International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Gamma-hydroxybutyric acid (GHB); Ketamine; Dextromethorphan; N-benzylpiperazine (BZP); 1-(3-trifluoromethylphenyl)piperazine (TFMPP); 1-(3-chlorophenyl)piperazine (mCPP); 1-(4-Methoxyphenyl)piperazine (MeOPP); 1-(3,4-methylenedioxybenzyl)piperazine (MDBP); Gamma-butyrolactone; 1,4-Butanediol

October 3, 2008 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; … Dextromethorphan …, 73 Fed. Reg. 51823 (September 5, 2008) [Docket No. FDA-2008-N-0448] Dear Sir or Madam: We are pleased to provide comments to the Food and Drug Administration on our perspectives related to the impact of potential international restrictions being placed on dextromethorphan. The National Association of Chain Drug Stores (NACDS) represents traditional drug stores, supermarkets, and mass merchants with pharmacies. Its more than 170 chain member companies include regional chains with a minimum of four stores to national companies. NACDS members also include more than 1,000 suppliers of pharmacy and front-end products, and nearly 90 international members representing 29 countries. Chains operate more than 39,000 pharmacies, and employ a total of more than 2.5 million employees, including 118,000 pharmacists. They fill more than 2.5 billion prescriptions yearly, and have annual sales of over $750 billion. For more information about NACDS, visit www.NACDS.org. Dextromethorphan is a safe and highly-effective antitussive. It is non-addictive. It is the most common ingredient in over-the-counter cough medicines in the United States. Dextromethorphan has no practical alternative. It was approved by the FDA in 1950s to replace codeine in cough syrups to prevent codeine abuse. When used in therapeutic doses, dextromethorphan produces very few side effects and has a decades-long history of safety and efficacy. We ask FDA to recommend to WHO that dextromethorphan not be subject to additional action by WHO's Expert Committee on Drug Dependence after the April 2009 pre-review. Additional action is not warranted, and could lead to substantial negative impacts upon U.S. citizens. 1.Legitimate use of Dextromethorphan Dextromethorphan is the most commonly used antitussive in the United States. It is available without a prescription, but is also included in some combination prescription products. It has been commercially available as an antitussive since the 1950s, and has a long and well-established history of safety. It is very well tolerated and is highly efficacious in the treatment of acute coughing, especially related to respiratory infections. It is available in both solid and liquid dosage forms. It is used for both adult and pediatric patients. 2.Abuse of Dextromethorphan Although dextromethorphan is an inherently safe substance, we are aware of reports of individuals taking massive doses, such as 25 times or more of the recommended dose, to achieve a hallucinogenic effect. Most of this abuse is of the finished, commercially-available products, which are swallowed whole. To our knowledge, chemical extraction is extremely rare. We are not aware of any routes of administration for abuse besides oral. This inappropriate use is among teenagers; in fact, the abuse of prescription and non-prescription medications commonly found in home medicine cabinets is a problem somewhat unique to the current generation of teenagers. This abuse, and how to address it, are common topics of debate and concern among policymakers. We expect the abuse of these products by teenagers to wane over time both as a result of successes from educational and similar efforts to reduce abuse, and as the novelty of abusing these products diminishes. 3.Control of Dextromethorphan Since dextromethorphan in not an addictive substance, it is not subject to the controlled substance laws of the United States federal or state governments. It is commonly available in nonprescription preparations, and can be purchased at most retail outlets in the country. While the ingredient is not subject to controls and while we are unaware of any reports of unfin…