Senate Will Take up Another Dextromethorphan Bill; CSA Scheduling MandatedNovember 15, 2007
In early October, we reported on legislation introduced in the U.S. House intended to restrict the distribution and possession of raw dextromethorphan, an antitussive drug found in many over-the-counter cold/cough drug products. Dextromethorphan is not a federally-controlled substance, however, the Drug Enforcement Administration (“DEA”) recently noted that it is reviewing the drug for possible control under the Controlled Substances Act (“CSA”).
In late October 2007, Senators Joseph Biden (D-DE) and Charles Grassley (R-IA) introduced the Dextromethorphan Abuse Reduction Act of 2007 (S. 2274). (Sen. Grassley’s press release is available here.) The bill, while recognizing that cough medications containing dextromethorphan are safe and effective when used properly, notes that dextromethorphan’s inexpensive cost, legal status and accessibility have contributed to its increased abuse, especially by teenagers. The bill notes that dextromethorphan abuse increased 10-fold between 1999 and 2004, with a 15-fold increase among children between 9 and 17 years old.
S. 2274, if enacted, would place unfinished dextromethorphan in Schedule V under the CSA. Schedule V substances have a low potential for abuse and have a currently accepted medical use in treatment in the U.S. Unfinished dextromethorphan is any form of the drug not in tablet, capsule, solution, liquid or other form intended for retail sale that usually contains inactive ingredients. Placement of unfinished dextromethorphan in Schedule V would subject entities that handle this drug to DEA registration, recordkeeping, reporting, and security requirements.
The legislation would also make it illegal to knowingly sell products containing dextromethorphan to individuals under 18 years old, and would impose civil penalties for persons who do so. Specifically, the bill creates civil penalties of not more than $1,000 for a first violation, up to $2,000 for a second violation, and $5,000 for a third violation. Retailers who fail to check a government-issued identification for an individual under 18 years old are deemed to have knowledge that the person was underage; however, the bill provides an affirmative defense for retailers who check identification and reasonably (though incorrectly) believe it to prove that the purchaser is over 18.
Finally, S. 2274 mandates the Attorney General (as delegated to DEA) to promulgate regulations governing sales of dextromethorphan over the Internet and the imposition of civil penalties, and recommends that manufacturers of dextromethorphan products place language about the dangers of dextromethorphan on packaging and that retailers use safeguards to protect against the theft dextromethorphan products.
Both the National Association of Chain Drug Stores and the Consumer Healthcare Products Association (“CHPA”) issued press releases commending the introduction S. 2274 and promised to work with Congress as the bill moves forward. CHPA notes in its press release that the organization “is spearheading several major campaigns to raise awareness of dextromethorphan abuse, including the comprehensive web site http://www.stopmedicine abuse.org.”