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PART 50—CLEARING REQUIREMENT from the date of publication of such DEPARTMENT OF JUSTICE clearing requirement determination in Authority: 7 U.S.C. 2 as amended by Pub. the Federal Register. Drug Enforcement Administration L. 111–203, 124 Stat. 1376. (3) All other swaps for which neither 21 CFR Part 1300 § 50.25 Clearing requirement compliance of the parties to the swap is eligible to schedule. claim the exception from the clearing [Docket No. DEA–341F] (a) Definitions. For the purposes of requirement set forth in section 2(h)(7) RIN 1117–AB31 this paragraph: of the Act and § 39.6, must comply with Active Fund means any private fund the requirements of section 2(h)(1)(A) of Classification of Two Steroids, as defined in section 202(a) of the the Act no later than two hundred and Prostanozol and Methasterone, as Investment Advisers Act of 1940, that is seventy (270) days from the date of Schedule III Anabolic Steroids Under not a third-party subaccount and that publication of such clearing the Controlled Substances Act executes 200 or more swaps per month requirement determination in the AGENCY: Drug Enforcement based on a monthly average over the 12 Federal Register. months preceding the Commission Administration (DEA), Department of issuing a clearing requirement (c) Nothing in this rule shall be Justice. determination under section 2(h)(2) of construed to prohibit any person from ACTION: Final rule. voluntarily complying with the the Act. SUMMARY: With the issuance of this Category 1 Entity means a swap requirements of section 2(h)(1)(A) of the Final Rule, the Administrator of the dealer, a security-based swap dealer; a Act sooner than the implementation DEA classifies the following two major swap participant; a major schedule provided under paragraph (b). steroids as ‘‘anabolic steroids’’ under security-based swap participant; or an Issued in Washington, DC, on July 24, the Controlled Substances Act (CSA): active fund. 2012, by the Commission. prostanozol (17b-hydroxy-5a- Category 2 Entity means a Sauntia Warfield, androstano[3,2-c]pyrazole) and commodity pool; a private fund as methasterone (2a,17a-dimethyl-5a- defined in section 202(a) of the Assistant Secretary of the Commission. androstan-17b-ol-3-one). These steroids Investment Advisers Act of 1940 other Appendices to Swap Transaction and their salts, esters, and ethers are than an active fund; or a person Compliance and Implementation Schedule III controlled substances predominantly engaged in activities that Schedule: Clearing Requirement under subject to the regulatory control are in the business of banking, or in Section 2(h) of the CEA—Commission provisions of the CSA. activities that are financial in nature as Voting Summary and Statements of DATES: Effective Date: August 29, 2012. defined in section 4(k) of the Bank Commissioners Holding Company Act of 1956, provided FOR FURTHER INFORMATION CONTACT: that, in each case, the entity is not a Note: The following appendices will not Alan G. Santos, Associate Deputy third-party subaccount. appear in the Code of Federal Regulations. Assistant Administrator, Office of Third-party Subaccount means an Diversion Control, Drug Enforcement account that is managed by an Appendix 1—Commission Voting Administration; Mailing Address: 8701 investment manager that is independent Summary Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 307–7165. of and unaffiliated with the account’s On this matter, Chairman Gensler and beneficial owner or sponsor, and is Commissioners Sommers, Chilton, O’Malia SUPPLEMENTARY INFORMATION: responsible for the documentation and Wetjen voted in the affirmative; no Legal Authority necessary for the account’s beneficial Commissioner voted in the negative. owner to clear swaps. The DEA implements and enforces (b) Upon issuing a clearing Appendix 1—Statement of Chairman Titles II and III of the Comprehensive requirement determination under Gary Gensler Drug Abuse Prevention and Control Act section 2(h)(2) of the Act, the of 1970, often referred to as the I support the final rule to establish a Commission may determine, based on Controlled Substances Act and the schedule to phase in compliance with the Controlled Substances Import and the group, category, type, or class of clearing requirement provisions in the Dodd- Export Act (21 U.S.C. 801–971), as swaps subject to such determination, Frank Wall Street Reform and Consumer amended (hereinafter, ‘‘CSA’’). The that the following schedule for Protection Act. compliance with the requirements of The rule gives market participants an implementing regulations for these section 2(h)(1)(A) of the Act shall apply: adequate amount of time to comply and statutes are found in Title 21 of the (1) A swap between a Category 1 helps facilitate an orderly transition to the Code of Federal Regulations (CFR), parts Entity and another Category 1 Entity, or new clearing requirements for the swaps 1300 to 1321. Under the CSA, controlled any other entity that desires to clear the market. The rule provides greater clarity to substances are classified in one of five transaction, must comply with the market participants regarding the timeframe schedules based upon their potential for requirements of section 2(h)(1)(A) of the for bringing their swaps into compliance abuse, their currently accepted medical Act no later than ninety (90) days from with the clearing requirement. use, and the degree of dependence the the date of publication of such clearing substance may cause. 