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SUBCHAPTER V - DRUGS AND DEVICES
PART A - DRUGS AND DEVICES
§ 351. Adulterated drugs and devices.
A drug or device shall be deemed to be adulterated -
- (a) Poisonous, insanitary, etc., ingredients; adequate controls in
manufacture
- (1) If it consists in whole or in part of any filthy, putrid, or decomposed
substance; or
- (2)
- (A) if it has been prepared, packed, or held under insanitary conditions
whereby it may have been contaminated with filth, or whereby it may have been
rendered injurious to health; or
- (B) if it is a drug and the methods used in, or the facilities or controls
used for, its manufacture, processing, packing, or holding do not conform to or
are not operated or administered in conformity with current good manufacturing
practice to assure that such drug meets the requirements of this chapter as to
safety and has the identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to possess; or
- (3) if its container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health; or
- (4) if (A) it bears or contains, for purposes of coloring only, a color
additive which is unsafe within the meaning of section 379e(a) of this title, or
(B) it is a color additive the intended use of which in or on drugs or devices
is for purposes of coloring only and is unsafe within the meaning of section
379e(a) of this title; or
- (5) if it is a new animal drug which is unsafe within the meaning of
section 360b of this title; or
- (6) if it is an animal feed bearing or containing a new animal drug, and
such animal feed is unsafe within the meaning of section 360b of this title.
- (b) Strength, quality, or purity differing from official
compendium
If it purports to be or is represented as a drug the name of which is
recognized in an official compendium, and its strength differs from, or its
quality or purity falls below, the standard set forth in such compendium. Such
determination as to strength, quality, or purity shall be made in accordance
with the tests or methods of assay set forth in such compendium, except that
whenever tests or methods of assay have not been prescribed in such compendium,
or such tests or methods of assay as are prescribed are, in the judgment of the
Secretary, insufficient for the making of such determination, the Secretary
shall bring such fact to the attention of the appropriate body charged with the
revision of such compendium, and if such body fails within a reasonable time to
prescribe tests or methods of assay which, in the judgment of the Secretary, are
sufficient for purposes of this paragraph, then the Secretary shall promulgate
regulations prescribing appropriate tests or methods of assay in accordance with
which such determination as to strength, quality, or purity shall be made. No
drug defined in an official compendium shall be deemed to be adulterated under
this paragraph because it differs from the standard of strength, quality, or
purity therefor set forth in such compendium, if its difference in strength,
quality, or purity from such standard is plainly stated on its label. Whenever a
drug is recognized in both the United States Pharmacopoeia and the Homoeopathic
Pharmacopoeia of the United States it shall be subject to the requirements of
the United States Pharmacopoeia unless it is labeled and offered for sale as a
homoeopathic drug, in which case it shall be subject to the provisions of the
Homoeopathic Pharmacopoeia of the United States and not to those of the United
States Pharmacopoeia.
- (c) Misrepresentation of strength, etc., where drug is
unrecognized in compendium
If it is not subject to the provisions of paragraph (b) of this section and
its strength differs from, or its purity or quality falls below, that which it
purports or is represented to possess.
- (d) Mixture with or substitution of another substance
If it is a drug and any substance has been (1) mixed or packed therewith so
as to reduce its quality or strength or (2) substituted wholly or in part
therefor.
- (e) Devices not in conformity with performance standards
If it is, or purports to be or is represented as, a device which is subject
to a performance standard established under section 360d of this title unless
such device is in all respects in conformity with such standard.
- (f) Certain class III devices
- (1) If it is a class III device -
- (A)
- (i) which is required by a regulation promulgated under subsection (b) of
section 360e of this title to have an approval under such section of an
application for premarket approval and which is not exempt from section 360e of
this title under section 360j(g) of this title, and
- (ii)
- (I) for which an application for premarket approval or a notice of
completion of a product development protocol was not filed with the Secretary
within the ninety-day period beginning on the date of the promulgation of such
regulation, or
- (II) for which such an application was filed and approval of the
application has been denied, suspended, or withdrawn, or such a notice was filed
and has been declared not completed or the approval of the device under the
protocol has been withdrawn;
- (B)
- (i) which was classified under section 360c(f) of this title into class
III, which under section 360e(a) of this title is required to have in effect an
approved application for premarket approval, and which is not exempt from
section 360e of this title under section 360j(g) of this title, and
- (ii) which has an application which has been suspended or is otherwise not
in effect; or
- (C) which was classified under section 360j(l) of this title into class
III, which under such section is required to have in effect an approved
application under section 360e of this title, and which has an application which
has been suspended or is otherwise not in effect.
- (2)
- (A) In the case of a device classified under section 360c(f) of this title
into class III and intended solely for investigational use, paragraph (FOOTNOTE
1) (1)(B) shall not apply with respect to such device during the period ending
on the ninetieth day after the date of the promulgation of the regulations
prescribing the procedures and conditions required by section 360j(g)(2) of this
title. (FOOTNOTE 1) So in original. Probably should be ''subparagraph''.
- (B) In the case of a device subject to a regulation promulgated under
subsection (b) of section 360e of this title, paragraph (FOOTNOTE 1) (1) shall
not apply with respect to such device during the period ending -
- (i) on the last day of the thirtieth calendar month beginning after the
month in which the classification of the device in class III became effective
under section 360c of this title, or
- (ii) on the ninetieth day after the date of the promulgation of such
regulation, whichever occurs later.
If it is a banned device.
- (h) Manufacture, packing, storage, or installation of device not
in conformity with applicable requirements or conditions
If it is a device and the methods used in, or the facilities or controls
used for, its manufacture, packing, storage, or installation are not in
conformity with applicable requirements under section 360j(f)(1) of this title
or an applicable condition prescribed by an order under section 360j(f)(2) of
this title.
- (i) Failure to comply with requirements under which device was
exempted for investigational use
If it is a device for which an exemption has been granted under section
360j(g) of this title for investigational use and the person who was granted
such exemption or any investigator who uses such device under such exemption
fails to comply with a requirement prescribed by or under such section.
§ 352. Misbranded drugs and devices.
A drug or device shall be deemed to be misbranded -
- (a) False or misleading label
If its labeling is false or misleading in any particular.
- (b) Package form; contents of label
If in package form unless it bears a label containing (1) the name and place
of business of the manufacturer, packer, or distributor; and (2) an accurate
statement of the quantity of the contents in terms of weight, measure, or
numerical count: Provided, That under clause (2) of this paragraph reasonable
variations shall be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary.
- (c) Prominence of information on label
If any word, statement, or other information required by or under authority
of this chapter to appear on the label or labeling is not prominently placed
thereon with such conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to render it likely
to be read and understood by the ordinary individual under customary conditions
of purchase and use.
- (d) Habit forming substances
If it is for use by man and contains any quantity of the narcotic or
hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal,
cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana,
morphine, opium, paraldehyde, peyote, or sulphonmethane; or any chemical
derivative of such substance, which derivative has been by the Secretary, after
investigation, found to be, and by regulations designated as, habit forming;
unless its label bears the name and quantity or proportion of such substance or
derivative and in juxtaposition therewith the statement ''Warning - May be habit
forming.''
