Federal
Register Notices > Rules
- 2006 > Interim Rule - Schedules of Controlled Substances: Exempt Anabolic Steroid Products
FR Doc E6-14516 [Federal Register: September 1, 2006 (Volume 71, Number
170)] [Rules and Regulations] [Page 51996-51998] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01se06-9]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-289I] RIN 1117-AB04
Schedules of Controlled Substances: Exempt Anabolic Steroid Products
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Interim rule and request for comments.
SUMMARY: The Drug Enforcement Administration (DEA) is 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: This rule is effective September 1, 2006. Written comments must be
postmarked, and electronic comments must be sent, on or before October 31,
2006.
ADDRESSES: To ensure proper handling of comments, please reference Docket
No. DEA-289 on all written and electronic correspondence. Written comments
sent via regular mail should be sent to the Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration, Washington, DC
20537, Attention: DEA Federal Register Representative/ODL. Written comments
sent via express mail should be sent to DEA Headquarters, Attention: DEA
Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria,
VA 22301. Comments may be sent electronically to dea.diversion.policy@usdoj.gov.
Comments may also be sent electronically through http://www.regulations.gov
using the electronic comment form provided at that site. DEA will accept
attachments to electronic comments in Microsoft Word, Word Perfect, Adobe PDF,
or Excel file formats only. DEA will not accept any file formats other than
those specifically listed here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., 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) (21 U.S.C. 801 et seq.). Section 1903 of the ASCA
provides that the Attorney General may exempt products which contain anabolic
steroids from all or any part of the Controlled Substances Act 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 (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 Sec. 1308.33 of Title 21 of the Code of Federal
Regulations. 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 identify 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 (DHHS) 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 DHHS along with a request for
evaluation and recommendation. In three separate letters dated March 30, 2006,
the Assistant Secretary of Health for DHHS recommended that all six products,
two products of esterified estrogen and methyltestosterone from each of the
three applications, be exempted from control under the CSA based on their
similarity to the products Estratest[reg], Estratest[reg] H.S., EssianTM and
EssianTM H.S., which have been exempted from control under the CSA.
DEA agrees with DHHS regarding the similarity of these products to products
which have already been exempted from the regulatory controls of the
Controlled Substances Act. Further, after reviewing several law enforcement
databases, DEA has not found evidence of significant abuse or trafficking of
these types of products.
The Deputy Assistant Administrator, having reviewed the applications,
recommendations of the Secretary, and other relevant information, finds that
the following six products have no significant potential for abuse: Esterified
Estrogens and Methyltestosterone, USP (1.25 mg/2.5 mg); Esterified Estrogens
and Methyltestosterone, USP (0.625 mg/ 1.25 mg); Methyltestosterone and
Esterified Estrogens (2.5 mg/1.25 mg); Methyltestosterone and Esterified
[[Page 51997]]
Estrogens (1.25 mg/0.625 mg); Esterified Estrogens/Methyltestosterone (1.25
mg/2.5 mg) Tablet; and Esterified Estrogens/Methyltestosterone (0.625 mg/1.25
mg) Tablet H.S. Information on these products is given below.
Exempt Anabolic Steroid Products
Trade name
|
Company
|
Form
|
Ingredients
|
Quantity
|
Esterified
Estrogens and Methyltestosterone, USP (1.25 /2.5 mg).
|
Interpharm, Inc |
Tablets |
Esterfied Estrogens
Methyltestosterone |
1.25 mg/Tablet.
2.5 mg/Tablet. mg |
Esterified Estrogens and Methyltestosterone, USP (0.625mg/1.25 mg).
|
Interpharm, Inc
|
Tablets
|
Esterfied Estrogens
Methyltestosterone |
0.625
mg/Tablet.
1.25 mg/Tablet.
|
Methyltestosterone and
Esterfied Estrogens (2.5 mg/1.25 mg).
|
Lannett Company, Inc
|
Tablets
|
Esterified Estrogens
Methyltestosterone
|
2.5 mg/Tablet.
1.25
mg/Tablet.
|
Methyltestosterone and Esterified Estrogens (Half Strength) (1.25 mg/0.625 mg).
|
Lannett Company, Inc
|
Tablets
|
Esterfied Estrogens
Methyltestosterone
|
0.625
mg/Tablet.
1.25 mg/Tablet.
|
Esterified Estrogens/Methyltestosterone, (1.25 mg/ 2.5 mg) Tablet.
|
ANDAPharm, LLC
|
Tablets
|
Esterfied Estrogens
Methyltestosterone |
1.25
mg/Tablet.
2.5 mg/Tablet.
|
Esterified Estrogens/ Methyltestosterone, (0.625 mg/1.25 mg) Tablet.
|
ANDAPharm, LLC
|
Tablets
|
Esterfied Estrogens
Methyltestosterone
|
0.625
mg/Tablet.
1.25 mg/Tablet.
|
Therefore, the Deputy Assistant Administrator hereby orders that the above
anabolic steroid products be added to the list of products excluded from
application of certain controls of the CSA and referenced in 21 CFR 1308.34.
