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Dates and Comment Period for USP–NF and FCC Publications Extended

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The U.S. Pharmacopeia (USP) is taking actions to help stakeholders currently facing numerous challenges with maintaining normal operations during, and responding to, the Coronavirus disease (COVID-19) global pandemic. In light of these circumstances, the USP Council of Experts (CoE) has adjusted the upcoming official/effective dates for the U.S. Pharmacopeia and National Formulary (USP–NF) and Food Chemicals Codex (FCC) publications as follows:

  • United States Pharmacopoeia and National Formulary
    • USP 43–NF 38 (published November 2019): Official date has been extended by six months from May 1, 2020 to Nov. 1, 2020
    • USP 43–NF 38, First Supplement (published February 2020): Official date has been extended by three months from Aug. 1, 2020 to Nov. 1, 2020

Per the USP–NF General Notices and Requirements, Section 3.10 Applicability of Standards, early adoption of revised standards in advance of the official date is allowed by USP, unless specified otherwise at the time of publication.

  • Food Chemicals Codex
    • FCC, Twelfth Edition (published December 2019): Effective date has been extended by six months from June 1, 2020 to Dec. 1, 2020

In addition, USP is extending the comment period deadlines for Pharmacopeial Forum (PF) 46(2) [Mar.–Apr.] 2020 by two months from May 31, 2020 to July 31, 2020.

In addition to proactively adjusting official dates and comment timelines for USP publications, USP may facilitate rapid compendial actions, if necessary, to prevent supply disruptions and ensure the availability of existing/new treatments.

The unfolding Coronavirus disease (COVID-19) outbreak is placing unprecedented burdens on the public health infrastructure, including the drug supply chain. The above actions are being taken to support industry and regulators while continuing to promote quality and public health during this difficult time.

For more information, visit www.usp.org/about/public-policy/covid-19.

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