Practitioner's Manual - SECTION II

SECTION II – GENERAL REQUIREMENTS

Schedules of Controlled Substances

The drugs and other substances that are considered controlled substances under the CSA are divided into five schedules. A complete list of the schedules is published annually on an updated basis in the DEA regulations, Title 21 of the Code of Federal Regulations, Sections 1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States and their relative abuse potential and likelihood of causing dependence when abused. Some examples of the drugs in each schedule are outlined below.

IMPORTANT NOTE:

All drugs listed in Schedule I have no currently accepted medical use in treatment in the United States and therefore may not be prescribed, administered, or dispensed for medical use. In contrast, drugs listed in Schedules II through V all have some accepted medical use and therefore may be prescribed, administered, or dispensed for medical use.

Schedule I Substances

Substances in this schedule have no currently accepted medical use in treatment in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.

Some examples of substances listed in Schedule I are: heroin; lysergic acid diethylamide (LSD); marijuana (cannabis); peyote; methaqualone; and methylene-dimethoxy-methamphetamine ("ecstasy").

The CSA allows for bona fide research with controlled substances in Schedule I, provided that the FDA has determined the researcher to be qualified and competent, and provided further that the FDA has determined the research protocol to be meritorious. Researchers who meet these criteria must obtain a separate registration to conduct research with a Schedule I controlled substance.

Schedule II Substances

Substances in this schedule have a high potential for abuse with severe psychological or physical dependence.

Examples of single entity Schedule II narcotics include morphine, codeine, and opium. Other Schedule II narcotic substances and their common name brand products include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®), and fentanyl (Sublimaze® or Duragesic®).

Examples of Schedule II stimulants include amphetamine (Dexedrine® or Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®). Other Schedule II substances include: cocaine, amobarbital, glutethimide, and pentobarbital.

Schedule III Substances

Substances in this schedule have a potential for abuse less than substances in Schedules I or II.

Examples of Schedule III narcotics include combination products containing less than 15 milligrams of hydrocodone per dosage unit (i.e., Vicodin®) and products containing not more than 90 milligrams of codeine per dosage unit (i.e., Tylenol with codeine®).

Examples of Schedule III non-narcotics include benzphetamine (Didrex®), phendimetrazine, dronabinol (Marinol®), ketamine, and anabolic steroids such as oxandrolone (Oxandrin®).

Schedule IV Substances

Substances in this schedule have a lower potential for abuse relative to substances in Schedule III.

Examples of a Schedule IV narcotics include propoxyphene (Darvon® and Darvocet-N 100®).

Other Schedule IV substances include alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).

Schedule V Substances

Substances in this schedule have a lower potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic and stimulant drugs. These are generally used for antitussive, antidiarrheal and analgesic purposes.

Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, and Phenergan with Codeine®).

Registration Requirements

Under the CSA, the term "practitioner"is defined as a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. Every person or entity that handles controlled substances must be registered with DEA or be exempt by regulation from registration.

The DEA registration grants practitioners federal authority to handle controlled substances. However, the DEA registered practitioner may only engage in those activities that are authorized under state law for the jurisdiction in which the practice is located. When federal law or regulations differ from state law or regulations, the practitioner is required to abide by the more stringent aspects of both the federal and state requirements. In many cases, state law is more stringent than federal law, and must be complied with in addition to federal law. Practitioners should be certain they understand their state as well as DEA controlled substance regulations.

Application for Registration

To obtain a DEA registration, a practitioner must apply using a DEA Form 224. Applicants may submit the form by hard copy or online. Complete instructions accompany the form. To obtain the application, DEA may be contacted at:

• www.DEAdiversion.usdoj.gov (DEA Diversion Internet Web Site)
• any DEA field office (see listing in Appendix E of this manual)
• DEA Headquarters’ Registration Section in Washington, D.C. at 1-800-882-9539 (Registration Call Center)

The DEA Form-224 may be completed online or in hard copy and mailed to:

Drug Enforcement Administration
Registration Unit
Central Station
P.O. Box 28083
Washington, D.C. 20038-8083

A sample DEA Form 224 – New Application for Registration, is located at Appendix H, DEA Forms.

Certificate of Registration

The DEA Certificate of Registration (DEA Form 223) must be maintained at the registered location in a readily retrievable manner and kept available for official inspection.