- (e) Designation of drugs or devices by established names
- (1) If it is a drug, unless (A) its label bears, to the exclusion of any
other nonproprietary name (except the applicable systematic chemical name or the
chemical formula),
- (i) the established name (as defined in subparagraph (3)) of the drug, if
such there be, and
- (ii), in case it is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including the quantity,
kind, and proportion of any alcohol, and also including, whether active or not,
the established name and quantity or proportion of any bromides, ether,
chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine,
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury ouabain
strophanthin, strychnine, thyroid, or any derivative or preparation of any such
substances, contained therein; Provided, That the requirement for stating the
quantity of the active ingredients, other than the quantity of those
specifically named in this paragraph, shall apply only to prescription drugs;
and
- (B) for any prescription drug the established name of such drug or
ingredient, as the case may be, on such label (and on any labeling on which a
name for such drug or ingredient is used) is printed prominently and in type at
least half as large as that used thereon for any proprietary name or designation
for such drug or ingredient: Provided, That to the extent that compliance with
the requirements of clause (A)(ii) or clause (B) of this subparagraph is
impracticable, exemptions shall be established by regulations promulgated by the
Secretary.
- (2) If it is a device and it has an established name, unless its label
bears, to the exclusion of any other nonproprietary name, its established name
(as defined in subparagraph (4)) prominently printed in type at least half as
large as that used thereon for any proprietary name or designation for such
device, except that to the extent compliance with the requirements of this
subparagraph is impracticable, exemptions shall be established by regulations
promulgated by the Secretary.
- (3) As used in subparagraph (1), the term ''established name'', with
respect to a drug or ingredient thereof, means (A) the applicable official name
designated pursuant to section 358 of this title, or (B), if there is no such
name and such drug, or such ingredient, is an article recognized in an official
compendium, then the official title thereof in such compendium, or (C) if
neither clause (A) nor clause (B) of this subparagraph applies, then the common
or usual name, if any, of such drug or of such ingredient, except that where
clause (B) of this subparagraph applies to an article recognized in the United
States Pharmacopeia and in the Homoeopathic Pharmacopoeia under different
official titles, the official title used in the United States Pharmacopeia shall
apply unless it is labeled and offered for sale as a homoeopathic drug, in which
case the official title used in the Homoeopathic Pharmacopoeia shall apply.
- (4) As used in subparagraph (2), the term ''established name'' with respect
to a device means (A) the applicable official name of the device designated
pursuant to section 358 of this title, (B) if there is no such name and such
device is an article recognized in an official compendium, then the official
title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of
this subparagraph applies, then any common or usual name of such device.
- (f) Directions for use and warnings on label
Unless its labeling bears (1) adequate directions for use; and (2) such
adequate warnings against use in those pathological conditions or by children
where its use may be dangerous to health, or against unsafe dosage or methods or
duration of administration or application, in such manner and form, as are
necessary for the protection of users, except that where any requirement of
clause •(1) of this paragraph, as applied to any drug or device, is not
necessary for the protection of the public health, the Secretary shall
promulgate regulations exempting such drug or device from such requirement.
- (g) Representations as recognized drug; packing and labeling;
inconsistent requirements for designation of drug
If it purports to be a drug the name of which is recognized in an official
compendium, unless it is packaged and labeled as prescribed therein. The method
of packing may be modified with the consent of the Secretary. Whenever a drug is
recognized in both the United States Pharmacopoeia and the Homoeopathic
Pharmacopoeia of the United States, it shall be subject to the requirements of
the United States Pharmacopoeia with respect to packaging and labeling unless it
is labeled and offered for sale as a homoeopathic drug, in which case it shall
be subject to the provisions of the Homoeopathic Pharmacopoeia of the United
States, and not those of the United States Pharmacopoeia, except that in the
event of inconsistency between the requirements of this paragraph and those of
paragraph (e) as to the name by which the drug or its ingredients shall be
designated, the requirements of paragraph (e) shall prevail.
- (h) Deteriorative drugs; packing and labeling
If it has been found by the Secretary to be a drug liable to deterioration,
unless it is packaged in such form and manner, and its label bears a statement
of such precautions, as the Secretary shall by regulations require as necessary
for the protection of the public health. No such regulation shall be established
for any drug recognized in an official compendium until the Secretary shall have
informed the appropriate body charged with the revision of such compendium of
the need for such packaging or labeling requirements and such body shall have
failed within a reasonable time to prescribe such requirements.
- (i) Drug; misleading container; imitation; offer for sale under
another name
- (1) If it is a drug and its container is so made, formed, or filled as to
be misleading; or
- (2) if it is an imitation of another drug; or (3) if it is offered for sale
under the name of another drug.
- (j) Health-endangering when used as prescribed
If it is dangerous to health when used in the dosage or manner, or with the
frequency or duration prescribed, recommended, or suggested in the labeling
thereof.
- (k) Insulin not properly certified
If it is, or purports to be, or is represented as a drug composed wholly or
partly of insulin, unless (1) it is from a batch with respect to which a
certificate or release has been issued pursuant to section 356 of this title,
and (2) such certificate or release is in effect with respect to such drug.
- (l) Antibiotic drugs improperly certified
If it is, or purports to be, or is represented as a drug (except a drug for
use in animals other than man) composed wholly or partly of any kind of
penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any
other antibiotic drug, or any derivative thereof, unless (1) it is from a batch
with respect to which a certificate or release has been issued pursuant to
section 357 of this title, and (2) such certificate or release is in effect with
respect to such drug: Provided, That this paragraph shall not apply to any drug
or class of drugs exempted by regulations promulgated under section 357(c) or
(d) of this title.
- (m) Color additives; packing and labeling
If it is a color additive the intended use of which is for the purpose of
coloring only, unless its packaging and labeling are in conformity with such
packaging and labeling requirements applicable to such color additive, as may be
contained in regulations issued under section 379e of this title.
- (n) Prescription drug advertisements: established name;
quantitative formula; side effects, contraindications, and effectiveness; prior
approval; false advertising; labeling; construction of the Convention on
Psychotropic Substances
In the case of any prescription drug distributed or offered for sale in any
State, unless the manufacturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect to that drug a
true statement of
- (1) the established name as defined in paragraph (e) of this section,
printed prominently and in type at least half as large as that used for any
trade or brand name thereof,
- (2) the formula showing quantitatively each ingredient of such drug to the
extent required for labels under paragraph (e) of this section, and
- (3) such other information in brief summary relating to side effects,
contraindications, and effectiveness as shall be required in regulations which
shall be issued by the Secretary in accordance with the procedure specified in
section 371(e) of this title, except that (A) except in extraordinary
circumstances, no regulation issued under this paragraph shall require prior
approval by the Secretary of the content of any advertisement, and (B) no
advertisement of a prescription drug, published after the effective date of
regulations issued under this paragraph applicable to advertisements of
prescription drugs, shall with respect to the matters specified in this
paragraph or covered by such regulations, be subject to the provisions of
sections 52 to 57 of title 15. This paragraph (n) shall not be applicable to any
printed matter which the Secretary determines to be labeling as defined in
section 321(m) of this title. Nothing in the Convention on Psychotropic
Substances, signed at Vienna, Austria, on February 21, 1971, shall be construed
to prevent drug price communications to consumers.
- (o) Drugs or devices from nonregistered establishments
If it was manufactured, prepared, propagated, compounded, or processed in an
establishment in any State not duly registered under section 360 of this title,
if it was not included in a list required by section 360(j) of this title, if a
notice or other information respecting it was not provided as required by such
section or section 360(k) of this title, or if it does not bear such symbols
from the uniform system for identification of devices prescribed under section
360(e) of this title as the Secretary by regulation requires.
