Drug Enforcement Administration, Department of Justice.
Order with opportunity for comment.
The Drug Enforcement Administration is denying applications to designate four in-process preparations containing trenbolone acetate as exempt anabolic steroid products under the Controlled Substances Act.
This order is effective December 16, 2020. Written comments must be postmarked, and electronic comments must be sent, on or before February 16, 2021.
To ensure proper handling of comments, please reference “Docket No. DEA–671” on all electronic and written correspondence, including any attachments.
Terrence L. Boos, Drug and Chemical Evaluation, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362–3249.
Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by DEA for public inspection online at
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Anabolic steroids are listed in schedule III of the Controlled Substances Act (CSA). 21 U.S.C. 802(41) and 812(c), Schedule III(e). The CSA further provides that the Attorney General may, by regulation, exempt from any or all CSA provisions any
DEA received an application from Ivy Animal Health, Inc. (Ivy), dated March 27, 2015, seeking to exempt two anabolic steroid-containing product preparations containing trenbolone acetate from control under the CSA. Letter from Ivy Animal Health, Inc. to DEA (Mar. 27, 2015), at 1. Specifically, the product preparations were Component TE–H in-process granulation and Component TE–H in-process pellets in bulk containers.
Ivy based its application on the grounds that DEA had previously exempted other in-process granulations and pellets containing trenbolone acetate, and the Component TE–H “product formulations contain the same active ingredients Trenbolone acetate and Estradiol” as the other in-process materials that are currently exempt.
Upon review of the application, DEA accepted it for filing. On April 29, 2015, DEA provided a copy of Ivy's application to the Secretary of Health and Human Services (HHS) and requested an evaluation and a recommendation.
DEA also received an application from Ivy Animal Health, Inc., dated April 30, 2015, seeking to exempt two anabolic steroid-containing product preparations containing trenbolone acetate from control under the CSA. Letter from Ivy Animal Health, Inc. to DEA (Apr. 30, 2015), at 1. Specifically, the product preparations were Component T–H in-process granulation and Component T–H in-process pellets in bulk containers.
Ivy based its application on the grounds that DEA had “previously identified Component TE–S in process granulation and in process pellets as exempt from the CSA as the formulation prevented significant potential for abuse.”
Upon review of the application, DEA accepted it for filing. On June 4, 2015, DEA provided a copy of Ivy's application to the Secretary of HHS and requested an evaluation and a recommendation.
On October 8, 2019, the Assistant Secretary for Health (ASH) provided HHS's evaluation and recommendation to DEA for both applications. Letter from Assistant Secretary for Health, HHS, to Acting Administrator, DEA, at 1 (Oct. 8, 2019) (ASH Letter). HHS found that “[a]lthough there is no evidence that trenbolone is being obtained from in-process materials there is evidence that it is being abused.”
With respect to the inclusion of estradiol in Component TE–H in-process granulation and Component TE–H in-process pellets, HHS found that “protocols and kits have been developed to purify trenbolone from estradiol.”
HHS thus concluded “that the products Component T–H in-process granulation and Component T–H in-process pellets, and Component TE–H in-process granulation and Component TE–H in-process pellets do not fit into the category of having no significant potential for abuse based on concentration, preparation, formulation, or delivery system.”
Further, after a review of the available kits and protocols, DEA finds this information credible, easy to understand, and requires no specialized skill or experience to carry out the required steps. Thus, DEA concludes that trenbolone acetate can be easily separated from estradiol and other excipient materials used to make Component TE–H in-process granulation, Component TE–H in-process pellets, Component T–H in-process granulation, and Component T–H in-process pellets. The composition of these in-process materials containing significant quantities of trenbolone acetate does not prevent significant potential for abuse.
Based on the evaluation and recommendation of the ASH, as well as DEA's review of available evidence of diversion of these types of products, the Assistant Administrator does not find that “because of [their] concentration, preparation, formulation, or delivery system,” Ivy's Component TE–H in-process granulation, Component TE–H in-process pellets, Component T–H in-process granulation, and Component T–H in-process pellets “ha[ve] no significant potential for abuse.” 21 CFR 1308.33(a).
Therefore, the Assistant Administrator, Diversion Control Division, hereby orders that the above products containing anabolic steroids not be exempted from application of any section of the CSA, and they are not to be included in the list of products described in 21 CFR 1308.34. These in-process materials remain controlled as an anabolic steroid in schedule III. Unless specifically excepted, to the extent Ivy handles trenbolone acetate in the manufacturing process, Ivy must comply with all applicable registration, security and recordkeeping requirements set forth in the CSA and DEA regulations. Exemptions granted or denied under 21 CFR 1308.33 are
This order does not apply to the final, packaged, and labeled products “containing an anabolic steroid, that are expressly intended for administration through implants to cattle or other nonhuman species” where the products “have been approved by the Secretary of Health and Human Services for such administration.” 21 CFR 1308.26(a). Under 21 U.S.C. 802(41)(B)(i), such products are excepted from the definition of an anabolic steroid without undergoing the exemption process described in 21 CFR 1308.33, and without any evaluation or determination of their abuse potential.
Pursuant to 21 CFR 1308.33, any interested person may submit written comments on, or objections to, the denial of an exemption for any product listed in this order, within 60 days of the date of publication of this order, as specified above. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Assistant Administrator, Diversion Control Division, may reconsider the application in light of the comments and objections filed. 21 CFR 1308.33. Thereafter, the Assistant Administrator shall amend his original order as he determines appropriate.