Exhibit F—Questions Often Asked About DEA Regulations

Do I really have to have my complete security system installed before my program is approved by DEA?

Yes. DEA will not approve your application until your security system is fully installed and functional. If you submit your application, DEA is willing to advise about the type of system that would pass an inspection; and your application will be held until your system is installed. It is a good idea to discuss security concerns with DEA before submitting your application. 21 CFR 1301.72-1301.74

What business activity should be checked on my application?

To complete the business activity section of your application you need to review DEA's definitions of compounder, detoxification treatment, and maintenance treatment to determine which service or combination of services you will provide at each site. DEA defines detoxification as the dispensing of medication by decreasing dosages for a "short-term" period of less than 30 days or a "long-term" period of 30-180 days. Maintenance means dispensing a narcotic drug for the treatment of narcotic dependence for a period of 21 or more days. A compounder is any program engaging in maintenance or detoxification that also mixes, prepares, packages, or changes the dosage form of a narcotic drug for use in maintenance or detoxification by another narcotic treatment program. So if you prepare medications in one site for dispensing at another site, your first site is a compounder. In cases where a conflict might arise between definitions of detoxification and maintenance, the narcotic treatment program must be registered with DEA in the business activity as maintenance and detoxification program. If a similar classification does not exist on your State application, the final determination whether the activity is detoxification or maintenance would be made by the SMA. 21 CFR 1301.2(d); (e); (h)

Who qualifies for the exemption from payment of qualifying fees?

Members of the U.S. military, Department of Veterans Affairs, or Public Health Service are exempt from payment of fees for registration. Also exempt are any official, employee, or other civil officer or agency of the United States, a State, or municipality who is authorized to purchase, dispense, administer, or conduct research or instructional activities in the course of that person's official capacity. 21 CFR 1301.13 (a)

Does DEA have recordkeeping requirements?

Yes. DEA has very strict requirements for records and inventories related to the control of diversion of narcotic drugs. Before submitting your application, it is a good idea to review your forms and proposed recordkeeping procedures with a DEA investigator to be sure you will be in compliance. 21 CFR 1304

Does my medical director have to be registered with DEA?

A separate registration is not required for the medical director as long as the physician is solely engaged in the usual course of business for the program and is licensed in the State of the program, and no other controlled substance activities are conducted. However, if the program conducts any controlled substance activity other than narcotic maintenance or detoxification, a separate registration is needed for those other activities. 21 CFR 1301.22 (a)(3); (6)

Why is the regular review of urinalysis results so important to DEA?

The regular review of urinalysis results can serve as a first indication of a patient's involvement in drug diversion. A patient who tests negative for methadone and positive for other illicit drugs may be involved in drug diversion. DEA considers adherence to medical standards an essential part of diversion control efforts of a program, and the review and follow-up of urinalysis results are considered critical.

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