- (p) Packaging or labeling of drugs in violation of regulations
If it is a drug and its packaging or labeling is in violation of an
applicable regulation issued pursuant to section 1472 or 1473 of title 15.
- (q) Restricted devices using false or misleading advertising or
used in violation of regulations
In the case of any restricted device distributed or offered for sale in any
State, if (1) its advertising is false or misleading in any particular, or (2)
it is sold, distributed, or used in violation of regulations prescribed under
section 360j(e) of this title.
- (r) Restricted devices not carrying requisite accompanying
statements in advertisements and other descriptive printed matter
In the case of any restricted device distributed or offered for sale in any
State, unless the manufacturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect to that device
(1) a true statement of the device's established name as defined in subsection
(e) of this section, printed prominently and in type at least half as large as
that used for any trade or brand name thereof, and (2) a brief statement of the
intended uses of the device and relevant warnings, precautions, side effects,
and contraindications and, in the case of specific devices made subject to a
finding by the Secretary after notice and opportunity for comment that such
action is necessary to protect the public health, a full description of the
components of such device or the formula showing quantitatively each ingredient
of such device to the extent required in regulations which shall be issued by
the Secretary after an opportunity for a hearing. Except in extraordinary
circumstances, no regulation issued under this paragraph shall require prior
approval by the Secretary of the content of any advertisement and no
advertisement of a restricted device, published after the effective date of this
paragraph shall, with respect to the matters specified in this paragraph or
covered by regulations issued hereunder, be subject to the provisions of
sections 52 through 55 of title 15. This paragraph shall not be applicable to
any printed matter which the Secretary determines to be labeling as defined in
section 321(m) of this title.
- (s) Devices subject to performance standards not bearing requisite
labeling
If it is a device subject to a performance standard established under
section 360d of this title, unless it bears such labeling as may be prescribed
in such performance standard.
- (t) Devices for which there has been a failure or refusal to give
required notification or to furnish required material or information
If it is a device and there was a failure or refusal (1) to comply with any
requirement prescribed under section 360h of this title respecting the device,
(2) to furnish any material or information required by or under section 360i of
this title respecting the device, or (3) to comply with a requirement under
section 360l of this title.
§ 353. Exemptions and consideration for certain drugs, devices,
and biological products.
- (a) Regulations for goods to be processed, labeled, or repacked
elsewhere
The Secretary is directed to promulgate regulations exempting from any
labeling or packaging requirement of this chapter drugs and devices which are,
in accordance with the practice of the trade, to be processed, labeled, or
repacked in substantial quantities at establishments other than those where
originally processed or packed, on condition that such drugs and devices are not
adulterated or misbranded under the provisions of this chapter upon removal from
such processing, labeling, or repacking establishment.
- (b) Prescription by physician; exemption from labeling and
prescription requirements; misbranded drugs; compliance with narcotic and
marihuana laws
- (1) A drug intended for use by man which -
- (A) is a habit-forming drug to which section 352(d) of this title applies;
or
- (B) because of its toxicity or other potentiality for harmful effect, or
the method of its use, or the collateral measures necessary to its use, is not
safe for use except under the supervision of a practitioner licensed by law to
administer such drug; or
- (C) is limited by an approved application under section 355 of this title
to use under the professional supervision of a practitioner licensed by law to
administer such drug; shall be dispensed only
- (i) upon a written prescription of a practitioner licensed by law to
administer such drug, or
- (ii) upon an oral prescription of such practitioner which is reduced
promptly to writing and filed by the pharmacist, or
- (iii) by refilling any such written or oral prescription if such refilling
is authorized by the prescriber either in the original prescription or by oral
order which is reduced promptly to writing and filed by the pharmacist. The act
of dispensing a drug contrary to the provisions of this paragraph shall be
deemed to be an act which results in the drug being misbranded while held for
sale.
- (2) Any drug dispensed by filling or refilling a written or oral
prescription of a practitioner licensed by law to administer such drug shall be
exempt from the requirements of section 352 of this title, except paragraphs
(a), (i)(2) and (3), (k), and (l), and the packaging requirements of paragraphs
(g), (h), and (p), if the drug bears a label containing the name and address of
the dispenser, the serial number and date of the prescription or of its filling,
the name of the prescriber, and, if stated in the prescription, the name of the
patient, and the directions for use and cautionary statements, if any, contained
in such prescription. This exemption shall not apply to any drug dispensed in
the course of the conduct of a business of dispensing drugs pursuant to
diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this
subsection.
- (3) The Secretary may by regulation remove drugs subject to sections 352(d)
and 355 of this title from the requirements of paragraph (1) of this subsection
when such requirements are not necessary for the protection of the public
health.
- (4) A drug which is subject to paragraph (1) of this subsection shall be
deemed to be misbranded if at any time prior to dispensing its label fails to
bear the statement ''Caution: Federal law prohibits dispensing without
prescription''. A drug to which paragraph (1) of this subsection does not apply
shall be deemed to be misbranded if at any time prior to dispensing its label
bears the caution statement quoted in the preceding sentence.
- (5) Nothing in this subsection shall be construed to relieve any person
from any requirement prescribed by or under authority of law with respect to
drugs now included or which may hereafter be included within the classifications
stated in sections 4721, 6001, and 6151 of title 26, or to marihuana as defined
in section 4761 of title 26.
- (c) Sales restrictions
- (1) No person may sell, purchase, or trade or offer to sell, purchase, or
trade any drug sample. For purposes of this paragraph and subsection (d) of this
section, the term ''drug sample'' means a unit of a drug, subject to subsection
(b) of this section, which is not intended to be sold and is intended to promote
the sale of the drug. Nothing in this paragraph shall subject an officer or
executive of a drug manufacturer or distributor to criminal liability solely
because of a sale, purchase, trade, or offer to sell, purchase, or trade in
violation of this paragraph by other employees of the manufacturer or
distributor.
- (2) No person may sell, purchase, or trade, offer to sell, purchase, or
trade, or counterfeit any coupon. For purposes of this paragraph, the term
''coupon'' means a form which may be redeemed, at no cost or at a reduced cost,
for a drug which is prescribed in accordance with subsection (b) of this
section.
- (3)
- (A) No person may sell, purchase, or trade, or offer to sell, purchase, or
trade, any drug -
- (i) which is subject to subsection (b) of this section, and
- (ii)
- (I) which was purchased by a public or private hospital or other health
care entity, or
- (II) which was donated or supplied at a reduced price to a charitable
organization described in section 501(c)(3) of title 26.
- (B) Subparagraph (A) does not apply to -
- (i) the purchase or other acquisition by a hospital or other health care
entity which is a member of a group purchasing organization of a drug for its
own use from the group purchasing organization or from other hospitals or health
care entities which are members of such organization,
- (ii) the sale, purchase, or trade of a drug or an offer to sell, purchase,
or trade a drug by an organization described in subparagraph (A)(ii)(II) to a
nonprofit affiliate of the organization to the extent otherwise permitted by
law,
- (iii) a sale, purchase, or trade of a drug or an offer to sell, purchase,
or trade a drug among hospitals or other health care entities which are under
common control,
- (iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or
trade a drug for emergency medical reasons, or
- (v) a sale, purchase, or trade of a drug, an offer to sell, purchase, or
trade a drug, or the dispensing of a drug pursuant to a prescription executed in
accordance with subsection (b) of this section. For purposes of this paragraph,
the term ''entity'' does not include a wholesale distributor of drugs or a
retail pharmacy licensed under State law and the term ''emergency medical
reasons'' includes transfers of a drug between health care entities or from a
health care entity to a retail pharmacy undertaken to alleviate temporary
shortages of the drug arising from delays in or interruptions of regular
distribution schedules.
