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U.S. Code as of:
01/19/04
Section 321. Definitions; generally
For the purposes of this chapter -
(a)(1) The term "State", except as used in the last sentence of
section 372(a) of this title, means any State or Territory of the
United States, the District of Columbia, and the Commonwealth of
Puerto Rico.
(2) The term "Territory" means any Territory or possession of the
United States, including the District of Columbia, and excluding
the Commonwealth of Puerto Rico and the Canal Zone.
(b) The term "interstate commerce" means (1) commerce between any
State or Territory and any place outside thereof, and (2) commerce
within the District of Columbia or within any other Territory not
organized with a legislative body.
(c) The term "Department" means Department of Health and Human
Services.
(d) The term "Secretary" means the Secretary of Health and Human
Services.
(e) The term "person" includes individual, partnership,
corporation, and association.
(f) The term "food" means (1) articles used for food or drink for
man or other animals, (2) chewing gum, and (3) articles used for
components of any such article.
(g)(1) The term "drug" means (A) articles recognized in the
official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official National Formulary,
or any supplement to any of them; and (B) articles intended for use
in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals; and (C) articles (other than food)
intended to affect the structure or any function of the body of man
or other animals; and (D) articles intended for use as a component
of any article specified in clause (A), (B), or (C). A food or
dietary supplement for which a claim, subject to sections
343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
and 343(r)(5)(D) of this title, is made in accordance with the
requirements of section 343(r) of this title is not a drug solely
because the label or the labeling contains such a claim. A food,
dietary ingredient, or dietary supplement for which a truthful and
not misleading statement is made in accordance with section
343(r)(6) of this title is not a drug under clause (C) solely
because the label or the labeling contains such a statement.
(2) The term "counterfeit drug" means a drug which, or the
container or labeling of which, without authorization, bears the
trademark, trade name, or other identifying mark, imprint, or
device, or any likeness thereof, of a drug manufacturer, processor,
packer, or distributor other than the person or persons who in fact
manufactured, processed, packed, or distributed such drug and which
thereby falsely purports or is represented to be the product of, or
to have been packed or distributed by, such other drug
manufacturer, processor, packer, or distributor.
(h) The term "device" (except when used in paragraph (n) of this
section and in sections 331(i), 343(f), 352(c), and 362(c) of this
title) means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is -
(1) recognized in the official National Formulary, or the
United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals, or
(3) intended to affect the structure or any function of the
body of man or other animals, and
which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement
of its primary intended purposes.
(i) The term "cosmetic" means (1) articles intended to be rubbed,
poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance,
and (2) articles intended for use as a component of any such
articles; except that such term shall not include soap.
(j) The term "official compendium" means the official United
States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
United States, official National Formulary, or any supplement to
any of them.
(k) The term "label" means a display of written, printed, or
graphic matter upon the immediate container of any article; and a
requirement made by or under authority of this chapter that any
word, statement, or other information appear on the label shall not
be considered to be complied with unless such word, statement, or
other information also appears on the outside container or wrapper,
if any there be, of the retail package of such article, or is
easily legible through the outside container or wrapper.
(l) The term "immediate container" does not include package
liners.
(m) The term "labeling" means all labels and other written,
printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.
(n) If an article is alleged to be misbranded because the
labeling or advertising is misleading, then in determining whether
the labeling or advertising is misleading there shall be taken into
account (among other things) not only representations made or
suggested by statement, word, design, device, or any combination
thereof, but also the extent to which the labeling or advertising
fails to reveal facts material in the light of such representations
or material with respect to consequences which may result from the
use of the article to which the labeling or advertising relates
under the conditions of use prescribed in the labeling or
advertising thereof or under such conditions of use as are
customary or usual.
(o) The representation of a drug, in its labeling, as an
antiseptic shall be considered to be a representation that it is a
germicide, except in the case of a drug purporting to be, or
represented as, an antiseptic for inhibitory use as a wet dressing,
ointment, dusting powder, or such other use as involves prolonged
contact with the body.
(p) The term "new drug" means -
(1) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of which
is such that such drug is not generally recognized, among experts
qualified by scientific training and experience to evaluate the
safety and effectiveness of drugs, as safe and effective for use
under the conditions prescribed, recommended, or suggested in the
labeling thereof, except that such a drug not so recognized shall
not be deemed to be a "new drug" if at any time prior to June 25,
1938, it was subject to the Food and Drugs Act of June 30, 1906,
as amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of which
is such that such drug, as a result of investigations to
determine its safety and effectiveness for use under such
conditions, has become so recognized, but which has not,
otherwise than in such investigations, been used to a material
extent or for a material time under such conditions.
