[Federal Register Volume 62, Number 192 (Friday, October 3, 1997)]
[Rules and Regulations]
[Pages 51774-51776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25973]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA No. 161F]
Schedules of Controlled Substances: Excluded Veterinary Anabolic
Steroid Implant Products
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The interim rule (62 FR 29289, May 30, 1997) which identified
eight veterinary anabolic steroid implant products as being excluded
[[Page 51775]]
from the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.) is
adopted without change.
DATES: Effective Date: October 3, 1997.
FOR FURTHER INFORMATION CONTACT:
Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, 202-
307-7183.
SUPPLEMENTARY INFORMATION: The Acting Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration (DEA),
published in the Federal Register, an interim rule which identified
eight products as being excluded veterinary anabolic steroid implant
products (62 FR 29289, May 30, 1997). Comments were requested, none
were received.
Therefore, pursuant to the authority delegated to the Administrator
of the DEA pursuant to 21 U.S.C. 871(a) and 28 CFR 0.100 and
redelegated to the Deputy Assistant Administrator of the Drug
Enforcement Administration Office of Diversion Control, pursuant to 28
CFR 0.104, appendix to subpart R, section 7(g), the Deputy Assistant
Administrator of the Office of Diversion Control hereby adopts as a
final rule, without change, the interim rule amending the products
which are described in 21 CFR 1308.26 which was published at 62 FR
29289 on May 30, 1997.
The veterinary anabolic steroid implant products which are
described in 21 CFR 1308.26 are excluded from application of the CSA in
relation to their production, distribution, and use in animals only. If
any person distributes, dispenses or otherwise diverts these products
to use in humans, he/she shall be deemed to have distributed a Schedule
III controlled substance and may be prosecuted for CSA violations. The
veterinary anabolic steroid implants products which are excluded from
application of the CSA are as follows:
Excluded Veterinary Anabolic Steroid Implant Products
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Trade name Company NDC or DIN No. Delivery system Ingredients Quantity
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Component E-H............. Vetlife, Inc., 021641-002 20 implant belt, 8 Testosterone propionate............... 200 mg/implant
Norcross, GA. pellets/implant. (25 mg/pellet)
Estradiol benzoate.................... 20 mg/implant
(2.5 mg/pellet)
Component E-H............. Elanco, 01968327 20 implant belt, 8 Testosterone propionate............... 200 mg/implant
Scarborough, ON. pellets/implant. (25 mg/pellet)
Estradiol benzoate.................... 20 mg/implant
(2.5 mg/pellet)
Component TE-S............ VetLife, Inc., 021641-004 20 implant belt, 6 Trenbolone acetate.................... 120 mg/implant
Norcross, GA. pellets/implant. (20 mg/pellet)
Estradiol............................. 24 mg/implant
(4 mg/pellet)
Component T-H............. VetLife, Inc., 021641-006 20 implant belt, 10 Trenbolone acetate.................... 200 mg/implant
Norcross, GA. pellets/implant. (20 mg/pellet)
Component T-S............. VetLife, Inc., 021641-005 20 implant belt, 7 Trenbolone acetate.................... 140 mg/implant
Norcross, GA. pellets/implant. (20 mg/pellet)
F-TO...................... Animal Health, 00093351 20 implant Testosterone propionate............... 200 mg/implant
Upjohn cartridge belt, 8 (25 mg/pellet)
International, pellets/implant. Oestradiol benzoate................... 20 mg/implant
Kalamazoo, MI. (2.5 mg/pellet)
Finaplix-H................ Hoechst Roussel 12799-807-10 10 implant Trenbolone acetate.................... 200 mg/implant
Vet, Somerville, cartridge, 10 (20 mg/pellet)
NJ. pellets/implant.
Finaplix-S................ Hoechst Roussel 12799-807-07 10 implant Trenbolone acetate.................... 140 mg/implant
Vet, Somerville, cartridge, 7 (20 mg/pellet)
NJ. pellets/implant.
