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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 on-line. 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 on-line 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 on-line. 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 on-line 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
on-line 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:
- Materially falsified any application filed
- Been convicted of a felony relating to a controlled substance or a List
I chemical
- Had their state license or registration suspended, revoked, or denied
- Committed an act which would render the DEA registration inconsistent
with the public interest
- 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:
- The recommendation of the appropriate state licensing board or
professional disciplinary authority
- The applicant’s experience in dispensing or conducting research with
respect to controlled substances
- The applicant’s conviction record under federal or state laws relating
to the manufacture, distribution, or dispensing of controlled substances
- Compliance with applicable state, federal, or local laws relating to
controlled substances
- 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:
- The dispensing, administering, or prescribing is in the usual course of
professional practice
- Practitioners are authorized to do so by the state in which they
practice
- The hospital or institution has verified that the practitioner is
permitted to dispense, administer or prescribe controlled substances
within the state
- The practitioner acts only within the scope of employment in the
hospital or institution
- 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 a 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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