- (d) Distribution of drug samples
- (1) Except as provided in paragraphs (2) and (3), no person may distribute
any drug sample. For purposes of this subsection, the term ''distribute'' does
not include the providing of a drug sample to a patient by a -
- (A) practitioner licensed to prescribe such drug,
- (B) health care professional acting at the direction and under the
supervision of such a practitioner, or
- (C) pharmacy of a hospital or of another health care entity that is acting
at the direction of such a practitioner and that received such sample pursuant
to paragraph (2) or (3).
- (2)
- (A) The manufacturer or authorized distributor of record of a drug subject
to subsection (b) of this section may, in accordance with this paragraph,
distribute drug samples by mail or common carrier to practitioners licensed to
prescribe such drugs or, at the request of a licensed practitioner, to
pharmacies of hospitals or other health care entities. Such a distribution of
drug samples may only be made -
- (i) in response to a written request for drug samples made on a form which
meets the requirements of subparagraph (B), and
- (ii) under a system which requires the recipient of the drug sample to
execute a written receipt for the drug sample upon its delivery and the return
of the receipt to the manufacturer or authorized distributor of record.
- (B) A written request for a drug sample required by subparagraph •(A)(i)
shall contain -
- (i) the name, address, professional designation, and signature of the
practitioner making the request,
- (ii) the identity of the drug sample requested and the quantity requested,
- (iii) the name of the manufacturer of the drug sample requested, and
- (iv) the date of the request.
- (C) Each drug manufacturer or authorized distributor of record which makes
distributions by mail or common carrier under this paragraph shall maintain, for
a period of 3 years, the request forms submitted for such distributions and the
receipts submitted for such distributions and shall maintain a record of
distributions of drug samples which identifies the drugs distributed and the
recipients of the distributions. Forms, receipts, and records required to be
maintained under this subparagraph shall be made available by the drug
manufacturer or authorized distributor of record to Federal and State officials
engaged in the regulation of drugs and in the enforcement of laws applicable to
drugs.
- (3) The manufacturer or authorized distributor of record of a drug subject
to subsection (b) of this section may, by means other than mail or common
carrier, distribute drug samples only if the manufacturer or authorized
distributor of record makes the distributions in accordance with subparagraph
(A) and carries out the activities described in subparagraphs (B) through (F) as
follows:
- (A) Drug samples may only be distributed -
- (i) to practitioners licensed to prescribe such drugs if they make a
written request for the drug samples, or
- (ii) at the written request of such a licensed practitioner, to pharmacies
of hospitals or other health care entities.
A written request for
drug samples shall be made on a form which contains the practitioner's name,
address, and professional designation, the identity of the drug sample
requested, the quantity of drug samples requested, the name of the manufacturer
or authorized distributor of record of the drug sample, the date of the request
and signature of the practitioner making the request.
- (B) Drug manufacturers or authorized distributors of record shall store
drug samples under conditions that will maintain their stability, integrity, and
effectiveness and will assure that the drug samples will be free of
contamination, deterioration, and adulteration.
- (C) Drug manufacturers or authorized distributors of record shall conduct,
at least annually, a complete and accurate inventory of all drug samples in the
possession of representatives of the manufacturer or authorized distributor of
record. Drug manufacturers or authorized distributors of record shall maintain
lists of the names and address of each of their representatives who distribute
drug samples and of the sites where drug samples are stored. Drug manufacturers
or authorized distributors of record shall maintain records for at least 3 years
of all drug samples distributed, destroyed, or returned to the manufacturer or
authorized distributor of record, of all inventories maintained under this
subparagraph, of all thefts or significant losses of drug samples, and of all
requests made under subparagraph (A) for drug samples. Records and lists
maintained under this subparagraph shall be made available by the drug
manufacturer or authorized distributor of record to the Secretary upon request.
- (D) Drug manufacturers or authorized distributors of record shall notify
the Secretary of any significant loss of drug samples and any known theft of
drug samples.
- (E) Drug manufacturers or authorized distributors of record shall report to
the Secretary any conviction of their representatives for violations of
subsection (c)(1) of this section or a State law because of the sale, purchase,
or trade of a drug sample or the offer to sell, purchase, or trade a drug
sample.
- (F) Drug manufacturers or authorized distributors of record shall provide
to the Secretary the name and telephone number of the individual responsible for
responding to a request for information respecting drug samples.
- (e) Wholesale distributors; guidelines for licensing; definitions
- (1)
- (A) Each person who is engaged in the wholesale distribution of a drug
subject to subsection (b) of this section and who is not the manufacturer or an
authorized distributor of record of such drug shall, before each wholesale
distribution of such drug (including each distribution to an authorized
distributor of record or to a retail pharmacy), provide to the person who
receives the drug a statement (in such form and containing such information as
the Secretary may require) identifying each prior sale, purchase, or trade of
such drug (including the date of the transaction and the names and addresses of
all parties to the transaction).
- (B) Each manufacturer of a drug subject to subsection (b) of this section
shall maintain at its corporate offices a current list of the authorized
distributors of record of such drug.
- (2)
- (A) No person may engage in the wholesale distribution in interstate
commerce of drugs subject to subsection (b) of this section in a State unless
such person is licensed by the State in accordance with the guidelines issued
under subparagraph (B).
- (B) The Secretary shall by regulation issue guidelines establishing minimum
standards, terms, and conditions for the licensing of persons to make wholesale
distributions in interstate commerce of drugs subject to subsection (b) of this
section. Such guidelines shall prescribe requirements for the storage and
handling of such drugs and for the establishment and maintenance of records of
the distributions of such drugs.
- (3) For the purposes of this subsection and subsection (d) of this section
-
- (A) the term ''authorized distributors of record'' means those distributors
with whom a manufacturer has established an ongoing relationship to distribute
such manufacturer's products, and
- (B) the term ''wholesale distribution'' means distribution of drugs subject
to subsection (b) of this section to other than the consumer or patient but does
not include intracompany sales and does not include distributions of drugs
described in subsection (c)(3)(B) of this section.
- (f) Veterinary prescription drugs
- (1)
- (A) A drug intended for use by animals other than man which -
- (i) because of its toxicity or other potentiality for harmful effect, or
the method of its use, or the collateral measures necessary for its use, is not
safe for animal use except under the professional supervision of a licensed
veterinarian, or
- (ii) is limited by an approved application under subsection (b) of section
360b of this title to use under the professional supervision of a licensed
veterinarian, shall be dispensed only by or upon the lawful written or oral
order of a licensed veterinarian in the course of the veterinarian's
professional practice.
- (B) For purposes of subparagraph (A), an order is lawful if the order -
- (i) is a prescription or other order authorized by law,
- (ii) is, if an oral order, promptly reduced to writing by the person
lawfully filling the order, and filed by that person, and
- (iii) is refilled only if authorized in the original order or in a
subsequent oral order promptly reduced to writing by the person lawfully filling
the order, and filed by that person.