Interested persons are invited to submit their comments to this interim
rule. If any comments or objections raise significant issues regarding any
finding of fact or conclusion of law upon which this order is based, the
Deputy Assistant Administrator shall immediately suspend the effectiveness of
this order until he may reconsider the application in light of the comments
and objections filed. Thereafter, the Deputy Assistant Administrator shall
reinstate, revoke, or amend his original order as he determines appropriate.
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. 605(b)).
Executive Order 12866
The Deputy Assistant Administrator has determined that this is not a
``significant rule,'' as that term is used in Executive Order 12866. This rule
exempts the identified steroid products from the regulatory controls that
apply to controlled substances. Therefore, this rule has not been reviewed by
the Office of Management and Budget.
Executive Order 12988
This interim 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 interim 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 law. Accordingly, this
rulemaking does not have federalism implications warranting the application of
Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This interim rule will not result in the expenditure by State, local or
tribal governments, in the aggregate, or by the private sector, of
$117,000,000 or more 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.
Small Business Regulatory Enforcement Fairness Act of 1996
This interim rule is not a major rule as defined by section 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 United
States-based companies to compete with foreign-based companies in domestic and
export markets.
Administrative Procedure Act
An agency may find good cause to exempt a rule from certain provisions of
the Administrative Procedure Act (5 U.S.C. 553), including Notice of Proposed
Rulemaking and the opportunity for public comment, if it is determined to be
unnecessary, impracticable, or contrary to the public interest (5 U.S.C.
553(b)(3)(B). Further, the Administrative Procedure Act permits an agency to
make this rule effective upon the date of publication if the rule is ``a
substantive rule which grants or recognizes an exemption or relieves a
restriction'' (5 U.S.C. 553(d)(1)). As the rule adds six anabolic steroid
products to the list of products exempted from regulatory control under the
Controlled Substances Act and provides a benefit to the affected public, DEA
finds that this rule meets the criteria set forth in 5 U.S.C. 553(b)(3)(B) and
5 U.S.C. 553(d)(1) for an exception to the usual notice and comment process.
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
Pursuant to the authority vested in the Attorney General by section 1903 of
the Anabolic Steroids Control Act of 1990, delegated to the Administrator of
the Drug Enforcement Administration pursuant to 21
U.S.C. 871(a) and 28 CFR
0.100, and redelegated to the Deputy Assistant Administrator of the DEA Office
of Diversion Control pursuant to 28 CFR part 0, Appendix to Subpart R, section
7(g), the Deputy Assistant Administrator hereby orders that the following
compounds, mixtures, or preparations containing anabolic steroids be exempted
from application of sections 302 through 309 and sections 1002 through 1004 of
the Controlled Substances Act (21
U.S.C. 822-829 and 21
U.S.C. 952-954) and 21
CFR 1301.13, 1301.22, 1301.71 through 1301.76 for administrative purposes only
and be
[[Page 51998]]
included in the list of products described in 21 CFR
1308.34.
New Exempt Anabolic Steroid Products
Trade name
|
Company
|
Form
|
Ingredients
|
Quantity
|
Esterified Estrogens and Methyltestosterone, USP (1.25 mg/ 2.5 mg).
|
Interpharm, Inc
|
Tablets
|
Esterfied Estrogens
Methyltestosterone
|
1.25 mg/Tablet.
2.5
mg/Tablet.
|
Esterified Estrogens and Methyltestosterone, USP
(0.625 mg/1.25 mg).
|
Interpharm, Inc
|
Tablets
|
Esterfied Estrogens
Methyltestosterone
|
0.625 mg/Tablet.
1.25 mg/Tablet.
|
Methyltestosterone and Esterified .
Estrogens (2.5 mg/1.25 mg)
|
Lannett Company, Inc
|
Tablets
|
Esterfied Estrogens
Methyltestosterone
|
1.25 mg/Tablet.
2.5
mg/Tablet.
|
Methyltestosterone and Esterified
Estrogens (Half Strength) (1.25 mg/0.625 mg).
|
Lannett Company, Inc
|
Tablets
|
Esterfied Estrogens
Methyltestosterone
|
0.625 mg/Tablet.
1.25
mg/Tablet.
|
Esterified Estrogens/Methyltestosterone, (1.25
mg/2.5 mg) Tablet.
|
ANDAPharm, LLC
|
Tablets
|
Esterfied Estrogens
Methyltestosterone
|
1.25 mg/Tablet.
2.5 mg/Tablet.
|
Esterified Estrogens/Methyltestosterone,
(0.625 mg/ 1.25 mg)
Tablet.
|
ANDAPharm, LLC
|
Tablets
|
Esterfied Estrogens
Methyltestosterone |
0.625 mg/Tablet.
1.25 mg/Tablet.
|
Dated: August 24, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion
Control.
[FR Doc. E6-14516 Filed 8-31-06; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
|