[Federal Register: March 17, 2008 (Volume 73, Number 52)]
[Rules and Regulations]
[Page 14178-14179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr08-6]
[[Page 14178]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-289F]
RIN 1117-AB04
Schedules of Controlled Substances: Exempt Anabolic Steroid
Products
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing an
Interim Rule designating six pharmaceutical preparations as exempt
anabolic steroid products under the Controlled Substances Act. This
action is part of the ongoing implementation of the Anabolic Steroids
Control Act of 1990.
DATES: Effective Date: This final rule is effective April 16, 2008.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-
7183.
SUPPLEMENTARY INFORMATION:
Background
The Anabolic Steroids Control Act (ASCA) of 1990 (Title XIX of Pub.
L. 101-647) placed anabolic steroids into schedule III of the
Controlled Substances Act (CSA). Section 1903 of the ASCA provides that
the Attorney General may exempt products which contain anabolic
steroids from all or any part of the CSA (21 U.S.C. 801 et seq.) if the
products have no significant potential for abuse. The authority to
exempt these products was delegated from the Attorney General to the
Administrator of the Drug Enforcement Administration (DEA) (28 CFR
0.100(b)), who in turn, redelegated this authority to the Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration (28 CFR Part 0, Appendix to Subpart R, Section 7(g)).
The procedure for implementing this section of the ASCA is found in 21
CFR 1308.33. Three applications which were in conformance with 21 CFR
1308.33 were received and forwarded to the Secretary of Health and
Human Services for evaluation. The purpose of this rule is to finalize
an interim rule regarding six products which the Deputy Assistant
Administrator, Office of Diversion Control, finds meet the exempt
anabolic steroid product criteria.
Anabolic Steroid Products Being Added to the List of Products Exempted
From Application of the CSA
DEA received three letters dated June 8, 2005, July 1, 2005 and
August 22, 2005, written to the DEA on behalf of Interpharm Inc.,
Lannett Company Inc., and ANDAPharm, LLC., respectively. Each of these
three letters contained an application to exempt from control under the
CSA two products, each containing esterified estrogens and
methyltestosterone. In two letters dated November 14, 2005, DEA
provided a copy of the Lannett and ANDAPharm applications to the
Department of Health and Human Services (HHS) along with a request for
evaluation and a recommendation. In a letter dated November 15, 2005,
DEA provided a copy of the Interpharm application to HHS along with a
request for evaluation and recommendation. In three separate letters
dated March 30, 2006, the Assistant Secretary of Health for HHS
recommended that all six products, two products of esterified estrogen
and methyltestosterone from each of three applications, be exempted
from control under the CSA based on their similarity to the products,
Estratest[reg], Estratest[reg] H.S., Essian\TM\ and Essian\TM\ H.S.,
which have been exempted from control under the CSA (71 FR 10835, March
3, 2006 and 71 FR 61876, October 20, 2006).
DEA agreed with HHS regarding the similarity of these products to
products which have already been exempted from the regulatory controls
of the CSA. Further, after reviewing several law enforcement databases,
DEA did not find evidence of significant abuse or trafficking of these
types of products. Therefore, DEA published an Interim rule with
request for comments (71 FR 51996, September 1, 2006) exempting these
products from regulatory control under the CSA.
Comments Received
DEA received one comment in opposition to the Interim Rule. As a
basis for this objection, the commenter cited generally to Article I,
Section 1 of the U.S. Constitution: ``All legislative powers herein
granted shall be vested in a Congress of the United States, which shall
consist of a Senate and House of Representatives.'' DEA has considered
the comment and determined that the objection is without legal basis.
Thus, the rule is being finalized without change. Accordingly, the
Deputy Assistant Administrator, Office of Diversion Control, hereby
affirms his order that the following anabolic steroid products be added
to the list of products excluded from application of certain controls
of the Controlled Substances Act and referenced in 21 CFR 1308.34.
Exempt Anabolic Steroid Products:
----------------------------------------------------------------------------------------------------------------
Trade name Company Form Ingredients Quantity
----------------------------------------------------------------------------------------------------------------
Esterified Estrogens and Interpharm, Inc.. Tablets.......... Esterified 1.25 mg/Tablet.
Methyltestosterone, USP (1.25 Estrogens. 2.5 mg/Tablet.
mg/2.5 mg). Methyltestosteron
e.
Esterified Estrogens and Interpharm, Inc.. Tablets.......... Esterified 0.625 mg/Tablet.
Methyltestosterone, USP Estrogens. 1.25 mg/Tablet.
(0.625 mg/1.25 mg). Methyltestosteron
e.
Methyltestosterone and Lannett Company, Tablets.......... Esterified 1.25 mg/Tablet.
Esterified Estrogens (2.5 mg/ Inc. Estrogens. 2.5 mg/Tablet.
1.25 mg). Methyltestosteron
e.
Methyltestosterone and Lannett Company, Tablets.......... Esterified 0.625 mg/Tablet.
Esterified Estrogens (Half Inc. Estrogens. 1.25 mg/Tablet.
Strength) (1.25 mg/0.625 mg). Methyltestosteron
e.
Esterified Estrogens/ ANDAPharm, LLC... Tablets.......... Esterified 1.25 mg/Tablet.
Methyltestosterone, (1.25 mg/ Estrogens. 2.5 mg/Tablet.
2.5 mg) Tablet. Methyltestosteron
e.
Esterified Estrogens/ ANDAPharm, LLC... Tablets.......... Esterified 0.625 mg/Tablet.
Methyltestosterone, (0.625 mg/ Estrogens. 1.25 mg/Tablet.
1.25 mg) Tablet. Methyltestosteron
e.
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[[Page 14179]]
Regulatory Certifications
Regulatory Flexibility Act
The granting of exemption status relieves persons who handle the
exempted products in the course of legitimate business from the
registration, recordkeeping, security, and other requirements imposed
by the CSA. Accordingly, the Deputy Assistant Administrator certifies
that this action will not have a significant economic impact upon a
substantial number of small entities whose interests must be considered
under the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866
The Deputy Assistant Administrator further certifies that this
rulemaking has been drafted in accordance with the principles in
Executive Order 12866. It has been determined that this is not a
significant regulatory action. Therefore, this action has not been
reviewed by the Office of Management and Budget. This final rule
exempts the identified steroid products from the regulatory controls
that apply to controlled substances.
Executive Order 12988
This rule 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 rule 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 or
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 the 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 million 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.
21 CFR Part 1308--Schedules of Controlled Substances
The Interim Rule with Request for Comment amending the list of
exempt anabolic steroid products described in 21 CFR 1308.34 published
at 71 FR 51996, September 1, 2006 is hereby adopted as a final rule
without change.
Dated: March 8, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E8-5173 Filed 3-14-08; 8:45 am]
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