The CSA requires that a separate registration be obtained for each principal place of business or professional practice where controlled substances are manufactured, distributed, or dispensed. DEA has historically provided an exception that a practitioner who is registered at one location, but also practices at other locations, is not required to register separately for any other location at which controlled substances are only prescribed. If the practitioner maintains supplies of controlled substances, administers, or directly dispenses controlled substances at the separate location the practitioner must obtain a separate DEA registration for that location. The exception applies only to a secondary location within the same state in which the practitioner maintains his/her registration. DEA individual practitioner registrations are based on state authority to dispense or conduct research with respect to controlled substances. Since a DEA registration is based on a state license, it cannot authorize controlled substance dispensing outside that state. Hence, the separate registration exception applies only to locations within the same state in which practitioners have their DEA registrations.

A duplicate Certificate of Registration may be requested online. It appears on DEA’s website, www.DEAdiversion.usdoj.gov, as follows:

 

Registration Renewals

Practitioner registrations must be renewed every three years. Renewal registrations use DEA Form 224a, Renewal Application for DEA Registration (see example at Appendix H, DEA Forms). The cost of the registration is indicated on the application form.

A renewal application is sent to the registrant approximately 45 days before the registration expiration date. The renewal application is sent to the address listed on the current registration certificate. If the renewal form is not received within 30 days before the expiration date of the current registration, the practitioner should contact the DEA registration office for their state, or DEA Headquarters at 1-800-882-9539, and request a renewal registration form.

The registration renewal application may be completed online at www.DEAdiversion.usdoj.gov, or in hard copy and mailed to:

Drug Enforcement Administration
Registration Unit
Central Station
P.O. Box 28083
Washington, D.C. 20038-8083

Change of Business Address

A practitioner who moves to a new physical location must request a modification of registration. A modification of registration can be requested online at www.DEAdiversion.usdoj.gov or in writing to the DEA field office responsible for that state. If the change in address involves a change in state, the proper state issued license and controlled substances registration must be obtained prior to the approval of modification of the federal registration. If the modification is approved, DEA will issue a new certificate of registration and,if requested, new Schedule II order forms (DEA Form-222, Official Order Form). A Renewal Application for Registration (DEA Form-224a) will only be sent to the registered address on file with DEA. It will not be forwarded.

Termination of Registration

Any practitioner desiring to discontinue business activities with respect to controlled substances must notify the nearest DEA field office (see Appendix E ) in writing. Along with the notification of termination of registration, the practitioner should send the DEA Certificate of Registration and any unused Official Order Forms (DEA Form-222) to the nearest DEA field office.

Denial, Suspension or Revocation of Registration

Under the CSA, DEA has the authority to deny, suspend, or revoke a DEA registration upon a finding that the registrant has:

1. Materially falsified any application filed
2. Been convicted of a felony relating to a controlled substance or a List I chemical
3. Had their state license or registration suspended, revoked, or denied
4. Committed an act which would render the DEA registration inconsistent with the public interest
5. Been excluded from participation in a Medicaid or Medicare program

In determining the public interest, the CSA states the following factors are to be considered:

1. The recommendation of the appropriate state licensing board or professional disciplinary authority
2. The applicant’s experience in dispensing or conducting research with respect to controlled substances
3. The applicant’s conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances
4. Compliance with applicable state, federal, or local laws relating to controlled substances
5. Such other conduct which may threaten the public health and safety

Practitioner’s Use of a Hospital’s DEA Registration Number

Practitioners (e.g., intern, resident, staff physician, mid-level practitioner) who are agents or employees of a hospital or other institution may, when acting in the usual course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution in which they are employed, provided that:

1. The dispensing, administering, or prescribing is in the usual course of professional practice
2. Practitioners are authorized to do so by the state in which they practice
3. The hospital or institution has verified that the practitioner is permitted to dispense, administer or prescribe controlled substances within the state
4. The practitioner acts only within the scope of employment in the hospital or institution
5. The hospital or institution authorizes the practitioner to dispense or prescribe under its registration and assigns a specific internal code number for each practitioner so authorized (See example of a specific internal code number below):

A current list of internal codes and the corresponding individual practitioners is to be maintained by the hospital or other institution. This list is to be made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner.

Inappropriate Use of the DEA Registration Number

DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system.

The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to each healthcare provider.  The Final Rule for establishment of the NPI system was published in the Federal Register (FR 3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004.  The effective date of this Final Rule was May 23, 2005; all covered entities must begin using the NPI in standard transactions by May 23, 2007.

Exemption of Federal Government Practitioners from Registration

The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase controlled substances in the course of his/her official duties. Such officials shall follow procedures set forth in Title 21, CFR § 1306 regarding prescriptions, but shall state the branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a Public Health Service employee is his/her Social Security identification number.

If Federal Government practitioners wish to maintain a DEA registration for a private practice, which would include prescribing for private patients, they must be fully licensed to handle controlled substances by the state in which they are located. Under these circumstances, the Federal Government practitioner will not be eligible for the fee exemption and must pay a fee for the registration.

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