[Federal Register Volume 62, Number 192 (Friday, October 3, 1997)]
[Rules and Regulations]
[Pages 51776-51778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25972]
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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.
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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:
[[Page 51777]]
Exempt Anabolic Steroid Products
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Trade name Company NDC No. Form Ingredients Quantity
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Andro-Estro 90-4................ Rugby 0536-1605 Vial........... Testosterone enanthate.................. 90 mg/ml
Laboratories, Estradiol valerate...................... 4 mg/ml
Rockville Centre,
NY.
Androgyn L.A.................... Forest 0456-1005 Vial........... Testosterone enanthate.................. 90 mg/ml
Pharmaceuticals, Estradiol valerate...................... 4 mg/ml
St. Louis, MO.
depANDROGYN..................... Forest 0456-1020 Vial........... Testosterone cypionate.................. 50 mg/ml
Pharmaceuticals, Estradiol cypionate..................... 2 mg/ml
St. Louis, MO.
DEPO-T.E........................ Quality Research 52765-257 Vial........... Testosterone cypionate.................. 50 mg/ml
Pharm., Carmel, Estradiol cypionate..................... 2 mg/ml
IN.
depTESTROGEN.................... Martica 51698-257 Vial........... Testosterone cypionate.................. 50 mg/ml
Pharmaceuticals, Estradiol cypionate..................... 2 mg/ml
Phoenix, AZ.
Duomone......................... Wintec 52047-360 Vial........... Testosterone enanthate.................. 90 mg/ml
Pharmaceutical, Estradiol valerate...................... 4 mg/ml
Pacific, MO.
DUO-SPAN II..................... Primedics 0684-0102 Vial........... Testosterone cypionate.................. 50 mg/ml
Laboratories, Estradiol cypionate..................... 2 mg/ml
Gardena, CA.
DURATESTRIN..................... W.E. Hauck, 43797-016 Vial........... Testosterone cypionate.................. 50 mg/ml
Alpharetta, GA. Estradiol cypionate..................... 2 mg/ml
Estratest....................... Solvay 0032-1026 TB............. Esterified estrogens.................... 1.25 mg
Pharmaceuticals, Methyltestosterone...................... 2.5 mg
Marietta, GA.
Estratest HS.................... Solvay 0032-1023 TB............. Esterified estrogens.................... 0.625 mg
Pharmaceuticals, Methyltestosterone...................... 1.25 mg
Marietta, GA.
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, Mrethyltestosterone..................... 1.25 mg
Shreveport, LA.
PAN ESTRA TEST.................. Pan American 0525-0175 Vial........... Testosterone cypionate.................. 50 mg/ml
Labs., Covington, Estradiol cypionate..................... 2 mg/ml
LA.
Premarin with Methyltestosterone Ayerst Labs. Inc., 0046-0879 TB............. Conjugated estrogens.................... 1.25 mg
New York, NY. Methyltestosterone...................... 10.0 mg
Premarin with Methyltestosterone Ayerst Labs. Inc., 0046-0878 TB............. Conjugated estrogens.................... 0.625 mg
New York, NY. Methyltestosterone...................... 5.0 mg
Synovex H in-process bulk Syntex Animal .............. Drum........... Testosterone propionate................. 25 mg/
pellets. Health, Palo Estradiol benzoate...................... 2.5 mg/pellet
Alto, CA.
Synovex H in-process granulation Syntex Animal .............. Drum........... Testosterone propionate................. 10 parts
Health, Palo Estradiol benzoate...................... 1 part
Alto, CA.
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 mg/
pellets. Health, Fort Estradiol benzoate...................... 3.50 mg/pellet
Dodge, IA.
Testagen........................ Clint 55553-257 Vial........... Testosterone cypionate.................. 50 mg/ml
Pharmaceuticals, Estradiol cypionate..................... 2 mg/ml
Nashville, TN.
TEST-ESTRO Cypionates........... Rugby 0536-9470 Vial........... Testosterone cypionate.................. 50 mg/ml
Laboratories, Estradiol cypionate..................... 2 mg/ml
Rockville Centre,
NY.
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/d.. Alza Corp., Palo 17314-2836 Patch.......... Testosterone............................ 15 mg
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.
Testosterone Cypionate/Estradiol Best Generics, No. 54274-530 Vial........... Testosterone cypionate.................. 50 mg/ml
Cypionate Injection. Miami Beach, FL. Estradiol cypionate..................... 2 mg/ml
Testosterone Cypionate/Estradiol Goldline Labs, Ft. 0182-3069 Vial........... Testosterone cypionate.................. 50 mg/ml
Cypionate Injection. Lauderdale, FL. Estradiol cypionate..................... 2 mg/ml
Testosterone Cyp 50 Estradiol I.D.E.-Interstate, 0814-7737 Vial........... Testosterone cypionate.................. 50 mg/ml
Cyp 2. Amityville, NY. Estradiol cypionate..................... 2 mg/ml
Testosterone Cypionate/Estradiol Schein 0364-6611 Vial........... Testosterone cypionate.................. 50 mg/ml
Cypionate Injection. Pharmaceuticals, Estradiol cypionate..................... 2 mg/ml
Port Washington,
NY.
Testosterone Cypionate/Estradiol Steris labs, Inc., 0402-0257 Vial........... Testosterone cypionate.................. 50 mg/ml
Cypionate Injection. Phoenix, AZ. Estradiol cypionate..................... 2 mg/ml
Testosterone Cypionate/Estradiol The Upjohn Co., 0009-0253 Vial........... Testosterone cypionate.................. 50 mg/ml
Cypionate Injection. kalamazoo, MI. Estradiol cypionate..................... 2 mg/ml
Testosterone Enanthate/Estradiol Goldline Labs, Ft. 0182-3073 Vial........... Testosterone enanthate.................. 90 mg/ml
Valerate Injection. Lauderdale, FL. Estradiol valerate...................... 4 mg/ml
Testosterone Enanthate/Estradiol Schein 0364-6618 Vial........... Testosterone enanthate.................. 90 mg/ml
Valerate Injection. Pharmaceuticals, Estradiol valerate...................... 4 mg/ml
Port Washington,
NY.
Testosterone Enanthate/Estradiol Steris Labs. Inc., 0402-0360 Vial........... Testosterone enanthate.................. 90 mg/ml
Valerate Injection. Phoenix, AZ. Estradiol valerate...................... 4 mg/ml
Tilapia Sex Reversal Feed Rangen, Inc., .............. Plastic Bags... Methyltestosterone...................... 60 mg/kg fish feed
(Investigational). Buhl, ID.
Tilapia Sex Reversal Feed Zeigler Brothers, .............. Plastic Bags... Methyltestosterone...................... 60 mg/kg fish feed
(Investigational. Inc., Gardners,
PA.
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[[Page 51778]]
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 Secs. 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.
[FR Doc. 97-25972 Filed 10-2-97; 8:45 am]
BILLING CODE 4410-09-M