[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: 21CFR526.1696a]

[Page 322-323]
 
                        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.  526.1696a  Penicillin G procaine in oil.

    (a) Specifications. Each milliliter contains penicillin G procaine 
equivalent to 100,000 units of penicillin G in peanut, sesame, or 
soybean oils.

[[Page 323]]

    (b) Related tolerances. See Sec.  556.510 of this chapter.
    (c) Sponsor. See No. 010515 in Sec.  510.600(c) of this chapter.
    (1) National Academy of Sciences/National Research Council (NAS/NRC) 
status. The conditions specified in paragraph (c)(2)(i)(B) of this 
section were NAS/NRC reviewed and found effective. Applications for 
these uses need not include effectiveness data as specified by Sec.  
514.111 of this chapter, but may require bioequivalency and safety 
information.
    (2) Conditions of use. Treating bovine mastitis caused by 
Streptococcus agalactiae, S. dygalactiae, and S. uberus in lactating 
cows as follows:
    (i) Three-dose regimen. Administer by intramammary infusion in each 
infected quarter as follows:
    (A) 6-milliliter dose (peanut oil). Treatment may be repeated at 12-
hour intervals. Milk that has been taken from animals during treatment 
and for 84 hours (7 milkings) after the latest treatment must not be 
used for food. Animals must not be slaughtered for food during treatment 
or within 4 days after the latest treatment.
    (B) 10-milliliter dose (sesame oil). Treatment may be repeated at 
12-hour intervals. Milk that has been taken from animals during 
treatment and for 60 hours (5 milkings) after the latest treatment must 
not be used for food. Animals must not be slaughtered for food during 
treatment or within 3 days after the latest treatment.
    (ii) Two-dose regimen. 10-milliliter dose (peanut oil). Administer 
by intramammary infusion in each infected quarter. Treatment may be 
repeated at intervals of 12 hours. Milk taken from animals during 
treatment and for 60 hours (5 milkings) after the latest treatment must 
not be used for food. Animals must not be slaughtered for food during 
treatment or within 4 days after latest treatment.
    (d) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (1) 10-milliliter dose (peanut oil). Administer by intramammary 
infusion in each infected quarter. Treatment may be repeated at 12-hour 
intervals for not more than three doses, as indicated by clinical 
response.
    (2) Indications for use. Treating bovine mastitis caused by 
Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating 
cows as follows:
    (3) Limitations. Milk that has been taken from animals during 
treatment and for 60 hours after the latest treatment must not be used 
for food. Animals must not be slaughtered for food during treatment or 
within 3 days after the latest treatment.
    (e) Sponsor. See No. 010515 (sesame oil) and No. 050604 (peanut oil) 
in Sec.  510.600(c) of this chapter.
    (1) NAS/NRC status. The conditions of use were NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
    (2) Single-dose regimen. One 10-milliliter dose (sesame oil or 
peanut oil) in each infected quarter at time of drying-off.
    (3) Indications of use. Treating bovine mastitis caused by 
Streptococcus agalactiae in dry cows.
    (4) Limitations. Discard all milk for 72 hours (6 milkings) 
following calving, or later as indicated by the marketable quality of 
the milk. Animals must not be slaughtered for food within 14 days 
postinfusion.

[57 FR 37335, Aug. 18, 1992, as amended at 58 FR 500, Jan. 6, 1993]