Federal Register Notices
> Rules - 2000
> Exempt Anabolic
Steroids Products
[Federal Register: July 14, 2000 (Volume 65, Number 136)]
[Rules and Regulations]
[Page 43690-43694]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy00-11]
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.
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 |
Component E-H in
process granulation. |
Company |
Ivy Laboratories,
Inc., Overland Park, KS. |
NDC No. |
|
Form |
Pail or drum |
Ingredients |
Testosterone
propionate |
Quantity |
10 parts |
|
Trade name |
Component E-H in
process pellets. |
Company |
Ivy Laboratories, Inc.
Overland Park, KS. |
NDC No. |
|
Form |
Pail |
Ingredients |
Estradiol benzoate |
Quantity |
1 part |
Ingredients |
Testosterone
propionate |
Quantity |
25mg |
|
Trade name |
Component TE-S in
process granulation. |
Company |
Ivy Laboratories, Inc.
Overland Park, KS. |
NDC No. |
|
Form |
Pail or drum |
Ingredients |
Estradiol benzoate |
Quantity |
2.5 mg/pellet |
Ingredients |
Trenbolone acetate |
Quantity |
5 parts |
|
Trade name |
Component TE-S in
process pellets. |
Company |
Ivy Laboratories, Inc.
Overland Park, KS. |
NDC No. |
|
Form |
Pail |
Ingredients |
Estradiol USP |
Quantity |
1 part |
Ingredients |
Trenbolone acetate |
Quantity |
120 mg |
|
Trade name |
Testoderm
with Adhesive 4 mg/d. |
Company |
Alza
Corp., Palo Alto, CA |
NDC No. |
Export
only |
Form |
Patch |
Ingredients |
Estradiol benzoate |
Quantity |
2.5 mg/pellet |
Ingredients |
Trenbolone acetate |
Quantity |
5 parts |
|
Trade name |
Testosterone
Ophthalmic Solutions. |
Company |
Allergan,
Irvine, CA |
NDC No. |
|
Form |
Ophthalmic
Solutions. |
Ingredients |
Testosterone |
Quantity |
<0.6%
w/v |
Ingredients |
Trenbolone acetate |
Quantity |
5 parts |
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
Trade name |
Andro-Estro
90-4 |
Company |
Rugby
Laboratories, Rockville Centre, NY |
NDC No. |
0536-1605 |
Form |
Vial |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
|
Trade name |
Androgyn
L.A |
Company |
Forest
Pharmaceuticals, St. Louis, MO |
NDC No. |
0456-1005 |
Form |
Vial |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
|
|
Trade name |
Component
E-H in process granulation. |
Company |
Ivy
Laboratories, Inc., Overland Park, KS. |
NDC No. |
|
Form |
Pail or
drum |
Ingredients |
Testosterone
propionate. |
Quantity |
10 parts |
|
|
|
|
Trade name |
Componenet
E-H in process pellets |
Company |
Ivy
Laboratories, Inc., Overland Park, KS. |
NDC No. |
|
Form |
Pail |
Ingredients |
Estradiol benzoate |
Quantity |
1 part |
Ingredients |
Testosterone
propionate |
Quantity |
25 mg/ |
|
|
Trade name |
Component
TE-S in process granulation |
Company |
Ivy
Laboratories, Inc., Overland Park, KS. |
NDC No. |
|
Form |
Pail or
drum |
Ingredients |
Estradiol benzoate |
Quantity |
2.5 mg/pellet |
Ingredients |
Trenbolone acetate |
Quantity |
5 parts |
|
|
Trade name |
Component TE-S in process pellets. |
Company |
Ivy Laboratories,
Inc.,
Overland Park, KS. |
NDC No. |
|
Form |
Pail |
Ingredients |
Estradiol USP |
Quantity |
1 part |
Ingredients |
Trenbolone acetate |
Quantity |
120 mg/ |
|
|
Trade name |
depANDROGYN |
Company |
Forest
Pharmaceuticals,
St. Louis, MO. |
NDC No. |
0456-1020 |
Form |
Vial |
Ingredients |
Estradiol USP |
Quantity |
24 mg/pellet |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Component
TE-S in process granulation |
Company |
Ivy
Laboratories, Inc., Overland Park, KS. |
NDC No. |
|
Form |
Pail or
drum |
Ingredients |
Estradiol benzoate |
Quantity |
2.5 mg/pellet |