(q)(1)(A) Except as provided in clause (B), the term "pesticide
chemical" means any substance that is a pesticide within the
meaning of the Federal Insecticide, Fungicide, and Rodenticide Act
[7 U.S.C. 136 et seq.], including all active and inert ingredients
of such pesticide. Notwithstanding any other provision of law, the
term "pesticide" within such meaning includes ethylene oxide and
propylene oxide when such substances are applied on food.
(B) In the case of the use, with respect to food, of a substance
described in clause (A) to prevent, destroy, repel, or mitigate
microorganisms (including bacteria, viruses, fungi, protozoa,
algae, and slime), the following applies for purposes of clause
(A):
(i) The definition in such clause for the term "pesticide
chemical" does not include the substance if the substance is
applied for such use on food, or the substance is included for
such use in water that comes into contact with the food, in the
preparing, packing, or holding of the food for commercial
purposes. The substance is not excluded under this subclause from
such definition if the substance is ethylene oxide or propylene
oxide, and is applied for such use on food. The substance is not
so excluded if the substance is applied for such use on a raw
agricultural commodity, or the substance is included for such use
in water that comes into contact with the commodity, as follows:
(I) The substance is applied in the field.
(II) The substance is applied at a treatment facility where
raw agricultural commodities are the only food treated, and the
treatment is in a manner that does not change the status of the
food as a raw agricultural commodity (including treatment
through washing, waxing, fumigating, and packing such
commodities in such manner).
(III) The substance is applied during the transportation of
such commodity between the field and such a treatment facility.
(ii) The definition in such clause for the term "pesticide
chemical" does not include the substance if the substance is a
food contact substance as defined in section 348(h)(6) of this
title, and any of the following circumstances exist: The
substance is included for such use in an object that has a food
contact surface but is not intended to have an ongoing effect on
any portion of the object; the substance is included for such use
in an object that has a food contact surface and is intended to
have an ongoing effect on a portion of the object but not on the
food contact surface; or the substance is included for such use
in or is applied for such use on food packaging (without regard
to whether the substance is intended to have an ongoing effect on
any portion of the packaging). The food contact substance is not
excluded under this subclause from such definition if any of the
following circumstances exist: The substance is applied for such
use on a semipermanent or permanent food contact surface (other
than being applied on food packaging); or the substance is
included for such use in an object that has a semipermanent or
permanent food contact surface (other than being included in food
packaging) and the substance is intended to have an ongoing
effect on the food contact surface.
With respect to the definition of the term "pesticide" that is
applicable to the Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.], this clause does not exclude any
substance from such definition.
(2) The term "pesticide chemical residue" means a residue in or
on raw agricultural commodity or processed food of -
(A) a pesticide chemical; or
(B) any other added substance that is present on or in the
commodity or food primarily as a result of the metabolism or
other degradation of a pesticide chemical.
(3) Notwithstanding subparagraphs (1) and (2), the Administrator
may by regulation except a substance from the definition of
"pesticide chemical" or "pesticide chemical residue" if -
(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or to human activities not involving the use of any
substances for a pesticidal purpose in the production, storage,
processing, or transportation of any raw agricultural commodity
or processed food; and
(B) the Administrator, after consultation with the Secretary,
determines that the substance more appropriately should be
regulated under one or more provisions of this chapter other than
sections 342(a)(2)(B) and 346a of this title.
(r) The term "raw agricultural commodity" means any food in its
raw or natural state, including all fruits that are washed,
colored, or otherwise treated in their unpeeled natural form prior
to marketing.
(s) The term "food additive" means any substance the intended use
of which results or may reasonably be expected to result, directly
or indirectly, in its becoming a component or otherwise affecting
the characteristics of any food (including any substance intended
for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food; and
including any source of radiation intended for any such use), if
such substance is not generally recognized, among experts qualified
by scientific training and experience to evaluate its safety, as
having been adequately shown through scientific procedures (or, in
the case of a substance used in food prior to January 1, 1958,
through either scientific procedures or experience based on common
use in food) to be safe under the conditions of its intended use;
except that such term does not include -
(1) a pesticide chemical residue in or on a raw agricultural
commodity or processed food; or
(2) a pesticide chemical; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or
approval granted prior to September 6, 1958, pursuant to this
chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et
seq.] or the Meat Inspection Act of March 4, 1907, as amended and
extended [21 U.S.C. 601 et seq.];
(5) a new animal drug; or
(6) an ingredient described in paragraph (ff) in, or intended
for use in, a dietary supplement.
