The following administrative words and phrases shall mean:
Animal and Plant Health Inspection Service.
The agency in the Department of Agriculture
responsible for administering the Virus-Serum-Toxin Act
The term biological products,
also referred to in this subchapter as biologics, biologicals, or products, shall mean all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms
, e.g., antibiotics), or analogous products at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals
and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. The term “biological products” includes but is not limited to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components, that are of natural or synthetic origin, or that are derived from synthesizing or altering various substances or components of substances such as microorganisms
, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies.
A product's intended use shall be determined through an objective standard and not a subjective one, and would be dependent on factors such as representations, claims (either oral or written), packaging, labeling, or appearance.
The term analogous products shall include:
Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which are similar in function to biological products in that they act, or are intended to act, through the stimulation, supplementation, enhancement, or modulation of the immune system or immune response; or
Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals through the detection or measurement of antigens, antibodies, nucleic acids, or immunity; or
Substances, at any stage of production, shipment, distribution, or sale, which resemble or are represented as biological products intended for use in the treatment of animals through appearance, packaging, labeling, claims (either oral or written), representations, or through any other means.
The term treatment shall mean the prevention, diagnosis, management, or cure of diseases of animals.
Department. The U.S. Department of Agriculture.
who sells, distributes, or otherwise places in channels of trade, one or more biological products he does not produce or import.
A marketing unit established by the licensee
which may be named on labels, advertisements and promotional material in addition to the name and address of the producer
establish principles or practices related to test procedures, manufacturing practices, product standards, scientific protocols, labeling
, and other technical or policy considerations. Guidelines
contain procedures or standards of general applicability
that are usually not regulatory in nature, but that are related to matters that fall under the Virus-Serum-Toxin Act
issued by the agency include Veterinary Biologics Licensing Considerations, Memoranda, Notices, and Supplemental Assay Methods.
Any group of animals
, including birds, fish, and reptiles, maintained at a common location (e.g. lot, farm or ranch) for any purpose. The herd
(or flock) includes all animals
subsequently housed at the common location. If the principal animals
of a group are moved to a different location, the group is still considered the same herd
Herd of origin.
from which the microorganism used as seed for production of an autogenous biologic is isolated. Offspring and excess breeding stock (not the principal animals) moved or sold from one group of animals
to another have changed herds and are no longer considered part of the herd
they originated from. Groups of animals
under the same ownership but at different locations are separate herds.
An examination made by an inspector
to determine the fitness of animals
, establishments, facilities, and procedures used in connection with the preparation, testing, and distribution of biological products
and the examination or testing of biological products
Any officer or employee of Animal and Plant Health Inspection Service
who is authorized by the Administrator
to do inspection
to whom an establishment
license and at least one product license has been issued.
Microscopic or submicroscopic organisms, which are sometimes referred to as organisms, which may introduce or disseminate disease
Any individual, firm, partnership, corporation, company, association, educational institution, State
or local governmental agency, or other organized group of any of the foregoing, or any agent, officer, or employee of any thereof.
All buildings, appurtenances, and equipment used to produce and store biological products
located within a particular land area shown on building plans or drawings furnished by the applicant or the licensee
and designated by an address adequate for identification.
Prepare or preparation.
Sometimes referred to as manufacture or produce, means the steps and procedures used in the processing, testing, packaging, labeling
, and storing of a biological product.
The provisions in parts 101
through 118 of this subchapter.
Research investigator or research sponsor.
who has requested authorization to ship an experimental biological product
for the purpose of evaluating such product, or has been granted such authorization.
of Agriculture of the United States
or any officer or employee of the Department
to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead.
A corporation in which a corporate licensee
owns in excess of 50 percent of the voting stock.
The Act of March 4, 1913, 37 Stat. 832-833; as amended December 23, 1985, Public Law 99-198, 99 Stat. 1654-1655; and as further amended September 28, 1988, Public Law 100-449, 102 Stat. 1868; 21 U.S.C. 151-159
U.S. Veterinary Biological Product License.
A document, sometimes referred to as a product license, which is issued pursuant to part 102 of
this subchapter to the holder of an establishment
license, as a part of and ancillary to the establishment
license, and which authorizes production of a specified biological product in the designated licensed establishment
U.S. Veterinary Biological Product Permit.
A document, sometimes referred to as a permit
, issued to a person
authorizing the importation of specified biological products
subject to restrictions and controls as provided in the regulations
U.S. Veterinary Biologics Establishment License.
A document referred to as an establishment
license, which is issued pursuant to part 102 of
this subchapter, authorizing the use of designated premises
for production of biological products
specified in one or more unexpired, unsuspended, and unrevoked product license(s).
[38 FR 8426, Apr. 2, 1973; 38 FR 9221, Apr. 12, 1973, as amended at 40 FR 46093, Oct. 6, 1975; 41 FR 44358, Oct. 8, 1976; 49 FR 22624, May 31, 1984; 52 FR 30131, Aug. 13, 1987; 56 FR 66782, 66783, Dec. 26, 1991; 57 FR 38756, Aug. 27, 1992; 62 FR 31328
, June 9, 1997; 64 FR 43044
, Aug. 9, 1999]