21 U.S.C. 812. The [FR Doc. 2012–18383 Filed 7–27–12; 8:45 am] requirement determination in the initial schedules of controlled Federal Register. BILLING CODE 6351–01–P substances by statute are found at 21 (2) A swap between a Category 2 U.S.C. 812(c) and the current list of Entity and a Category 1 Entity, another scheduled substances is published at 21 Category 2 Entity, or any other entity CFR Part 1308. that desires to clear the transaction, On November 29, 1990, the President must comply with the requirements of signed into law the Anabolic Steroids section 2(h)(1)(A) of the Act no later Control Act of 1990 (Title XIX of Pub. than one hundred and eighty (180) days L. 101–647), which became effective

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February 27, 1991. This law established 2004). These effects often come at a cost cholesterol levels, which may increase and regulated anabolic steroids as a to the healthy individual who the risk of strokes and cardiovascular class of drugs under Schedule III of the experiences clear physical and heart attacks. Furthermore, anabolic CSA. As a result, a new anabolic steroid psychological complications (Trenton steroid abuse is purported to induce is not scheduled according to the and Currier, 2005; Brower, 2002; Hall et psychological effects such as aggression, procedures set out in 21 U.S.C. 811, but al., 2005). increased feelings of hostility, and is administratively classified as an In the United States, only a small psychological dependence and anabolic steroid through the rulemaking number of anabolic steroids are addiction (Brower, 2002; Kanayama et process if it meets the regulatory approved for either human or veterinary al., 2008). definition of an anabolic steroid in 21 use. Approved medical uses for anabolic Upon abrupt termination of long-term CFR 1300.01. steroids include treatment of androgen anabolic steroid abuse, a withdrawal On October 22, 2004, the President deficiency in hypogonadal males, syndrome may appear including severe signed into law the Anabolic Steroid adjunctive therapy to offset protein depression. Additionally, polysubstance Control Act of 2004 (Pub. L. 108–358), catabolism associated with prolonged abuse is routinely associated with which became effective on January 20, administration of corticosteroids, anabolic steroid abuse, where ancillary 2005. Section 2(a) of the Anabolic treatment of delayed puberty in boys, drugs, including recreational and Steroid Control Act of 2004 amended 21 treatment of metastatic breast cancer in prescription drugs, are abused in U.S.C. 802(41)(A) by replacing the women, and treatment of anemia response to unwanted side effects (Hall existing definition of ‘‘anabolic steroid.’’ associated with specific diseases (e.g., et al., 2005; Parkinson et al., 2005; The Anabolic Steroid Control Act of anemia of chronic renal failure, Skarberg et al., 2009). 2004 classifies a drug or hormonal Fanconi’s anemia, and acquired aplastic A review of the scientific literature substance as an anabolic steroid if the anemia). However, with the exception of finds adverse health effects including following four criteria are met: (A) The the treatment of male hypogonadism, liver toxicity with renal failure reported substance is chemically related to anabolic steroids are not the first-line in conjunction with methasterone abuse testosterone; (B) the substance is treatment due to the availability of other (Shah et al., 2008; Jasiurkowski et al., pharmacologically related to preferred treatment options. DEA is not 2006; Singh et al., 2009; Nasr and testosterone; (C) the substance is not an aware of any legitimate medical use or Ahmad, 2008; and Krishnan et al., estrogen, progestin, or a corticosteroid; New Drug Applications (NDA) for the 2009). In March 2006, the U.S. Food and and (D) the substance is not two substances that DEA is proposing to Drug Administration (FDA) issued a dehydroepiandrosterone (DHEA). Any classify by this NPRM as anabolic Warning Letter in response to adverse substance that meets these criteria is steroids under the definition set forth health effects associated with the considered an anabolic steroid and must under 21 U.S.C. 802(41)(A). Moreover, product Superdrol (methasterone). In be listed as a Schedule III controlled DEA has been unable to identify any July 2009, FDA issued a warning substance. chemical manufacturers currently using regarding bodybuilding products these substances as intermediates in containing steroid or steroid-like Background their manufacturing processes. substances. In this warning, a product In a Notice of Proposed Rulemaking Adverse health effects are associated containing the THP ether derivative of (NPRM) published on November 23, with abuse of anabolic steroids and prostanozol was named in conjunction 2011 (76 FR 72355), DEA proposed depend on several factors (e.g., age, sex, with other products presenting safety classification of two steroids as anabolic steroid used, the amount used, concerns. Schedule III anabolic steroids under the and the duration of use) (Hall and Hall, CSA: Prostanozol and methasterone. 