OTC Medicines

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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

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

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

While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized.

Jun 14, 2016

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

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

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

CHPA issued the following statement following the Food and Drug Administration’s announcement of a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription monograph drugs.

May 10, 2016

CHPA applauds the state of Georgia for becoming the thirty-third state to adopt the real-time, stop-sale technology called the National Precursor Log Exchange (NPLEx).

Apr 28, 2016

CHPA, which represents leading manufacturers of OTC cough medicines, strongly supports this legislation and is joined many by substance abuse prevention organizations such as the Community Anti-Drug Coalitions of America and the Partnership for Drug-Free Kids.

Apr 20, 2016

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