[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR526.1590]

[Page 322]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 526--INTRAMAMMARY DOSAGE FORMS--Table of Contents
 
Sec.  526.1590  Novobiocin oil suspension.

    (a)(1) Specifications. Each 10 milliliters of oil suspension 
contains the equivalent of 400 milligrams of novobiocin (present as 
sodium novobiocin).
    (2) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.460 of this chapter.
    (4) Conditions of use--(i) Amount. Ten milliliters (equivalent to 
400 milligrams of novobiocin) infused in each quarter.
    (ii) Indications for use. It is used in dry cows for the treatment 
of mastitis caused by susceptible strains of Staphylococcus aureus and 
Streptococcus agalactiae.
    (iii) Limitations. Infuse each quarter at the time of drying off, 
but not less than 30 days prior to calving. Do not slaughter treated 
animals for food use for 30 days following udder infusion. For udder 
installation for the treatment of mastitis in dry cows only.
    (b)(1) Specifications. Each 10 milliliters of oil suspension 
contains the equivalent of 150 milligrams of novobiocin (present as 
sodium novobiocin).
    (2) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.460 of this chapter.
    (4) Conditions of use--(i) Amount. Infuse 10 milliliters (equivalent 
to 150 milligrams of novobiocin) in each quarter after milking. Repeat 
treatment once after 24 hours.
    (ii) Indications for use. Use in lactating cows for treatment of 
mastitis caused by susceptible strains of Staphylococcus aureus.
    (iii) Limitations. Do not milk for at least 6 hours after treatment; 
afterwards, milk at regular intervals. Milk taken from treated animals 
within 72 hours (6 milkings) after latest treatment must not be used for 
food. Do not slaughter treated animals for food for 15 days following 
latest treatment. If redness, swelling, or abnormal milk persists or 
increases after treatment, discontinue use and consult a veterinarian. 
For udder instillation in lactating cattle only. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[43 FR 10554, Mar. 14, 1978]