Up Close and Personal - Pharmaceutical Technology

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Up Close and Personal
Regulators and standard-setting bodies are re-examining over-the-counter drugs.


Pharmaceutical Technology
Volume 35, Issue 5, pp. 44-50

Monograph modifications

USP is in the process of updating its compendial monographs and FDA applauds this change, which will help improve the standards companies follow when making drug products. In fact, the agency, along with the Consumer Healthcare Products Association (CHPA), is working closely with USP on the pharmacopeial convention's monograph modernization project, which began in 2010. The aim is to update key USP compendial monographs (to clarify, these are different from FDA's OTC monographs) to incorporate modern analytical methods and technologies.

The most significant gaps reside in USP monographs that have relatively nonspecific identification and/or assay procedures and in monographs lacking procedures for impurities and degradants, says Karen Russo, vice-president for small molecules at USP. In addition to these gaps, methods for certain procedures are outdated (e.g., packed column gas-chromatography and wet-chemistry techniques) and need updating.


Behind the Counter
Furthermore, USP notes that only about 25% of the monographs targeted for revision are OTC-related. Although, says USP, it's important to note that the same product or active pharmaceutical ingredient can be used in OTC and prescription form based on the dose or other FDA criteria.

In February 2011, the standard-setting body said it would be focusing on a few specific OTC monographs based on an FDA request. The agency asked USP to make a priority the monographs for acetaminophen and diphenhydramine (as well as copovidone, crospovidone, povidone, and talc) based on potential health concerns with these drugs (4).

"Acetaminophen- and diphenhydramine-containing drug products are two of the highest-volume selling OTC monograph drugs," explains FDA's Kubaska. "There are known impurities in both of these drugs that represent known (acetaminophen) and theoretical (diphenhydramine) concerns with respect to toxicity. So, the extent of exposure (using sales volume as a surrogate) and toxicity concerns played key roles in the selection of these drugs...."

Adds Russo, "The challenge with diphenhydramine and acetaminophen are the many drug products, particularly those combined with other drugs, and the variety of dosage forms, such as tablets and oral liquids. For example, there are more than 25 acetaminophen-containing dosage form monographs in the USPNF representing primarily OTC drugs."

Another challenge to the project overall, says Russo, is finding the replacement procedures for those monographs that need revision. "We encourage manufacturers to submit their procedures to USP so that the monograph can be revised to incorporate the new procedure(s).... USP is ... using its own laboratory resources to the extent possible to develop and validate procedures to serve as the basis for the monograph revisions; however, we are not able to accomplish this on our own." In addition, says Russo, USP has to find procedures that can accommodate all manufacturers of a given drug substance or drug product.

There is no set deadline for completing the monograph project, according to USP, although a general target is to finish before the 2010–2015 convention cycle ends. USP is hosting an OTC workshop in September 2011 to discuss with industry and FDA some of these compendial issues. (For more details on the monograph modernization project, see the Inside USP column in this issue "Monograph Makeover Requires Industry Input".)


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