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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.2345c—Tetracycline boluses.

520.2345c—Tetracycline boluses.

(a) Specifications. Each bolus contains 500 milligrams of tetracycline (as the hydrochloride).
(b) Sponsors. See No. 053501 in § 510.600(c) of this chapter for use as in paragraph (d)(1) of this section. See No. 000009 in § 510.600(c) of this chapter for use as in paragraph (d)(2) of this section.
(c) Related tolerances. See § 556.720 of this chapter.
(d) Conditions of use. Calves— (1) Amount. 10 milligrams per pound of body weight per day in divided doses.
(i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia caused by Pasteurella spp., Hemophilus spp., and Klebsiella spp.
(ii) Limitations. Administer orally for 3 to 5 days; do not slaughter animals for food within 14 days of treatment; use as sole source of tetracycline.
(iii) National Academy of Sciences/National Research Council (NAS/NRC) status. The conditions of use specified in paragraph (d)(1)(i) of this section were NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in § 514.111 of this chapter, but may require bioequivalency and safety information.
(2) Amount. 10 milligrams per pound of body weight per day in two divided doses.
(i) Indications for use. Treatment of bacterial pneumonia caused by organisms susceptible to tetracycline, bacterial enteritis caused by E. coli, and salmonella organisms susceptible to tetracycline.
(ii) Limitations. Administer orally for not more than 5 days; do not slaughter animals for food within 12 days of treatment; use as sole source of tetracycline.

Code of Federal Regulations

[57 FR 37328, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]