Heifer-oid................ Anchor Division, ............... Single & 20 implant Testosterone propionate............... 200 mg/implant
Boehringer cartridge belts, 8 (25 mg/pellet)
Ingelheim, St. pellets/implant. Estradiol benzoate.................... 20 mg/implant
Joseph, MO. (2.5 mg/pellet)
Heifer-oid................ Bio-Ceutic ............... 20 implant Testosterone propionate............... 200 mg/implant
Division, cartridge belt, 8 (25 mg/pellet)
Boehringer pellets/implant. Estradiol benzoate.................... 20 mg/implant
Ingelheim, St. (2.5 mg/pellet)
Joseph, MO.
Heifer-oid................ Ivy Laboratories, ............... Single & 20 implant Testosterone propionate............... 200 mg/implant
Inc., Overland cartridge belts, 8 (25 mg/pellet)
Park, KS. pellets/implant. Estradiol benzoate.................... 20 mg/implant
(2.5 mg/pellet)
Implus-H.................. The Upjohn Co., 0009-0434-01 20 implant Testosterone propionate............... 200 mg/implant
Kalamazoo, MI. cartridge belt, 8 (25 mg/pellet)
pellets/implant. Estradiol benzoate.................... 20 mg/implant
(2.5 mg/pellet)
Implus-H.................. Upjohn Co., Animal 06-0434-01 20 implant Testosterone propionate............... 200 mg/implant
Health Div., 01968327 cartridge belt, 8 (25 mg/pellet)
Orangeville, ON. pellets/implant. Estradiol benzoate.................... 20 mg/implant
(2.5 mg/pellet)
Revalor-G................. Hoechst Roussel 12799-811 10 implant Trenbolone acetate.................... 40 mg/implant
Vet, Somerville, cartridge 2 (20 mg/pellet)
NJ. pellets/implant. Estradiol............................. 4 mg/implant
(2 mg/pellet)
[[Page 51776]]
Revalor-H................. Hoechst Roussel 12799-810 10 implant Trenbolone acetate.................... 140 mg/implant
Vet, Somerville, cartridge, 7 (20 mg/pellet)
NJ. pellets/implant. Estradiol............................. 14 mg/implant
(2 mg/pellet)
Revalor-S................. Hoechst Roussel 12799-809 10 implant Trenbolone acetate.................... 120 mg/implant
Vet, Somerville, cartridge, 6 (20 mg/pellet)
NJ. pellets/implant. Estradiol............................. 24 mg/implant
4 mg/pellet)
Synovex H................. Fort Dodge Labs, 0856-3901 10 implant clip, 8 Testosterone propionate............... 200 mg/implant
Fort Dodge, IA. pellets/implant. (25 mg/pellet)
Estradiol benzoate.................... 20 mg/implant
(2.5 mg/pellet)
Synovex H................. Syntex ............... 10 implant clip, 8 Testosterone propionate............... 200 mg/implant
Laboratories, Palo pellets/implant. (25 mg/pellet)
Alto, CA. Estradiol benzoate.................... 20 mg/implant
(2.5 mg/pellet)
Synovex Plus.............. Fort Dodge Labs, 0856-3904 10 implant clip, 8 Trenbolone acetate.................... 200 mg/implant
Fort Dodge, IA. pellets/implant. (25 mg/pellet)
Estradiol............................. 28 mg/implant
(3.5 mg/pellet)
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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 Deputy Assistant Administrator, Office of Diversion Control, in
accordance with the Regulatory Flexibility Act [5 U.S.C. 605(b)], has
reviewed this rule and by approving it certifies that it will not have
a significant economic impact on a substantial number of small-business
entities. The inclusion of a product in 21 CFR 1308.26 relieves persons
who handle the product in the course of legitimate business from the
requirements imposed by 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 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 have significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of the United States-based companies to
complete 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.
Dated: September 8, 1997.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 97-25973 Filed 10-2-97; 8:45 am]
BILLING CODE 4410-09-M