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`21 C.F.R. § 600.3
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`CODE OF FEDERAL REGULATIONS
`TITLE 21—FOOD AND DRUGS
`CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SER-
`VICES
`SUBCHAPTER F—BIOLOGICS
`PART 600—BIOLOGICAL PRODUCTS: GENERAL
`SUBPART A—GENERAL PROVISIONS
`© 1998 West, a Thomson business. No claim to original U.S. Govt. works
`Current through April 1, 1998, 63 FR 16076
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`§ 600.3 Definitions.
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`As used in this subchapter:
`(a) “Act” means the Public Health Service Act (58 Stat. 682), approved July 1, 1944.
`(b) “Secretary” means the Secretary of Health and Human Services and any other officer or employee of the De-
`partment of Health and Human Services to whom the authority involved has been delegated.
`(c) “Commissioner of Food and Drugs” means the Commissioner of the Food and Drug Administration.
`(d) “Center for Biologics Evaluation and Research” means Center for Biologics Evaluation and Research of the
`Food and Drug Administration.
`(e) “State” means a State or the District of Columbia, Puerto Rico, or the Virgin Islands.
`(f) “Possession” includes among other possessions, Puerto Rico and the Virgin Islands.
`(g) “Products” includes biological products and trivalent organic arsenicals.
`(h) “Biological product” means any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to
`the prevention, treatment or cure of diseases or injuries of man:
`(1) A virus is interpreted to be a product containing the minute living cause of an infectious disease and includes
`but is not limited to filterable viruses, bacteria, rickettsia, fungi, and protozoa.
`(2) A therapeutic serum is a product obtained from blood by removing the clot or clot components and the blood
`cells.
`(3) A toxin is a product containing a soluble substance poisonous to laboratory animals or to man in doses of 1
`milliliter or less (or equivalent in weight) of the product, and having the property, following the injection of
`non-fatal doses into an animal, of causing to be produced therein another soluble substance which specifically
`neutralizes the poisonous substance and which is demonstrable in the serum of the animal thus immunized.
`(4) An antitoxin is a product containing the soluble substance in serum or other body fluid of an immunized an-
`imal which specifically neutralizes the toxin against which the animal is immune.
`(5) A product is analogous:
`(i) To a virus if prepared from or with a virus or agent actually or potentially infectious, without regard to the
`degree of virulence or toxicogenicity of the specific strain used.
`(ii) To a therapeutic serum, if composed of whole blood or plasma or containing some organic constituent or
`product other than a hormone or an amino acid, derived from whole blood, plasma, or serum.
`(iii) To a toxin or antitoxin, if intended, irrespective of its source of origin, to be applicable to the prevention,
`treatment, or cure of disease or injuries of man through a specific immune process.
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`(i) “Trivalent organic arsenicals” means arsphenamine and its derivatives (or any other trivalent organic arsenic
`compound) applicable to the prevention, treatment, or cure of diseases or injuries of man.
`(j) A product is deemed “applicable to the prevention, treatment, or cure of diseases or injuries of man” irre-
`spective of the mode of administration or application recommended, including use when intended through ad-
`ministration or application to a person as an aid in diagnosis, or in evaluating the degree of susceptibility or im-
`munity possessed by a person, and including also any other use for purposes of diagnosis if the diagnostic sub-
`stance so used is prepared from or with the aid of a biological product.
`(k) “Proper name”, as applied to a product, means the name designated in the license for use upon each package
`of the product.
`(l) “Dating period” means the period beyond which the product cannot be expected beyond reasonable doubt to
`yield its specific results.
`(m) “Expiration date” means the calendar month and year, and where applicable, the day and hour, that the dat-
`ing period ends.
`(n) The word “standards” means specifications and procedures applicable to an establishment or to the manufac-
`ture or release of products, which are prescribed in this subchapter and which are designed to insure the contin-
`ued safety, purity and potency of such products.
`(o) The word “continued” as applied to the safety, purity and potency of products is interpreted to apply to the
`dating period.
`(p) The word “safety” means the relative freedom from harmful effect to persons affected, directly or indirectly,
`by a product when prudently administered, taking into consideration the character of the product in relation to
`the condition of the recipient at the time.
`(q) The word “sterility” is interpreted to mean freedom from viable contaminating microorganisms, as determ-
`ined by the tests prescribed in § 610.12 of this chapter.
`(r) “Purity” means relative freedom from extraneous matter in the finished product, whether or not harmful
`to the recipient or deleterious to the product. “Purity” includes but is not limited to relative freedom from resid-
`ual moisture or other volatile substances and pyrogenic substances.
`(s) The word “potency” is interpreted to mean the specific ability or capacity of the product, as indicated by ap-
`propriate laboratory tests or by adequately controlled clinical data obtained through the administration of the
`product in the manner intended, to effect a given result.
`(t) “Manufacturer” means any legal person or entity engaged in the manufacture of a product subject to license
`under the act; “Manufacturer” also includes any legal person or entity who is an applicant for a license where the
`applicant assumes responsibility for compliance with the applicable product and establishment standards.
`(u) “Manufacture” means all steps in propagation or manufacture and preparation of products and includes but is
`not limited to filling, testing, labeling, packaging, and storage by the manufacturer.
`(v) “Location” includes all buildings, appurtenances, equipment and animals used, and personnel engaged by a
`manufacturer within a particular area designated by an address adequate for identification.
`(w) “Establishment” includes all locations.
`(x) “Lot” means that quantity of uniform material identified by the manufacturer as having been thoroughly
`mixed in a single vessel.
`(y) A “filling” refers to a group of final containers identical in all respects, which have been filled with the same
`product from the same bulk lot without any change that will affect the integrity of the filling assembly.
`(z) “Process” refers to a manufacturing step that is performed on the product itself which may affect its safety,
`purity or potency, in contrast to such manufacturing steps which do not affect intrinsically the safety, purity or
`potency of the product.
`(aa) “Selling agent” or “distributor” means any person engaged in the unrestricted distribution, other than by
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`sale at retail, of products subject to license.
`(bb) “Container” (referred to also as “final container”) is the immediate unit, bottle, vial, ampule, tube, or other
`receptacle containing the product as distributed for sale, barter, or exchange.
`(cc) “Package” means the immediate carton, receptacle, or wrapper, including all labeling matter therein and
`thereon, and the contents of the one or more enclosed containers. If no package, as defined in the preceding sen-
`tence, is used, the container shall be deemed to be the package.
`(dd) “Label” means any written, printed, or graphic matter on the container or package or any such matter
`clearly visible through the immediate carton, receptacle, or wrapper.
`(ee) “Radioactive biological product” means a biological product which is labeled with a radionuclide or inten-
`ded solely to be labeled with a radionuclide.
`(ff) Amendment is the submission of information to a pending license application or supplement, to revise or
`modify the application as originally submitted.
`(gg) Supplement is a request to the Director, Center for Biologics Evaluation and Research, to approve a change
`in an approved license application.
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`[38 FR 32048, Nov. 20, 1973, as amended at 40 FR 31313, July 25, 1975; 49 FR 23833, June 8, 1984; 55 FR
`11014, March 26, 1990; 61 FR 24232, May 14, 1996; 62 FR 39901, July 24, 1997]
`21 C. F. R. § 600.3
`21 CFR § 600.3
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`END OF DOCUMENT
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