[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Rules and Regulations]
[Pages 51234-51236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23971]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-327F]
Schedules of Controlled Substances; Placement of Fospropofol 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 Deputy Administrator
of the Drug Enforcement Administration (DEA) places the substance
fospropofol, including its salts, isomers and salts of isomers whenever
the existence of such salts, isomers, and salts of isomers is possible,
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 fospropofol and products containing
fospropofol.
DATES: Effective Date: November 5, 2009.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield,
Virginia 22152, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Background
On December 12, 2008, the Food and Drug Administration (FDA)
approved fospropofol for marketing under the trade name Lusedra[reg] in
the United States as a drug product indicated for monitored anesthesia
care (MAC) sedation in adult patients undergoing diagnostic or
therapeutic procedures.
Fospropofol, 2,6-diisopropopylphenoxymethyl phosphate disodium, is
a water soluble, phosphono-O-methyl prodrug of propofol. It is
metabolized in the body to propofol, the active metabolite. Propofol
has been available for medical use in the United States since 1989 and
is not currently a controlled substance. The pharmacological effects of
fospropofol are attributed to the pharmacological actions of propofol.
Propofol binds to [gamma]-aminobutyric acid (GABAA) receptor
and acts as a modulator by potentiating the activity of GABA at this
receptor.
Since propofol is the active metabolite of fospropofol, the abuse
potential of fospropofol is comparable to that of propofol. Animal
self-administration studies demonstrated that the reinforcing effects
of propofol are relatively low and comparable to midazolam and other
schedule IV benzodiazepines. Fospropofol elicits behavioral effects
similar to methohexital and midazolam, schedule IV sedative-hypnotics.
Since fospropofol is a new molecular entity, there has been no
evidence of diversion, abuse, or law enforcement encounters involving
the drug.
On February 27, 2009, the Acting Assistant Secretary for Health,
Department of Health and Human Services (DHHS), sent the Deputy
Administrator of DEA a scientific and medical evaluation and a letter
recommending that fospropofol be placed into schedule IV of the CSA.
Enclosed with the February 27, 2009, letter was a document prepared by
the FDA entitled, ``Basis for the Recommendation for Control of
Fospropofol and Its Salts in Schedule IV of the Controlled Substances
Act (CSA).'' The document contained a review of the factors which the
CSA requires the Secretary to consider (21 U.S.C. 811(b)).
After a review of the available data, including the scientific and
medical evaluation and the scheduling recommendation from DHHS, the
Deputy Administrator of the DEA published a Notice of Proposed
Rulemaking entitled ``Schedules of Controlled Substances: Placement of
Fospropofol into Schedule IV'' on July 23, 2009 (74 FR 36424), which
proposed placement of fospropofol into schedule IV of the CSA. The
proposed rule provided an opportunity for all interested persons to
submit their written comments on or before August 24, 2009.
Comments Received
The DEA received two comments in response to the Notice of Proposed
Rulemaking. One comment received from a concerned citizen did not
relate to fospropofol, the substance that is being controlled. Thus DEA
did not consider this comment.
[[Page 51235]]
Another comment received from a professional organization of
anesthesiologists is in agreement with the findings of scientific and
medical evaluation that formed the basis for the present rule
controlling fospropofol as a schedule IV substance and it fully
supported this control action.
Scheduling of Fospropofol
Based on the recommendation of the Acting 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 available data by
DEA, the Deputy Administrator of DEA, pursuant to sections 201(a) and
201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:
(1) Fospropofol has a low potential for abuse relative to the drugs
or substances in schedule III. Although there is no direct comparison
to a schedule III substance, this finding is based on the demonstration
of the abuse potential of propofol, the active metabolite, relative to
the schedule IV substances, methohexital and midazolam;
(2) Fospropofol has a currently accepted medical use in treatment
in the United States; and
(3) Abuse of fospropofol may lead to limited physical dependence or
psychological dependence relative to the drugs or other substances in
schedule III. This finding is based on the symptoms exhibited upon
withdrawal from propofol.
