We submit these comments on behalf of CHPA in response to the proposed rule regarding security requirements for manufacturers, distributors, importers, and exporters of pseudoephedrine, ephedrine, and phenylpropanolamine.
This letter is submitted on behalf of CHPA, FMI, HDMA, and NACDS. The purpose of the letter is to express our united concern that the DEA’s proposed rule is not supported by existing evidence and will impose a significant burden on the regulated industry.
Comments on proposed revisions to the Proposition 65 prioritization procedure submitted by the Consumer Healthcare Products Association, Grocery Manufacturers of America, and the National Food Processors Association.
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.
We would like to commend the U.S. Government position previously taken on the vitamin and mineral supplement draft guidelines, and encourage the U.S. Government to maintain a similar position.
CHPA requests CFSAN to commit to the finalization of Good Manufacturing Practices for dietary supplements as one of its highest priorities for FY 2005.
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.