[Federal Register Volume 62, Number 104 (Friday, May 30, 1997)]
[Rules and Regulations]
[Pages 29288-29289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14111]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA No. 160I]
Schedules of Controlled Substances: Exempt Anabolic Steroid
Products
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Interim rule and request for comments.
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SUMMARY: The Drug Enforcement Administration (DEA) is designating ten
preparations as exempt anabolic steroid products. This action, as part
of the ongoing implementation of the Anabolic Steroid Control Act of
1990, removes certain regulatory controls pertaining to Schedules III
substances from the designated entities.
DATES: Effective Date: May 30, 1997. Comments must be submitted on or
before July 29, 1997.
ADDRESSES: Comments and objections should be submitted to the Acting
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537. Attention: DEA
Federal Register Representative/CCR.
FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and
Chemical Evaluation Section, 202-307-7183.
SUPPLEMENTARY INFORMATION: Section 1903 of the Anabolic Steroids
Control Act of 1990 (ASCA) (title XIX of Pub. L. 101-647) provides that
the Attorney General may exempt products which contain anabolic
steroids from all or any part of the Controlled Substances Act (CSA)
(21 U.S.C. 801 et seq.) if the products have no significant potential
for abuse. The procedure for implementing this section of the ASCA is
described in Sec. 1308.33 of Title 21 Code of Federal Regulations. The
purpose of this rule is to identify ten products for which applications
were made and which the Acting Deputy Assistant Administrator finds
meet the exempt anabolic steroid product criteria.
The Acting Deputy Assistant Administrator, Office of Diversion
Control, having reviewed the applications, the recommendations of the
Secretary of the Department of Health and Human Services, and other
relevant information, finds that each of the products described below
has no significant potential for abuse because of its concentration,
preparation, mixture or delivery system. Therefore, pursuant to the
authority vested in the Attorney General by title XIX of Public Law
101-647 as delegated to the Administrator of the DEA pursuant to 21
U.S.C. 871(a) and 28 CFR 0.100, the Acting Deputy Assistant
Administrator hereby orders that the following anabolic steroid
containing compounds, mixtures, or preparations be exempted from
application of sections 302 through 309 and 1002 through 1004 of the
CSA (21 U.S.C. 822-829 and 952-954) and Secs. 1301.11, 1301.13, 1301.71
through 1301.76 of Title 21 Code of Federal Regualtions for
administrative purposes only and be included in the list of products
described in 21 CFR 1308.34.
[[Page 29289]]
Exempt Anabolic Steroid Products
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Trade name Company NDC No. Form Ingredients Quantity
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Menogen....................... Sage 59243-570 TB.................... Esterified estrogens............... 1.25 mg.
Pharmaceuticals, Methyltestosterone................. 2.5 mg.
Shreveport, LA.
Menogen HS.................... Sage 59243-560 TB.................... Esterified estrogens............... 0.625 mg.
Pharmaceuticals, Methyltestosterone................. 1.25 mg.
Shreveport, LA.
Synovex Plus, in-process, Fort Dodge Animal ........... Drum.................. Trenbolone acetate................. 25 parts.
granulation. Health, Fort Estradiol benzoate................. 3.5 parts.
Dodge, IA.
Synovex Plus, in-process, bulk Fort Dodge Animal ........... Drum.................. Trenbolone acetate................. 25.00 mg.
pellets. Health, Fort Estradiol benzoate................. 3.50 mg pellet.
Dodge, IA.
Testoderm, 4 mg/d............. Alza Corp., Palo 17314-4608 Patch................. Testosterone....................... 10 mg.
Alto, CA.
Testoderm, 6 mg/d............. Alza Corp., Palo 17314-4609 Patch................. Testosterone....................... 15 mg.
Alto, CA.
Testoderm, with Adhesive, 6 mg/ Alza Corp., Palo 17314-2836 Patch................. Testosterone....................... 15 mg.
d. Alto, CA.
Testoderm, in-process film.... Alza Corp., Palo ........... Sheet................. Testosterone....................... 0.25 mg/cm \2\.
Alto, CA.
Testoderm, with Adhesive, in- Alza Corp., Palo ........... Sheet................. Testosterone....................... 0.25 mg/cm \2\.
process film. Alto, CA.
Tilapia Sex Reversal Feed Rangen, Inc., ........... Plastic Bags.......... Methyltesterone.................... 60 mg/kg fish feed.
(Investigational). Buhl, ID.
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Interested persons are invited to submit their comments in writing
in regard 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 Acting 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, he shall reinstate, revoke, or amend his
original order as he determines appropriate.
This exemption relieves persons who handle the products in the
course of legitimate business from the registration, records, reports,
prescription, physical security, import, and export requirements
associated with Schedule III substances. Accordingly, the Acting Deputy
Assistant Administrator certifies that this action will have no impact
on the ability of small businesses to compete and he therefore
determines that no regulatory flexibility analysis is required.
This action has been analyzed in accordance with the principles and
criteria contained in E.O. 12612, and it has been determined that this
matter does not have sufficient federalism implications to require the
preparation of a Federalism Assessment.
It has been determined that drug control matters are not subject to
review by the Office of Management and Budget (OMB) pursuant to the
provisions of E.O. 12866. Accordingly, this action is not subject to
those provisions of E.O. 12778 which are contingent upon review by OMB.
Nevertheless, the Acting Deputy Assistant Administrator has determined
that this is not a ``major rule,'' as that term is used in E.O. 18866,
and that it would otherwise meet the applicable standards of sections
2(a) and 2(b)(2) of E.O. 12778.
Dated: May 21, 1997.
Terrance W. Woodworth,
Acting Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration.
[FR Doc. 97-14111 Filed 5-29-97; 8:45 am]
BILLING CODE 4410-09-M
