OTC Medicines

CHPA and its members share DEA's concerns regarding the diversion of pseudoephedrine, ephedrine, and phenylpropanolamine products. However, CHPA does not believe that the notice of proposed rulemaking provides interested parties an adequate record to evaluate and comment upon the security measures DEA now proposes.

The Industry Coalition on 21 CFR Part 11 is pleased to submit the attached Citizen Petition to FDA for consideration. The Coalition comprises 13 trade associations representing manufacturers of products including foods, drugs, cosmetics, veterinary drugs, and medical devices.

CHPA comments on the proposed rule, which is intended to bring FDA regulations into compliance with section 17 of the Best Pharmaceuticals for Children Act.

CHPA submits these comments on behalf of member companies who market OTC drugs for urinary pain relief. Our comments are in response to FDA’s notice requesting information about marketed urinary analgesic/antiseptic drug products that have not yet undergone FDA evaluation.

The Consumer Healthcare Products Association supports the Federal Highway Administration's interim final rule allowing pharmacy signs on federal-aid highways.

We are encouraged that the agency is seeking to provide guidance on how to utilize the TEA process and that the agency has acted on TEAs and has published notices of eligibility for ingredients and conditions based on TEA submissions.

These comments are in response to the "interpretive rule" DEA published to provide a "Clarification of the Exemption of Sales by Retail Distributors of Pseudoephedrine and Phenylpropanolamine Products."

FDA announced a reopening of the administrative record for the rulemaking for OTC laxative drug products. CHPA sees this as an appropriate time to get clarification on an allowable statement of identity for OTC laxative drug products that contain fiber.

CHPA wishes to draw attention to the restrictive environment on where nonprescription medicines can be sold in Japan as a barrier to market entry for such products.

The following comments are submitted by the Joint Oral Care Task Group of CHPA and the Cosmetic, Toiletry, and Fragrance Association with respect to the establishment of a Monograph for OTC Antigingivitis/Antiplaque Drug Products.