[Federal Register Volume 65, Number 136 (Friday, July 14, 2000)]
[Rules and Regulations]
[Pages 43690-43694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17915]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-187F]
RIN 1117-AA51


Schedules of Controlled Substances: Exempt Anabolic Steroids 
Products

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) published an interim 
rule with request for comments (65 FR 3124, Jan. 20, 2000, as corrected 
at 65 FR 5024, Feb. 2, 2000) which identified six anabolic steroid 
products as being exempt from certain regulatory provisions of the 
Controlled Substances Act (21 U.S.C. 801 et seq.) (CSA). No

[[Page 43691]]

comments were received. Therefore, the interim rule is being adopted 
without change.

EFFECTIVE DATE: July 14, 2000.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, D.C. 20537; Telephone (202) 307-7183.

SUPPLEMENTARY INFORMATION:

What Does This Rule Accomplish and by What Authority Is It Being 
Issued?

    This rule finalizes an interim rule (65 FR 3124, Jan. 20, 2000, as 
corrected at 65 FR 5024, Feb. 2, 2000) which identified six products as 
being exempt from certain portions of the Controlled Substances Act (21 
U.S.C. 801 et seq.) (CSA). Section 1903 of the Anabolic Steroids 
Control Act of 1990 (title XIX of Pub. L. 101-647) (ASCA) provides that 
the Attorney General may exempt products which contain anabolic 
steroids from all or any part of the CSA if the products have no 
significant potential for abuse. The procedure for implementing this 
section of the ASCA is described in 21 CFR 1308.33. Exempt status 
removes each product from application of the registration, labeling, 
records, reports, prescription, physical security, and import and 
export restrictions associated with Schedule III substances.

Why Did DEA Add Six Products to the List of Exempt Anabolic 
Steroids Products?

    Manufacturers of six anabolic steroid products submitted exempt 
status applications to the Deputy Assistant Administrator for the DEA 
Office of Diversion Control in accordance with 21 CFR 1308.33. Each 
application delineated a set of facts which the applicant believed 
justified the exempt status of its product. The applicants provided 
information which they believed showed that because of the specific 
product preparation, concentration, mixture, or delivery system these 
products had no significant potential for abuse. Upon acceptance of the 
applications, the Deputy Assistant Administrator requested from the 
Assistant Secretary for Health, Department of Health and Human Services 
(HHS) a recommendation as to whether these products should be 
considered for exemption from certain portions of the CSA. The Deputy 
Assistant Administrator received the determination and recommendation 
of the Assistant Secretary for Health and Surgeon General that there 
was sufficient evidence to establish that each product does not possess 
a significant potential for abuse.

Which Anabolic Steroid Products Are Effected and When Does the Rule 
Become Affective?

    In the interim rule, the Deputy Assistant Administrator identified 
the following six products as being exempt from application of sections 
302 and through 309 and 1002 through 1004 of the CSA (21 U.S.C. 822-829 
and 952-954) and 21 CFR 1301.13, 1301.22, and 1301.71 through 1301.76:

                                                            Exempt Anabolic Steroid Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Trade name                      Company                  NDC No.                Form                 Ingredients              Quantity
--------------------------------------------------------------------------------------------------------------------------------------------------------
Component E-H in process           Ivy Laboratories, Inc.,    ....................  Pail or drum........  Testosterone propionate.  10 parts
 granulation.                       Overland Park, KS.
                                                                                                          Estradiol benzoate......  1 part
Component E-H in process pellets.  Ivy Laboratories, Inc.,    ....................  Pail................  Testosterone propionate.  25 mg/
                                    Overland Parks, KS.
                                                                                                          Estradiol benzoate......  2.5 mg/pellet
Component TE-S in process          Ivy Laboratories, Inc.,    ....................  Pail or drum........  Trenbolone acetate......  5 parts
 granulation.                       Overland Park, KS.
                                                                                                          Estradiol USP...........  1 part
Component TE-S in process pellets  Ivy Laboratories, Inc.,    ....................  Pail................  Trenbolone acetate......  120 mg/
                                    Overland Parks, KS.
                                                                                                          Estradiol USP...........  24 mg/pellet
Testoderm with Adhesive 4 mg/d...  Alza Corp., Palo Alto,CA.  Export only.........  Patch...............  Testosterone............  10 mg
Testosterone Ophthalmic Solutions  Allergan, Irvine, CA.....  ....................  Ophthalmic Solutions  Testosterone............  0.6% w/v
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The interim rule became immediately effective on publication in the 
Federal Register, January 20, 2000, in order to provide a health 
benefit to the public by more expeditiously increasing the access to 
these anabolic steroid products and to reduce regulatory restrictions 
that DEA (in consultation with HHS) has determined to be an unnecessary 
burden on the businesses manufacturing these products.