2005; Quaglio et al., 2009). These Evaluation of Statutory Factors for DEA believes that prostanozol (17b- include cardiovascular, dermatological, Classification as an Anabolic Steroid hydroxy-5a-androstano[3,2-c]pyrazole) behavioral, hepatic, and gender specific With the issuance of this Final Rule, and methasterone (2a,17a-dimethyl-5a- endocrine side effects. Anabolic steroids DEA classifies prostanozol (17b- androstan-17b-ol-3-one) meet this have direct and indirect impact on the hydroxy-5a-androstano[3,2-c]pyrazole) definition of anabolic steroid. developing adolescent brain and and methasterone (2a,17a-dimethyl-5a- Anabolic steroids are a class of drugs behavior (Sato et al., 2008). androstan-17b-ol-3-one) as anabolic structurally related to the endogenous Furthermore, adolescent abuse of steroids under the definition set forth hormone testosterone that exert anabolic steroids may result in stunted under 21 U.S.C. 802(41)(A). As noted androgenic (masculinizing) as well as growth due to premature closure of the previously, a drug or hormonal anabolic (body building) effects. These growth plates in long bones. substance is classified as an anabolic effects are mediated primarily through In adolescent boys, anabolic steroid steroid by meeting the following four binding of the anabolic steroid to the abuse can cause precocious sexual definitional requirements: (A) The androgen receptor in target tissues development. In both girls and women, substance is chemically related to (Evans, 2004). Anabolic effects include anabolic steroid abuse induces testosterone; (B) the substance is promotion of protein synthesis in permanent physical changes such as pharmacologically related to skeletal muscle and bone, while the deepening of the voice, increased facial testosterone; (C) the substance is not an androgenic effects are characterized by and body hair growth, menstrual estrogen, progestin, or corticosteroid; the development of male secondary irregularities, and clitoral hypertrophy. and (D) the substance is not DHEA. sexual characteristics such as hair In men, anabolic steroid abuse can growth, deepening of the voice, cause testicular atrophy, decreased (A) Chemically Related to Testosterone glandular activity, thickening of the sperm count, and sterility. To classify a substance as an anabolic skin, and central nervous system effects Gynecomastia (i.e., enlargement of the steroid, a substance must be chemically (Kicman, 2008). Anabolic efficacy is male breast tissue) can develop with the related to testosterone. A structure characterized by positive nitrogen abuse of those anabolic steroids with activity relationship (SAR) evaluation balance and protein metabolism, estrogenic actions. In both men and for each substance compared the resulting in increases in protein women, anabolic steroid abuse can chemical structure of the steroid to that synthesis and lean body mass (Evans, damage the liver and may result in high of testosterone. Substances with a

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structure similar to that of testosterone testosterone, can be established by information as to both affinity and are predicted to possess comparable performing one or more of the following ability to activate the receptor. Receptor pharmacological and biological activity. androgenic and anabolic activity assays: binding and transactivation studies are Prostanozol is also known by the ventral prostate assay, seminal vesicle valuable tools in evaluating following name: 17b-hydroxy-5a- assay, levator ani assay, and androgen pharmacological activity and drawing androstano[3,2-c]pyrazole. DEA receptor binding and efficacy assays. comparisons to other substances. A determined that the chemical structure These assays are described below. steroid displaying affinity for the of prostanozol is similar to testosterone, Ventral Prostate Assay, Seminal androgen receptor and properties of differing by only the attachment of a Vesicle Assay, and Levator Ani Assay: being an agonist in transactivation pyrazole ring at carbon 2 (C2) and The classic scientific procedure for studies is determined to be carbon 3 (C3) positions of the evaluating androgenic (masculinizing) pharmacologically similar to androstane skeleton, replacing the C3- and anabolic (muscularizing) effects of a testosterone. keto group and the lack of a double steroid is the ventral prostate assay, Studies used to evaluate anabolic bond between carbon 4 (C4) and carbon seminal vesicle assay, and levator ani steroids are the androgen receptor 5 (C5) positions. Similar modifications assay. This testing paradigm allows for binding assay and the androgen receptor to testosterone’s chemical structure have the direct comparison to testosterone. transactivation assay. Both are well- been documented and, in general, they Select male accessory tissues (i.e., the established and provide significant have been found to be well tolerated, ventral prostate, seminal vesicles, and utility in evaluating steroids for affinity displaying both anabolic and levator ani muscle) are testosterone to their biological target and the androgenic activity (Fragkaki et al., sensitive, specifically