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USP delays revised chapters; USP to be "informational" only


September 26, 2019

By Brian Ward

USP announced this week that it would be delaying the implementation of three new and revised chapters; <795> Pharmaceutical Compounding—Nonsterile Preparations, <797> Pharmaceutical Compounding—Sterile Preparations, and <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging. Originally intended to take effect on December 1, it’s unclear how long the delay for these chapters will be.

Meanwhile, USP <800> will still take effect on December 1, the Healthcare Quality and Safety team at USP explained that it would only be “informational and not compendially applicable.”

“It means that [<800>] is an official chapter, but since it’s compendially related to <795> and <797>, isn’t enforceable until the others are official,” Patricia Kienle, RPh, the director of Accreditation and Medication Safety for Cardinal Health, explained to Pharmacy Practice News. “USP, of course, does not enforce these chapters; state boards of pharmacy and other regulators and accreditation organizations do. Some states have said that they are going to enforce <800> beginning on Dec. 1, but we don’t know yet how this will affect those plans.”

The delay was due to the number of appeals that USP received about certain provisions in <795>, <797>, and <825>.

“In accordance with USP’s Bylaws, the responsible Expert Committees worked with a sense of urgency to consider the information raised in the appeals and issued decisions on the appeals,” the Healthcare Quality and Safety team wrote in a letter to stakeholders. “In accordance with USP’s formal appeals process, stakeholders who submitted appeals on the compounding chapters have requested further review by an appointed Panel. USP’s Bylaws provide that the official date of a standard under appeal must be postponed while an appeal is pending.”

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