posted February 06, 2000 10:35 PM            

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Archive-Name: gov/us/fed/nara/fed-register/2000/jan/20/65FR3124
Posting-number: Volume 65, Issue 13, Page 3124 [Federal Register: January
20, 2000 (Volume 65, Number 13)] [Rules and Regulations] [Page 3124-3126]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ja00-3]
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DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308
[DEA No. 187I] RIN 1117-AA51 Schedules of Controlled Substances: Exempt
Anabolic Steroid Products AGENCY: Drug Enforcement Administration,
Department of Justice. ACTION: Interim rule and request for comments.
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SUMMARY: The Drug Enforcement Administration (DEA) is designating six
preparations as exempt anabolic steroid products. This action, as part of
the ongoing implementation of the Anabolic Steroids Control Act of 1990,
removes certain regulatory controls pertaining to Schedule III substances
from the designated entities. DATES: Effective date: January 20, 2000.
Comments must be submitted on or before March 20, 2000. ADDRESSES: Comments
and objections should be submitted to the Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration, Washington,
DC. 20537; Attention: DEA Federal Register Representative/CCR. [[Page
3125]] FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration, Washington,
DC 20537; Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: What Does
This Rule Accomplish and by What Authority Is It Being Issued: 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 Controlled Substances Act
(CSA) (21 U.S.C. 801 et seq.) 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. The purpose of this rule is to identify six
products for which applications were made and which the Deputy Assistant
Administrator for the DEA Office of Diversion Control finds meet the exempt
anabolic steroid product criteria. Why Is DEA Adding Anabolic Steroid
Products to the List of Exemptions? In accordance with 21 CFR 1308.33
applications for the exemption of six anabolic steroid products were
submitted by the products' manufacturers to the Deputy Assistant
Administrator for the DEA Office of Diversion Control. Each application
delineated a set of facts which the applicant believed justified the exempt
status of its product. The applicants provides data 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 these 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 which contain anabolic steroids should be considered for exemption
from certain portions of the CSA. The Deputy Assistant Administrator has
received the determination and recommendations of the Assistant Secretary
for Health and Surgeon General, that there was sufficient evidence to
establish that these products do not possess a significant potential for
abuse. Which Anabolic Steroid Products Are Affected? The Deputy Assistant
Administrator, having reviewed the applications, the recommendations of the
Assistant Secretary for Health and Surgeon General, and other relevant
information, finds that each of the products described below has no
significant potential for abuse because of its concentration, preparation,
mixture, or delivery system. What Action Can Individuals Take if They Are
Concerned About the Impact of this Rule? Interested persons are invited to
submit their comments in writing with regard to this interim rule. If any
comments or objections raise significant issues regarding any finding of
fact or conclusion of law upon which this order is based, the Deputy
Assistant Administrator shall immediately suspend the effectiveness of this
order until he may reconsider the application in light of the comments and
objections filed. Thereafter, the Deputy Assistant Administrator shall
reinstate, revoke, or amend his original order as he determines appropriate.
Miscellaneous Matter--Correction In a previously published rule, an exempt
anabolic steroid product was identified in the list referred to in 21 CFR
1308.34 by its active ingredients rather than its trade name. See 62 FR
51776, October 3, 1997. Exemptions are granted, in accordance with the ASCA
and the implementing regulations, to specific products. Therefore, DEA is
correcting the list referred to in 21 CFR 1308.34 to describe the product by
its specific trade name, Depo-Testadiol. The corrected information for this
product in the list referred to in 21 CFR 1308.34 is:
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Trade name Company NDC No. Form Ingredients Quantity
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Depo-Testadiol..................... The Upjohn Company, 0009-0253
Vial............. Testosterone cypionate, 50 mg/ml, 2 mg.ml. Kalamazoo, MI.
Estradiol cypionate.
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Why is DEA making this rule immediately effective? This rule is being made
immediately effective 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. Plain English 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, DC 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 a 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. Administrative Procedure Act 5 U.S.C. 553 This rule provides a
health benefit to the public by more expeditiously increasing the access to
these anabolic steroid products and reducing regulatory restrictions that
DEA and HHS have determined to be unnecessary. Therefore DEA has determined
that it is contrary to the public interest to delay the effectiveness of
this rule by requiring notice of proposed rulemaking and delay the
effective date. The relief from these administrative restrictions will
provide monetary savings to each of the three pharmaceutical manufacturers
who applied for these exemptions. In addition to the economic gain to the
pharmaceutical industry, these exemptions provide significant benefits to
the general public by increasing the availability of these drug products for
the legitimate medical treatment for which they were intended. [[Page
3126]] Executive Order 12866 This interim rule has been drafted and
reviewed in accordance with Executive Order 12866, section 1(b), Principles
of Regulation. The Deputy Assistant Administrator, Office of Diversion
Control, has determined that this rule is a significant regulatory action
under Executive Order 12866, section 3(f), Regulatory Planning and Review,
and accordingly this rule has been reviewed by the Office of Management and
Budget. This regulation exempts those who handle the affected products in
the course of legitimate business from the restrictions associated with
Schedule III allowing for a more efficient and cost effective means of doing
business. These exemptions will provide direct economic relief and financial
savings to the three manufacturer applicants requesting these actions. This
regulation is in the public interest and provides more expedient access to
these products which, in turn, has the potential to improve the health
benefits to the public. Executive Order 13132 This rule will not have
substantial direct effects on the United States, on the relationship between
the national government and the United States, or on the distribution of
power and responsibilities among the various levels of government.
Therefore, in accordance with Executive Order 13132, it is 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 the United
States based companies to compete with foreign-based companies in domestic
and export markets. PART 1308--[AMENDED] Pursuant to the authority vested
in the Attorney General by section 1903 of the ASCA, 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 DEA Office of
Diversion Control pursuant to 28 CFR 0.104, Appendix to Subpart R, section
7(g), the Deputy Assistant Administrator hereby orders that the following
compounds, mixtures, or preparations containing anabolic steroids be
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 21 CFR 1301.11, 1301,13,
1301.71 through 1301.76 for administrative purposes only and be included in
the list of products described in 21 CFR 1308.34. Sec. 1308.34 Amended
Exempt Anabolic Steroid Products
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Trade name Company NDC No. Form Ingredients Quality
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Component E-H in Process Pellets Ivy Laboratories, .....................
Pail................... Testosterone 25 mg/pellet, 2.5 mg/pellet. Inc.
Overland propionate, Park, KS. Estradiol benzoate. Component E-H in Process
Ivy Laboratories, ..................... Pail or Drum........... Testosterone
10 parts, 1 part. Granulation. Inc. Overland propionate, Park, KS. Estradiol
benzoate. Component TE-S in Process Ivy Laboratories, .....................
Pail................... Trenbolone acetate, 120 mg/pellet, 24 mg/pellet.
Pellets. Inc. Overland Estradiol USP. Park, KS. Component TE-S in Process
Ivy Laboratories, ..................... Pail or Drum........... Trenbolone
acetate, 5 parts, 1 part. Granulation. Inc. Overland Estradiol USP. Park,
KS. Testoderm with Adhesive 4 mg/d.. Alza Corp, Palo Export only..........
Patch.................. Testosterone....... 10 mg. Alto, CA. Testosterone
Ophthalmic Allergan, Irvine, ..................... Ophthalmic Solutions...
Testosterone....... 0.6 w/v. Solutions. CA.
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Dated: January 11, 2000. John H. King, Deputy Assistant Administrator,
Office of Diversion Control. [FR Doc 00-1347 Filed 1-19-00; 8:45 am] BILLING
CODE 4410-09-M

