Karen A. Russo

In early 2007, the United States Pharmacopeia (USP) produced 

which allows the organization to create web-based monographs with available official USP reference standards in advance of a US Food and Drug Administration approval of a manufacturer's product for which the monographs are applicable. In response to comments, USP recently revised the guideline and has made it available as version 2.1. This article describes the purpose of the guideline and notes the revisions.

 allows development and online publication of monographs for certain drug products and their drug substances that have been or will be submitted to FDA for approval to market in the United States. It is intended to be useful particularly for generics manufacturers and drug-master-file (DMF) holders, because at times an existing USP monograph is not suitable at the time of FDA approval. Without a suitable monograph, the generics manufacturer and referenced DMF holder may experience marketing delays. In some ways, the pending monograph approach is similar to FDA's tentative approval, which has been applied recently to drug combinations used to treat HIV/AIDS (1). After posting on USP's website, the pending monograph is authorized rather than official (i.e., it is text authorized by USP, but it is not legally enforceable by FDA), and the manufacturer may not use USP on certificates of analysis or on container labeling. If the manufacturer receives marketing approval from FDA, a pending monograph and associated reference standards may move to official status in 

USP has revised the guideline to take into account several comments:  					

Clarification of what constitutes intent to file with FDA.

A requirement that the sponsor promptly inform USP of any changes to methods or specifications that arise during the regulatory review and approval process. This will ensure consistency between the proposed monograph and the private specification approved by FDA. 

Use of USP's Revision Bulletin process to move a pending monograph to official status upon product approval, which will allow monographs to become official more quickly than under the Interim Revision Announcement process formerly used. 

A requirement that USP must receive the bulk material necessary to develop any USP reference standard(s) before the proposed monograph is posted on USP's website. This will help manufacturers meet the requirement that the USP reference standard(s) must be available, as feasible, when the product is approved and the monograph becomes official.

Patients and consumers have a right to good quality drugs. These are available in the US thanks to many requirements, including testing to ensure quality. USP's primary public health purpose is to create and maintain sound public monographs with reference materials to allow this testing. The general idea is articulated clearly in the US Federal Food, Drug, and Cosmetic Act and ties FDA to USP in a historic public–private partnership that has benefited practitioners and patients for many years. The partnership is critically important in an era when adulterated and counterfeit drugs are on the rise.

The guideline is intended to assist all manufacturers seeking FDA approval to enter the US market quickly, with a solid public monograph available as well as associated reference standards at the time of approval. Pending the time to market in the US, the policy also gives the opportunity to manufacturers, regulators, and anyone in other countries to use an authorized pending monograph and official USP reference materials to check the quality of medicines.

 is director of small molecules and monograph acquisition, and 

* is executive vice-president and chief executive officer, both at the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8300, 

*To whom all correspondence should be addressed.

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV 

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USP's guideline for pending monographs can speed up publication of monograhs and time to market.