What Comments to the Interim Rule Were Received?

    Comments to the interim rule were requested, none were received.

What Exempt Anabolic Steroid Products are Included in the List 
Referred to in 21 CFR 1308.34?

    With the publication of this final rule, the complete list of 
products referred to in 21 CFR 1308.34 is as follows:

                                                            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 Laboratories,        0536-1605              Vial...............  Testosterone enanthate..  90 mg/ml
                                    Rockville Centre, NY.
                                                                                                          Estradiol valerate......  4 mg/ml
Androgyn L.A.....................  Forest Pharmaceuticals,    0456-1005              Vial...............  Testosterone enanthate..  90 mg/ml
                                    St. Louis, MO.
                                                                                                          Estradiol valerate......  4 mg/ml

[[Page 43692]]

 
Component E-H in process           Ivy Laboratories, Inc.,                           Pail or drum.......  Testosterone propionate.  10 parts
 granulation.                       Overland Park, KS.
                                                                                                          Estradiol benzoate......  1 part
Componenet E-H in process pellets  Ivy Laboratories, Inc.,                           Pail...............  Testosterone propionate.  25 mg/
                                    Overland Park, KS.
                                                                                                          Estradiol benzoate......  2.5 mg/pellet
Component TE-S in process          Ivy Laboratories, Inc.,                           Pail or drum.......  Trenbolone acetate......  5 parts
 granulation.                       Overland Park, KS.
                                                                                                          Estradiol USP...........  1 part
Component TE-S in process pellets  Ivy Laboratories, Inc.,                           Pail...............  Trenbolone acetate......  120 mg/
                                    Overland Park, KS.
                                                                                                          Estradiol USP...........  24 mg/pellet
depANDROGYN......................  Forest Pharmaceuticals,    0456-1020              Vial...............  Testosterone cypionate..  50 mg/ml
                                    St. Louis, MO.
                                                                                                          Estradiol cypionate.....  2 mg/ml
DEPTO-T.E........................  Quality Research Pharm.,   52765-257              Vial...............  Testosterone cypionate..  50 mg/ml
                                    Carmel, IN.
                                                                                                          Estradiol cypionate.....  2 mg/ml
Depo-Testadiol...................  The Upjohn Company,        0009-0253              Vial...............  Testosterone cypionate..  50 mg/ml
                                    Kalamazoo, MI.
                                                                                                          Estradiol cypionate.....  2 mg/ml
depTESTROGEN.....................  Martica Pharmaceuticals,   51698-257              Vial...............  Testosterone cypionate..  50 mg/ml
                                    Phoenix, AZ.
                                                                                                          Estradiol cypionate.....  2 mg/ml
Duomone..........................  Wintec Pharmaceutical,     52047-360              Vial...............  Testosterone enanthate..  90 mg/ml
                                    Pacific, MO.
                                                                                                          Estradiol valerate......  4 mg/ml
DUO-SPAN II......................  Primedics Laboratories,    0684-0102              Vial...............  Testosterone cypionate..  50 mg/ml
                                    Gardena, CA.
                                                                                                          Estradiol cypionate.....  2 mg/ml
DURATESTRIN......................  W. E. Hauck, Alpharetta,   43797-016              Vial...............  Testosterone cypionate..   50 mg/ml
