21 C.F.R. § 520.823 Erythromycin phosphate.
Title 21 - Food and Drugs
(a) Specifications. Erythromycin phosphate is the phosphate salt of the antibiotic substance produced by the growth of Streptomyces erythreus or the same antibiotic substance produced by any other means. One gram of erythromycin phosphate is equivalent to 0.89 gram of erythromycin master standard. (b) Sponsor. See No. 061623 in §510.600(c) of this chapter. (c) Related tolerances. See §556.230 of this chapter. (d) Conditions of use. It is used in drinking water as follows: (1) Broiler and replacement chickens—(i) Amount. 0.500 gram per gallon. (ii) Indications for use. As an aid in the control of chronic respiratory disease due to Mycoplasma gallisepticum susceptible to erythromycin. (iii) Limitations. Administer for 5 days; do not use in replacement pullets over 16 weeks of age; do not use in chickens producing eggs for human consumption; to assure effectiveness, treated birds must consume enough medicated water to provide a therapeutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter. (2) Replacement chickens and chicken breeders—(i) Amount. 0.500 gram per gallon. (ii) Indications for use. As an aid in the control of infectious coryza due to Hemophilus gallinarum susceptible to erythromycin. (iii) Limitations. Administer for 7 days; do not use in replacement pullets over 16 weeks of age; do not use in chickens producing eggs for human consumption; to assure effectiveness, treated birds must consume enough medicated water to provide a therapeutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter. (3) Growing turkeys—(i) Amount. 0.500 gram per gallon. (ii) Indications for use. As an aid in the control of blue comb (nonspecific infectious enteritis) caused by organisms susceptible to erythromycin. (iii) Limitations. Administer for 7 days; do not use in turkeys producing eggs for human consumption; to assure effectiveness, treated birds must consume enough medicated water to provide a therapeutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter. [40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.823 Erythromycin phosphate.
