[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR114.10]

[Page 756-757]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 114_PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS--Table of 
Contents
 
Sec. 114.10  Antibiotics as preservatives.

    Antibiotics are authorized for use as preservatives for biological 
products if used within the limitations as to kinds and amounts 
prescribed in this section.
    (a) When an antibiotic or combination of antibiotics, with or 
without a fungistat is to be used in the preparation of a biological 
product, the kind(s) and amount(s) of each shall be specified in the 
outline for such product in such a way that the concentration in the 
final product may be calculated. Except as may be approved by the 
Administrator, only those individual antibiotics or combinations of 
antibiotics listed in paragraphs (b) and (c) of this section shall be 
used.
    (b) Permitted individual antibiotics:
    (1) The antibiotic level of a specified individual antibiotic in one 
ml. of a biological product, when prepared as recommended for use, shall 
not exceed the amounts listed in this paragraph: Provided, That in the 
case a desiccated biological product is to be used with an indefinite 
quantity of water or other menstruum, the determination shall be based 
on 30 ml. per 1,000 dose vial or equivalent.
    (2) Except as prescribed in paragraph (c) of this section, only one 
antibiotic shall be used as a preservative in a biological product. The 
kind and maximum amount per ml. of such antibiotic shall be restricted 
to:

Amphotericin B..................................  2.5 mcg.
Nystatin (Mycostatin)...........................  30.0 units
Tetracyclines...................................  30.0 mcg.

[[Page 757]]


Penicillin......................................  30.0 units
Streptomycin....................................  30.0 mcg.
Polymyxin B.....................................  30.0 mcg.
Neomycin........................................  30.0 mcg.
Gentamicin......................................  30.0 mcg.


    (c) Permitted combinations:
    (1) Penicillin and streptomycin.
    (2) Either amphotericin B or nystatin, but not both, may be used 
with one of the other antibiotics listed in paragraph (b) of this 
section, or with a combination of penicillin and streptomycin, or with a 
combination of polymyxin B and neomycin.
    (3) The maximum amount of each antibiotic in a combination shall be 
the amount prescribed for such antibiotic in paragraph (b) of this 
section.
    (d) Antibiotics used in virus seed stock purification are not 
restricted as to kind or amounts provided carryover into the final 
product is controlled and specified in outlines of production.

[39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991