Regulations &
Codified CSA > CFR >
Section 1308 > Section
1308.34 > Section 1308.34a
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA No. 160F]
Schedules of Controlled Substances: Exempt Anabolic Steroid Products
AGENCY: Drug Enforcement Administration, Department of Justice
ACTION: Final rule.
SUMMARY: The interim rule (62 FR 29288, May 30, 1997) which identified ten anabolic
steroid products as being exempt from certain regulatory provisions of 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 ten products as being exempt anabolic steroid products
(62 FR 29288, 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 1308.34 which was published at 62 FR 29288 on May 30, 1997.
The anabolic steroid containing compounds, mixtures, or preparations which are described in 21
CFR 1308.34 are as follows:
EXEMPT ANABOLIC STEROID PRODUCTS
Trade name |
Andro-Estro 90-4 |
Company |
Rugby Laboratories, Rockville Centre, NY |
NDC No. |
0536-1605 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone enanthate
|
90 mg/ml
|
Estradiol valerate |
4 mg/ml |
|
Trade name |
Androgyn L.A. |
Company |
Forest Pharmaceuticals, St. Louis, MO |
NDC No. |
0456-1005 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone enanthate
|
90 mg/ml
|
Estradiol valerate |
4 mg/ml |
|
Trade name |
depANDROGYN |
Company |
Forest Pharmaceuticals, St. Louis, MO |
NDC No. |
0456-1020 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
DEPO-T.E. |
Company |
Quality Research Pharm., Carmel, IN |
NDC No. |
52765-257 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
depTESTROGEN |
Company |
Martica Pharmaceuticals, Phoenix, AZ |
NDC No. |
51698-257 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Duomone |
Company |
Wintec Pharmaceutical, Pacific, MO |
NDC No. |
52047-360 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone enanthate
|
90 mg/ml
|
Estradiol valerate |
4 mg/ml |
|
Trade name |
DUO-SPAN II |
Company |
Primedics Laboratories, Gardena, CA |
NDC No. |
0684-0102 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
DURATESTRIN |
Company |
W.E. Hauck, Alpharetta, GA |
NDC No. |
43797-016 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Estratest |
Company |
Solvay Pharmaceuticals, Marietta, GA |
NDC No. |
0032-1026 |
Form |
TB |
Ingredients |
Quantity |
Estenfield estrogens
|
1.25 mg
|
Methyltestosterone |
2.5 mg |
|
Trade name |
Estratest HS |
Company |
Solvay Pharmaceuticals, Marietta, GA |
NDC No. |
0032-1023 |
Form |
TB |
Ingredients |
Quantity |
Estenfield estrogens
|
0.625 mg
|
Methyltestosterone |
1.25 mg |
|
Trade name |
Menogen |
Company |
Sage Pharmaceuticals, Shreveport, LA |
NDC No. |
59243-570 |
Form |
TB |
Ingredients |
Quantity |
Estenfield estrogens
|
1.25 mg
|
Methyltestosterone |
2.5 mg |
|
Trade name |
Menogen HS |
Company |
Sage Pharmaceuticals, Shreveport, LA |
NDC No. |
59243-560 |
Form |
TB |
Ingredients |
Quantity |
Estenfield estrogens
|
0.625 mg
|
Methyltestosterone |
1.25 mg |
|
Trade name |
PAN ESTRA TEST |
Company |
Pan AmericanLabs., Covington, LA |
NDC No. |
0525-0175 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Premarin with Methyltestosterone |
Company |
Ayerst Labs, Inc., New York, NY |
NDC No. |
0046-0879 |
Form |
TB |
Ingredients |
Quantity |
Conjugated estrogens
|
1.25 mg
|
Methyltestosterone |
10.0 mg |
|
Trade name |
Premarin with Methyltestosterone |
Company |
Ayerst Labs, Inc. New York, NY |
NDC No. |
0046-0878 |
Form |
TB |
Ingredients |
Quantity |
Conjugated estrogens
|
0.625 mg
|
Methyltestosterone |
5.0 mg |
|
Trade name |
Synovex H in-process bulk pellets |
Company |
Syntex Animal Health, Palo Alto, CA |
NDC No. |
|
Form |
Drum |
Ingredients |
Quantity |
Testosterone propionate |
25 mg
|
Estradiol benzoate |
2.5 mg/pellet |
|
Trade name |
Synovex H in-process granulation |
Company |
Syntex Animal Health, Palo Alto, CA |
NDC No. |
|
Form |
Drum |
Ingredients |
Quantity |
Testosterone propionate |
10 parts
|
Estradiol benzoate |
1 part |
|
Trade name |
Synovex Plus in-process granulation |
Company |
Fort Dodge Animal Health, Fort Dodge, IA |
NDC No. |
|
Form |
Drum |
Ingredients |
Quantity |
Trenbolone acetate
|
25 parts
|
Estradiol benzoate |
