[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: 21CFR526.1696d]

[Page 324]
 
                        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.  526.1696d  Penicillin G procaine-novobiocin for intramammary infusion.

    (a) Specifications. For lactating cattle: each 10-milliliter dose 
contains 100,000 units of penicillin G procaine and 150 milligrams of 
novobiocin as novobiocin sodium. For dry cows: 200,000 units of 
penicillin G procaine and 400 milligrams of novobiocin as novobiocin 
sodium.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Lactating cows--(i) Amount. 10 
milliliters in each infected quarter after milking. Repeat once after 24 
hours.
    (ii) Indications for use. Treating lactating cows for mastitis 
caused by susceptible strains of Staphylococcus aureus, Streptococcus 
agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis.
    (iii) Limitations. For udder instillation in lactating cattle only. 
Do not milk for at least 6 hours after treatment; thereafter, milk at 
regular intervals. Milk taken from treated animals within 72 hours (6 
milkings) after the latest treatment must not be used for food. Treated 
animals must not be slaughtered for food for 15 days following the 
latest treatment. If redness, swelling, or abnormal milk persists, 
discontinue use and consult a veterinarian.
    (2) Dry cows--(i) Amount. 10 milliliters in each quarter at time of 
drying off.
    (ii) Indications for use. Treatment of subclinical mastitis caused 
by susceptible strains of Staphylococcus aureus and Streptococcus 
agalactiae.
    (iii) Limitations. For udder instillation in dry cows only. Do not 
use less than 30 days prior to calving. Milk from treated cows must not 
be used for food during the first 72 hours after calving. Treated 
animals must not be slaughtered for food for 30 days following udder 
infusion.

[57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]