[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: 9CFR107]
 
[Page 604-605]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 107_EXEMPTIONS FROM PREPARATION PURSUANT TO AN UNSUSPENDED AND 
UNREVOKED LICENSE
 
Sec.
107.1 Veterinary practitioners and animal owners.
107.2 Products under State license.
 
    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
 
Sec. 107.1  Veterinary practitioners and animal owners.
 
    Products prepared as provided in paragraphs (a) and (b) of this 
section and establishments in which such products are prepared, shall be 
exempt from preparation pursuant to unsuspended and unrevoked 
establishment and product licenses. Persons exempt from licensure under 
this part shipping products which contain live organisms shall provide 
any information the Administrator may require prior to shipment, or at 
any other time deemed necessary, in order to assess the products' safety 
and effect on the environment. The shipment or delivery for shipment 
anywhere in or from the United States of any exempted product which is 
worthless, contaminated, dangerous, or harmful is prohibited, and any 
person shipping such product, or delivering such product for shipment, 
shall be subject to sanctions under the Act.
    (a)(1) Products prepared by a veterinary practitioner (veterinarian) 
solely for administration to animals in the course of a State licensed 
professional practice of veterinary medicine by such veterinarian under 
a veterinarian-client-patient relationship and establishments in which 
such products are prepared shall be exempt from licensing under the Act 
and regulations. Such a relationship is considered to exist when:
    (i) The veterinarian has assumed the responsibility for making 
medical judgments regarding the health of the animal(s) and the need for 
medical treatment, and the client (owner or other caretaker) has agreed 
to follow the instructions of the veterinarian; and when
    (ii) There is sufficient knowledge of the animal(s) by the 
veterinarian to initiate at least a general or preliminary diagnosis of 
the medical condition of the animal(s). This means that the veterinarian 
has recently seen and is personally acquainted with the keeping and care 
of the animal(s), and/or by medically appropriate and timely visits to 
the premises where the animal(s) are kept; and when
    (iii) The practicing veterinarian is readily available for followup 
in case of adverse reactions or failure of the regimen.
    (2) Veterinarians preparing products subject to the exemption for 
products under this section shall maintain and make available for 
inspection by Animal and Plant Health Inspection Service representatives 
or other Federal employees designated by the Secretary such records as 
are necessary to establish that a valid veterinarian-client-patient 
relationship exists and that there is a valid basis for the exemption 
under this section.
    (b) Products prepared by a person solely for administration to 
animals owned by that person shall be exempt from the requirement that 
preparation be pursuant to an unsuspended and unrevoked license.
 
[52 FR 30131, Aug. 13, 1987, as amended at 56 FR 66783, Dec. 26, 1991]
 
Sec. 107.2  Products under State license.
 
    (a) The Administrator shall exempt from the requirement of 
preparation pursuant to an unsuspended and unrevoked USDA establishment 
and product license, any biological product prepared solely for 
distribution within the State of production pursuant to a license 
granted by such State under a
 
[[Page 605]]
 
program determined by the Administrator to be consistent with the intent 
of the Act to prohibit the preparation, sale, barter, exchange, or 
shipment of worthless, contaminated, dangerous, or harmful biological 
products.
    (b) A request for exemption under this section must be made by the 
appropriate State authority and shall include information demonstrating 
that:
    (1) The State has the authority to license viruses, serums, toxins, 
and analogous products and establishments that produce such products; 
and
    (2) The State has the authority to review the purity, safety, 
potency, and efficacy of such products prior to release to the market; 
and
    (3) The State has the authority to review product test results to 
assure compliance with applicable standards of purity, safety, and 
potency prior to release to the market; and
    (4) The State has the authority to deal effectively with violations 
of State law regulating viruses, serums, toxins, and analogous products; 
and
    (5) The State effectively exercises the authority specified in 
paragraphs (b)(1) through (4) of this section consistent with the intent 
of the Act prohibiting the preparation, sale, barter, exchange, or 
shipment of worthless, contaminated, dangerous, or harmful viruses, 
serums, toxins, or analogous products.
    (c) Each product to be exempted and each establishment preparing 
such product shall be identified by the State and the State shall give 
written notification to the Administrator of each such product and 
establishment. The State shall also give written notice to the 
Administrator of each new license issued and of each license terminated.
    (d) In order to determine whether a State exercises its authority 
with respect to biological products and establishments and whether its 
laws and regulations are being achieved, the Administrator, in 
cooperation with proper State authorities, may conduct an on-site 
evaluation of the State's program which may include inspection of 
establishments and/or products to be included under the exemptions in 
this section.
 
[52 FR 30131, Aug. 13, 1987, as amended at 56 FR 66783, Dec. 26, 1991]