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Regulations &
Codified CSA > CFR >
Section 1308 > Section
1308.26 > Section 1308.26a
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.
SUMMARY: The interim rule (62 FR 29289, May 30, 1997) which identified eight veterinary
anabolic steroid implant products as being exempt 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)9, the Deputy Assistant Administrator of the Office of
Diversion Control, hereby adopts as a final rule, without change, the interim rule amending 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
| Trade name |
Component E-H |
| Company |
VetLife, Inc., Norcross
GA |
| NDC or DIN No. |
021641-002 |
| Delivery System |
20 implant belt, 8 pellets/implant |
| Ingredients |
Quantity |
| Testosterone propionate |
200 mg/implant (25 mg/pellet) |
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet) |
|
| Trade name |
Component E-H |
| Company |
Elanco, Scarborough, ON |
| NDC or DIN No. |
01968327 |
| Delivery System |
20 implant belt, 8 pellets/implant |
| Ingredients |
Quantity |
| Testosterone propionate |
200 mg/implant (25 mg/pellet) |
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet) |
|
| Trade name |
Component TE-S |
| Company |
VetLife, Inc., Norcross, GA |
| NDC or DIN No. |
021641-004 |
| Delivery System |
20 implant belt, 6 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate |
120 mg/implant (20 mg/pellet) |
| Estradiol |
24 mg/implant (4 mg/pellet) |
|
| Trade name |
Component T-H |
| Company |
VetLife, Inc., Norcross, GA |
| NDC or DIN No. |
021641-006 |
| Delivery System |
20 implant belt, 10 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate |
200 mg/implant (20 mg/pellet) |
|
| Trade name |
Component T-S |
| Company |
VetLife, Inc., Norcross, GA |
| NDC or DIN No. |
021641-005 |
| Delivery System |
0 implant belt, 7 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate |
140 mg/implant (20 mg/pellet) |
|
| Trade name |
F-TO |
| Company |
Animal Health, Upjohn International, Kalamazoo, MI |
| NDC or DIN No. |
00093351 |
| Delivery System |
20 implant cartridge belt, 8 pellets/implant |
| Ingredients |
Quantity |
| Testosterone propionate |
200 mg/implant (25 mg/pellet)
|
| Oestradiol benzoate |
20 mg/implant (2.5 mg/pellet) |
|
| Trade name |
Finaplix-H |
| Company |
Hoechst Roussel Vet, Somerville, NJ |
| NDC or DIN No. |
12799-807-10 |
| Delivery System |
10 implant cartridge, 10 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate |
200 mg/implant (20 mg/pellet)
|
|
| Trade name |
Finaplix-S |
| Company |
Hoechst Roussel Vet, Somerville, NJ |
| NDC or DIN No. |
12799-807-07 |
| Delivery System |
10 implant cartridge, 7 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate |
140 mg/implant (20 mg/pellet)
|
|
| Trade name |
Heifer-oid |
| Company |
Anchor Division, Boehringer Ingelheim, St. Joseph, MO |
| NDC or DIN No. |
|
| Delivery System |
Single & 20 implant cartridge belts, 8 pellets/implant |
| Ingredients |
Quantity |
| Testosterone propionate
|
200 mg/implant (25 mg/pellet)
|
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet)
|
|
| Trade name |
Heifer-oid |
| Company |
Bio-Ceutic Division, Boehringer Ingelheim, St. Joseph, MO |
| NDC or DIN No. |
|
| Delivery System |
20 implant cartridge belt, 8 pellets/implant |
| Ingredients |
Quantity |
| Testosterone propionate
|
200 mg/implant (25 mg/pellet)
|
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet)
|
|
| Trade name |
Heifer-oid |
| Company |
Ivy Laboratories, Inc., Overland Park, KS |
| NDC or DIN No. |
|
| Delivery System |
Single & 20 implant cartridge belts, 8 pellets/implant |
| Ingredients |
Quantity |
| Testosterone propionate
|
200 mg/implant (25 mg/pellet)
|
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet)
|
|
| Trade name |
Implus-H |
| Company |
The Upjohn Co., Kalamazoo, MI |
| NDC or DIN No. |
0009-0434-01 |
| Delivery System |
20 implant cartridge belt, 8 pellets/implant |
| Ingredients |
Quantity |
| Testosterone propionate
|
200 mg/implant (25 mg/pellet)
|
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet)
|
|
| Trade name |
Implus-H |
| Company |
Upjohn Co.,
Animal
Health Div.,
Orangeville,
ON |
| NDC or DIN No. |
06-0434-01
01968327 |
| Delivery System |
20
implant
cartridge belt,
8
pellets/implant |
| Ingredients |
Quantity |
| Testosterone propionate
|
200 mg/implant (25 mg/pellet)
|
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet)
|
|
| Trade name |
Revalor-G |
| Company |
Hoechst Roussel Vet, Somerville, NJ |
| NDC or DIN No. |
12799-811 |
| Delivery System |
10 implant cartridge, 2 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate
|
40 mg/implant (20 mg/pellet)
|
| Estradiol |
4 mg/implant (2 mg/pellet)
|
|
| Trade name |
Revalor-H |
| Company |
Hoechst Roussel Vet, Somerville, NJ |
| NDC or DIN No. |
12799-810 |
| Delivery System |
10 implant cartridge,
7 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate
|
140 mg/implant (20 mg/pellet)
|
| Estradiol |
14 mg/implant (2 mg/pellet)
|
|
| Trade name |
Revalor-S |
| Company |
Hoechst Roussel Vet, Somerville, NJ |
| NDC or DIN No. |
12799-809 |
| Delivery System |
10 implant cartridge,
6 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate
|
120 mg/implant (20 mg/pellet)
|
| Estradiol |
24 mg/implant (4 mg/pellet)
|
|
| Trade name |
Synovex H |
| Company |
Fort Dodge Labs, Fort Dodge, IA |
| NDC or DIN No. |
0856-3901 |
| Delivery System |
10 implant cartridge, 8 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone propionate
|
200 mg/implant (25 mg/pellet)
|
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet)
|
|
| Trade name |
Synovex H |
| Company |
Syntex Laboratories, Palo Alto, CA |
| NDC or DIN No. |
|
| Delivery System |
10 implant cartridge, 8 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone propionate
|
200 mg/implant (25 mg/pellet)
|
| Estradiol benzoate |
20 mg/implant (2.5 mg/pellet)
|
|
| Trade name |
Synovex
Plus |
| Company |
Fort Dodge
Labs, Fort
Dodge, IA |
| NDC or DIN No. |
0856-3904 |
| Delivery System |
10 implant cartridge, 8 pellets/implant |
| Ingredients |
Quantity |
| Trenbolone acetate
|
200 mg/implant (25 mg/pellet)
|
| Estradiol |
28 mg/implant (3.5 mg/pellet)
|
|
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 compete 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
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NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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