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."
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.
Personal Care Products Council and CHPA comments in response to FDA rule regarding labeling and effectiveness requirements for certain OTC sunscreen products.
CHPA strongly supports the unanimous votes by the advisory committees to add weight-based dosing directions to the existing age-based labeled dosing directions for children.
Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application.” These comments are focused on issues related to dietary supplements as referenced in the draft guidance.