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Subchapter E—Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors

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Subchapter E—Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PART 101—DEFINITIONS immunostimulants, certain cytokines, antigenic or immunizing components Sec. of live organisms, and diagnostic com- 101.1 Applicability. ponents, that are of natural or syn- 101.2 Administrative terminology. thetic origin, or that are derived from 101.3 Biological products and related terms. synthesizing or altering various sub- 101.4 Labeling terminology. stances or components of substances 101.5 Testing terminology. such as microorganisms, genes or ge- 101.6 Cell cultures. netic sequences, carbohydrates, pro- 101.7 Seed organisms. teins, antigens, allergens, or anti- AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, bodies. 2.80, and 371.4. (1) A product’s intended use shall be SOURCE: 38 FR 8426, Apr. 2, 1973, unless oth- determined through an objective stand- erwise noted. ard and not a subjective one, and would be dependent on factors such as rep- § 101.1 Applicability. resentations, claims (either oral or When used in parts 101 through 117 of written), packaging, labeling, or ap- this subchapter, the meaning of the pearance. words and phrases listed shall be as de- (2) The term analogous products shall fined in this part. include: (i) Substances, at any stage of pro- § 101.2 Administrative terminology. duction, shipment, distribution, or The following administrative words sale, which are intended for use in the and phrases shall mean: treatment of animals and which are Adjacent herd. Adjacent herds are similar in function to biological prod- herds physically contiguous to the herd ucts in that they act, or are intended of origin; there are no herds between to act, through the stimulation, sup- an adjacent herd and the herd of origin. plementation, enhancement, or modu- Administrator. The Administrator, lation of the immune system or im- Animal and Plant Health Inspection mune response; or Service, or any person authorized to (ii) Substances, at any stage of pro- act for the Administrator. duction, shipment, distribution, or Animal and Plant Health Inspection sale, which are intended for use in the Service. The agency in the Department treatment of animals through the de- of Agriculture responsible for admin- tection or measurement of antigens, istering the Virus-Serum-Toxin Act. antibodies, nucleic acids, or immunity; Biological products. The term biologi- or cal products, also referred to in this (iii) Substances, at any stage of pro- subchapter as biologics, biologicals, or duction, shipment, distribution, or products, shall mean all viruses, se- sale, which resemble or are represented rums, toxins (excluding substances as biological products intended for use that are selectively toxic to microorga- in the treatment of animals through nisms, e.g., antibiotics), or analogous appearance, packaging, labeling, products at any stage of production, claims (either oral or written), rep- shipment, distribution, or sale, which resentations, or through any other are intended for use in the treatment means. of animals and which act primarily (3) The term treatment shall mean the through the direct stimulation, sup- prevention, diagnosis, management, or plementation, enhancement, or modu- cure of diseases of animals. lation of the immune system or im- Department. The U.S. Department of mune response. The term ‘‘biological Agriculture. products’’ includes but is not limited Distributor. A person who sells, dis- to vaccines, bacterins, allergens, anti- tributes, or otherwise places in chan- bodies, antitoxins, toxoids, nels of trade, one or more biological 666 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00676 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 kpayne on DSK54DXVN1OFR with $$_JOB Animal and Plant Health Inspection Service, USDA § 101.2 products he does not produce or im- Licensed establishment. An establish- port. ment operated by a person holding an Division. A marketing unit estab- unexpired, unsuspended, and unrevoked lished by the licensee which may be U.S. Veterinary Biologics Establish- named on labels, advertisements and ment License. promotional material in addition to Licensee. A person to whom an estab- the name and address of the producer. lishment license and at least one prod- Domestic animals. All animals, other uct license has been issued. than man, including poultry. Microorganisms. Microscopic or sub- Establishment. One or more premises microscopic organisms, which are designated on the establishment li- sometimes referred to as organisms, cense. which may introduce or disseminate Guidelines. Guidelines establish prin- disease of animals. ciples or practices related to test pro- Nonadjacent herd. Nonadjacent herds cedures, manufacturing