Updated: As of November 22nd, 2019, the USP will delay implementing previously suggested changes to USP 795 and 797 chapters until further notice.
The USP published revisions to USP 795, 797, and 825 on June 1, 2019. The documents are available for free download until December 2019.
We’ve previously published a host of articles in regards to the USP compounding cleanrooms, particularly, environments related to USP 797 and USP 800.
November 22nd, 2019 Update
USP Postpones Intended Date for USP 795 + 797 Revisions: Suspends Adoption Until Further Notice
"In light of these appeals, and in accordance with our Bylaws, USP is postponing the official date of <797> until further notice. In the interim, the current official version of <797> (last revised in 2008) including the section Radiopharmaceuticals as CSPs will remain official. The decisions on the appeals to <797> do not foreclose the possibility of future revisions to this chapter."
USP 797: "The currently official version of General Chapter <797> (last revised in 2008) remains official until further notice." -USP.org
September 23rd, 2019 Update:
The revisions to <795> and <797> published on June 1, 2019 and which make reference to <800>, have been postponed until further notice, pending resolution of appeals of those chapters.
Although these revisions have been postponed, USP <800> will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendiously applicable.
When Does USP 800 Become Official?
For all of the latest documentation including 797, 795, and 825. Apply here for the bulk USP document downloads at no cost.
Where Can I See a full List of Changes and USP Revisions?
USP compounding changes are shown on the USP website.
Notable revisions include:
Some information sources have been revised or redacted.
“Additionally, a reference in <800> to <797> will be aligned based on the revisions to <797>. The modifications will become official on December 1, 2019, to coincide with the official date of general chapters <795>, <797>, and <800>.”
“The official date of <800> was previously postponed to align with the revisions to Pharmaceutical Compounding—Nonsterile Preparations <795> and Pharmaceutical Compounding—Sterile Preparations <797>.”
Who Do USP Revisions Impact the Most?
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Disclaimer
Consulting a contamination control specialist about your specific needs or requirements is best practice. The information herein is for discussion only does not constitute a recommendation for your facility.
Effective cleaning requires a case-by-case evaluation and consideration for state, federal, and local authority. It is the responsibility of the manufacturer to outline, define, revise, and validate standard procedures and protocols internally.
Web content provided by Production Automation Corporation (PAC) makes no claims as to the final interpretations or implementation of regulatory documents, organizational standards, or best practices as provided by stakeholders, CDC, FDA, WHO, OSHA, Poison Control, State Board of Pharmacy, or United States Pharmacopeia (USP).
