DEA Sets Self-Certification Fees

By John A. Gilbert & Larry K. Houck  –      

The Drug Enforcement Administration (“DEA”) published a final rule on December 29, 2008 setting annual self-certification fees at $21 for “regulated sellers.”  “Regulated sellers,” persons and entities who sell scheduled listed chemical products at retail locations, must self-certify with DEA that they comply with certain requirements of the Combat Methamphetamine Epidemic Act of 2005 (“CMEA”).  The final rule is effective February 1, 2009.

Still left unanswered is what responsibility will suppliers or customers of these regulated entities have to determine whether the entity has submitted self-certification to DEA. For example, it is likely that DEA could hold suppliers accountable if there is a diversion issue and it turns out the purchaser has not self-certified.

The final rule states that regulated sellers cannot sell nonprescription products containing ephedrine, pseudoephedrine and phenylpropanolamine (“scheduled listed chemical products”) unless they have self-certified.  This certification must state that:

• Their employees have undergone training about CMEA requirements;
• They maintain records of that training;
• They understand that they cannot sell more than 3.6 grams of such products in a calendar day;
• Nonliquid products are packaged as required under the law;
• Scheduled listed chemical products are stored behind the counter or in a locked cabinet;
• They maintain a written or electronic logbook with required sales documentation; and
• They will disclose logbook information only to law enforcement authorities or to facilitate a product recall.

The Appropriations Act of 1993 requires DEA to set registrant fees to ensure the recovery of the full costs of operating the various aspects of the Diversion Control Program.  DEA determined that self-certification is one of the “various aspects” of its diversion control program.  DEA therefore calculated the Fiscal Year 2006 self-certification set-up costs, and operating and maintenance costs in Fiscal Year 2007 and 2008 to arrive at $2,240,496.  DEA divided the total cost by double the anticipated population of 55,000 affected regulated sellers (110,000) to reflect the initial self-certification and one renewal by each during the period.  DEA rounded the fee up to $21.00 per regulated seller.  DEA could not determine the cost of enforcement activities and subsequent proceedings and promised to recover their costs through fees revised by future rules. 

DEA waived self-certification fees for regulated sellers who hold current registrations to dispense controlled substances as pharmacies, rationalizing that “the retail sale of scheduled listed chemical products is essentially the same activity as dispensing (that is, sale at retail) of controlled substances.”