                                    GA.
                                                                                                          Estradiol cypionate.....   2 mg/ml
Estratest........................  Solvay Pharmaceuticals,    0032-1026              TB.................  Esterifield estrogens...  1.25 mg
                                    Marietta, GA.
                                                                                                          Methyltestosterone......  2.5 mg
Estratest HS.....................  Solvay Pharmaceuticals,    0032-1023              TB.................  Esterifield estrogens...  0.625 mg
                                    Marietta, GA.
                                                                                                          Methyltestosterone......  1.25 mg
Menogen..........................  Sage Pharmaceuticals,      59243-570              TB.................  Esterifield estrogens...  1.25 mg
                                    Shreveport, LA.
                                                                                                          Methyltestosterone......  2.5 mg
Menogen HS.......................  Sage Pharmaceutical,       59243-560              TB.................  Esterifield estrogens...  .0625 mg
                                    Shreveport, LA.
                                                                                                          Methyltestosterone......  1.25 mg
PAN ESTRA TEST...................  Pan American Labs.,        0525-0175              Vial...............  Testosterone cypionate..  50 mg/ml
                                    Covington, LA.
                                                                                                          Estradiol cypionate.....  2 mg/ml
Premarin with Methyltestosterone.  Ayerst Labs. Inc,. New     0046-0878              TB.................  Conjugated estrogens....  0.625 mg
                                    York, NY.
                                                                                                          Methyltestosterone......  5.0 mg
Premarin with Methyltestosterone.  Ayerst Labs. Inc., New     0046-0879              TB.................  Conjugated estrogens....  1.25 mg
                                    York, NY.
                                                                                                          Methyltestosterone......  10.0 mg
Synovex H in-process bulk pellets  Syntex Animal health,                             Drum...............  Testosterone propionate.  25 mg
                                    Palo Alto, CA.
                                                                                                          Estradiol benzoate......  2.5 mg/pellet
Synovex H in-process granulation.  Syntex Animal Health,                             Drum...............  Testosterone propionate.  10 part
                                    Palo Alto, CA.
                                                                                                          Estradiol benzoate......  1 part
Synovex Plus in-process bulk       Fort Dodge Animal Health,                         Drum...............  Trenbolone acetate......  25 mg/
 pellets.                           Fort Dodge, IA.
                                                                                                          Estradiol benzoate......  3.50 mg/pellet
Synovex Plus in-process            Fort Dodge Animal Health,                         Drum...............  Trenbolone acetate 25
 granulation.                       Fort Dodge, IA.                                                        parts.
                                                                                                          Estradiol benzoate......  3.5 parts
Testagen.........................  Clint Pharmaceuticals,     55553-257              Vial...............  Testosterone cypionate..  50 mg/ml
                                    Nashville, TN.
                                                                                                          Estradiol cypionate.....  2 mg/ml
TEST-ESTRO Cypionates............  Rugby Laboratories         0536-9470              Vial...............  Testosterone cypionate..  50 mg/ml
                                    Rockvill Centre, NY.
                                                                                                          Estradiol cypionate.....  2 mg/ml

[[Page 43693]]

