subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "558"
part_subject: "NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS"
subpart_code: "B"
subpart_subject: "Specific New Animal Drugs for Use in Animal Feeds"
section_number: "558.450"
section_subject: "Oxytetracycline."
cfr_reference: "21 CFR 558.450"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Each pound of Type A medicated article contains:
(1)Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride.
(2)Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride.
(b)Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1)No. 066104: Type A medicated articles as in paragraph (a)(1) of this section.
(2)No. 069254: Type A medicated articles as in paragraph (a)(2) of this section.
(c)Related tolerances. See § 556.500 of this chapter.
(d)Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2)The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.
(3)In accordance with § 558.5, labeling shall bear the statement: “For use in dry animal feed only. Not for use in liquid feed supplements.”