[Federal Register Volume 62, Number 190 (Wednesday, October 1, 1997)]
[Rules and Regulations]
[Pages 51370-51371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25969]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-166F]


Schedules of Controlled Substances Placement of Butorphanol Into 
Schedule IV

AGENCY: Drug Enforcement Administration, Department of 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 
substance butorphanol, including its salts and optical isomers, into 
Schedule IV of the Controlled Substances Act (CSA). As a result of this 
rule, the regulatory controls and criminal sanctions of Schedule IV 
will be applicable to the manufacture, distribution, dispensing, 
importation and exportation of butorphanol and products containing 
butorphanol.

EFFECTIVE DATE: October 31, 1997.

FOR FURTHER INFORMATION CONTACT:
Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug 
Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-
7183.

SUPPLEMENTARY INFORMATION: Butorphanol is classified as an opioid 
agonist-antagonist analgesic that is marketed as a prescription drug 
under the trade name Stadol <SUP></SUP> for the relief of moderate to 
severe pain in humans. It is also marketed as a veterinary product 
under the trade names Torbugesic <SUP></SUP> and Torbutrol 
<SUP></SUP> for use in horses and dogs. It was first marketed as an 
injectable product in 1979. Although there was limited abuse of the 
injectable product among certain populations, significant abuse was not 
observed until after the nasal spray was introduced in 1992.
    The Acting Deputy Administrator of the DEA received a letter dated 
September 30, 1996, from the Assistant Secretary for Health, on behalf 
of the Secretary of the Department of Health and Human Services (DHHS), 
recommending that the drug product, Stadol <SUP></SUP> NS Nasal Spray, 
be placed into Schedule IV of the CSA. Enclosed with the September 30, 
1996, letter from the Assistant Secretary was a scientific and medical 
evaluation prepared by the Food and Drug Administration (FDA). The 
document contained a review of the factors which the CSA requires the 
Secretary to consider (21 U.S.C. 811(b)). Correspondence from the 
Acting Assistant Secretary for Health dated June 19, 1997, confirmed 
that the DHHS recommendation included the substance butorphanol and its 
salts and isomers. The Acting Deputy Administrator of the DEA, in a 
July 10, 1997, Federal Register notice (62 FR 37004 proposed to place 
butorphanol into Schedule IV of the CSA. The notice provided an 
opportunity for all interested persons to submit their comments, 
objections, or requests for a hearing in writing on the proposed 
scheduling of butorphanol until August 11, 1997. DEA received nine 
comments regarding the proposal. Comments in support of the proposal 
were received from six organizations: National Association of Boards of 
Pharmacy, Missouri Department of Mental Health, Missouri Department of 
Health, Missouri Department of Economic Development's State Board of 
Registration for the Healing Arts, Texas State Board of Pharmacy and 
Public Citizen. The American Veterinary Medical Association noted that 
controlled substances are subject to additional recordkeeping and 
storage requirements, but recognized the abuse potential of 
butorphanol. It recommended that if butorphanol is to be controlled, it 
be classified at a level no greater than Schedule IV.
    Bristol-Myers Squibb commented that the abuse potential of 
butorphanol nasal spray is low, as evidenced by the low number of 
adverse reaction reports received by the company per number of 
prescriptions. Bristol-Myers Squibb did support the placement of 
butorphanol in Schedule IV. Fort Dodge Animal Health commented that 
there was little abuse of the butorphanol veterinary products and did 
not support the scheduling of the veterinary products. This scheduling 
action, however, is based on the abuse and dependence potentials of the 
substance butorphanol. It was determined that butorphanol, whether 
administered orally, intravenously, or intranasally, had an abuse 
potential consistent with control in Schedule IV of the CSA. 
Furthermore, available data does not differentiate the abuse potential 
of butorphanol-containing

