[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: 9CFR114.2]

[Page 749-750]
 
                  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. 114.2  Products not prepared under license.

    (a) When an establishment license is issued, if biological products 
which were not prepared in compliance with the regulations are in the 
establishment, such products shall not be shipped or delivered for 
shipment or otherwise dealt with as having been prepared under such 
regulations.
    (b) Except as provided in 9 CFR part 103, a biological product shall 
not be prepared in a licensed establishment unless the person to whom 
the establishment license is issued holds an unexpired, unsuspended, and 
unrevoked product license issued by the Administrator to prepare such 
biological product, or unless the products prepared are subject to the 
provisions of Sec. 107.2 of this subchapter.
    (c) A biological product produced in a USDA-licensed establishment 
shall be produced under a U.S. Veterinary Biological Product License or 
a license granted by a State under Sec. 107.2 (referred to as a State 
biological product license and the products prepared pursuant thereto as 
State-licensed biological products, including autogenous biologics), but 
not under both a U.S. Veterinary Biological Product License and a State 
biological product license. Before a U.S. Veterinary Biological Product 
License (including a conditional license) is issued, the licensee shall 
relinquish its State license for that product: Provided, That autogenous 
biologics shall not be subject to this provision when they are prepared 
in accordance with the provisions of paragraph (c)(5) of this section.
    (1) State-licensed biological products (including autogenous 
biologics) shall only be distributed or shipped intrastate, must not 
bear a U.S. Veterinary Biologics Establishment License Number, and must 
not otherwise be represented in any manner as having met the 
requirements for a U.S. Veterinary Biological Product license. Labeling 
of State- and USDA-licensed biological products produced in the same 
establishment must be distinctly different in color and design.
    (2) All biological products in USDA-licensed establishments, whether 
licensed by USDA or by the State, shall be prepared only in locations 
indicated in legends filed in accordance with 9 CFR part 108. A 
description of each State-licensed product must be filed with the Animal 
and Plant Health Inspection Service as part of the blueprint legends and 
must be sufficient for Animal and Plant Health Inspection Service to 
determine any risk to the production of other products in the licensed 
establishment and to determine that adequate procedures are followed to 
prevent contamination during production.
    (3) Records in such establishments must be maintained in accordance 
with Sec. Sec. 116.1 and 116.2 of this subchapter and shall include all 
products licensed by the State or USDA.

[[Page 750]]

    (4) Reports prescribed in Sec. 116.5 of this subchapter for USDA-
licensed establishments shall be submitted for all veterinary biological 
products in the establishment.
    (5) Under the following conditions, an autogenous biologic may be 
produced in a USDA-licensed establishment under either a State or U.S. 
Veterinary Biological Product License:
    (i) When a culture of microorganisms, isolated from a herd in a 
State, is received at a USDA-licensed establishment that is in the same 
State but that holds both a State and a U.S. Veterinary Biological 
Products License for autogenous biologics, the isolate shall be 
designated by the licensee for use in the production of an autogenous 
biological product under either the State product license, or the U.S. 
Veterinary Biological Product License: Provided, That the isolate meets 
the requirements of the respective regulatory authority for an 
autogenous biologic. If, after producing the product pursuant to one 
license, the licensee elects to produce an autogenous biologic from the 
same isolate under provisions of the other license, the licensee may do 
so only with the approval of the other licensing authority.
    (ii) The true name of a State-licensed autogenous biologic shall 
specify the State of licensure: e.g.

`` ---------- Autogenous Bacterin''

 (State)

or ---------- Autogenous Vaccine''.

 (State)

[39 FR 16869, May 10, 1974, as amended at 60 FR 48021, Sept. 21, 1995]