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CHPA comments on issues associated with the public health benefit of certain drugs being available without a prescription, but only after intervention by a pharmacist.

We understand that FDA is considering a switch of a second generation antihistamine, from prescription to OTC status, over the objections of the company. CHPA opposes a policy to force switch over the objections of the drug sponsor.

This submission represents CHPA's detailed written comments as follow-up to the June meeting and is intended to complement the Association's oral presentation.

CHPA presentations at Food and Drug Administration OTC Part 15 hearing - Over-the-Counter Medications: A Success Story.

CHPA comments on proposed recommendations for the reauthorization of the Prescription Drug User Fee Act.

CHPA and its member companies have an interest and expertise in label comprehension studies and support FDA's efforts to develop guidance for industry on this important topic.

Letter to the FDA's LT Darrell Lyons requesting additional time to address the Nonprescription Drugs Advisory Committee.

Enclosed herein are comments on "Guidance for Industry: Self-Selection Studies for Nonprescription Drug Products."

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.