OTC Medicines

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two flasks and a beaker on a table in a lab

Submission

Comments to USP: Multiple Active Ingredient Product Monographs

Letter to Drs. Femia and Santos regarding multiple active ingredient product monographs.

Sep 9, 2016

Over the Next Ten Years DXM Will Save Consumers and the Healthcare System $22-31 Billion

Infographic

Over the Next Ten Years DXM Will Save Consumers and the Healthcare System $22-31 Billion

Sep 1, 2016

hands in sterile gloves holding manufactured white tablets

Submission

Comments to FDA: Quality Attribute Considerations for Chewable Tablets

Our member companies generally support the recommendations found in the guidance but have concerns about the scope of hardness measurements and maximum break strength value.

Aug 16, 2016

FDA headquarters sign in Washington DC

Press Releases and Statements

CHPA Statement on Status of Industry Efforts to Modernize the OTC Monograph System, Including Discussions on a User Fee Program

CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive, and accommodating to innovation.

Jul 12, 2016

happy group of teens

Press Releases and Statements

OTC Industry Program to Reduce Teen Abuse of Cough Medicine Containing Dextromethorphan Explored in Peer-Reviewed Journal

Substance Abuse Treatment, Prevention, and Policy recently published a case study authored by CHPA about the association’s efforts to curb teen abuse of OTC cough medicine containing dextromethorphan.

Jun 27, 2016

Black teenager on their smartphone

Press Releases and Statements

CHPA Applauds Delaware Lawmakers for Age-18 Sales Law on Cough Medicine

CHPA released the following statement today in support of a Delaware law prohibiting the sale of OTC medicines containing the cough suppressant dextromethorphan (DXM) to minors.

Jun 17, 2016

FDA headquarters sign in Washington DC

Submission

Comments to FDA: OTC Monograph Reform and User Fees

While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized.

Jun 14, 2016

FDA headquarters sign in Washington DC

Press Releases and Statements

CHPA Statement on FDA Public Meeting on OTC Monograph User Fees

Unlike other drugs subject to user fees, nonprescription drugs under the Monograph system are not subject to FDA approval prior to marketing. Many of these ingredients have been marketed for more than 40 years, with a long history of safe use. We must define value differently than industries subject to FDA approval prior to marketing.

Jun 10, 2016

Orange CHPA logo on dark blue background

Submission

Comments to FDA: Review and Action on OTC Time and Extent Applications

CHPA comments on the Agency’s review and action on OTC time and extent applications. This proposed rule would supplement the time and extent application process for OTC drugs by establishing timelines and performance metrics for the Agency’s review of non-sunscreen TEAs.

May 17, 2016

three quarter view of U.S. capitol building from below

Press Releases and Statements

CHPA Applauds Senate Introduction of DXM Abuse Prevention Act

CHPA is pleased to lend its strong support for the DXM Abuse Prevention Act (S. 2994), introduced into the U.S. Senate by Senators Bob Casey Jr. (D-PA) and Lisa Murkowski (R-AK).

May 16, 2016

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