EliteFitness.com Bodybuilding ForumsExempt Anabolic Steroid Products. This action is part of the ongoing implementation of the Exempt anabolic steroid products Steroids Control Act of Three applications which were in conformance with 21 CFR The purpose of this rule is to finalize an interim rule regarding six products which the Deputy Assistant Administrator, Office of Diversion Control, finds meet the exempt exempt anabolic steroid products steroid product criteria. Each of these three letters contained an application to exempt from control under the CSA two products, each containing esterified estrogens and methyltestosterone. In three separate letters dated March 30,the Assistant Secretary of Health for HHS recommended that all six products, two products of esterified estrogen and methyltestosterone from each of three applications, be exempted from control under the CSA based on their similarity to the products, Estratest[reg], Estratest[reg] Hgh peptides benefits.
Schedules of controlled substances; exempt anabolic steroid products. Final rule. - PubMed - NCBI
This action, as part of the ongoing implementation of the Anabolic Steroids Control Act of , removes certain regulatory controls pertaining to Schedule III substances from the designated entities.
Comments must be submitted on or before March 20, 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.
In accordance with 21 CFR 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. 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.
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. In a previously published rule, an exempt anabolic steroid product was identified in the list referred to in 21 CFR See 62 FR , October 3, Exemptions are granted, in accordance with the ASCA and the implementing regulations, to specific products.
The corrected information for this product in the list referred to in 21 CFR 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.
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.
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. 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.
This interim rule has been drafted and reviewed in accordance with Executive Order , 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 , 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.
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 , it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of Exempt Anabolic Steroid Products.
This is an unofficial version. Drug Enforcement Administration, Department of Justice. Interim rule and request for comments. Miscellaneous Matter--Correction In a previously published rule, an exempt anabolic steroid product was identified in the list referred to in 21 CFR Why is DEA making this rule immediately effective? Administrative Procedure Act 5 U.
Executive Order 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.
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