Federal Register Notices
> Scheduling
Actions - 2000
> Exempt Anabolic
Steroids Products; Republication
[Federal Register: August 2, 2000 (Volume 65, Number
149)]
[Rules and Regulations]
[Page 47306-47309]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au00-17]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA-187F]
RIN 1117-AA51
Schedules of Controlled Substances: Exempt Anabolic Steroids Products;
Republication
Editorial Note:
Due to numerous printing errors, rule document FR Doc. 00-17915
originally published at 65 FR 43690-43694, Friday, July 14, 2000 is
being reprinted in its entirety.
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 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
[[Page 47307]]
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 Affected and
When Does the Rule Become Effective?
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 |
Ingredients |
Estradiol
benzoate |
Quantity |
1 part |
|
Trade name |
Component E-H in
process pellets. |
Company |
Ivy Laboratories, Inc.
Overland Park, KS. |
NDC No. |
|
Form |
Pail |
Ingredients |
Testosterone
propionate |
Quantity |
25 mg |
Ingredients |
Estradiol benzoate |
Quantity |
2.5 mg/pellet |
|
Trade name |
Component TE-S in
process granulation. |
Company |
Ivy Laboratories, Inc.
Overland Park, KS. |
NDC No. |
|
Form |
Pail or drum |
Ingredients |
Trenbolone acetate |
Quantity |
5 parts |
Ingredients |
Estradiol USP |
Quantity |
1 part |
|
Trade name |
Component TE-S in
process pellets. |
Company |
Ivy Laboratories, Inc.
Overland Park, KS. |
NDC No. |
|
Form |
Pail |
Ingredients |
Trenbolone acetate |
Quantity |
120 mg |
Ingredients |
Estradiol USP |
Quantity |
24 mg/pellet |
|
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 |
Testosterone
Ophthalmic Solutions. |
Company |
Allergan,
Irvine, CA |
NDC No. |
|
Form |
Ophthalmic
Solutions. |
Ingredients |
Testosterone |
Quantity |
<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
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 |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
|
Trade name |
Androgyn
L.A |
Company |
Forest
Pharmaceuticals, St. Louis, MO |
NDC No. |
0456-1005 |
Form |
Vial |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
Ingredients |
Estradiol valerate |
Quantity |
4 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 |
Ingredients |
Estradiol benzoate |
Quantity |
1 part |
|
Trade name |
Componenet
E-H in process pellets |
Company |
Ivy
Laboratories, Inc., Overland Park, KS. |
NDC No. |
|
Form |
Pail |
Ingredients |
Testosterone
propionate |
Quantity |
25 mg/ |
Ingredients |
Estradiol benzoate |
Quantity |
2.5 mg/pellet |
|
Trade name |
Component
TE-S in process granulation |
Company |
Ivy
Laboratories, Inc., Overland Park, KS. |
NDC No. |
|
Form |
Pail or
drum |
Ingredients |
Trenbolone acetate |
Quantity |
5 parts |
Ingredients |
Estradiol USP |
Quantity |
1 part |
|
Trade name |
Component TE-S in process pellets. |
Company |
Ivy Laboratories,
Inc.,
Overland Park, KS. |
NDC No. |
|
Form |
Pail |
Ingredients |
Trenbolone acetate |
Quantity |
120 mg/ |
Ingredients |
Estradiol USP |
Quantity |
24 mg/pellet |
|
Trade name |
depANDROGYN |
Company |
Forest
Pharmaceuticals,
St. Louis, MO. |
NDC No. |
0456-1020 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
DEPTO-T.E |
Company |
Quality Research Pharm.,
Carmel, IN. |
NDC No. |
52765-257 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
Depo-Testadiol |
Company |
The Upjohn
Company,
Kalamazoo, MI. |
NDC No. |
0009-0253 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
depTESTROGEN |
Company |
Martica
Pharmaceuticals,
Phoenix, AZ. |
NDC No. |
51698-257 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
Duomone |
Company |
Wintec
Pharmaceutical,
Pacific, MO. |
NDC No. |
52047-360 |
Form |
Vial |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
|
Trade name |
DUO-SPAN II |
Company |
Primedics
Laboratories, Gardena, CA. |
NDC No. |
0684-0102 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
DURATESTRIN |
Company |
W. E. Hauck,
Alpharetta,
GA. |
NDC No. |
43797-016 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
Estratest |
Company |
Solvay
Pharmaceuticals,
Marietta, GA. |
NDC No. |
0032-1026 |
Form |
TB |
Ingredients |
Esterifield estrogens |
Quantity |
1.25 mg |
Ingredients |
Methyltestosterone |
Quantity |
2.5 mg |
|
Trade name |
Estratest HS |
Company |
Solvay
Pharmaceuticals,
Marietta, GA. |
NDC No. |
0032-1023 |
Form |
TB |
Ingredients |
Esterifield estrogens |
Quantity |
0.625 mg |
Ingredients |
Methyltestosterone |
Quantity |
1.25 mg |
|
Trade name |
Menogen |
Company |
Sage
Pharmaceuticals,
Shreveport, LA. |
NDC No. |
59243-570 |
Form |
TB |
Ingredients |
Esterifield estrogens |
Quantity |
1.25 mg |
Ingredients |
Methyltestosterone |
Quantity |
2.5 mg |
|
Trade name |
Menogen HS |
Company |
Sage
Pharmaceutical,
Shreveport, LA. |
NDC No. |
59243-560 |
Form |
TB |
Ingredients |
Esterifield estrogens |
Quantity |
.0625 mg |
Ingredients |
Methyltestosterone |
Quantity |
1.25 mg |
|
Trade name |
PAN ESTRA TEST |
Company |
Pan American
Labs.,
Covington, LA. |
NDC No. |
0525-0175 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
Premarin with Methyltestosterone. |
Company |
Ayerst Labs. Inc,.