Based on these findings, the Deputy Administrator of DEA concludes
that fospropofol, including its salts, isomers and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible warrants control in schedule IV of the CSA. (21 U.S.C.
812(b)(4))
Requirements for Handling Fospropofol
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with fospropofol, or who desires to manufacture, distribute,
dispense, import, export, engage in instructional activities or conduct
research with fospropofol, must be registered to conduct such
activities in accordance with part 1301 of Title 21 of the Code of
Federal Regulations. Any person who is currently engaged in any of the
above activities and is not registered with DEA must submit an
application for registration on or before November 5, 2009 and may
continue their activities until DEA has approved or denied that
application.
Security. Fospropofol is subject to schedules III-V security
requirements and must be manufactured, distributed, and stored in
accordance with Sec. Sec. 1301.71, 1301.72(b), (c), and (d), 1301.73,
1301.74, 1301.75(b) and (c), 1301.76, and 1301.77 of Title 21 of the
Code of Federal Regulations on or after November 5, 2009.
Labeling and Packaging. All labels and labeling for commercial
containers of fospropofol must comply with requirements of Sec. Sec.
1302.03-1302.07 of Title 21 of the Code of Federal Regulations on or
after November 5, 2009.
Inventory. Every registrant required to keep records and who
possesses any quantity of fospropofol must keep an inventory of all
stocks of fospropofol on hand pursuant to Sec. Sec. 1304.03, 1304.04
and 1304.11 of Title 21 of the Code of Federal Regulations on or after
November 5, 2009. Every registrant who desires registration in schedule
IV for fospropofol must conduct an inventory of all stocks of the
substance on hand at the time of registration.
Records. All registrants must keep records pursuant to Sec. Sec.
1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of Title 21 of the Code
of Federal Regulations on or after November 5, 2009.
Prescriptions. All prescriptions for fospropofol or prescriptions
for products containing fospropofol must be issued pursuant to
Sec. Sec. 1306.03-1306.06 and 1306.21, 1306.22-1306.27 of Title 21 of
the Code of Federal Regulations on or after November 5, 2009.
Importation and Exportation. All importation and exportation of
fospropofol must be in compliance with part 1312 of Title 21 of the
Code of Federal Regulations on or after November 5, 2009.
Criminal Liability. Any activity with fospropofol not authorized
by, or in violation of, the Controlled Substances Act or the Controlled
Substances Import and Export Act shall be unlawful on or after November
5, 2009.
Regulatory Certifications
Executive Order 12866
In accordance with the provisions of the CSA (21 U.S.C. 811(a)),
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
12866, section 3(d)(1).
Regulatory Flexibility Act
The Deputy Administrator, in accordance with the Regulatory
Flexibility Act (5 U.S.C. 601-612), has reviewed this final rule and by
approving it certifies that it will not have a significant economic
impact on a substantial number of small entities. Fospropofol products
will be used for monitored anesthesia care (MAC) sedation in adult
patients undergoing diagnostic or therapeutic procedures. Handlers of
fospropofol also handle other controlled substances used for sedation
which are already subject to the regulatory requirements of the CSA.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under provisions of the Unfunded Mandates
Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by Sec. 804 of the Small
Business Regulatory Enforcement Fairness Act of 1996 (Congressional
Review Act). 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 United States-based
companies to compete with foreign based companies in domestic and
export markets.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Narcotics, Prescription drugs.
0
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 DEA
by Department of Justice regulations (28 CFR 0.100), and redelegated to
the Deputy Administrator pursuant to 28
[[Page 51236]]
CFR 0.104, the Deputy Administrator hereby amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
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.
0
2. Section 1308.14 is amended in paragraph (c), by redesignating
paragraphs (c)(23) through (c)(51) as paragraphs (c)(24) through
(c)(52) and adding a new paragraph (c)(23) as follows:
Sec. 1308.14 Schedule IV.
* * * * *
(c) * * *
(23) Fospropofol................................................ 2138
* * * * *
Dated: September 28, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-23971 Filed 10-5-09; 8:45 am]
BILLING CODE 4410-09-P