CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART B—Specific New Animal Drugs for Use in Animal Feeds (§558.55 to §558.680) > 558.618—Tilmicosin.

558.618—Tilmicosin.

(a) Specifications. Type A medicated article containing 20 percent tilmicosin as tilmicosin phosphate (90.7 grams per pound).
(b) Approvals. See No. 000986 in § 510.600(c) of this chapter.
(c) Special considerations. (1) Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See § 558.6 of this chapter for additional requirements for the use of products regulated as veterinary feed directives (VFDs).
(2) The expiration date of VFDs for tilmicosin must not exceed 90 days from the time of issuance. VFDs for tilmicosin shall not be refilled.
(3) Do not use in Type B or Type C medicated feeds containing bentonite.
(d) Related tolerances. See § 556.735 of this chapter.
(e) Conditions of use. It is used in swine feed as follows:
(1) Amount per ton. 181 grams to 363 grams tilmicosin.
(2) Indications for use. For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.
(3) Limitations. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an expected disease outbreak. Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before reinitiating a further course of therapy with an appropriate antimicrobial. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Do not allow horses or other equines access to feeds containing tilmicosin. Withdraw 7 days before slaughter.

Code of Federal Regulations

[61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, 1997, as amended at 64 FR 13679, Mar. 22, 1999; 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, 2002; 69 FR 78306, Dec. 30, 2004]