Ingredients |
Trenbolone acetate |
Quantity |
5 parts |
|
|
Trade name |
DEPTO-T.E |
Company |
Quality Research Pharm.,
Carmel, IN. |
NDC No. |
52765-257 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Depo-Testadiol |
Company |
The Upjohn
Company,
Kalamazoo, MI. |
NDC No. |
0009-0253 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
depTESTROGEN |
Company |
Martica
Pharmaceuticals,
Phoenix, AZ. |
NDC No. |
51698-257 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Duomone |
Company |
Wintec
Pharmaceutical,
Pacific, MO. |
NDC No. |
52047-360 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
|
|
Trade name |
DUO-SPAN II |
Company |
Primedics
Laboratories, Gardena, CA. |
NDC No. |
0684-0102 |
Form |
Vial |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
DURATESTRIN |
Company |
W. E. Hauck,
Alpharetta,
GA. |
NDC No. |
43797-016 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Estratest |
Company |
Solvay
Pharmaceuticals,
Marietta, GA. |
NDC No. |
0032-1026 |
Form |
TB |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Esterifield estrogens |
Quantity |
1.25 mg |
|
|
Trade name |
Estratest HS |
Company |
Solvay
Pharmaceuticals,
Marietta, GA. |
NDC No. |
0032-1023 |
Form |
TB |
Ingredients |
Methyltestosterone |
Quantity |
2.5 mg |
Ingredients |
Esterifield estrogens |
Quantity |
0.625 mg |
|
|
Trade name |
Menogen |
Company |
Sage
Pharmaceuticals,
Shreveport, LA. |
NDC No. |
59243-570 |
Form |
TB |
Ingredients |
Methyltestosterone |
Quantity |
1.25 mg |
Ingredients |
Esterifield estrogens |
Quantity |
1.25 mg |
|
|
Trade name |
Menogen HS |
Company |
Sage
Pharmaceutical,
Shreveport, LA. |
NDC No. |
59243-560 |
Form |
TB |
Ingredients |
Methyltestosterone |
Quantity |
2.5 mg |
Ingredients |
Esterifield estrogens |
Quantity |
.0625 mg |
|
|
Trade name |
PAN ESTRA TEST |
Company |
Pan American
Labs.,
Covington, LA. |
NDC No. |
0525-0175 |
Form |
Vial |
Ingredients |
Methyltestosterone |
Quantity |
1.25 mg |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Premarin with Methyltestosterone. |
Company |
Ayerst Labs. Inc,.
New
York, NY. |
NDC No. |
0046-0878 |
Form |
TB |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Conjugated estrogens |
Quantity |
0.625 mg |
|
|
Trade name |
Premarin with Methyltestosterone. |
Company |
Ayerst Labs. Inc.,
New
York, NY. |
NDC No. |
0046-0879 |
Form |
TB |
Ingredients |
Methyltestosterone |
Quantity |
5.0 mg |
Ingredients |
Conjugated estrogens |
Quantity |
1.25 mg |
|
|
Trade name |
Synovex H in-process bulk pellets. |
Company |
Syntex Animal
health,
Palo Alto, CA. |
NDC No. |
|
Form |
Drum |
Ingredients |
Methyltestosterone |
Quantity |
10.0 mg |
Ingredients |
Testosterone propionate |
Quantity |
25 mg |
|
|
Trade name |
Synovex H in-process granulation. |
Company |
Syntex Animal
Health,
Palo Alto, CA. |
NDC No. |
|
Form |
Drum |
Ingredients |
Estradiol benzoate |
Quantity |
2.5 mg/pellet |
Ingredients |
Testosterone propionate |
Quantity |
10 part |
|
|
Trade name |
Synovex Plus in-process bulk pellets. |
Company |
Fort
Dodge Animal
Health, Fort Dodge, IA. |
NDC No. |
|
Form |
Drum |
Ingredients |
Estradiol benzoate |
Quantity |
1 part |
Ingredients |
Trenbolone acetate |
Quantity |
25 mg/ |
|
|
Trade name |
Synovex Plus
in-process granulation. |
Company |
Fort Dodge Animal
Health,
Fort Dodge,
IA. |
NDC No. |
|
Form |
Drum |
Ingredients |
Estradiol benzoate |
Quantity |
3.50 mg/pellet |
Ingredients |
Trenbolone acetate 25
parts |
|
|
Trade name |
Testagen |
Company |
Clint
Pharmaceuticals,
Nashville, TN. |
NDC No. |
55553-257 |