 
Testoderm 4 mg/d.................  Alza Copr., Palo Alto, CA  17314-4608             Patch..............  Testosterone............  10 mg
Testoderm 6 mg/d.................  Alza Corp., Palo Alto, CA  17314-4609             Patch..............  Testosterone............  15 mg
Testoderm with Adhesive 4 mg/d...  Alza Corp., Palo Alto, CA  Export only            Patch..............  Testosterone............  10 mg
Testoderm with Adhesive 6 mg/d...  Alza Corp., Palo Alto, CA  17314-2836             Patch..............  Testosterone............  15 mg
Testoderm in-process film........  Alza Corp, Palo Alto, CA.                         Sheet..............  Testosterone............  0.25 mg/cm2
Testoderm with Adhesive in-        Alza Corp., Palo Alto, CA                         Sheet..............  Testosterone............  0.25 mg/cm2
 process film.
Testosterone Cypionate/Estradiol   Best Generics, No. Miami   54274-530              Vial...............  Testosterone cypionate..  50 mg/ml
 Cypionate Injection.               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.....   2mg/ml
Testosterone Cyp 50 Estradiol Cyp  I.D.E.-Interstate,         0814-7737              Vial...............  Testosterone cypionate..  50 mg/ml
 2.                                 Amityville, NY.
                                                                                                          Estradiol cypionate.....  2 mg/ml
Testosterone Cypionate/Estradiol   Schein Pharmaceuticals,    0364-6611              Vial...............  Testosterone cypionate..  50 mg/ml
 Cypionate Injection.               Port Washington, NY.
                                                                                                          Estradiol cypionate.....   2mg/ml
Testosterone Cypionate/Estradiol   Steris Labs. Inc.,         0402-0257              Vial...............  Testosterone cypionate..  50 mg/ml
 Cypionate Injection.               Phoenix, AZ.
                                                                                                          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 Pharmaceuticals,    0364-6618              Vial...............  Testosterone enanthate..  90 mg/ml
 Valerate Injection.                Port Washington, NY.
                                                                                                          Estradiol valerate......  4 mg/ml
Testosterone Enanthate/Estradiol   Steris Labs. Inc.,         0402-0360              Vial...............  Testosterone enanthate..  90 mg/ml
 Valerate Injection.                Phoenix, AZ.
                                                                                                          Estradiol valerate......  4 mg/ml
Testosterone Ophthalmic Solutions  Allergan, Irvine, CA.....                         Ophthalmic           Testosterone............  0.6% w/v
                                                                                      solutions.
Tilapia Sex Reversal Feed          Rangen, Inc., Buhl, ID...                         Plastic bags.......  Methyltestosterone......  60 mg/kg fish feed
 (Investigational).
Tilapia Sex Reversal Feed          Ziegler Brothers, Inc.,                           Plastic bags.......  Methyltestosterone......  60 mg/kg fish feed
 (Investigational).                 Gardners, PA.
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    Additional copies of this list may be obtained by submitting a 
written request to the Drug and Chemical Evaluation Section, Office of 
Diversion Control, Drug Enforcement Administration, Washington, D.C. 
20537.

Plain Language Instructions

    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
this regulation, call or write Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537, Telephone (202) 307-7297.

Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator, for the DEA 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 significant economic impact on a substantial number of 
small business entities. The granting of exempt status relieves persons 
who handle the exempt products in the course of legitimate business 
from the registration, labeling, records, reports, prescription, 
physical security, and import and export restrictions imposed by the 
CSA.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles in 
Executive Order 12866, section 1(b). The Office of Management and 
Budget (OMB) reviewed the interim rule as a significant action; the DEA 
received no comments regarding the interim rule. This final rule falls 
into a category of regulatory actions which OMB has determined are 
exempt from regulatory review. Therefore, this action has not been 
reviewed by the OMB.

Executive Order 13132

    This action has been analyzed in accordance with the principles and 
criteria in Executive Order 13132 and it has been determined that this 
rule does not have sufficient federalism implications to warrant the 
preparation of a Federalism Assessment.

Unfunded Mandates Reform Act of 1995

    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.

Small Business Regulatory Enforcement Fairness Act of 1996

    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

[[Page 43694]]

result in an annual effect on the economy of $100,000,000 or more; a 
major increase in costs or prices; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of United States-based companies to compete with foreign-
based companies in domestic and export markets.

PART 1308--[AMENDED]

    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 which was published at 65 FR 3124 on Jan. 20, 
2000 and corrected at 65 FR 5024, on Feb. 2, 2000, amending the list 
described in 21 CFR 1308.34.

    Dated: July 3, 2000.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 00-17915 Filed 7-13-00; 8:45 am]
BILLING CODE 4410-09-M