OTC Medicines

Submission

CHPA and PCPC Comments Regarding Content and Format of Labeling for Human Nonprescription Drug Products

In general, members are very satisfied with the existing regulations for content on the PDP, and recommend that no additional guidance on this topic is needed.

Nov 8, 2022

Other Issues

Labeling

Submission

Comments Regarding Providing OTC Monograph Submissions in Electronic Format

This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Nov 7, 2022

Monograph Reform

woman worker in protective clothing operating production of tablets in sterile environment

Submission

Comments Regarding Quantitative Labeling of Sodium, Potassium, and Phosphorus for OTC and Prescription Drug Products

Nov 7, 2022

Weekly Voice

Federal Register (FR) Notices, October 24, 2022

Oct 28, 2022

Press Releases and Statements

OTC Hearing Aid Rule Takes Effect Next Week

The Consumer Healthcare Products Association (CHPA) applauds the U.S. Food and Drug Administration’s (FDA) final rule establishing a regulatory category for over-the-counter (OTC) hearing aids which will officially take effect Monday.

Oct 13, 2022

Rx-to-OTC Switch

Weekly Voice

Federal Register (FR) Notices, October 10, 2022

Oct 10, 2022

Submission

Comments to FDA: Remote Regulatory Assessments Draft Guidance

Sep 30, 2022

Newsletters

Federal Register (FR) Notices, September 12, 2022

Sep 15, 2022

Press Releases and Statements

CHPA Applauds Progress as FDA Moves Forward on First-Ever Switch Application for OTC Oral Contraception “Opill”

CHPA President and CEO, Scott Melville, today released the following statement in response to the U.S. Food and Drug Administration’s announcement of a joint meeting between its Advisory Committees on Nonprescription Drugs and Obstetrics and Reproductive and Urologic Drugs.

Sep 12, 2022