ANNOUNCEMENT - Effective February 1, 2009

Dear Regulated Seller:

On December 29, 2008, the Drug Enforcement Administration (DEA) published a Final Rule in the Federal Register entitled "Final Rule: Combat Methamphetamine Epidemic Act of 2005: Fee for Self-Certification for Regulated Sellers of Scheduled Listed Chemical Products (PDF) (December 29, 2008)." The Rule became effective on February 1, 2009 and established a $21 self-certification fee for regulated sellers of scheduled listed chemical products (SLCPs) that are not DEA pharmacy registrants. SLCPs are defined by the Combat Methamphetamine Epidemic Act of 2005 (CMEA) as any product that may be marketed or distributed lawfully in the United States under the Federal Food, Drug and Cosmetic Act as a nonprescription drugthat contains ephedrine, pseudoephedrine, or phenylpropanolamine.

As part of the requirements of CMEA, an annual self-certification is required for all regulated sellers of scheduled listed chemical products. A regulated seller must not sell SLCPs unless it has self-certified with DEA. In self-certifying, the regulated seller is confirming:

  • Employees have been trained.
  • Records of the training are being maintained.
  • Sales limits are being enforced.
  • Products are being stored behind the counter or in a locked cabinet.
  • A written or electronic logbook is being maintained.

Training materials designed by DEA must be used, although a regulated seller may include information in addition to that provided by DEA. DEA training materials may be found on the Diversion Control Program website. The self-certification is subject to the provisions of 18 U.S.C. §1001. A regulated seller who knowingly or willfully certifies to facts that are not true is subject to fines and imprisonment.

The only way to self-certify is through the internet at the Diversion Control Program website, Self-certification can be accomplished on any computer - at the store, at home, at the library, or at any other location. At the end of the self-certification process, you will need a credit/debit card to pay the $21 self-certification fee and a printer to print the certificate for your location. If you do not have a printer, you can prompt the system to mail the certificate to you.

Steps to Self-Certify

  • Website: To start the self-certification process, go to Scroll to the right and down until you reach a yellow square labeled, "Combat Meth Act of 2005." Double click on the yellow square. This will open the page that has information about the CMEA.
  • Training: Scroll down the page until you reach a section called "Required Training and Self-Certification." Click on "Training for Retail Distributors" or "Training for Mobile Retail Vendors," as appropriate. You must use this material to train all employees who sell scheduled listed chemical products.
  • Self-certification: To self-certify the retail location, click on "Self-Certification" under Required Training and Self-Certification. On the next page, click on the button for "self-certify" and then click the button "Click to start."
    • Go to the bottom of the next page. It will ask for a DEA registration number.
      • If you are a DEA registered retail pharmacy, enter your registration number.
      • If you are not a retail pharmacy registered with DEA, leave it blank and click the "next" button.
    • Fill in the next page with the required information including the store's tax identification number. The field for an email address is optional and does not need to be completed. When you have completed the page, click "next." You will have a chance to review the information you have entered and change any information that is incorrect.
    • If you are not a pharmacy, you will be asked to enter your credit/debit card information to pay the $21 fee.
    • Scroll down that page and you will be asked to check a box that indicates you agree to certain requirements. It is important that you read the requirements as the self-certification is a legal document.
    • Scroll further down the page and you will be requested to enter the name of the person self-certifying for the location and date. Click "submit."
  • Printing the certificate: Before you print, set the page layout to LANDSCAPE (go to File on the menu bar > page layout > landscape in the bottom left corner; click OK). Then print the certificate.
    • If you do not have a printer: Scroll down below the certificate and click the button marked "Request Mailed Certificate."

Completing this process means you have self-certified with DEA to sell scheduled listed chemical products. To verify you have successfully self-certified, you are provided with a certificate containing a self-certification number in the upper right corner. The expiration date of the certificate is listed under the self-certification number. Please note it is your responsibility to annually renew your self-certification before the certificate expires if you wish to continue selling scheduled listed chemical products at retail.

If you have questions regarding the self-certification process, please contact DEA's Registration and Program Support Section at (800) 882-9539. If you have questions regarding other regulatory matters, please contact the Liaison and Policy Section at (202) 307-7297.