Less is More: Modernizing Quality Standards for Over-The-Counter Drugs

Consumers consider over-the-counter medicines

Millions of consumers rely on over-the-counter (OTC) drug products every day to address an assortment of ailments, and while many OTC drugs are regulated differently than prescription medicines approved by the FDA, the public expects the same quality.

USP’s global mission is to promote public standards that help ensure the identity, quality, strength, safety and benefits of medicines – and a sustainable strategy  that ensures OTC standards remain current at all times is a major focus because of the wide public exposure and access to these products. This is not an isolated concern: In fact, the FDA recently called for ideas about how the OTC system might be improved, drawing numerous comments – including USP’s belief that public standards can help play a role in an overall solution

The biggest challenge springs from the diversity of the OTC marketplace, which includes hundreds of active ingredients and thousands of different formulations. Combine that with branding differences and the number of versions grows exponentially, while the rapid reformulation of OTC products adds further complications.

To address these unique circumstances, USP’s Council of Experts – a volunteer body that helps USP set standards – is discussing a system that includes fewer procedures which are capable of analyzing greater numbers of drug products: truly a case of “less equals more.”  This new approach would allow for the timely and efficient development of public standards that can help maintain the quality of a multitude of OTC drugs, while still allowing manufacturers the flexibility for continued improvements through reformulation of their products.  

Grouping together as many active ingredients as possible, which can be separated by a single testing system, would allow USP to organize related tests and procedures in one place. The issue of how to best assess organic impurities - naturally occurring but undesirable byproducts of the manufacturing process - is still being formulated, but an approach to also minimize the number of methods and possibly maximize the number of specified substances is being considered. The analytical challenges posed by this proposed approach are unique and formidable, but we believe the advent and adoption of modern technologies now makes these hurdles possible to surmount.

The designed approach is intended to account for the frequent reformulation by manufacturers of different product combinations and to ensure that the procedures will be applicable for their intended use. This would also allow for more rapid coverage of new combination products without creating barriers to innovation and will define basic, but meaningful, quality standards.

Note: This new proposed approach would complement USP’s current public standards for various drug substances (active ingredients) – and we also remain committed to modernizing these standards. 

We look forward to a continued dialog with the FDA and other stakeholders as we work on these concepts. Those interested in developments regarding the modernization of OTC compendial standards, or other discussions concerning USP’s public standards, may be interested in our Pharmacopeial Forum – a free online journal that publishes proposed revisions to USP-NF for public review and comment. Additionally, we continue to seek volunteer experts for USP’s Council of Experts and Expert Committees, and USP regularly engages with concerned parties through our Stakeholder Forums and organizations such as the Consumer Healthcare Products Association (CHPA) regarding these topics.

Jon Clark, M.S., is vice president of chemical medicines at USP.

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