requiring modulation of activity. The androgen 2009; Vida, 1969). Clinton and testosterone to grow and remain receptor binding assay provides specific coworkers, in their synthesis of healthy. Upon the removal of the testes detail as to the affinity of a steroid for prostanozol, described the modification (i.e., castration), the primary the androgen receptor (biological target as a fusion of a pyrazole ring to the endogenous source of testosterone is of anabolic steroids). To assess further androstane steroidal nucleus at C2 and eliminated causing the atrophy of the whether the steroid is capable of C3 (Clinton et al., 1961). Further ventral prostate, seminal vesicles, and activating the androgen receptor, the analysis finds the chemical structure of levator ani muscle (Eisenberg et al., androgen receptor transactivation assay prostanozol to be very similar to the 1949; Nelson et al., 1940; Scow, 1952; evaluates the binding of a steroid to the anabolic steroid stanozolol. The two Wainman and Shipounoff, 1941). androgen receptor and subsequent structures differ only about a 17a- Numerous scientific studies have interaction with DNA. In this study, methyl group (alpha methyl group demonstrated the ability of exogenous transcription of a reporter gene provides attached to carbon 17). testosterone or a pharmacologically information as to a steroid’s ability to Methasterone is known by the similar steroid administered to rats modulate a biological event. This following chemical names: 2a,17a- following castration to maintain the activity measurement provides dimethyl-5a-androstan-17b-ol-3-one; normal weight and size of all three information as to the potency of a 2a,17a-dimethyl-17b-hydroxy-5a- testosterone sensitive organs (Biskind steroid to bind to a receptor and either androstan-3-one; 17a-methyl- and Meyer, 1941; Dorfman and initiate or inhibit the transcription of drostanolone; methasteron; Dorfman, 1963; Dorfman and Kincl, the reporter gene. The androgen methyldrostanolone; 2a,17a- 1963; Kincl and Dorfman, 1964; Nelson receptor binding assay and androgen dimethyldihydrotestosterone; and et al., 1940; Scow, 1952; Wainman and receptor transactivation assay are highly 2a,17a-dimethyl-etiocholan-17b-ol-3- Shipounoff, 1941). Thus, a steroid with valuable tools in assessing the potential one. DEA has determined that the testosterone-like activity will also activity of a steroid and comparing the chemical structure of methasterone is prevent the atrophy of these three activity to testosterone. chemically related to testosterone. The testosterone-dependent organs in Results of the Androgenic and chemical structure of methasterone castrated rats. Anabolic Activity Assays: DEA reviewed differs from testosterone by the Castrated male rats are administered the published scientific literature, and following three chemical groups: An the steroid for a number of days, then pharmacological studies were alpha methyl group at carbon 17 (C17), the rats are euthanized and the undertaken to collect additional an alpha methyl group at C2, and the previously described tissues are excised information on prostanozol and lack of a double bond between spanning and weighed. Tissue weights from the methasterone in several different C4 and C5. Removal of the C4–C5 three animal test groups are compared, androgenic and anabolic activity assays. double bond (A-ring) and methylation at castrated animals alone, castrated Findings from these studies indicate the C2 and C17 positions has been animals receiving the steroid, and that in addition to being structurally shown to increase anabolic activity healthy intact animals (control), to similar to testosterone, prostanozol and (Zaffroni, 1960; Fragkaki et al., 2009). assess anabolic and androgenic activity. methasterone have similar Furthermore, methyl group substitution A reduction in tissue weights relative to pharmacological activity as testosterone. at the C2 and C17 has been reported to the control group suggests a lack of Prostanozol impair aromatization, thus, prolonging androgenic and/or anabolic activity. An the anabolic effect (Fragkaki et al., increase in tissue weights relative to the The chemical synthesis and anabolic 2009). castrated rats receiving no steroid and androgenic effects of prostanozol suggests an androgenic and/or anabolic (17b-hydroxy-5a-androstano[3,2- (B) Pharmacologically Related to effect. c]pyrazole) were published in 1961 Testosterone Androgen Receptor Binding and (Clinton et al., 1961). Clinton and A substance must also be Efficacy Assay: Anabolic steroids bind coworkers evaluated the anabolic pharmacologically related to with the androgen receptor to exert their activity by means of nitrogen balance testosterone (i.e., produce similar biological effect. Affinity for the and androgenic activity based on weight biological effects) to be classified as a receptor is evaluated in the receptor changes of the ventral prostrate of Schedule III anabolic steroid. The binding assay, while the transactivation prostanozol upon subcutaneous pharmacology of a steroid, as related to (functional) assay provides additional administration to rats with the reference

