[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR112.3]

[Page 587-588]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 112--PACKAGING AND LABELING--Table of Contents
 
Sec. 112.3  Diluent labels.

    Each final container of diluent, other than a liquid biological 
product, packaged with desiccated biological products shall bear a label 
that includes the following:
    (a) The name--Sterile Diluent.
    (b) True name of the biological product with which the diluent is 
packaged, except that when the firm packages all desiccated biological 
products with the same diluent, or two or more types of diluent are 
used, and the licensees' methods of identification and storage insure 
that all products are packaged with the correct type of diluent, labels 
affixed to the containers of diluent are exempt from this provision.
    (c) The recoverable quantity of contents in cubic centimeters (cc) 
or milliliters (ml).
    (d) A serial number by which the diluent can be identified with the 
manufacturer's records of preparation;
    (e) Name and address of the licensee or the permittee;
    (f) In the case of a diluent with which a desiccated biological 
product is to come in contact while the diluent is in its original 
container; and,
    (1) Is in a multiple-dose container, a positive warning that all of 
the biological product shall be used at the time the container is first 
opened; and/or
    (2) The biological product is composed of viable or dangerous 
organisms or viruses, the notice, ``Burn this container and all unused 
contents,'' except that, in the case of a small one-dose container, the 
statement ``Burn this container'' or ``Burn this vial'' may be used.

[[Page 588]]

    (g) The establishment license number or the permit number, as the 
case may be, in one of the forms provided in Sec. 112.2(a)(3).

[38 FR 12094, May 9, 1973; 38 FR 13476, May 22, 1973, and amended at 39 
FR 16856, May 10, 1974]