OTC Medicines

FDA intends to expand the scope of Redbook to include chemical safety assessments for all products over which FDA's Center for Food Safety and Applied Nutrition has statutory authority. We urge FDA to provide clear and specific guidance for applying these principles within each particular context.

Please accept this letter as an official request from the CHPA to participate in the selection process for nonvoting industry representatives for several public advisory committees for the Center for Drug Research & Evaluation.

Letter to Principal Scientific Liaison, U.S. Pharmacopeia, regarding Proposals for Developing Compendial Quality Standards for OTC Drugs.

We ask that in its review of the Proposed Orders, FDA take our framework into consideration when making its GRASE determinations.

CHPA appreciates the opportunity to provide comments to the FDA in response to “Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen”. CHPA and its member companies have an interest and expertise in acetaminophen-containing OTC products and support FDA’s efforts to improve the safe use of acetaminophen.

In principle, CHPA supports an early approval program for proposed proprietary drug names. However, should FDA decide to implement a program, we expect that FDA would publish a draft Guidance for Industry and we would provide further comment based on the criteria.

Letter to Mr. Brown regarding U.S. Pharmacopeia draft publication, "General Chapter <909> Uniformity of Dose from Oral Suspensions in Multi-Unit Containers."