practices, are all herds other than the herd of ori- product standards, scientific protocols, gin and other than herds adjacent to labeling, and other technical or policy the herd of origin. Herds adjacent to considerations. Guidelines contain pro- the herd of origin but in a different cedures or standards of general applica- State from the herd of origin are also bility that are usually not regulatory considered nonadjacent herds. in nature, but that are related to mat- Permittee. A person who resides in the ters that fall under the Virus-Serum- United States or operates a business Toxin Act. Guidelines issued by the establishment within the United agency include Veterinary Biologics States, to whom a permit to import bi- Licensing Considerations, Memoranda, ological products has been issued. Notices, and Supplemental Assay Person. Any individual, firm, partner- Methods. ship, corporation, company, associa- Herd. Any group of animals, includ- tion, educational institution, State or ing birds, fish, and reptiles, maintained local governmental agency, or other at a common location (e.g. lot, farm or organized group of any of the fore- ranch) for any purpose. The herd (or going, or any agent, officer, or em- flock) includes all animals subse- ployee of any thereof. quently housed at the common loca- Premises. All buildings, appur- tion. If the principal animals of a group tenances, and equipment used to are moved to a different location, the produce and store biological products group is still considered the same herd. located within a particular land area Herd of origin. The herd from which shown on building plans or drawings the microorganism used as seed for furnished by the applicant or the li- production of an autogenous biologic is censee and designated by an address isolated. Offspring and excess breeding adequate for identification. stock (not the principal animals) Prepare or preparation. Sometimes re- moved or sold from one group of ani- ferred to as manufacture or produce, mals to another have changed herds means the steps and procedures used in and are no longer considered part of the processing, testing, packaging, la- the herd they originated from. Groups beling, and storing of a biological prod- of animals under the same ownership uct. but at different locations are separate Regulations. The provisions in parts herds. 101 through 118 of this subchapter. Inspection. An examination made by Research investigator or research spon- an inspector to determine the fitness of sor. A person who has requested au- animals, establishments, facilities, and thorization to ship an experimental bi- procedures used in connection with the ological product for the purpose of preparation, testing, and distribution evaluating such product, or has been of biological products and the examina- granted such authorization. tion or testing of biological products. Secretary. The Secretary of Agri- Inspector. Any officer or employee of culture of the United States or any of- Animal and Plant Health Inspection ficer or employee of the Department to Service who is authorized by the Ad- whom authority has heretofore been ministrator to do inspection work. delegated, or to whom authority may 667 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00677 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 kpayne on DSK54DXVN1OFR with $$_JOB § 101.3 9 CFR Ch. I (1–1–18 Edition) hereafter be delegated, to act in his unrevoked product license for such stead. product. Subsidiary. A corporation in which a (b) Experimental biological product. A corporate licensee owns in excess of 50 biological product which is being eval- percent of the voting stock. uated to substantiate an application Veterinary Services. Veterinary Serv- for a product license or permit. ices unit of Animal and Plant Health (c) Completed product. A biological Inspection Service of the Department. product in bulk or final container pro- Virus-Serum-Toxin Act. The Act of duced in compliance with the regula- March 4, 1913, 37 Stat. 832–833; as tions to final form and composition. amended December 23, 1985, Public Law (d) Finished product. A completed 99–198, 99 Stat. 1654–1655; and as further product which has been bottled, sealed, amended September 28, 1988, Public packaged, and labeled as required by Law 100–449, 102 Stat. 1868; 21 U.S.C. the regulations. 151–159. (e) Released product. A finished prod- U.S. Veterinary Biological Product Li- uct released for marketing after all re- cense. A document, sometimes referred quirements have been satisfactorily to as a product license, which is issued complied with. pursuant to part 102 of this subchapter (f) Fraction. A specific antigen, its to the holder of an establishment li- antibodies, or its antitoxin which con- cense, as a part of and ancillary to the stitutes a component of
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