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: "558.325"
section_subject: "Lincomycin."
cfr_reference: "21 CFR 558.325"
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 20 or 50 grams of lincomycin (as lincomycin hydrochloride) per pound.
(b)Sponsors. See No. 054771 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.360 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 lincomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for lincomycin shall not be refilled.
(3)Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following:
(i)“CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”
(4)Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following:
(i)“CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”
(ii)“CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.”