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Our member companies generally support the recommendations found in the guidance but have concerns about the scope of hardness measurements and maximum break strength value.

CHPA is generally supportive of the revision proposal to update and clarify the Chapter. We would however request that the implementation be delayed for 24 months.

The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) request that FDA withdraw its Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).

Because of FDA's safety concerns regarding the control and monitoring of levomethorphan, CHPA supports the control of levomethorphan as an impurity and respectfully submits the following comments regarding the proposed updates to the DXM monograph as proposed in the IRA published in PF 40(3).

Letter regarding modernization of the USP compendia for OTC medicines. CHPA supports improving the compendial test methods and establishing product standards for safety.

CHPA supports rules governing the regulation of dietary supplements as a special type of food. The association has long advocated Good Manufacturing Practices for dietary supplements.

CHPA strongly supports USP's efforts to address impurity control in drug substances and products. Overall the newly revised chapters provide reasonable guidance and direction for controlling organic impurities.

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

The proper application/usage, scope, and cause for revisions of the <661> suite of chapters is not clear nor intuitive which is a concern given the potential impact.

Letter regarding the Healthcare Distribution Alliance position on the Draft Guidance for Industry: Initiation of Voluntary Recalls.