[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: 9CFR101.4]

[Page 568]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 101--DEFINITIONS--Table of Contents
 
Sec. 101.4  Labeling terminology.

    Terms pertaining to identification and packaging of biological 
products shall mean:
    (a) Label. All written, graphic, or printed matter:
    (1) Upon or attached to a final container of a biological product;
    (2) Appearing upon any immediate carton or box used to package such 
final container; and
    (3) Appearing on any accompanying enclosures (leaflets, inserts, or 
circulars) on which required information or directions as to the use of 
the biological product shall be found.
    (b) Labeling. All labels and other written, printed, or graphic 
matter accompanying the final container.
    (c) Final container. The unit, bottle, vial, ampule, tube, or other 
receptacle into which any biological product is filled for distribution 
and sale.
    (d) True name. The name entered on the product license or permit at 
the time of issuance to differentiate the biological product from 
others: Provided, That, the principal part of such name shall be 
emphasized on such license or permit by being more prominently lettered 
than descriptive terms which may be necessary to complete the 
differentiation.
    (e) Serial number. Numbers or numbers and letters used to identify 
and distinguish one serial from others.
    (f) Expiration date. A date designating the end of the period during 
which a biological product, when properly stored and handled, can be 
expected with reasonable certainty, to be efficacious.
    (g) Label number. A number assigned by Animal and Plant Health 
Inspection Service to each label or sketch submitted for review.
    (h) Master label. The finished carton, container, or enclosure label 
for the smallest size final container that is authorized for a 
biological product, that serves as the Master template label applicable 
to all other size containers or cartons of the same product that is 
marketed by a licensee, subsidiary, division, or distributor.

[38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 56 
FR 66782, Dec. 26, 1991; 61 FR 29464, June 11, 1996]