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standard testosterone propionate. The administration, methasterone prevented methasterone are not estrogens, potency ratio of anabolic activity to the atrophy (loss in weight) of ventral progestins, or corticosteroids and these androgenic activity for prostanozol was prostate, seminal vesicles, and levator anabolic steroids are not exempt from reported to be eight (Clinton et al., ani muscle. Tissue weight increases for control on this basis. 1961). In another study, prostanozol was the castrated methasterone-treated (D) Not Dehydroepiandrosterone reported to have approximately the animals were comparable to the same relative binding affinity for human castrated rats treated with testosterone Dehydroepiandrosterone, also known sex steroid binding protein as and methyltestosterone. These results as DHEA, is exempt from control as an testosterone (Cunningham et al., 1981). were consistent with earlier findings anabolic steroid by definition (21 U.S.C. To build on these findings, a that methasterone is anabolic and 802(41)(A)). Prostanozol and pharmacological study 1 was conducted androgenic (Zaffaroni, 1960; Ringold et methasterone are not to evaluate the anabolic and androgenic al., 1959). Functional assays were also dehydroepiandrosterone and therefore, effects of prostanozol in castrated male undertaken to further evaluate are not exempt from control on this rats. Results were compared to methasterone.1 Methasterone displayed basis. testosterone by a similar protocol. affinity for the androgen receptor Comments Received Administration of prostanozol to comparable to testosterone in a castrated male rats by subcutaneous competitive binding assay.1 In the On November 23, 2011, DEA injection prevented the atrophy (loss in androgen receptor transactivation assay, published a NPRM (76 FR 72355) to weight) of the ventral prostate, seminal methasterone displayed increased classify prostanozol and methasterone vesicles, and levator ani muscle.1 These activity relative to testosterone.1 Effects as Schedule III anabolic steroids. The testosterone sensitive tissues elicited by methasterone in the proposed rule provided an opportunity experienced increases in weight androgen transactivation assay were for all interested persons to submit their comparable to testosterone in castrated consistent and comparable to those of comments on or before January 23, male rats. Results from this study testosterone. Collectively, in vivo and in 2012. In response to the request, DEA support that prostanozol possesses both vitro results indicate that the received three comments. Comment: One commenter disagreed androgenic and anabolic activity. pharmacology of methasterone is similar that anabolic steroids, and in particular Additional studies were conducted to to testosterone. those encountered in dietary further assess prostanozol’s anabolic (C) Not Estrogens, Progestins, and supplements, should be placed in effect. In a competitive binding assay, Corticosteroids Schedule III of the CSA. He indicated prostanozol was found to possess that classifying these substances as affinity for the androgen receptor DEA has determined that prostanozol Schedule III anabolic steroids would comparable to testosterone.1 In the and methasterone are unrelated to force the public to procure other, non- androgen receptor transactivation assay, estrogens, progestins, and regulated and unsafe substitutes from prostanozol displayed increased activity corticosteroids. DEA evaluated the SAR illicit sources in the future, and that relative to testosterone.1 Effects elicited for each of the substances. The chemical DEA should employ an alternate by prostanozol in this transactivation structure of each substance was method of regulation. assay were consistent and comparable to compared to that of estrogens, progestins, and corticosteroids, since DEA Response: DEA disagrees with those of testosterone. Taken together, chemical structure can be related to its this comment. As stated in the NPRM data from in vitro and in vivo assays pharmacological and biological activity. and this Final Rule, these substances indicate the pharmacology of DEA found that these two substances were found to be similar in structure prostanozol to be similar to testosterone. lack the necessary chemical structures and pharmacology to testosterone Methasterone to impart significant estrogenic activity through substantive scientific The synthesis of methasterone (e.g., aromatic A ring) (Duax et al., 1988; evaluation and investigation. Further, (2a,17a-dimethyl-5a-androstan-17b-ol- Jordan et al., 1985; Williams and the United States Food and Drug 3-one) was reported in 1956 and the Stancel, 1996), progestational activity Administration has issued multiple anabolic activity in 1959 (Ringold and (e.g., 17b-alkyl group) (Williams and warnings regarding dietary Rosenkranz, 1956; Ringold et al., 1959). Stancel, 1996), or corticosteroidal supplements, especially concerning Methasterone was described as a potent activity (e.g., 17b-ketone group or 11b- contamination through novel synthetic anabolic agent exhibiting weak hydroxyl group) (Miller et al., 2002). steroids that do not qualify as dietary androgenic activity in the castrated male Furthermore, methasterone was ingredients. Regarding the commenter’s request for rat (Ringold et al., 1959). Zaffaroni