[Federal Register Volume 61, Number 215 (Tuesday, November 5, 1996)]
[Rules and Regulations]
[Pages 56893-56894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28294]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA-152P]
Schedules of Controlled Substances: Placement of Remifentanil
Into Schedule II
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Final rule.
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SUMMARY: With the issuance of this final rule, the Acting Deputy
Administrator of the Drug Enforcement Administration (DEA) places the
narcotic drug, remifentanil and salts thereof, into Schedule II of the
Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.). This rule
imposes the regulatory controls and criminal sanctions of a Schedule II
narcotic substance under the CSA on the manufacture, distribution,
dispensing, importation, and exportation of remifentanil and salts
thereof. Remifentanil hydrochloride was recently approved by the Food
and Drug Administration (FDA) for marketing as an intravenous analgesic
agent.
EFFECTIVE DATE: November 5, 1996.
FOR FURTHER INFORMATION CONTACT:
Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug
Enforcement Administration, Washington, DC 20537, Telephone: 202-307-
7183.
SUPPLEMENTARY INFORMATION: Remifentanil is a narcotic drug
pharmacologically similar to, but shorter acting than, fentanyl,
alfentanil and sufentanil. Remifentanil hydrochloride will be marketed
under the trade name of ULTIVA as an intravenous analgesic agent for
use during the induction and maintenance of general anesthesia and
monitored anesthesia care. The Assistant Secretary for Health, acting
on behalf of the Secretary of the Department of Health and Human
Services (DHHS), by letter dated August 23, 1996, recommended to the
Deputy Administrator of the DEA that remifentanil, and its salts, be
placed into Schedule II of the CSA. The Deputy Administrator of the
DEA, in a September 16, 1996, Federal Register notice (61 FR 48655)
proposed placing remifentanil, and salts thereof, into Schedule II of
the CSA. Interested parties were given until October 16, 1996, to
submit comments, objections or requests for a hearing regarding the
proposal. None were received.
Based on the scientific and medical evaluation and scheduling
recommendation contained in the August 23, 1996, letter from the
Assistant Secretary for Health, DHHS, the Acting Deputy Administrator
of the DEA, pursuant to the provisions of 21 U.S.C. 811 (a) and (b) and
812(b), finds that:
(1) Remifentanil has a high potential for abuse;
(2) Remifentanil has a currently accepted medical use in treatment
in the United States; and
(3) Abuse of remifentanil may lead to severe psychological or
physical dependence.
The above findings are consistent with the placement of
remifentanil into Schedule II of the CSA. The Acting Deputy
Administrator further finds that remifentanil is an opiate as defined
in 21 U.S.C. 802(18) since it has an addiction-forming and addiction-
sustaining liability similar to morphine. Consequently, remifentanil is
a narcotic since the definition of narcotics, as stated in 21 U.S.C.
802(17)(A), includes; ``Opium, opiates, derivatives of opium and
opiates.''
In order to make a remifentanil pharmaceutical product available
for medical use as soon as possible, the Schedule II control of
remifentanil will be effective November 5, 1996. In the event that this
poses special hardships on any registrant, the DEA will entertain any
justified request of an extension of
[[Page 56894]]
time. The applicable regulations are as follows:
1. Registration. Any person who manufactures, distributes
dispenses, imports or exports remifentanil or who engages in research
or conducts instructional activities with remifentanil, or who proposes
to engage in such activities, must be registered to conduct such
activities in accordance with Parts 1301 and 1311 of Title 21 of the
Code of Federal Regulations.
2. Security. Remifentanil must be manufactured, distributed and
stored in accordance with Secs. 1301.71, 1301.72 (a), (c), and (d),
1301.73, 1301.74, 1301.75 (b) and (c) and 1301.76 of Title 21 of the
Code of Federal Regulations.
3. Labeling and packaging. All labels on commercial containers of,
and all labeling of, remifentanil which is distributed on and after
November 5, 1996 shall comply with the requirements of Secs. 1302.03-
1302.05 and 1302.07-1302.08 of Title 21 of the Code of Federal
Regulations.
4. Quotas. Quotas for remifentanil are established pursuant to Part
1303 of Title 21 of the Code of Federal Regulations.
5. Inventory. Registrants possessing remifentanil are required to
take inventories pursuant to Secs. 1304.04 and 1304.11-1304.19 of Title
21 of the Code of Federal Regulations.
6. Records. All registrants must keep records pursuant to
Secs. 1304.04 and 1304.21-1304.29 of Title 21 of the Code of Federal
Regulations.
7. Reports. All registrants are required to file reports pursuant
to Secs. 1304.34-1304.37 of Title 21 of the Code of Federal
Regulations.
8. Order Forms. Each distribution of remifentanil requires the use
of an order form pursuant to Part 1305 of Title 21 of the Code of
Federal Regulations.
9. Prescriptions. As remifentanil has been approved by the FDA for
use in medical treatment, the drug may be dispensed by prescription.
Prescriptions for remifentanil are to be issued pursuant to
Secs. 1306.01-1306.07 and 1306.11-1306.15 of Title 21 of the Code of
Federal Regulations.
10. Importation and Exportation. All importation and exportation of
remifentanil shall be in compliance with Part 1312 of Title 21 of the
Code of Federal Regulations.
11. Criminal Liability. Any activity with remifentanil not
authorized by, or in violation of, the CSA or the Controlled Substances
Import and Export Act shall be unlawful.
In accordance with the provisions of the CSA [21 U.S.C. 811(a)],
this order to place remifentanil into Schedule II of the CSA is a
formal rulemaking ``on the record after opportunity for a hearing.''
Such proceedings are conducted pursuant to the provisions of 5 U.S.C.
556 and 557 and, as such, are exempt from review by the Office of
Management and Budget pursuant to Executive Order (E.O.) 12866, Section
3(d)(1).
The Acting Deputy Administrator, in accordance with the Regulatory
Flexibility Act [5 U.S.C. 605(b)], has reviewed this rule and by
approving it certifies that it will not have a significant economic
impact on a substantial number of small-business entities. Remifentanil
is a new drug in the United States; recent approval of the product and
its labeling by the FDA will allow it to be marketed once it is placed
into Schedule II of the CSA. Remifentanil, a potent opioid drug, can
produce drug dependence of the morphine type. This drug is likely to be
diverted and abused if access to it is not closely monitored. The
labeled indication for use of remifentanil is to provide analgesia
during the induction and maintenance of general anesthesia. It is to be
administered by trained professionals in monitored anesthesia care
settings. Schedule II narcotic control will provide the necessary drug
monitoring. Small-business entities which are likely to handle this
drug maintain a Schedule II narcotic registration with the DEA. This
rule will allow these entities to have access to a new pharmaceutical
product.
This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with E.O. 12612, it is
determined that this rule does not have sufficient federalism
implications to warrant the preparation of a Federalism Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Narcotics, Prescription drugs.
Under the authority vested in the Attorney General by Section
201(a) of the CSA [21 U.S.C. 811(a)], and delegated to the
Administrator of the DEA by the Department of Justice regulations (28
CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28
CFR 0.104, the Acting Deputy Administrator hereby orders that 21 CFR
part 1308 be amended as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.
2. Section 1308.12 is amended by redesignating the existing
paragraph (c)(26) as (c)(27) and adding a new paragraph (c)(26) to read
as follows:
Sec. 1308.12 Schedule II.
* * * * *
(c) * * *
(26) Remifentanil..................................................9739
* * * * *
Dated: October 26, 1996.
James S. Milford, Jr.,
Acting Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 96-28294 Filed 11-4-96; 8:45 am]
BILLING CODE 4410-09-M