On March 12, the United States Pharmacopeia announced the results of the last minute appeal that was filed earlier this year- just before the anticipated implementation deadline for the updated USP Chapter 795, USP Chapter 797 and brand new USP Chapter 825.
To summarize the actions taken, the USP has accepted the appeal for USP Chapter 797 and has charged the original development committee with re-looking at the requirements contained, particularly around beyond-use dating requirements. While the draft requirements are being reviewed, the 2014 USP Chapter 797 ( last revised 2008) and USP Chapter 795 from 2014 will remain as the expected standard for compliance.
The appeal for USP Chapter 825, specific to radiopharmaceuticals was denied and USP will now assign a new implementation date as they are required to provide a minimum of a 6-month implementation period.
To read the details directly from USP, follow this link:
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