and reported to display anti-estrogenic alternative regulation of these coworkers reported methasterone activity in mouse assay to assess substances. DEA regulates the possessed one-fifth the androgenic estrogen stimulated uterine growth manufacture, importation, export, activity and four times the anabolic (Dorfman et al., 1961). To assess the distribution, and sale of controlled activity of the anabolic steroid estrogenic, progestational, and corticosteroid activity of prostanozol substances for medical, scientific, or methyltestosterone, when administered and methasterone, these substances other legitimate uses pursuant to the orally to the experimental animal were evaluated in receptor binding and CSA. These substances have not been (Zaffaroni et al., 1960). Additional pharmacological studies functional transactivation assays. approved as safe for human were undertaken to further evaluate the Prostanozol and methasterone showed consumption and, despite the androgenic and anabolic effects of low binding affinity for the estrogen, commenter’s unsubstantiated and methasterone.1 Methasterone was progesterone, and glucocorticoid factually inaccurate claims of their administered subcutaneously and orally receptors. Furthermore, these steroids benefits, should neither be consumed to castrated male rats. By both routes of displayed low to no transactivation nor should other unapproved mediated by the estrogen receptors, substances ever be sought from any 1 The study by Bioqual, Inc., Rockville, MD, may progesterone receptors, or source, illicit or otherwise. be found at http://www.regulations.gov in the glucocorticoid receptors. Therefore, The additional remarks this electronic docket associated with this rulemaking. based on these data, prostanozol and commenter made regarding a perceived

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disparity between men and women in register with DEA and will be permitted Schedule III security requirements and access to hormonal products, and other to distribute these substances only to will be required to be manufactured, perceived problems with the regulation other DEA registrants. Only persons distributed, and stored in accordance of substances by the government, are not registered as dispensers will be allowed with 21 CFR 1301.71, 1301.72(b), (c), germane to this rulemaking. to dispense these substances to end and (d), 1301.73, 1301.74, 1301.75(b) Comment: Two separate commenters users. The CSA defines a practitioner as and (c), 1301.76 and 1301.77. agreed placement of these two ‘‘a physician, dentist, veterinarian, Labeling and Packaging. All labels substances under the CSA was scientific investigator, pharmacy, and labeling for commercial containers appropriate as provided per the hospital, or other person licensed, of substances defined as anabolic Anabolic Steroid Control Act of 2004. registered, or otherwise permitted, by steroids will be required to comply with DEA Response: DEA appreciates the the United States or the jurisdiction in the requirements of 21 CFR 1302.03– support for this rulemaking. As which he practices or does research, to 1302.07. discussed above, prostanozol and distribute, dispense, conduct research Inventory. Every registrant required to methasterone are similar in structure with respect to, administer, or use in keep records and who possesses any and pharmacology to testosterone and teaching or chemical analysis, a quantity of any substance defined as an are not approved for human controlled substance in the course of anabolic steroid will be required to keep consumption. DEA believes their professional practice or research.’’ 21 an inventory of all stocks of the placement into Schedule III as anabolic U.S.C. 802(21). At present, there are no substances on hand pursuant to 21 steroids will provide the appropriate approved medical uses for these two U.S.C. 827 and 21 CFR 1304.03, 1304.04 safeguards to limit their availability to substances. Until a manufacturer and 1304.11. Every registrant who and prevent their abuse by the public. applies to the FDA and gains approval desires registration in Schedule III for for products containing these any substance defined as an anabolic Conclusion substances, no person may dispense steroid will be required to conduct an After evaluation of the statutory them in response to a prescription. inventory of all stocks of the substances factors above and consideration of the Additionally, these two substances on hand at the time of registration. comments to the NPRM, DEA concludes may only be imported for medical, Records. All registrants will be that prostanozol and methasterone meet scientific, or other legitimate uses (21 required to keep records, as generally the CSA definition of ‘‘anabolic steroid’’ U.S.C. 952(b)) under an import provided in 21 U.S.C. 827(a) and because each substance is: (A) declaration filed with DEA (21 CFR specifically pursuant to 21 CFR 1304.03, Chemically related to testosterone; (B) 1312.18). Importation of these 1304.04, 1304.05, 1304.21, 1304.22, and pharmacologically related to substances will be illegal unless the 1304.23. testosterone; (C) not an estrogen, person importing these substances is Prescriptions. All prescriptions for progestin, or a corticosteroid; and (D) registered with DEA as an importer or these Schedule III substances or for not DHEA (21 U.S.C. 802(41)). Once a researcher and files the required products containing these Schedule III substance is determined to be an declaration for each shipment. Any substances, if approved in the future by anabolic steroid, DEA has no discretion individual who purchases either of FDA, will be required to be issued regarding the placement of these these substances directly from foreign pursuant to 21 U.S.C. 829(b) and 21 CFR substances into Schedule III of the CSA. companies and has them shipped to the 1306.03–1306.06 and 1306.21–1306.27. United States will be considered to be All prescriptions for these Schedule III Impact of Classification as Anabolic importing even if the steroids are compounds or for products containing Steroids intended for personal use. Illegal these Schedule III substances, if With the publication of this Final importation of these substances will be authorized for refilling, will be limited Rule, DEA classifies prostanozol (17b- a violation of the CSA that may result to five refills within six months of the hydroxy-5a-androstano[3,2-c]pyrazole) in imprisonment and fines pursuant to date of issuance of the prescription. and methasterone (2a,17a-dimethyl-5a- 21 U.S.C. 960. Controlled substance dispensing via the androstan-17b-ol-3-one) as Schedule III Internet will have to comply with 21 anabolic steroids subject to the CSA. Requirements for Handling Substances U.S.C. 829(e). Any person who manufactures, Defined as Anabolic Steroids Importation and Exportation. All distributes, dispenses, imports, or As of the effective date of this Final importation and exportation of any exports prostanozol or methasterone, or Rule, prostanozol and methasterone are substance defined as an anabolic steroid who engages in research or conducts subject to CSA regulatory controls and will be required to be in compliance instructional activities with respect to the administrative, civil, and criminal with 21 U.S.C. 952(b), 953(e), and 21 these two substances, will be required to sanctions applicable to the manufacture, CFR Part 1312. obtain a Schedule III registration in distribution, dispensing, importation, Disposal. Persons who possess accordance with the CSA and its and exportation of a Schedule III substances that become classified as implementing regulations. controlled substance, including the anabolic steroids and who wish to As of the effective date of this Final following: dispose of them rather than becoming Rule, the manufacture, import, export, Registration. Any person who registered to handle them should distribution, or sale of prostanozol or manufactures, distributes, dispenses, contact their local DEA Diversion field methasterone, except by DEA imports, exports, or engages in research office for assistance in disposing of registrants, is a violation of the CSA that or conducts instructional activities with these substances legally pursuant to 21 may result in imprisonment and fines a substance defined as an anabolic CFR 1307.21. The DEA Diversion field (see, e.g., 21 U.S.C. 841 and 960). steroid, or who desires to engage in such office will provide the person with Possession of these two steroids, unless activities, will be required to be instructions regarding the disposal. A legally obtained, is also subject to registered to conduct such activities list of local DEA Diversion field offices criminal penalties pursuant to 21 U.S.C. with Schedule III controlled substances may be found at http:// 844. in accordance with 21 CFR Part 1301. www.deadiversion.usdoj.gov. Manufacturers and importers of these Security. Substances defined as Criminal Liability. Any activity with two substances will be required to anabolic steroids will be subject to any substance defined as an anabolic

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steroid not authorized by, or in violation are already in compliance with the CSA Executive Order 13175 of, the Controlled Substances Act or the and DEA implementing regulations This rule will not have tribal Controlled Substances Import and regarding the handling of Schedule III implications and will not impose Export Act will be unlawful. substances. substantial direct compliance costs on Regulatory Analyses Executive Orders 12866 and 13563 Indian tribal governments. Paperwork Reduction Act Regulatory Flexibility Act This rulemaking has been drafted in The Administrator hereby certifies accordance with the principles of This rule regulates two anabolic that this rulemaking has been drafted in Executive Order 12866, 1(b), as steroids, which are neither approved for accordance with the Regulatory reaffirmed by Executive Order 13563. medical use in humans nor approved for Flexibility Act (5 U.S.C. 601–612). This This rule is not a significant regulatory administration to cattle or other non- regulation will not have a significant action but has been reviewed by the humans. Only chemical manufacturers economic impact on a substantial Office of Management and Budget. As who may use these substances as number of small entities. As of March discussed above, the effect of this rule chemical intermediates for the synthesis 2010, DEA had identified approximately will be to remove products