(t)(1) The term "color additive" means a material which -
(A) is a dye, pigment, or other substance made by a process of
synthesis or similar artifice, or extracted, isolated, or
otherwise derived, with or without intermediate or final change
of identity, from a vegetable, animal, mineral, or other source,
and
(B) when added or applied to a food, drug, or cosmetic, or to
the human body or any part thereof, is capable (alone or through
reaction with other substance) of imparting color thereto;
except that such term does not include any material which the
Secretary, by regulation, determines is used (or intended to be
used) solely for a purpose or purposes other than coloring.
(2) The term "color" includes black, white, and intermediate
grays.
(3) Nothing in subparagraph (1) of this paragraph shall be
construed to apply to any pesticide chemical, soil or plant
nutrient, or other agricultural chemical solely because of its
effect in aiding, retarding, or otherwise affecting, directly or
indirectly, the growth or other natural physiological processes of
produce of the soil and thereby affecting its color, whether before
or after harvest.
(u) The term "safe" as used in paragraph (s) of this section and
in sections 348, 360b, and 379e of this title, has reference to the
health of man or animal.
(v) The term "new animal drug" means any drug intended for use
for animals other than man, including any drug intended for use in
animal feed but not including such animal feed, -
(1) the composition of which is such that such drug is not
generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness
of animal drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the labeling
thereof; except that such a drug not so recognized shall not be
deemed to be a "new animal drug" if at any time prior to June 25,
1938, it was subject to the Food and Drug Act of June 30, 1906,
as amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) the composition of which is such that such drug, as a
result of investigations to determine its safety and
effectiveness for use under such conditions, has become so
recognized but which has not, otherwise than in such
investigations, been used to a material extent or for a material
time under such conditions.
(w) The term "animal feed", as used in paragraph (w) (!1) of this
section, in section 360b of this title, and in provisions of this
chapter referring to such paragraph or section, means an article
which is intended for use for food for animals other than man and
which is intended for use as a substantial source of nutrients in
the diet of the animal, and is not limited to a mixture intended to
be the sole ration of the animal.
(x) The term "informal hearing" means a hearing which is not
subject to section 554, 556, or 557 of title 5 and which provides
for the following:
(1) The presiding officer in the hearing shall be designated by
the Secretary from officers and employees of the Department who
have not participated in any action of the Secretary which is the
subject of the hearing and who are not directly responsible to an
officer or employee of the Department who has participated in any
such action.
(2) Each party to the hearing shall have the right at all times
to be advised and accompanied by an attorney.
(3) Before the hearing, each party to the hearing shall be
given reasonable notice of the matters to be considered at the
hearing, including a comprehensive statement of the basis for the
action taken or proposed by the Secretary which is the subject of
the hearing and a general summary of the information which will
be presented by the Secretary at the hearing in support of such
action.
(4) At the hearing the parties to the hearing shall have the
right to hear a full and complete statement of the action of the
Secretary which is the subject of the hearing together with the
information and reasons supporting such action, to conduct
reasonable questioning, and to present any oral or written
information relevant to such action.
(5) The presiding officer in such hearing shall prepare a
written report of the hearing to which shall be attached all
written material presented at the hearing. The participants in
the hearing shall be given the opportunity to review and correct
or supplement the presiding officer's report of the hearing.
(6) The Secretary may require the hearing to be transcribed. A
party to the hearing shall have the right to have the hearing
transcribed at his expense. Any transcription of a hearing shall
be included in the presiding officer's report of the hearing.
(y) The term "saccharin" includes calcium saccharin, sodium
saccharin, and ammonium saccharin.
(z) The term "infant formula" means a food which purports to be
or is represented for special dietary use solely as a food for
infants by reason of its simulation of human milk or its
suitability as a complete or partial substitute for human milk.
(aa) The term "abbreviated drug application" means an application
submitted under section 355(j) of this title for the approval of a
drug that relies on the approved application of another drug with
the same active ingredient to establish safety and efficacy, and -
(1) in the case of section 335a of this title, includes a
supplement to such an application for a different or additional
use of the drug but does not include a supplement to such an
application for other than a different or additional use of the
drug, and
(2) in the case of sections 335b and 335c of this title,
includes any supplement to such an application.
(bb) The term "knowingly" or "knew" means that a person, with
respect to information -
(1) has actual knowledge of the information, or
(2) acts in deliberate ignorance or reckless disregard of the
truth or falsity of the information.
