21 CFR 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.
(a) Any person seeking to have any anabolic steroid product, which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the Secretary of Health and Human Services for such administration, identified as being excluded from any schedule, pursuant to section 102(41)(B)(i) of the Act ( 21 U.S.C. 802(41)(B)(i)), may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration . See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.
(b) An application for any exclusion under this section shall be submitted in triplicate and contain the following information:
(1) The name and address of the applicant;
(2) The name of the product;
(3) The chemical structural formula or description for any anabolic steroid contained in the product;
(4) A complete description of dosage and quantitative composition of the dosage form;.
(5) The conditions of use including whether or not Federal law restricts this product to use by or on the order of a licensed veterinarian;
(6) A description of the delivery system in which the dosage form will be distributed with sufficient detail to identify the product (e.g. 20 cartridge brown plastic belt);
(7) The label and labeling of the immediate container and the commercial containers, if any, of the product;.
(8) The name and address of the manufacturer of the dosage form if different from that of the applicant; and
(9) Evidence that the product has been approved by the Secretary of Health and Human Services for administration through implant to cattle or other nonhuman species.
(c) Within a reasonable period of time after the receipt of an application for an exclusion under this section, the Administrator shall notify the applicant of his acceptance or nonacceptance of the application, and if not accepted, the reason therefore. The Administrator need not accept an application for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth as to be readily understood. The applicant may amend the application to meet the requirements of paragraph (b) of this section. If the application is accepted for filing, the Administrator shall issue and have published in the Federal Register his order on the application, which shall include a reference to the legal authority under which the order is issued and the findings of fact and conclusions of law upon which the order is based. This order shall specify the date on which it will take effect. The Administrator shall permit any interested person to file written comments on or objections to the order within 60 days of the date of publication in the Federal Register. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator shall immediately suspend the effectiveness of the order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.
(d) The Administrator may at any time revoke or modify any designation of excluded status granted pursuant to this section by following the procedures set forth in paragraph (c) of this section for handling an application for an exclusion which has been accepted for filing.