Enclosed are comments on "Guidance for Industry; Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use - Labeling for Products that Contain Acetaminophen."
Presentation by Scott Melville, president and CEO of CHPA regarding using innovative technologies and other conditions of safe use to expand which drug products can be considered nonprescription.
This report will reveal analysis and insight into what factors help stimulate growth in the categories that are driving the independent pharmacy front-end.
The reason we’re here today is to discuss a provision of the Affordable Care Act that requires holders of tax‐preferred healthcare accounts to seek a prescription if they wish to use those accounts to purchase an OTC medicine. We believe this requirement is bad policy for both the American consumer and the U.S. healthcare system.
The proposed rule will require child-resistant packaging for OTC and prescription products containing the equivalent of 0.08 milligrams or more of an imidazoline.
CHPA encourages FDA to work with industry and other stakeholders to develop and discuss alternatives to an ingredient ban. Given the extremely low levels of gluten in OTC drugs today, a ban would unnecessarily disrupt the supply chain and may limit the availability of important products relied on by millions of consumers.