containing of other steroids would be required to 75 dietary supplements that were these substances from the over-the- register with DEA under the CSA. currently or had been promoted for counter marketplace. DEA has no basis However, DEA has not been able to building muscle and increasing strength for estimating the size of the market for identify any chemical manufacturers that purported to contain prostanozol or these products. DEA notes, however, that are currently using these substances methasterone. Thirteen dietary that virtually all of the substances are as intermediates in their manufacturing supplements were purported to contain imported. According to U.S. processes. Thus DEA does not expect prostanozol and 62 dietary supplements International Trade Commission data, this rule to impose any additional were purported to contain the import value of all anabolic steroids paperwork burden on the regulated methasterone. These dietary in 2009 was $5.9 million. These two industry. supplements are marketed and sold over substances would be a subset of those Unfunded Mandates Reform Act of 1995 the Internet. imports. The total market for products The manufacturers and distributors of containing these substances, therefore, This rule will not result in the dietary supplements purported to is probably quite small. Moreover, DEA expenditure by state, local, and tribal contain prostanozol and methasterone believes that the importation of these governments, in the aggregate, or by the also sell a variety of other dietary two substances is for illegitimate private sector, of $136,000,000 or more supplements. DEA has identified a purposes. (adjusted for inflation) in any one year, substantial number of Internet and will not significantly or uniquely The benefit of controlling these affect small governments. Therefore, no distributors that sell these dietary substances is to remove from the supplements. However, these actions were deemed necessary under marketplace substances that have the provisions of the Unfunded distributors also sell a variety of other dangerous side effects and no legitimate nutritional products. Without Mandates Reform Act of 1995, 2 U.S.C. medical use in treatment in the United 1532. information on the percentage of States. As discussed in detail above, revenues derived from these dietary these substances can produce serious List of Subjects in 21 CFR Part 1300 supplements, DEA is not able to health effects in adolescents and adults. Chemicals, Drug traffic control. determine the economic impact of the If medical uses for these substances are removal of these dietary supplements For the reasons set out above, 21 CFR developed and approved, the drugs part 1300 is amended as follows: alone on the business of the firms. would be available as Schedule III These steroids have been the focus of controlled substances in response to a PART 1300—DEFINITIONS warning letters issued by the FDA. prescription issued by a medical However, products continue to be professional for a legitimate medical ■ 1. The authority citation for part 1300 marketed despite these warnings. DEA purpose. Until that time, however, this continues to read as follows: has not been able to identify any action will bar the importation, chemical manufacturers that are Authority: 21 U.S.C. 802, 821, 829, 871(b), exportation, and sale of these two 951, 958(f). currently using these substances as substances except for legitimate ■ 2. In § 1300.01, the definition of intermediates in their manufacturing research or industrial uses. process(es). As of March 2010, DEA had Anabolic steroid under paragraph (b) is identified 13 chemical manufacturers Executive Order 12988 amended by: ■ A. Redesignating paragraphs (32) and distributors that sell at least one of through (63) as (33) through (64), the two steroids. Most of these This regulation meets the applicable standards set forth in Sections 3(a) and ■ B. Adding a new paragraph (32), companies are located in China and sell ■ C. Further redesignating newly a variety of other anabolic steroids. DEA 3(b)(2) of Executive Order 12988 Civil Justice Reform. designated paragraphs (58) through (64) notes that, as the vast majority of as (59) through (65), and entities handling these substances are Executive Order 13132 ■ D. Adding new paragraph (58). Internet based, it is virtually impossible The additions read as follows: to accurately quantify the number of This rulemaking does not preempt or persons handling these substances at modify any provision of State law; nor § 1300.01 Definitions relating to controlled any given time. DEA has not identified does it impose enforcement substances. any company based in the United States responsibilities on any State; nor does it * * * * * that manufactures or distributes these diminish the power of any State to (b) * * * substances. DEA notes, upon placement enforce its own laws. Accordingly, this Anabolic steroid *** into Schedule III, these substances may rulemaking does not have federalism (32) Methasterone (2a,17a-dimethyl- be used for analytical purposes. These implications warranting the application 5a-androstan-17b-ol-3-one) companies are registered with DEA and of Executive Order 13132. * * * * *

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