§520.1263b. Lincomycin hydrochloride soluble powder.

21 C.F.R. § 520.1263b

(a)

Specifications. Each gram of soluble powder contains lincomycin hydrochloride equivalent to 0.4 grams of lincomycin.

(b)

Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:

(1)

Nos. 061133 and 066104 for use as in paragraph (d) of this section.

(2)

Nos. 016592 and 076475 for use as in paragraphs (d)(1) and (2) of this section.

(c)

Tolerances. See § 556.360 of this chapter.

(d)

Conditions of use—

(1)

Swine—

(i)

Amount. Administer at a dose rate of 250 milligrams (mg) of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per pound of body weight per day. The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin Type A medicated article at 100 grams lincomycin per ton of complete feed as the sole ration according to label directions. A dose of 3.8 mg lincomycin per pound of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lb of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water proportioner to deliver 1 ounce of stock solution per gallon of drinking water. After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin Type A medicated article at 40 grams lincomycin per ton of complete feed as the sole ration.

(ii)

Indications for use. For the treatment of swine dysentery (bloody scours) in swine. Not for use in pregnant swine or swine intended for breeding.

(iii)

Limitations. Discard medicated drinking water if not used within 2 days. Fresh stock should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. If clinical signs of bloody scours (watery, mucoid, or bloody stools) have not improved during the first 6 days of medication, discontinue treatment and redetermine the diagnosis. On rare occasions, some pigs may show reddening of the skin, swelling of the anus, and irritable behavior. These conditions have been self-correcting within five to seven days without discontinuing the lincomycin treatment. The safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2)

Broiler chickens—

(i)

Amount. Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water. Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7 consecutive days. After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin Type A medicated article at 2 grams lincomycin per ton of complete feed.

(ii)

Indications for use. For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens.

(iii)

Limitations. Not for use in laying hens or breeder chickens. Discard medicated drinking water if not used within 2 days. Fresh stock should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3)

Honey bees—

(i)

Amount. Administer 100 mg lincomycin per hive once weekly for 3 weeks. Mix 250 mg LINCOMIX Soluble Powder (100 mg lincomycin) with 20 g confectioners'/powder sugar and dust over the top bars of the brood chamber.

(ii)

Indications for use. For the control of American foulbrood (Paenibacillus larvae) in honey bees.

(iii)

Limitations. The drug should be fed early in the spring or late in the fall and consumed by the bees before the main honey flow begins to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Notes, amendments, and revision history

Amendments

[48 FR 3966, Jan. 28, 1983, as amended at 55 FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; 78 FR 28823, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019. Redesignated at 85 FR 18119, Apr. 1, 2020, as amended at 88 FR 16547, Mar. 20, 2023; 88 FR 84700, Dec. 6, 2023; 91 FR 20340, Apr. 16, 2026; 91 FR 33071, June 3, 2026]

§520.1263b. Lincomycin hydrochloride soluble powder.

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