USP Opens Door to Pending Monographs for Excipients

May 13, 2010
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

Effective May 1, 2010, the US Pharmacopeia revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and ultimately can be included in an official National Formulary (NF) monograph.

According to the updated guideline, the purpose of a pending monograph is to ensure that an official monograph is ready as soon as possible after the US Food and Drug Administration grants final approval of the drug product and its components. In the past, excipient monographs were not created until FDA approved them as part of a new drug application (NDA) or abbreviated new drug application. However, a novel-excipient evaluation procedure developed by the International Pharmaceutical Excipients Council last year seems to have paved the way for FDA to review novel excipients outside of the NDA process and, under certain conditions, for USP to accept the excipients as subjects of monographs (see previous story in PharmTech’s November 2009 issue).

Pending monographs are published electronically on the USP website at the end of each month based on information included in NDAs and other FDA filings. Pending monographs are considered authorized but not official.

The revised USP guideline also states that a company cannot use “USP” or “NF” labeling based on adherence to a draft or authorized pending monograph. Such labels are only permitted in reference to official monographs published in the USPNF, which are legally enforceable by FDA.