The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.
Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.
Lawmakers should refrain from imposing unnecessary access barriers to diphenhydramine, as leading manufacturers continuously assess and implement efforts to curb teen abuse without limiting adult availability.
As a direct result of the PROTECT initiative, CHPA developed a voluntary guideline for industry suggesting ways to standardize volumetric measures in dosing directions and dosing devices for oral pediatric liquid drug products.
This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
CHPA and its members, the U.S. manufacturers and distributors of OTC medicines and nutritional supplements, recognize the efforts of the FDA to further develop methodologies and techniques for characterization of nanomaterials for drug applications.
