Submission of modernization proposals and donor recognition

Parties wishing to support the updating of standards can submit monograph modernization proposals to USP and donate associated reference standards. To maintain consistency with FDA-approved control strategies, USP prefers to receive submissions from manufacturers of FDA-approved products or manufacturers intending to seek FDA approval (the latter category of submissions will be initially considered for publication as a pending standard through USP s Pending Monograph process). Submissions, especially new impurity procedures, from other sources (e.g., contract laboratories, academic institutions, and analytical instrumentation/equipment manufacturers) will be accepted by USP on a case-by-case basis. Additional information about submitting proposals is available at http://www.usp.org/pdf/EN/USPNF/revisionRequestChecklist.pdf.

Recognizing the importance of industry contributions, USP recently expanded its Donor Recognition Program. Under the program, qualifying donors of monographs and reference materials are recognized through a portfolio of options. For example, donors may be recognized in USP publications and at the USP Science & Standards Symposium, formerly known as the Annual Scientific Meeting. In additon, donors may receive complimentary or discounted registrations to the USP Science & Standards Symposium; complimentary workshop registrations; a complimentary print subscription to USP-NF, the Food Chemicals Codex (FCC), or Dietary Supplements Compendium; complimentary registration for an on-site USP Pharmacopeial Education course; one-year, multiple-user license of electronic USP-NF or FCC; and complimentary USP Reference Standards. The expanded program is meant to acknowledge that the development of quality standards is truly a cooperative and collaborative effort. In USP s mission to protect public health through the establishment and maintenance of quality standards, USP appreciates the vital participation of industry.

One of the most important elements of the monograph modernization effort will be the public review of modernization proposals. All proposals will be published in the Pharmacopeial Forum (PF), the vehicle through which USP develops and revises USP-NF standards, and will follow USP s established process for public review and comment. Because any single proposal for modernization has the potential to impact the industry significantly (manufacturers will be required to comply with updated standards upon their effective date), USP would like to emphasize the importance of reviewing submissions to PF and encourages manufacturers to provide comments. More information about the program is available at http://www.usp.org/USPNF/submit-Monograph/improveMon.html.

Karen A. Russo, PhD, is vice-president, small molecules, at the US Pharmacopeial Convention (USP).