[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.3]

[Page 5-7]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 600--BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 600.3  Definitions.


    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 Department 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 animal 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

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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.
    (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 irrespective of the mode of 
administration or application recommended, including use when intended 
through administration or application to a person as an aid in 
diagnosis, or in evaluating the degree of susceptibility or immunity 
possessed by a person, and including also any other use for purposes of 
diagnosis if the diagnostic substance 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 dating period ends.
    (n) The word standards means specifications and procedures 
applicable to an establishment or to the manufacture or release of 
products, which are prescribed in this subchapter or established in the 
biologics license application designed to insure the continued 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 determined by the tests prescribed in 
Sec. 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 residual 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 appropriate 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 has the same meaning as ``facility'' in section 
351 of the Public Health Service Act and 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.

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    (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 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 sentence, 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 intended 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.
    (hh) Distributed means the biological product has left the control 
of the licensed manufacturer.
    (ii) Control means having responsibility for maintaining the 
continued safety, purity, and potency of the product and for compliance 
with applicable product and establishment standards, and for compliance 
with current good manufacturing practices.

[38 FR 32048, Nov. 20, 1973, as amended at 40 FR 31313, July 25, 1975; 
55 FR 11014, Mar. 26, 1990; 61 FR 24232, May 14, 1996; 62 FR 39901, July 
24, 1997; 64 FR 56449, Oct. 20, 1999; 65 FR 66634, Nov. 7, 2000]