- (C) The act of dispensing a drug contrary to the provisions of this
paragraph shall be deemed to be an act which results in the drug being
misbranded while held for sale.
- (2) Any drug when dispensed in accordance with paragraph (1) of this
subsection -
- (A) shall be exempt from the requirements of section 352 of this title,
except subsections (a), (g), (h), (i)(2), (i)(3), and (p) of such section, and
- (B) shall be exempt from the packaging requirements of subsections (g),
(h), and (p) of such section, if -
- (i) when dispensed by a licensed veterinarian, the drug bears a label
containing the name and address of the practitioner and any directions for use
and cautionary statements specified by the practitioner, or
- (ii) when dispensed by filling the lawful order of a licensed veterinarian,
the drug bears a label containing the name and address of the dispenser, the
serial number and date of the order or of its filling, the name of the licensed
veterinarian, and the directions for use and cautionary statements, if any,
contained in such order. The preceding sentence shall not apply to any drug
dispensed in the course of the conduct of a business of dispensing drugs
pursuant to diagnosis by mail.
- (3) The Secretary may by regulation exempt drugs for animals other than man
subject to section 360b of this title from the requirements of paragraph (1)
when such requirements are not necessary for the protection of the public
health.
- (4) A drug which is subject to paragraph (1) shall be deemed to be
misbranded if at any time prior to dispensing its label fails to bear the
statement ''Caution: Federal law restricts this drug to use by or on the order
of a licensed veterinarian.''. A drug to which paragraph (1) does not apply
shall be deemed to be misbranded if at any time prior to dispensing its label
bears the statement specified in the preceding sentence.
- (g) Regulation of combination products
- (1) The Secretary shall designate a component of the Food and Drug
Administration to regulate products that constitute a combination of a drug,
device, or biological product. The Secretary shall determine the primary mode of
action of the combination product. If the Secretary determines that the primary
mode of action is that of -
- (A) a drug (other than a biological product), the persons charged with
premarket review of drugs shall have primary jurisdiction,
- (B) a device, the persons charged with premarket review of devices shall
have primary jurisdiction, or
- (C) a biological product, the persons charged with premarket review of
biological products shall have primary jurisdiction.
- (2) Nothing in this subsection shall prevent the Secretary from using any
agency resources of the Food and Drug Administration necessary to ensure
adequate review of the safety, effectiveness, or substantial equivalence of an
article.
- (3) The Secretary shall promulgate regulations to implement market
clearance procedures in accordance with paragraphs (1) and (2) not later than 1
year after November 28, 1990.
- (4) As used in this subsection:
- (A) The term ''biological product'' has the meaning given the term in
section 262(a) of title 42.
- (B) The term ''market clearance'' includes -
- (i) approval of an application under section 355, 357, 360e, or 360j(g) of
this title,
- (ii) a finding of substantial equivalence under this part, and
- (iii) approval of a product or establishment license under subsection (a)
or (d) of section 262 of title 42.
§ 354. Repealed.
§ 354. Repealed. Pub. L. 86-618, title I, Sec. 103(a)(2), July 12,
1960, 74 Stat. 398
§ 355. New drugs.
- (a) Necessity of effective approval of application
No person shall introduce or deliver for introduction into interstate
commerce any new drug, unless an approval of an application filed pursuant to
subsection (b) or (j) of this section is effective with respect to such drug.
- (b) Filing application; contents
- (1) Any person may file with the Secretary an application with respect to
any drug subject to the provisions of subsection (a) of this section. Such
person shall submit to the Secretary as a part of the application
- (A) full reports of investigations which have been made to show whether or
not such drug is safe for use and whether such drug is effective in use;
- (B) a full list of the articles used as components of such drug;
- (C) a full statement of the composition of such drug;
- (D) a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of such drug;
- (E) such samples of such drug and of the articles used as components
thereof as the Secretary may require; and
- (F) specimens of the labeling proposed to be used for such drug. The
applicant shall file with the application the patent number and the expiration
date of any patent which claims the drug for which the applicant submitted the
application or which claims a method of using such drug and with respect to
which a claim of patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture, use, or sale of the drug.
If an application is filed under this subsection for a drug and a patent which
claims such drug or a method of using such drug is issued after the filing date
but before approval of the application, the applicant shall amend the
application to include the information required by the preceding sentence. Upon
approval of the application, the Secretary shall publish information submitted
under the two preceding sentences.
- (2) An application submitted under paragraph (1) for a drug for which the
investigations described in clause (A) of such paragraph and relied upon by the
applicant for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were conducted shall also
include -
- (A) a certification, in the opinion of the applicant and to the best of his
knowledge, with respect to each patent which claims the drug for which such
investigations were conducted or which claims a use for such drug for which the
applicant is seeking approval under this subsection and for which information is
required to be filed under paragraph (1) or subsection (c) of this section -
- (i) that such patent information has not been filed,
- (ii) that such patent has expired,
- (iii) of the date on which such patent will expire, or
- (iv) that such patent is invalid or will not be infringed by the
manufacture, use, or sale of the new drug for which the application is
submitted; and
- (B) if with respect to the drug for which investigations described in
paragraph (1)(A) were conducted information was filed under paragraph (1) or
subsection (c) of this section for a method of use patent which does not claim a
use for which the applicant is seeking approval under this subsection, a
statement that the method of use patent does not claim such a use.
- (3)
- (A) An applicant who makes a certification described in paragraph
(2)(A)(iv) shall include in the application a statement that the applicant will
give the notice required by subparagraph (B) to -
- (i) each owner of the patent which is the subject of the certification or
the representative of such owner designated to receive such notice, and
- (ii) the holder of the approved application under subsection (b) of this
section for the drug which is claimed by the patent or a use of which is claimed
by the patent or the representative of such holder designated to receive such
notice.
- (B) The notice referred to in subparagraph (A) shall state that an
application has been submitted under this subsection for the drug with respect
to which the certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of the drug before the expiration of the
patent referred to in the certification. Such notice shall include a detailed
statement of the factual and legal basis of the applicant's opinion that the
patent is not valid or will not be infringed.
- (C) If an application is amended to include a certification described in
paragraph (2)(A)(iv), the notice required by subparagraph (B) shall be given
when the amended application is submitted.
- (c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order
- (1) Within one hundred and eighty days after the filing of an application
under subsection (b) of this section, or such additional period as may be agreed
upon by the Secretary and the applicant, the Secretary shall either -
- (A) approve the application if he then finds that none of the grounds for
denying approval specified in subsection (d) of this section applies, or
- (B) give the applicant notice of an opportunity for a hearing before the
Secretary under subsection (d) of this section on the question whether such
application is approvable. If the applicant elects to accept the opportunity for
hearing by written request within thirty days after such notice, such hearing
shall commence not more than ninety days after the expiration of such thirty
days unless the Secretary and the applicant otherwise agree. Any such hearing
shall thereafter be conducted on an expedited basis and the Secretary's order
thereon shall be issued within ninety days after the date fixed by the Secretary
for filing final briefs.
