OTC Medicines

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The noteworthy "Flag the Label" program has been adopted by members of the Consumer Healthcare Products Association to aid in alerting consumers to significant changes in nonprescription medicines.

CHPA opposes mandatory manufacturer-funded drug take-back programs as they threaten the affordability of OTC medications that consumers rely on as the first line of defense against common ailments.

The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.

FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.

The bipartisan federal Combat Meth Epidemic Act strikes the proper policy balance between restricting pseudoephedrine access for illicit use without unduly burdening consumers seeking safe, effective cold relief. Therefore, state legislators should refrain from overriding federal guidelines requiring prescriptions for these legitimate over-the-counter medications.

As a direct result of the PROTECT initiative, CHPA developed a voluntary guideline for industry suggesting ways to standardize volumetric measures in dosing directions and dosing devices for oral pediatric liquid drug products.

This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).

Lawmakers should refrain from imposing unnecessary restrictions limiting consumer purchase quantities or behind-the-counter placement for loperamide, as leading manufacturers have already implemented package adjustments to limit potential abuse of these medications by consumers.

CHPA and its members, the U.S. manufacturers and distributors of OTC medicines and nutritional supplements, recognize the efforts of the FDA to further develop methodologies and techniques for characterization of nanomaterials for drug applications.

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