PART 101—DEFINITIONS Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. Source: 38 FR 8426, Apr. 2, 1973, unless otherwise noted. § 101.1 Applicability. When used in parts 101 through 117 of this subchapter, the meaning of the words and phrases listed shall be as defined in this part. § 101.2 Administrative terminology. The following administrative words and phrases shall mean: Adjacent herd. Administrator. Adverse event. Adverse event report. (1) An identifiable reporter; (2) An identifiable animal; (3) An identifiable biologic product; and (4) One or more adverse events. Animal and Plant Health Inspection Service. Biological products. biological products, (1) 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. (2) The term analogous products (i) 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 (ii) 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 (iii) 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. (3) The term treatment Department. Distributor. Division. Domestic animals. Establishment. Guidelines. Herd. Herd of origin. Inspection. Inspector. Licensed establishment. Licensee. Microorganisms. Nonadjacent herd. Permittee. Person. Premises. Prepare or preparation. Regulations. Research investigator or research sponsor. Secretary. Subsidiary. Veterinary Services. Virus-Serum-Toxin Act. U.S. Veterinary Biological Product License. U.S. Veterinary Biological Product Permit. U.S. Veterinary Biologics Establishment License. [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; 83 FR 22835, May 17, 2018] § 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. (b) Experimental biological product. (c) Completed product. (d) Finished product. (e) Released product. (f) Fraction. (g) Diluent. (h) Serial. Provided, (i) Subserial. (j) Outline of production. (k) Product Code Number. (l) Harvest date. (m) Bacterin. (n) Toxoid. (o) Bacterin-toxoid. (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, (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. (q) Combination package. [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; 81 FR 59433, Aug. 30, 2016] § 101.4 Labeling terminology. Terms pertaining to identification and packaging of biological products shall mean: (a) Label. (1) Upon or attached to a final container of a biological product; (2) Appearing upon any immediate carton or box used to package such final container; and (3) Appearing on any accompanying enclosures (leaflets, inserts, or circulars) on which required information or directions as to the use of the biological product shall be found. (b) Labeling. (c) Final container. (d) True name. Provided, (e) Serial number. (f) Expiration date. (g) Label number. (h) Master label. [38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 56 FR 66782, Dec. 26, 1991; 61 FR 29464, June 11, 1996] § 101.5 Testing terminology. Terms used when evaluating biological products shall mean: (a) Standard Requirement. (b) Log. (c) Pure or purity. (d) Safe or safety. (e) Sterile or sterility. (f) Potent or potency. (g) Efficacious or efficacy. (h) Dose. (i) Vaccinate. (j) Control animal. (k) Day. (l) Test results. (1) No Test. (2) Satisfactory. (3) Unsatisfactory. (4) Inconclusive. (m) Healthy. (n) Unfavorable reactions. (o) Master reference. (1) A completed serial of vaccine or bacterin prepared in accordance with a filed Outline of Production; (2) A purified preparation of a protective immunogen or antigen; or (3) A nonadjuvanted harvested culture of microorganisms. (p) Working reference. (1) Master References; or (2) Serials of product that have been prepared and qualified, in a manner acceptable to Animal and Plant Health Inspection Service for use as reference preparations. (q) Qualifying serial. (2) Qualifying serials used to requalify or extend the dating period of a Master Reference shall be determined to be immunogenic in accordance with methods deemed appropriate by the Animal and Plant Health Inspection Service as provided in paragraph (a)(1) of this section, and, in addition, shall be within their permitted dating period and have been prepared in accordance with the production method described in the currently filed Outline of Production. (r) Immunogenicity. (s) Stability-indicating assay. [38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 41 FR 6751, Feb. 13, 1976; 43 FR 3701, Jan. 27, 1978; 56 FR 66782, 66783 Dec. 26, 1991; 62 FR 19037, Apr. 18, 1997; 79 FR 55969, Sept. 18, 2014; 83 FR 11143, Mar. 14, 2018] § 101.6 Cell cultures. When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures, the following terms shall mean: (a) Batches of primary cells. (b) Cell line. (c) Subculture. (d) Master Cell Stock (MCS). [38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 49 FR 22624, May 31, 1984] § 101.7 Seed organisms. When used in conjunction with or in reference to seed organisms, the following shall mean: (a) Master Seed. (b) Working Seed. (c) Production Seed. [49 FR 22625, May 31, 1984]