standards requiring continued and on-going diligence to meet and exceed practice standards.

With this delay, the USP is offering sites the ability to download the finalized pdf copy of USP 800 free of charge with a registration by the site. In addition to downloading the chapter, sites should sign up to receive free updates from the USP on new chapters and updates to others: www.USP.org

Count Down to Safety: 99 weeks

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