[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: 9CFR112.6]

[Page 591]
 
                  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. 112.6  Packaging biological products.

    (a) Each multiple-dose final container of a biological product which 
requires a diluent for administration shall be packaged in an individual 
carton with a container of the proper volume of diluent for that dose as 
specified in the filed Outline of Production. Each multiple-dose final 
container of a product which does not require a diluent for 
administration need not be packaged in an individual carton unless the 
final container labeling does not contain all information required by 
the regulations. Such information must be included in or on a carton. 
Exceptions are provided in paragraphs (c) and (d) of this section and 
Sec. 112.8.
    (b) Single-dose final containers of a product need not be packaged 
one per carton. For single-dose products which require a diluent for 
administration, the number of containers of the proper amount of diluent 
specified in the filed Outline of Production for the number of doses 
contained in the carton shall be included in each carton.
    (c) Poultry products for mass administration (including but not 
limited to administration through drinking water and spray) and products 
used in automatic vaccinating systems (including but not limited to 
pneumatic beak injectors and automated needle injectors) may be packaged 
in multiple-dose final containers as specified in the filed Outline of 
Production. Poultry products for manual administration to individual 
birds shall not exceed 1,000 doses in each final container. Diluent need 
not be packaged with the final container(s) of the product, but the 
licensee shall provide the required number of containers of diluent as 
specified in the filed Outline of Production. The following requirements 
apply to cartons containing more than one final container of poultry 
product:
    (1) They shall be sealed prior to leaving the licensed 
establishment.
    (2) The contents may not be repackaged.
    (3) The contents of such cartons may not be sold in fractional 
units.
    (4) The following statement must appear in a prominent place on the 
carton label: ``Federal regulations prohibit the repackaging or sale of 
the contents of this carton in fractional units. Do not accept if seal 
is broken.''
    (d) Diluent for the following products need not be packaged with the 
final container(s) of the product, but the licensee shall provide the 
consumer with the required number of containers of the proper amount of 
diluent as specified in the filed Outline of Production:
    (1) Marek's Disease Vaccine.
    (2) Poultry vaccines administered to individual birds using 
automatic vaccinating equipment.
    (e) Final containers of biological product prepared at a licensed 
establishment, or imported, in cartons or other containers shall not be 
removed from such cartons or containers for sale or distribution, unless 
each final container bears, or is packaged in a carton with, complete 
and approved labeling which is affixed to or included with each 
container by the licensed establishment producing the product or by the 
producer in the case of imported product: Provided, That this paragraph 
is not intended to apply to licensed veterinary practitioners 
administering or dispensing biological products in the course of their 
practice under a veterinary-client-patient-relationship as that term is 
used in Sec. 107.1.
    (f) Labels which are affixed to or included with a biological 
product shall not be removed or altered in any manner.

[47 FR 8761, Mar. 2, 1982, as amended at 48 FR 12691, Mar. 28, 1983; 59 
FR 43445, Aug. 24, 1994; 64 FR 43044, Aug. 9, 1999]