OTC Medicines

CHPA is supportive of the proposal to rely on a general chapter structure and publishing quality standards for new compendial drug product monographs. We would however request the publication of Chapters <321> and <327> be delayed until a number of details can be addressed.

CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Best Practices in Developing Proprietary Names for Drugs”. CHPA members hope the Agency will find the suggested revisions in these comments informative as the final version of the guidance is developed.

Because of FDA's safety concerns regarding the control and monitoring of levomethorphan, CHPA supports the control of levomethorphan as an impurity and respectfully submits the following comments regarding the proposed updates to the DXM monograph as proposed in the IRA published in PF 40(3).

Comments regarding a citizen petition requesting that the Commissioner of Food and Drugs add a warning to the labeling of all nonprescription drug products containing ingredients with anticholinergic or histamine inverse agonist effects to indicate that products with these ingredients can cause a confusional state.

The Petitioners request that the Commissioner of Food and Drugs add a warning to the labeling of all nonprescription drug products containing an ingredient with “anticholinergic or histamine H1 inverse agonist effects” noting that the product can cause a confusional state.

CHPA applauds and is strongly supportive of FDA's re-examination of the monograph system in an effort to complete the OTC Drug Review.

Comments regarding guidance for clinical investigators, sponsors, and institutional review boards on investigational new drug applications - Determining whether human research studies can be conducted without an investigational new drug application.

CHPA and its member companies strongly support the OTC Monograph System, which effectively and efficiently regulates the majority of OTC medicines on the U.S. market.