Senate Passes Bill Further Amending the CMEA (Our 600th FDA Law Blog Post!)

By John A. Gilbert & Larry K. Houck –

The Senate recently passed S. 256 which places additional requirements on retailers that sell ephedrine and pseudoephedrine.  The bill, known as the “Combat Methamphetamine Enhancement Act of 2009,” was referred to the House (H.R. 2923), which in turn referred it to the Energy and Commerce Committee and the Committee on the Judiciary.

The bill would amend the federal Controlled Substances Act by restricting the distribution and sale of “scheduled listed chemical products,” ephedrine and pseudoephedrine, following restrictions imposed by the Combat Methamphetamine Epidemic Act of 2005.   In summary, the bill would:

• restrict regulated sellers like pharmacies from selling ephedrine and pseudoephedrine at retail unless they have self-certified to the Drug Enforcement Administration (“DEA”), and include a statement that they understand the requirements;
• require DEA to implement self-certification criteria for mail order distributors;
• require DEA to make the list of those who have self-certified with the agency publicly available, and post it on the DEA website;
• prohibit distribution of ephedrine or pseudoephedrine to regulated sellers like pharmacies unless they are registered with DEA or are on DEA’s self-certification list; and
• provide a civil penalty for the negligent failure to self-certify.

The bill is the most recent attempt by Congress to restrict the availability of ephedrine and pseudoephedrine, including cough and cold products, from illicit use in the clandestine manufacture of methamphetamine.  The 2005 Act limited sales and purchase quantities, prohibited direct access by customers, required sellers to maintain a logbook of sales with customer information and train their employees on the requirements and self-certify that training to DEA.

The current bill eases the burden somewhat on distributors by requiring them to confirm that prospective customers are registered with DEA or confirm with the public self-certification list on DEA’s website that they have self-certified with DEA.  This is a better result than requiring that distributors in all cases have to maintain an document the self certification of its customers.  It also requires the DEA to update the self-certification list on a daily basis.

The bill is an attempt to make yet more refinements to the federal law to stop the ability of so called “smurfers” from targeting retail sellers by purchasing ephedrine or pseudoephedrine for the purposes of diverting the product for illicit production of methamphetamine.  We continue to be concerned that the continued emphasis on restrictions of distributors and retailers of these legitimate medicines adversely effect the ability of legitimate customers to purchase these products.  There needs to be more thought to how these continued restrictions on retail sales effect these customers while looking for a more comprehensive approach to stopping the smurfers.