[Federal Register Volume 65, Number 149 (Wednesday, August 2, 2000)]
[Rules and Regulations]
[Pages 47306-47309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: R0-17915]
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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; 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.
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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 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
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Trade name Company NDC No. Form Ingredients Quantity
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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
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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
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
[[Page 47308]]
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 parts
granulation. Fort Dodge, IA. 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
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..... 2 mg/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).
[[Page 47309]]
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 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