[[Page 51371]]

human products from that of veterinary products. Fort Dodge presented 
no additional data in this regard.
    Based on the scientific and medical evaluation and the 
recommendation of the Assistant Secretary for Health, received in 
accordance with section 201(b) of the Act [21 U.S.C. 811(b)], and the 
independent review of the DEA, the Acting Deputy Administrator of the 
DEA, pursuant to sections 201(a) and 201(b) of the Act (21 U.S.C. 
811(a) and 811(b)), finds that:
    (1) Butorphanol has a low potential for abuse relative to the drugs 
or other substances in Schedule III;
    (2) Butorphanol has a currently accepted medical use in treatment 
in the United States; and
    (3) Abuse of butorphanol may lead to limited physical dependence 
and psychological dependence relative to the drugs or other substances 
in Schedule III.
    Based on these findings, the Acting Deputy Administrator of the DEA 
concludes that butorphanol, including its salts and isomers, warrants 
control in Schedule IV in the CSA. The Schedule IV controls of 
butorphanol will be effective on October 31, 1997, except as indicated 
below. In the event that the regulations impose special hardships on 
the registrants, the DEA will entertain any justified request for an 
extension of time to comply with the Schedule IV regulations regarding 
butorphanol. The applicable regulations are as follows:
    1. Registration. Any person who manufactures, distributes, 
dispenses, imports or exports butorphanol activities or who engages in 
research or conducts instructional activities with butorphanol, or who 
proposes to engage in such activities, must submit an application for 
Schedule IV registration in accordance with Part 1301 of Title 21 of 
the Code of Federal Regulations. Any person who is currently lawfully 
engaged in any of the above activities must submit an application for 
registration by October 31, 1997. Any such person may then continue 
their lawful activities until the Administration has approved or denied 
that application.
    2. Security. Butorphanol must be manufactured, distributed and 
stored in accordance with Secs. 1301.71, 1301.72(b), (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, butorphanol which is distributed on and after 
April 1, 1998 shall comply with the requirements of Secs. 1302.03-
1302.07 of Title 21 of the Code of Federal Regulations. Any commercial 
containers of butorphanol packaged on or before April 1, 1998 and not 
meeting the requirements specified in Secs. 1302.03-1302.07 of Title 21 
of the Code of Federal Regulations shall not be distributed on or after 
July 1, 1998.
    4. Inventory. Registrants possessing butorphanol are required to 
take inventories pursuant to Secs. 1304.03, 1304.04 and 1304.11 of 
Title 21 of the Code of Federal Regulations.
    5. Records. All registrants must keep records pursuant to 
Secs. 1304.03, 1304.04 and 1304.21-1304.23 of Title 21 of the Code of 
Federal Regulations.
    6. Prescriptions. All prescriptions for butorphanol are to be 
issued pursuant to Secs. 1306.03-1306.06 and 1306.21-1306.26 of Title 
21 of the Code of Federal Regulations. All prescriptions for products 
containing butorphanol issued on or before October 31, 1997, if 
authorized for refilling, shall as of that date be limited to five 
refills and shall not be refilled after April 1, 1998.
    7. Importation and Exportation. All importation and exportation of 
butorphanol shall be in compliance with Part 1312 of Title 21 of the 
Code of Federal Regulations.
    8. Criminal Liability. Any activity with butorphanol not authorized 
by, or in violation of, the CSA or the Controlled Substances Import and 
Export Act shall be unlawful on or after October 31, 1997.
    In accordance with the provisions of 21 U.S.C. 811(a) of the CSA, 
this action 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 proposed rule and by approving it certifies that it will 
not have a significant economic impact on a substantial number of 
small-business entities. Butorphanol products are prescription 
products. Handlers of butorphanol also handle other controlled 
substances which are already subject to the regulatory requirements of 
the CSA.
    This rule will not result in the expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and it will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under provisions of the Unfunded Mandates Reform act of 1995.
    This rule is not a major rule as defined by Sec. 804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996. This rule will 
not result in an annual effect on the economy of $100,000,000 or more; 
a major increase in costs or prices; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of the United States-based companies to compete with 
foreign-based companies in domestic and export markets.
    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 will 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 Acting Deputy Administrator pursuant 
to 28 CFR 0.104, the Acting Deputy Administrator hereby amends 21 CFR 
part 1308 as follows.

PART 1308--[AMENDED]

    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 1308.14 is amended by adding a new paragraph (f)(2) to 
read as follows:


Sec. 1308.14   Schedule IV.

* * * * *
    (f) * * *
    (2) Butorphanol (including its optical isomers)--9720

    Dated: September 22, 1997.
James S. Milford,
Acting Deputy Administration.
[FR Doc. 97-25969 Filed 9-30-97; 8:45 am]
BILLING CODE 4410-09-M