posted February 07, 2000 12:37 AM            

I don't think this is a landmark ruling, but I don't think these are animal products. (Not a flame Macro - let me explain)

Note the phrases, "in order to provide a health benefit to the puiblic by increasing the access to these AS products..."

Also, "in the public interest" and "general health benefits" is mentioned a few times in there as well.

Doesn't sound like veterinary uses though that is possible....

To me, it seems as though pharmaceutical companies are recognizing the potential to use testosterone medically - it is known to boost immune function among other things and that is probably the idea behind what looks to be the eye drops.

Also these three companies know the FDA isn't going to start legalizing AS in bunches. I am guessing that these companies applied to have a few products legalized, for very limited uses - the patches and eye drops for example.

Look in the post and see where it refers to this ruling as "not a major rule" and "will not have a major effect on the economy...." as well as "will not result in an aggregate expenditure of over $100,000,000 by national state and local governments...."

In other words, this is small potatoes to the FDA. The pharm companies know that if they apply for more legalizations, it would necessitate a major rule, which would require more time (the FDA can take years to rule on issues), more scrutiny, etc., and have less chance of being approved.

I speculate that the pharm companies in time will use the successes of these products to lobby for further legalizations, as the use of testosterone for medical purposes becomes more clearly understood.

That said, we are a long way from walking into a pharmacy and buying test cyp OTC. I personally am in support of decriminalizing all drugs....how dare the government tell me what to put in my body.

Anyway that's my take on it.

Matt