- (2) If the patent information described in subsection (b) of this section
could not be filed with the submission of an application under subsection (b) of
this section because the application was filed before the patent information was
required under subsection (b) of this section or a patent was issued after the
application was approved under such subsection, the holder of an approved
application shall file with the Secretary the patent number and the expiration
date of any patent which claims the drug for which the application was submitted
or which claims a method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person not licensed by the
owner engaged in the manufacture, use, or sale of the drug. If the holder of an
approved application could not file patent information under subsection (b) of
this section because it was not required at the time the application was
approved, the holder shall file such information under this subsection not later
than thirty days after September 24, 1984, and if the holder of an approved
application could not file patent information under subsection (b) of this
section because no patent had been issued when an application was filed or
approved, the holder shall file such information under this subsection not later
than thirty days after the date the patent involved is issued. Upon the
submission of patent information under this subsection, the Secretary shall
publish it.
- (3) The approval of an application filed under subsection (b) of this
section which contains a certification required by paragraph (2) of such
subsection shall be made effective on the last applicable date determined under
the following:
- (A) If the applicant only made a certification described in clause (i) or
(ii) of subsection (b)(2)(A) of this section or in both such clauses, the
approval may be made effective immediately.
- (B) If the applicant made a certification described in clause (iii) of
subsection (b)(2)(A) of this section, the approval may be made effective on the
date certified under clause (iii).
- (C) If the applicant made a certification described in clause (iv) of
subsection (b)(2)(A) of this section, the approval shall be made effective
immediately unless an action is brought for infringement of a patent which is
the subject of the certification before the expiration of forty-five days from
the date the notice provided under paragraph (3)(B) is received. If such an
action is brought before the expiration of such days, the approval may be made
effective upon the expiration of the thirty-month period beginning on the date
of the receipt of the notice provided under paragraph (3)(B) or such shorter or
longer period as the court may order because either party to the action failed
to reasonably cooperate in expediting the action, except that -
- (i) if before the expiration of such period the court decides that such
patent is invalid or not infringed, the approval may be made effective on the
date of the court decision,
- (ii) if before the expiration of such period the court decides that such
patent has been infringed, the approval may be made effective on such date as
the court orders under section 271(e)(4)(A) of title 35, or
- (iii) if before the expiration of such period the court grants a
preliminary injunction prohibiting the applicant from engaging in the commercial
manufacture or sale of the drug until the court decides the issues of patent
validity and infringement and if the court decides that such patent is invalid
or not infringed, the approval shall be made effective on the date of such court
decision.
In such an action, each of the parties shall
reasonably cooperate in expediting the action. Until the expiration of
forty-five days from the date the notice made under paragraph (3)(B) is
received, no action may be brought under section 2201 of title 28 for a
declaratory judgment with respect to the patent. Any action brought under such
section 2201 shall be brought in the judicial district where the defendant has
its principal place of business or a regular and established place of business.
- (D)
- (i) If an application (other than an abbreviated new drug application)
submitted under subsection (b) of this section for a drug, no active ingredient
(including any ester or salt of the active ingredient) of which has been
approved in any other application under subsection (b) of this section, was
approved during the period beginning January 1, 1982, and ending on September
24, 1984, the Secretary may not make the approval of another application for a
drug for which the investigations described in clause (A) of subsection (b)(1)
of this section and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and for which the applicant has not
obtained a right of reference or use from the person by or for whom the
investigations were conducted effective before the expiration of ten years from
the date of the approval of the application previously approved under subsection
(b) of this section.
- (ii) If an application submitted under subsection (b) of this section for a
drug, no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application under subsection
(b) of this section, is approved after September 24, 1984, no application which
refers to the drug for which the subsection (b) application was submitted and
for which the investigations described in clause (A) of subsection (b)(1) of
this section and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and for which the applicant has not
obtained a right of reference or use from the person by or for whom the
investigations were conducted may be submitted under subsection (b) of this
section before the expiration of five years from the date of the approval of the
application under subsection (b) of this section, except that such an
application may be submitted under subsection (b) of this section after the
expiration of four years from the date of the approval of the subsection (b)
application if it contains a certification of patent invalidity or
noninfringement described in clause (iv) of subsection (b)(2)(A) of this
section. The approval of such an application shall be made effective in
accordance with this paragraph except that, if an action for patent infringement
is commenced during the one-year period beginning forty-eight months after the
date of the approval of the subsection (b) application, the thirty-month period
referred to in subparagraph (C) shall be extended by such amount of time (if
any) which is required for seven and one-half years to have elapsed from the
date of approval of the subsection (b) application.
- (iii) If an application submitted under subsection (b) of this section for
a drug, which includes an active ingredient (including any ester or salt of the
active ingredient) that has been approved in another application approved under
subsection (b) of this section, is approved after September 24, 1984, and if
such application contains reports of new clinical investigations (other than
bioavailability studies) essential to the approval of the application and
conducted or sponsored by the applicant, the Secretary may not make the approval
of an application submitted under subsection (b) of this section for the
conditions of approval of such drug in the approved subsection (b) application
effective before the expiration of three years from the date of the approval of
the application under subsection (b) of this section if the investigations
described in clause (A) of subsection (b)(1) of this section and relied upon by
the applicant for approval of the application were not conducted by or for the
applicant and if the applicant has not obtained a right of reference or use from
the person by or for whom the investigations were conducted.
- (iv) If a supplement to an application approved under subsection (b) of
this section is approved after September 24, 1984, and the supplement contains
reports of new clinical investigations (other than bioavailabilty (FOOTNOTE 1)
studies) essential to the approval of the supplement and conducted or sponsored
by the person submitting the supplement, the Secretary may not make the approval
of an application submitted under subsection (b) of this section for a change
approved in the supplement effective before the expiration of three years from
the date of the approval of the supplement under subsection (b) of this section
if the investigations described in clause (A) of subsection (b)(1) of this
section and relied upon by the applicant for approval of the application were
not conducted by or for the applicant and if the applicant has not obtained a
right of reference or use from the person by or for whom the investigations were
conducted. (FOOTNOTE 1) So in original. Probably should be
''bioavailability''.
- (v) If an application (or supplement to an application) submitted under
subsection (b) of this section for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient) that has been approved in
another application under subsection (b) of this section, was approved during
the period beginning January 1, 1982, and ending on September 24, 1984, the
Secretary may not make the approval of an application submitted under this
subsection and for which the investigations described in clause (A) of
subsection (b)(1) of this section and relied upon by the applicant for approval
of the application were not conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use from the person by or for
whom the investigations were conducted and which refers to the drug for which
the subsection (b) application was submitted effective before the expiration of
two years from September 24, 1984.
- (d) Grounds for refusing application; approval of application;
''substantial evidence'' defined
If the Secretary finds, after due notice to the applicant in accordance with
subsection (c) of this section and giving him an opportunity for a hearing, in
accordance with said subsection, that
- (1) the investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b) of this section, do not include
adequate tests by all methods reasonably applicable to show whether or not such
drug is safe for use under the conditions prescribed, recommended, or suggested
in the proposed labeling thereof;
- (2) the results of such tests show that such drug is unsafe for use under
such conditions or do not show that such drug is safe for use under such
conditions;
- (3) the methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are inadequate to preserve its
identity, strength, quality, and purity;
- (4) upon the basis of the information submitted to him as part of the
application, or upon the basis of any other information before him with respect
to such drug, he has insufficient information to determine whether such drug is
safe for use under such conditions; or
- (5) evaluated on the basis of the information submitted to him as part of
the application and any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have the effect it
purports or is represented to have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof; or
- (6) the application failed to contain the patent information prescribed by
subsection (b) of this section; or
- (7) based on a fair evaluation of all material facts, such labeling is
false or misleading in any particular; he shall issue an order refusing to
approve the application.
