[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR101.3]

[Page 525-526]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 101--DEFINITIONS--Table of Contents
 
Sec. 101.3  Biological products and related terms.

    When used in conjunction with or in reference to a biological 
product, the following terms shall mean:
    (a) Licensed biological product. A biological product prepared 
within a licensed establishment by a person holding an unexpired, 
unsuspended, and unrevoked product license for such product.
    (b) Experimental biological product. A biological product which is 
being evaluated to substantiate an application for a product license or 
permit.
    (c) Completed product. A biological product in bulk or final 
container produced in compliance with the regulations to final form and 
composition.
    (d) Finished product. A completed product which has been bottled, 
sealed, packaged, and labeled as required by the regulations.
    (e) Released product. A finished product released for marketing 
after all requirements have been satisfactorily complied with.
    (f) Fraction. A specific antigen, its antibodies, or its antitoxin 
which constitutes a component of a biological product.
    (g) Diluent. A liquid used to rehydrate a desiccated product or a 
liquid used to dilute another substance.
    (h) Serial. The total quantity of completed product which has been 
thoroughly mixed in a single container and identified by a serial 
number: Provided, That, when all or part of a serial of liquid 
biological product is packaged as diluent for all or part of a serial of 
desiccated product, the resulting combination packages shall be 
considered a serial of the multiple fraction product.
    (i) Subserial. Each of two or more properly identified portions of a 
serial which are further processed at different times or under different 
conditions such as, but not limited to, being desiccated in different 
size final containers and/or at different times.
    (j) Outline of production. A detailed protocol of methods of 
manufacture to be followed in the preparation of a biological product 
and which may sometimes be referred to as an outline.
    (k) Product Code Number. A number assigned by Animal and Plant 
Health Inspection Service to each type of licensed biological product.
    (l) Harvest date. Unless otherwise specified in a filed Outline of 
Production, the harvest date shall be the date blood or tissues are 
collected for production or the date cultures of living microorganisms 
are removed from production incubators.

[[Page 526]]

    (m) Bacterin. An inactivated bacterial product consisting of an 
antigenic suspension of organisms or particulate parts of organisms, 
representing a whole culture or a concentrate thereof, with or without 
the unevaluated growth products, which has been inactivated as 
demonstrated by acceptable tests written into the filed Outline of 
Production for the product.
    (n) Toxoid. An inactivated bacterial product which consists of a 
sterile, antigenic toxin or toxic growth product, which has resulted 
from the growth of bacterial organisms in a culture medium from which 
the bacterial cells have been removed, which has been inactivated 
without appreciable loss of antigenicity as measured by suitable tests, 
and which is nontoxic as demonstrated by acceptable tests written into 
the filed Outline of Production.
    (o) Bacterin-toxoid. An inactivated bacterial product which is 
either:
    (1) A suspension of organisms, representing a whole culture or a 
concentrate thereof, with the toxic growth products from the culture 
which has been inactivated without appreciable loss of antigenicity as 
measured by suitable tests, the inactivation of organisms and toxins 
being demonstrated by acceptable tests written into the filed Outline of 
Production: Provided, That it shall contain cellular antigens and shall 
stimulate the development of antitoxin; or
    (2) A combination product in which one or more toxoids or bacterin-
toxoids is combined with one or more bacterins or one or more bacterin-
toxoids.
    (p) Bacterial extract. An inactivated bacterial product which 
consists of the sterile, nontoxic, antigenic derivatives extracted from 
bacterial organisms or from culture medium in which bacterial organisms 
have grown.

[38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 50 
FR 24903, June 14, 1985; 56 FR 66782, Dec. 26, 1991; 60 FR 14354, Mar. 
17, 1995]