New
York, NY. |
NDC No. |
0046-0878 |
Form |
TB |
Ingredients |
Conjugated estrogens |
Quantity |
0.625 mg |
Ingredients |
Methyltestosterone |
Quantity |
5.0 mg |
|
Trade name |
Premarin with Methyltestosterone. |
Company |
Ayerst Labs. Inc.,
New
York, NY. |
NDC No. |
0046-0879 |
Form |
TB |
Ingredients |
Conjugated estrogens |
Quantity |
1.25 mg |
Ingredients |
Methyltestosterone |
Quantity |
10.0 mg |
|
Trade name |
Synovex H in-process bulk pellets. |
Company |
Syntex Animal
health,
Palo Alto, CA. |
NDC No. |
|
Form |
Drum |
Ingredients |
Testosterone propionate |
Quantity |
25 mg |
Ingredients |
Estradiol benzoate |
Quantity |
2.5 mg/pellet |
|
Trade name |
Synovex H in-process granulation. |
Company |
Syntex Animal
Health,
Palo Alto, CA. |
NDC No. |
|
Form |
Drum |
Ingredients |
Testosterone propionate |
Quantity |
10 part |
Ingredients |
Estradiol benzoate |
Quantity |
1 part |
|
Trade name |
Synovex Plus in-process bulk pellets. |
Company |
Fort
Dodge Animal
Health, Fort Dodge, IA. |
NDC No. |
|
Form |
Drum |
Ingredients |
Trenbolone acetate |
Quantity |
25 mg/ |
Ingredients |
Estradiol benzoate |
Quantity |
3.50 mg/pellet |
|
Trade name |
Synovex Plus
in-process granulation. |
Company |
Fort Dodge Animal
Health,
Fort Dodge,
IA. |
NDC No. |
|
Form |
Drum |
Ingredients |
Trenbolone acetate |
Quantity |
25 parts |
Ingredients |
Estradiol benzoate |
Quantity |
3.5 parts |
|
Trade name |
Testagen |
Company |
Clint
Pharmaceuticals,
Nashville, TN. |
NDC No. |
55553-257 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
TEST-ESTRO Cypionates |
Company |
Rugby
Laboratories
Rockvill Centre, NY. |
NDC No. |
0536-9470 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
Testoderm 4 mg/d |
Company |
Alza Copr., Palo Alto, CA |
NDC No. |
17314-4608 |
Form |
Patch |
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 |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate
Injection. |
Company |
Goldline Labs,
Ft.
Lauderdale, Fl. |
NDC No. |
0182-3069 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2mg/ml |
|
Trade name |
Testosterone Cyp 50 Estradiol Cyp 2. |
Company |
I.D.E.-Interstate,
Amityville, NY. |
NDC No. |
0814-7737 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate
Injection. |
Company |
Schein
Pharmaceuticals,
Port Washington, NY. |
NDC No. |
0364-6611 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2mg/ml |
|
Trade name |
Testosterone Cypionate/Estradiol Cypionate
Injection. |
Company |
Steris Labs.
Inc.,
Phoenix, AZ. |
NDC No. |
0402-0257 |
Form |
Vial |
Ingredients |
Testosterone cypionate |
Quantity |
50 mg/ml |
Ingredients |
Estradiol cypionate |
Quantity |
2 mg/ml |
|
Trade name |
Testosterone Enanthate/Estradiol Valerate
Injection. |
Company |
Goldline Labs,
Ft.
Lauderdale, Fl. |
NDC No. |
0182-3073 |
Form |
Vial |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
|
Trade name |
Testosterone Enanthate/Estradiol Valerate
Injection. |
Company |
Schein
Pharmaceuticals,
Port Washington, NY. |
NDC No. |
0364-6618 |
Form |
Vial |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
|
Trade name |
Testosterone Enanthate/Estradiol Valerate
Injection. |
Company |
Steris Labs.
Inc.,
Phoenix, AZ. |
NDC No. |
0402-0360 |
Form |
Vial |
Ingredients |
Testosterone enanthate |
Quantity |
90 mg/ml |
Ingredients |
Estradiol valerate |
Quantity |
4 mg/ml |
|
Trade name |
Testosterone Ophthalmic Solutions. |
Company |
Allergan, Irvine, CA |
NDC No. |
|
Form |
Ophthalmic
solutions. |
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 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]
Editorial Note: Due to numerous printing
errors, rule document FR Doc. 00-17915 originally published at 65 FR
43690-43694, Friday, July 14, 2000 is being reprinted in its entirety.
[FR Doc. R0-17915 Filed 8-1-00; 8:45
am]
BILLING CODE 1505-01-D
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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