If, after such notice and opportunity for hearing, the Secretary finds that
clauses (1) through (6) do not apply, he shall issue an order approving the
application. As used in this subsection and subsection (e) of this section, the
term ''substantial evidence'' means evidence consisting of adequate and
well-controlled investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the effectiveness of
the drug involved, on the basis of which it could fairly and responsibly be
concluded by such experts that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof.
- (e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to public health
The Secretary shall, after due notice and opportunity for hearing to the
applicant, withdraw approval of an application with respect to any drug under
this section if the Secretary finds
- (1) that clinical or other experience, tests, or other scientific data
show that such drug is unsafe for use under the conditions of use upon the basis
of which the application was approved;
- (2) that new evidence of clinical experience, not contained in such
application or not available to the Secretary until after such application was
approved, or tests by new methods, or tests by methods not deemed reasonably
applicable when such application was approved, evaluated together with the
evidence available to the Secretary when the application was approved, shows
that such drug is not shown to be safe for use under the conditions of use upon
the basis of which the application was approved; or
- (3) on the basis of new information before him with respect to such drug,
evaluated together with the evidence available to him when the application was
approved, that there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling thereof; or
- (4) the patent information prescribed by subsection (c) of this section was
not filed within thirty days after the receipt of written notice from the
Secretary specifying the failure to file such information; or
- (5) that the application contains any untrue statement of a material fact:
Provided, That if the Secretary (or in his absence the officer acting as
Secretary) finds that there is an imminent hazard to the public health, he may
suspend the approval of such application immediately, and give the applicant
prompt notice of his action and afford the applicant the opportunity for an
expedited hearing under this subsection; but the authority conferred by this
proviso to suspend the approval of an application shall not be delegated.
The Secretary may also, after due notice and opportunity for hearing to the
applicant, withdraw the approval of an application submitted under subsection
(b) or (j) of this section with respect to any drug under this section if the
Secretary finds (1) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed to
maintain such records or to make required reports, in accordance with a
regulation or order under subsection (k) of this section or to comply with the
notice requirements of section 360(k)(2) of this title, or the applicant has
refused to permit access to, or copying or verification of, such records as
required by paragraph (2) of such subsection; or (2) that on the basis of new
information before him, evaluated together with the evidence before him when the
application was approved, the methods used in, or the facilities and controls
used for, the manufacture, processing, and packing of such drug are inadequate
to assure and preserve its identity, strength, quality, and purity and were not
made adequate within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of; or (3) that on the basis of new
information before him, evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on a fair evaluation
of all material facts, is false or misleading in any particular and was not
corrected within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of. Any order under this subsection
shall state the findings upon which it is based.
- (f) Revocation of order refusing, withdrawing or suspending
approval of application
Whenever the Secretary finds that the facts so require, he shall revoke any
previous order under subsection (d) or (e) of this section refusing,
withdrawing, or suspending approval of an application and shall approve such
application or reinstate such approval, as may be appropriate.
Orders of the Secretary issued under this section shall be served
- (1) in person by any officer or employee of the department designated
by the Secretary or
- (2) by mailing the order by registered mail or by certified mail addressed
to the applicant or respondent at his last-known address in the records of the
Secretary.
An appeal may be taken by the applicant from an order of the Secretary
refusing or withdrawing approval of an application under this section. Such
appeal shall be taken by filing in the United States court of appeals or the
circuit wherein such applicant resides or has his principal place of business,
or in the United States Court of Appeals for the District of Columbia Circuit,
within sixty days after the entry of such order, a written petition praying that
the order of the Secretary be set aside. A copy of such petition shall be
forthwith transmitted by the clerk of the court to the Secretary, or any officer
designated by him for that purpose, and thereupon the Secretary shall certify
and file in the court the record upon which the order complained of was entered,
as provided in section 2112 of title 28. Upon the filing of such petition such
court shall have exclusive jurisdiction to affirm or set aside such order,
except that until the filing of the record the Secretary may modify or set aside
his order. No objection to the order of the Secretary shall be considered by the
court unless such objection shall have been urged before the Secretary or unless
there were reasonable grounds for failure so to do. The finding of the Secretary
as to the facts, if supported by substantial evidence, shall be conclusive. If
any person shall apply to the court for leave to adduce additional evidence, and
shall show to the satisfaction of the court that such additional evidence is
material and that there were reasonable grounds for failure to adduce such
evidence in the proceeding before the Secretary, the court may order such
additional evidence to be taken before the Secretary and to be adduced upon the
hearing in such manner and upon such terms and conditions as to the court may
seem proper. The Secretary may modify his findings as to the facts by reason of
the additional evidence so taken, and he shall file with the court such modified
findings which, if supported by substantial evidence, shall be conclusive, and
his recommendation, if any, for the setting aside of the original order. The
judgment of the court affirming or setting aside any such order of the Secretary
shall be final, subject to review by the Supreme Court of the United States upon
certiorari or certification as provided in section 1254 of title 28. The
commencement of proceedings under this subsection shall not, unless specifically
ordered by the court to the contrary, operate as a stay of the Secretary's
order.
- (i) Exemptions of drugs for research; discretionary and mandatory
conditions; direct reports to Secretary
The Secretary shall promulgate regulations for exempting from the operation
of the foregoing subsections of this section drugs intended solely for
investigational use by experts qualified by scientific training and experience
to investigate the safety and effectiveness of drugs. Such regulations may,
within the discretion of the Secretary, among other conditions relating to the
protection of the public health, provide for conditioning such exemption upon -
- (1) the submission to the Secretary, before any clinical testing of a
new drug is undertaken, of reports, by the manufacturer or the sponsor of the
investigation of such drug, of preclinical tests (including tests on animals) of
such drug adequate to justify the proposed clinical testing;
- (2) the manufacturer or the sponsor of the investigation of a new drug
proposed to be distributed to investigators for clinical testing obtaining a
signed agreement from each of such investigators that patients to whom the drug
is administered will be under his personal supervision, or under the supervision
of investigators responsible to him, and that he will not supply such drug to
any other investigator, or to clinics, for administration to human beings; and
- (3) the establishment and maintenance of such records, and the making of
such reports to the Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not limited to analytical
reports by investigators) obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to evaluate the safety and
effectiveness of such drug in the event of the filing of an application pursuant
to subsection (b) of this section.
Such regulations shall provide that such exemption shall be conditioned upon
the manufacturer, or the sponsor of the investigation, requiring that experts
using such drugs for investigational purposes certify to such manufacturer or
sponsor that they will inform any human beings to whom such drugs, or any
controls used in connection therewith, are being administered, or their
representatives, that such drugs are being used for investigational purposes and
will obtain the consent of such human beings or their representatives, except
where they deem it not feasible or, in their professional judgment, contrary to
the best interests of such human beings. Nothing in this subsection shall be
construed to require any clinical investigator to submit directly to the
Secretary reports on the investigational use of drugs.