Form |
Vial |
Ingredients |
Estradiol benzoate |
Quantity |
3.5 parts |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
TEST-ESTRO Cypionates |
Company |
Rugby
Laboratories
Rockvill Centre, NY. |
NDC No. |
0536-9470 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Testoderm 4 mg/d |
Company |
Alza Copr., Palo Alto, CA |
NDC No. |
17314-4608 |
Form |
Patch |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone |
Quantity |
10 mg |
|
|
Trade name |
Testoderm 6 mg/d |
Company |
Alza Corp., Palo Alto, CA |
NDC No. |
17314-4609 |
Form |
Patch |
Ingredients |
Testosterone |
Quantity |
15 mg |
|
|
Trade name |
Testoderm with Adhesive 4 mg/d |
Company |
Alza Corp., Palo Alto, CA |
NDC No. |
Export
only |
Form |
Patch |
Ingredients |
Testosterone |
Quantity |
10 mg |
|
|
Trade name |
Testoderm with Adhesive 6 mg/d |
Company |
Alza Corp., Palo Alto, CA |
NDC No. |
17314-2836 |
Form |
Patch |
Ingredients |
Testosterone |
Quantity |
15 mg |
|
|
Trade name |
Testoderm in-process film |
Company |
Alza Corp, Palo Alto,
CA |
NDC No. |
|
Form |
Sheet |
Ingredients |
Testosterone |
Quantity |
0.25 mg/cm2 |
|
|
Trade name |
Testoderm with Adhesive in-process film. |
Company |
Alza Corp., Palo Alto,
CA |
NDC No. |
|
Form |
Sheet |
Ingredients |
Testosterone |
Quantity |
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 |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
|
Quantity |
|
|
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate
Injection. |
Company |
Goldline Labs,
Ft.
Lauderdale, Fl. |
NDC No. |
0182-3069 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Testosterone Cyp 50 Estradiol Cyp 2. |
Company |
I.D.E.-Interstate,
Amityville, NY. |
NDC No. |
0814-7737 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate
Injection. |
Company |
Schein
Pharmaceuticals,
Port Washington, NY. |
NDC No. |
0364-6611 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate
Injection. |
Company |
Steris Labs.
Inc.,
Phoenix, AZ. |
NDC No. |
0402-0257 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2mg/ml |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
|
|
Trade name |
Testosterone Enanthate/Estradiol Valerate
Injection. |
Company |
Goldline Labs,
Ft.
Lauderdale, Fl. |
NDC No. |
0182-3073 |
Form |
Vial |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
|
|
Trade name |
Testosterone Enanthate/Estradiol Valerate
Injection. |
Company |
Schein
Pharmaceuticals,
Port Washington, NY. |
NDC No. |
0364-6618 |
Form |
Vial |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
|
|
Trade name |
Testosterone Enanthate/Estradiol Valerate
Injection. |
Company |
Steris Labs.
Inc.,
Phoenix, AZ. |
NDC No. |
0402-0360 |
Form |
Vial |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
|
|
Trade name |
Testosterone Ophthalmic Solutions. |
Company |
Allergan, Irvine, CA |
NDC No. |
|
Form |
Ophthalmic
solutions. |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
Ingredients |
Testosterone |
Quantity |
< 0.6% w/v |
|
|
Trade name |
Tilapia Sex Reversal
Feed (Investigational). |
Company |
Rangen, Inc.,
Buhl, ID |
NDC No. |
|
Form |
Plastic bags |
Ingredients |
Methyltestosterone |
Quantity |
60 mg/kg fish
feed |
|
|
Trade name |
Tilapia Sex Reversal
Feed (Investigational). |
Company |
Ziegler
Brothers,
Inc.,
Gardners, PA. |
NDC No. |
|
Form |
Plastic bags |
Ingredients |
Methyltestosterone |
Quantity |
60 mg/kg fish
feed |
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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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