Guideline for Pending Monographs 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.Revision
USP has revised the guideline to take into account several comments:
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.
Karen A. Russo, PhD, is director of small molecules and monograph acquisition, and Roger L. Williams, MD,* is executive vice-president and chief executive officer, both at the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8300, firstname.lastname@example.org
*To whom all correspondence should be addressed.
1. FDA, Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV (Rockville, MD, May 2004).