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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.823]



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

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.823 Erythromycin.

(a) Specifications. Each gram of powder contains erythromycin phosphate equivalent to 0.89 gram of erythromycin master standard.

(b) Sponsor. See No. 061133 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. Administer 0.500 gram per gallon for 5 days.

(ii) Indications for use. As an aid in the control of chronic respiratory disease due to Mycoplasma gallisepticum susceptible to erythromycin.

(iii) Limitations. Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Replacement chickens and chicken breeders - (i) Amount. Administer 0.500 gram per gallon for 7 days.

(ii) Indications for use. As an aid in the control of infectious coryza due to Haemophilus gallinarum susceptible to erythromycin.

(iii) Limitations. Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Growing turkeys - (i) Amount. Administer 0.500 gram per gallon for 7 days.

(ii) Indications for use. As an aid in the control of blue comb (nonspecific infectious enteritis) caused by organisms susceptible to erythromycin.

(iii) Limitations. Do not use in turkeys producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[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; 79 FR 28821, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, 2016; 84 FR 8972, Mar. 13, 2019]

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