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: "558.261"
section_subject: "Florfenicol."
cfr_reference: "21 CFR 558.261"
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. Type A medicated articles containing florfenicol in the following concentrations:
(1)40 grams per kilogram for use as in paragraph (e)(1) of this section.
(2)500 grams per kilogram for use as in paragraph (e)(2) of this section.
(b)Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.283 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 florfenicol medicated feeds:
(i)For swine must not exceed 90 days from the date of issuance.
(ii)For fish must not exceed 6 months from the date of issuance.
(4)Type A medicated articles and medicated feeds intended for use in fish shall bear the following: “Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.”