USP and FDA take aim at OTC medicine quality

The US Pharmacopeia is planning to update its monographs for over-the-counter medicines and will hold a joint workshop with the US Food and Drug Administration in September to get feedback on how to proceed.

Topics set for discussion include new monographs for acetaminophen and diphenhydramine, updated quality standards, new tests for impurities and how to handle categories of products - such as mouthwashes and medicated shampoos - that are not currently addressed in USP's National Formulary.

"Prescription and many over-the-counter drugs are regulated differently under the law, but it is equally important for both categories of products to be of high quality, supported by up-to-date, scientifically sound public standards that all manufacturers must adhere to," said the director of the FDA's Center for Drug Evaluation and Research (CDER), Janet Woodcock.

Modernised standards are particularly important as OTC drugs are generally used without oversight by a healthcare practitioner, she added.

More information on the event is available here.