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.
The DEA invited comments on the proposed rule to revise existing regulations that manage quotas for controlled substances and List I chemicals held by DEA-registered manufacturers. We have comments on three areas within the proposed rule.
Today, the manufacturers of OTC medicines containing pseudoephedrine call on Congress to improve the Combat Methamphetamine Epidemic Act by requiring a unified, national electronic tracking system to block illegal sales of PSE‐containing medicines.
CHPA is deeply concerned that safe and effective medicines manufactured by its member companies are being diverted to manufacture meth. We understand the scope of this problem and are committed to the need for strong action to prevent the diversion of these important medicines to the illegal manufacturing of methamphetamine.
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."
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.
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.
Letter from the Consumer Healthcare Products Association, the Food Marketing Institute, the Healthcare Distribution Management Association, and the National Association of Chain Drugstores regarding controlled substances and Lis I chemical registration application fees.
