Questions and Answers Related to Diversion
Over the twenty-two years I spent with the DEA, I have been interpreting the Controlled Substances Act (CSA) and the Code of Federal Regulations (CFR) for the pharmaceutical industry . Here are some useful answers to questions I’ve come across over the years.
ANSWER: It is the regulations enforced by DEA with regards to controlled substances and listed chemicals. A copy can be purchased through the Government Printing Office (866) 512-1800 or http://bookstore.gpo.gov. If you deal with controlled substances and regulated chemicals, we recommend that you have a copy at your facility. The book is revised as of April 1st of each year.
ANSWER: The DEA Office of Diversion is responsible. Go to their website for more information. www.deadiversion.usdoj.gov
ANSWER: When DEA Diversion appears at your facility to do an unannounced administrative inspection, an Administrative Notice of Inspection (DEA Form 82) is presented to the person responsible for all RECORKEEPING and SECURITY. This form is similar to a Consent to Search form. In all cases, DEA Diversion Investigators will request that you sign the form on behalf of the company giving them permission to be on your premise.
Go to Title 21 Code of Federal Regulations Section 1316 for more information.
ANSWER: Your company can receive a Letter of Admonition, or required to attend an Administrative Hearing, or agree to a Memorandum of Understanding. If the violation is serious enough, DEA Diversion may petition the DEA Chief Counsel in order to obtain an Immediate Suspension or an Order to Show Cause your DEA registration. DEA can also use the option to go to the U.S. Attorney’s Office and seek a civil action against your company. A fine for any violation can vary from $10,000 per violation for an improperly filled DEA Form 222 to $25,000 for each importation violation or for each exportation violation. The real question is, can you afford to lose your company’s DEA registration?
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ANSWER: The Ryan Haight Online Pharmacy Consumer Protection Act, effective April 13, 2009, added new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet. Click here: More information.
ANSWER: Go to the DEA Diversion website. Click on "Applications" under the REGISTRATION tab. Use the credit cards that the site recommends. If you mail in your request with a check, it may take weeks before the action you requested may take place.
ANSWER: Yes. You can read more about this in Title 21 Code of Federal Regulations Section 1304.04(a) for CONTROLLED SUBSTANCES and Section 1310.04(a) for LISTED CHEMICALS.
ANSWER: Yes. Go to the DEA Diversion website and Click on "Applications" under the REGISTRATION tab then scroll down to Registration Tools and locate the Registration Changes link below. Your request will be forwarded to the DEA Division where your registration is located.
ANSWER: Two years. For further information see Title 21 Code of Federal Regulations Section 1304.04(a).
ANSWER: DEA Form 106. It must be “Reported within one business day of discovery of such loss or theft”. For further information see Title 21 Code of Federal Regulations Section 1301.76(b).