3.5 parts |
|
Trade name |
Synovex Plus in-process bulk pellets |
Company |
Fort Dodge Animal Health, Fort Dodge, IA |
NDC No. |
|
Form |
Drum |
Ingredients |
Quantity |
Trenbolone acetate
|
25 mg
|
Estradiol benzoate |
3.50 mg/pellet |
|
Trade name |
Testagen |
Company |
Clint Pharmaceuticals, Nashville, TN |
NDC No. |
55553-257 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
TEST-ESTRO Cypionates |
Company |
Rugby Laboratories, Rockville Centre, NY |
NDC No. |
0536-9470 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Testoderm 4 mg/d |
Company |
Alza Corp., Palo Alto, CA |
NDC No. |
17314-4608 |
Form |
Patch |
Ingredients |
Quantity |
Testosterone |
10 mg |
|
Trade name |
Testoderm 6 mg/d |
Company |
Alza Corp., Palo Alto, CA |
NDC No. |
17314-4609 |
Form |
Patch |
Ingredients |
Quantity |
Testosterone |
15 mg |
|
Trade name |
Testoderm with Adhesive 6 mg/d |
Company |
Alza Corp., Palo Alto, CA |
NDC No. |
17314-2836 |
Form |
Patch |
Ingredients |
Quantity |
Testosterone |
15 mg |
|
Trade name |
Testoderm in-process film |
Company |
Alza Corp., Palo Alto, CA |
NDC No. |
|
Form |
Sheet |
Ingredients |
Quantity |
Testosterone |
0.25 mg/cm2 |
|
Trade name |
Testoderm with Adhesive in-process film |
Company |
Alza Corp., Palo Alto, CA |
NDC No. |
|
Form |
Sheet |
Ingredients |
Quantity |
Testosterone |
0.25 mg/cm2 |
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate injection |
Company |
Best Generics, No. Miami Beach, FL |
NDC No. |
54274-530 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate injection |
Company |
Goldline Labs, Ft. Lauderdale, FL |
NDC No. |
0182-3069 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Testosterone Cyp 50 Estradiol Cyp 2 |
Company |
I.D.E.-Interstate, Amityville, NY |
NDC No. |
0814-7737 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate Injection |
Company |
Schein Pharmaceuticals, Port Washington, NY |
NDC No. |
0364-6611 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate injection |
Company |
Steris labs, Inc., Phoenix, AZ |
NDC No. |
0402-0257 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate Injection |
Company |
The Upjohn Co., Kalamazoo, MI |
NDC No. |
0009-0253 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone cypionate
|
50 mg/ml
|
Estradiol cypionate |
2 mg/ml |
|
Trade name |
Testosterone Enanthate/Estradiol Valerate Injection |
Company |
Goldline Labs, Ft. Lauderdale, FL |
NDC No. |
0182-3073 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone enanthate
|
90 mg/ml
|
Estradiol valerate |
4 mg/ml |
|
Trade name |
Testosterone Enanthate/Estradiol Valerate Injection |
Company |
Schein Pharmaceuticals, Port Washington, NY |
NDC No. |
0364-6618 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone enanthate
|
90 mg/ml
|
Estradiol valerate |
4 mg/ml |
|
Trade name |
Testosterone Enanthate/Estradiol Valerate Injection |
Company |
Steris Labs., Inc., Phoenix, AZ |
NDC No. |
0402-0360 |
Form |
Vial |
Ingredients |
Quantity |
Testosterone enanthate
|
90 mg/ml
|
Estradiol valerate |
4 mg/ml |
|
Trade name |
Tilapia Sex Reversal Feed (Investigational) |
Company |
Rangen, Inc., Buhl, ID |
NDC No. |
|
Form |
Plastic Bags |
Ingredients |
Quantity |
Methyltestosterone |
60 mg/kg fish feed |
|
Trade name |
Tilapia Sex Reversal Feed (Investigational) |
Company |
Zeigler Brothers, Inc., Gardeners, PA |
NDC No. |
|
Form |
Plastic Bags |
Ingredients |
Quantity |
Methyltestosterone |
60 mg/kg fish feed |
|
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 1308.34 relieves persons who handle the product
in the course of legitimate business from the registration, records, reports, prescription, physical
security, import and export requirements associated with Schedule III controlled substances
under the CSA. Specifically, the products are 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 Sections 1301.11,
1301.13 and 1301.71 through 1301.76 of Title 21 Code of Federal Regulations.
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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unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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