(cc) For purposes of section 335a of this title, the term "high
managerial agent" -
(1) means -
(A) an officer or director of a corporation or an
association,
(B) a partner of a partnership, or
(C) any employee or other agent of a corporation,
association, or partnership,
having duties such that the conduct of such officer, director,
partner, employee, or agent may fairly be assumed to represent
the policy of the corporation, association, or partnership, and
(2) includes persons having management responsibility for -
(A) submissions to the Food and Drug Administration regarding
the development or approval of any drug product,
(B) production, quality assurance, or quality control of any
drug product, or
(C) research and development of any drug product.
(dd) For purposes of sections 335a and 335b of this title, the
term "drug product" means a drug subject to regulation under
section 355, 360b, or 382 of this title or under section 262 of
title 42.
(ee) The term "Commissioner" means the Commissioner of Food and
Drugs.
(ff) The term "dietary supplement" -
(1) means a product (other than tobacco) intended to supplement
the diet that bears or contains one or more of the following
dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet
by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or
combination of any ingredient described in clause (A), (B),
(C), (D), or (E);
(2) means a product that -
(A)(i) is intended for ingestion in a form described in
section 350(c)(1)(B)(i) of this title; or
(ii) complies with section 350(c)(1)(B)(ii) of this title;
(B) is not represented for use as a conventional food or as a
sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does -
(A) include an article that is approved as a new drug under
section 355 of this title or licensed as a biologic under
section 262 of title 42 and was, prior to such approval,
certification, or license, marketed as a dietary supplement or
as a food unless the Secretary has issued a regulation, after
notice and comment, finding that the article, when used as or
in a dietary supplement under the conditions of use and dosages
set forth in the labeling for such dietary supplement, is
unlawful under section 342(f) of this title; and
(B) not include -
(i) an article that is approved as a new drug under section
355 of this title, certified as an antibiotic under section
357 of this title, or licensed as a biologic under section
262 of title 42, or
(ii) an article authorized for investigation as a new drug,
antibiotic, or biological for which substantial clinical
investigations have been instituted and for which the
existence of such investigations has been made public,
which was not before such approval, certification, licensing, or
authorization marketed as a dietary supplement or as a food
unless the Secretary, in the Secretary's discretion, has issued a
regulation, after notice and comment, finding that the article
would be lawful under this chapter.
Except for purposes of paragraph (g), a dietary supplement shall be
deemed to be a food within the meaning of this chapter.
(gg) The term "processed food" means any food other than a raw
agricultural commodity and includes any raw agricultural commodity
that has been subject to processing, such as canning, cooking,
freezing, dehydration, or milling.
(hh) The term "Administrator" means the Administrator of the
United States Environmental Protection Agency.
(ii) The term "compounded positron emission tomography drug" -
(1) means a drug that -
(A) exhibits spontaneous disintegration of unstable nuclei by
the emission of positrons and is used for the purpose of
providing dual photon positron emission tomographic diagnostic
images; and
(B) has been compounded by or on the order of a practitioner
who is licensed by a State to compound or order compounding for
a drug described in subparagraph (A), and is compounded in
accordance with that State's law, for a patient or for
research, teaching, or quality control; and
(2) includes any nonradioactive reagent, reagent kit,
ingredient, nuclide generator, accelerator, target material,
electronic synthesizer, or other apparatus or computer program to
be used in the preparation of such a drug.
(jj) The term "antibiotic drug" means any drug (except drugs for
use in animals other than humans) composed wholly or partly of any
kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, bacitracin, or any other drug intended for human
use containing any quantity of any chemical substance which is
produced by a micro-organism and which has the capacity to inhibit
or destroy micro-organisms in dilute solution (including a
chemically synthesized equivalent of any such substance) or any
derivative thereof.
(kk) Priority supplement. - The term "priority supplement" means
a drug application referred to in section 101(4) of the Food and
Drug Administration Modernization Act of 1997 (111 Stat. 2298).
(ll)(1) The term "single-use device" means a device that is
intended for one use, or on a single patient during a single
procedure.
(2)(A) The term "reprocessed", with respect to a single-use
device, means an original device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a
patient. The subsequent processing and manufacture of a reprocessed
single-use device shall result in a device that is reprocessed
within the meaning of this definition.
(B) A single-use device that meets the definition under clause
(A) shall be considered a reprocessed device without regard to any
description of the device used by the manufacturer of the device or
other persons, including a description that uses the term
"recycled" rather than the term "reprocessed".
(3) The term "original device" means a new, unused single-use
device.
(mm)(1) The term "critical reprocessed single-use device" means a
reprocessed single-use device that is intended to contact normally
sterile tissue or body spaces during use.
(2) The term "semi-critical reprocessed single-use device" means
a reprocessed single-use device that is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the
body.
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