[Title 21 CFR 522.2640b]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS]
[Sec. 522.2640b - Tylosin tartrate for injection.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  6
  1996-04-01
  1996-04-01
  false
  
  522.2640b
  Sec. 522.2640b
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
    ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
    IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
  


Sec. 522.2640b  Tylosin tartrate for injection.

    (a) Specifications. The drug is a sterile powder containing a 
mixture of tylosin tartrate and sodium citrate which is reconstituted to 
provide 25 milligrams of tylosin activity per milliliter. Tylosin as the 
tartrate salt, conforms to the appropriate antibiotic standard. Tylosin 
contains at least 95 percent tylosin as a combination of tylosin A, 
tylosin B, tylosin C, and tylosin D of which at least 80 percent is 
tylosin A as determined by a method entitled ``Determination of Factor 
Content in Tylosin by High Performance Liquid Chromatography,'' which is 
incorporated by reference. Copies are available from the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, or available for inspection at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20001.
    (b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.740 of this chapter.
    (d) Conditions of use--(1) Chickens--(i) Amount. 25 milligrams per 2 
pounds of body weight.
    (ii) Indications for use. As an aid in the control and treatment of 
chronic respiratory disease caused by Mycoplasma gallisepticum sensitive 
to tylosin.
    (iii) Limitations. Not for use in laying chickens producing eggs for 
human consumption; inject under the loose skin of the neck behind the 
head; if no improvement is noted within 5 days, diagnosis should be 
reevaluated; do not treat within 3 days of slaughter.
    (2) Turkeys--(i) Amount. 6.25 to 12.5 milligrams per sinus.
    (ii) Indications for use. As an aid in the control and treatment of 
infectious sinusitis caused by Mycoplasma gallisepticum sensitive to 
tylosin.
    (iii) Limitations. Do not use in laying turkeys producing eggs for 
human consumption; inject 6.25 milligrams to 12.5 milligrams per sinus 
depending on severity of condition; treatment may be repeated in 10 days 
if the swelling persists; do not treat within 5 days of slaughter; may 
be used in conjunction with tylosin in drinking water as indicated in 
Sec. 520.2640(e)(2) of this chapter.

[46 FR 48643, Oct. 2, 1981, as amended at 50 FR 49841, Dec. 5, 1985; 50 
FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 1994]