- (j) Abbreviated new drug applications
- (k) Records and reports; required information; regulations and
orders; access to records
- (1) In the case of any drug for which an approval of an application filed
under subsection (b) or (j) of this section is in effect, the applicant shall
establish and maintain such records, and make such reports to the Secretary, of
data relating to clinical experience and other data or information, received or
otherwise obtained by such applicant with respect to such drug, as the Secretary
may by general regulation, or by order with respect to such application,
prescribe on the basis of a finding that such records and reports are necessary
in order to enable the Secretary to determine, or facilitate a determination,
whether there is or may be ground for invoking subsection (e) of this section.
Regulations and orders issued under this subsection and under subsection (i) of
this section shall have due regard for the professional ethics of the medical
profession and the interests of patients and shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request, by the persons to
whom such regulations or orders are applicable, of similar information received
or otherwise obtained by the Secretary.
- (2) Every person required under this section to maintain records, and every
person in charge or custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or employee at all
reasonable times to have access to and copy and verify such records.
- (l) Public disclosure of safety and effectiveness data
Safety and effectiveness data and information which has been submitted in an
application under subsection (b) of this section for a drug and which has not
previously been disclosed to the public shall be made available to the public,
upon request, unless extraordinary circumstances are shown -
- (1) if no work is being or will be undertaken to have the application
approved,
- (2) if the Secretary has determined that the application is not approvable
and all legal appeals have been exhausted,
- (3) if approval of the application under subsection (c) of this section is
withdrawn and all legal appeals have been exhausted,
- (4) if the Secretary has determined that such drug is not a new drug, or
- (5) upon the effective date of the approval of the first application under
subsection (j) of this section which refers to such drug or upon the date upon
which the approval of an application under subsection (j) of this section which
refers to such drug could be made effective if such an application had been
submitted.
For purposes of this section, the term ''patent'' means a patent issued by
the Patent and Trademark Office of the Department of Commerce.
§ 356. Certification of drugs containing insulin.
- (a) Standards for certification
The Secretary, pursuant to regulations promulgated by him, shall provide for
the certification of batches of drugs composed wholly or partly of insulin. A
batch of any such drug shall be certified if such drug has such characteristics
of identity and such batch has such characteristics of strength, quality, and
purity, as the Secretary prescribes in such regulations as necessary to
adequately insure safety and efficacy of use, but shall not otherwise be
certified. Prior to the effective date of such regulations the Secretary, in
lieu of certification, shall issue a release for any batch which, in his
judgment, may be released without risk as to the safety and efficacy of its use.
Such release shall prescribe the date of its expiration and other conditions
under which it shall cease to be effective as to such batch and as to portions
thereof.
Regulations providing for such certification shall contain such provisions
as are necessary to carry out the purposes of this section, including provisions
prescribing (1) standards of identity and of strength, quality, and purity; (2)
tests and methods of assay to determine compliance with such standards; (3)
effective periods for certificates, and other conditions under which they shall
cease to be effective as to certified batches and as to portions thereof; (4)
administration and procedure; and (5) such fees, specified in such regulations,
as are necessary to provide, equip, and maintain an adequate certification
service. Such regulations shall prescribe no standard of identity or of
strength, quality, or purity for any drug different from the standard of
identity, strength, quality, or purity set forth for such drug in an official
compendium.
- (c) Tests or methods of assay; revision
Such regulations, insofar as they prescribe tests or methods of assay to
determine strength, quality, or purity of any drug, different from the tests or
methods of assay set forth for such drug in an official compendium, shall be
prescribed, after notice and opportunity for revision of such compendium, in the
manner provided in the second sentence of section 351(b) of this title. The
provisions of subsections (e), (f), and (g) of section 371 of this title shall
be applicable to such portion of any regulation as prescribes any such different
test or method, but shall not be applicable to any other portion of any such
regulation.
§ 357. Certification of drugs containing penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug.
- (a) Regulations prescribed by Secretary; release prior to
certification; ''antibiotic drug'' defined
The Secretary, pursuant to regulations promulgated by him, shall provide for
the certification of batches of drugs (except drugs for use in animals other
than man) composed wholly or partly of any kind of penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or
any derivative thereof. A batch of any such drug shall be certified if such drug
has such characteristics of identity and such batch has such characteristics of
strength, quality, and purity, as the Secretary prescribes in such regulations
as necessary to adequately insure safety and efficacy of use, but shall not
otherwise be certified. Prior to the effective date of such regulations the
Secretary, in lieu of certification, shall issue a release for any batch which,
in his judgment, may be released without risk as to the safety and efficacy of
its use. Such release shall prescribe the date of its expiration and other
conditions under which it shall cease to be effective as to such batch and as to
portions thereof. For purposes of this section and of section 352(l) of this
title, the term ''antibiotic drug'' means any drug intended for use by man
containing any quantity of any chemical substance which is produced by a
microorganism and which has the capacity to inhibit or destroy microorganisms in
dilute solution (including the chemically synthesized equivalent of any such
substance).
- (b) Provisions of regulations
Regulations providing for such certifications shall contain such provisions
as are necessary to carry out the purposes of this section, including provisions
prescribing (1) standards of identity and of strength, quality, and purity; (2)
tests and methods of assay to determine compliance with such standards; (3)
effective periods for certificates, and other conditions under which they shall
cease to be effective as to certified batches and as to portions thereof; (4)
administration and procedure; and (5) such fees, specified in such regulations,
as are necessary to provide, equip, and maintain an adequate certification
service. Such regulations shall prescribe only such tests and methods of assay
as will provide for certification or rejection within the shortest time
consistent with the purposes of this section.
- (c) Exemption of drugs not involving safety and efficacy of use;
considerations; certification after exemption; labeling and advertising claims
Whenever in the judgment of the Administrator, (FOOTNOTE 1) the requirements
of this section and of section 352(l) of this title with respect to any drug or
class of drugs are not necessary to insure safety and efficacy of use, the
Administrator (FOOTNOTE 1) shall promulgate regulations exempting such drug or
class of drugs from such requirements. In deciding whether an antibiotic drug,
or class of antibiotic drugs, is to be exempted from the requirement of
certification the Secretary shall give consideration, among other relevant
factors, to - (FOOTNOTE 1) See Transfer of Functions note below.
- (1) whether such drug or class of drugs is manufactured by a person
who has, or hereafter shall have, produced fifty consecutive batches of such
drug or class of drugs in compliance with the regulations for the certification
thereof within a period of not more than eighteen calendar months, upon the
application by such person to the Secretary; or
- (2) whether such drug or class of drugs is manufactured by any person who
has otherwise demonstrated such consistency in the production of such drug or
class of drugs, in compliance with the regulations for the certification
thereof, as in the judgment of the Secretary is adequate to insure the safety
and efficacy of use thereof.
When an antibiotic drug or a drug manufacturer has been exempted from the
requirement of certification, the manufacturer may still obtain certification of
a batch or batches of that drug if he applies for and meets the requirements for
certification. Nothing in this chapter shall be deemed to prevent a manufacturer
or distributor of an antibiotic drug from making a truthful statement in
labeling or advertising of the product as to whether it has been certified or
exempted from the requirement of certification.
- (d) Exemption of drugs stored, processed, and labeled at plants
other than manufacturer's, used in manufacture of other drugs or for
investigational purposes; discretionary and mandatory conditions; direct reports
to Secretary
The Administrator (FOOTNOTE 1) shall promulgate regulations exempting from
any requirement of this section and of section 352(l) of this title, (1) drugs
which are to be stored, processed, labeled, or repacked at establishments other
than those where manufactured, on condition that such drugs comply with all such
requirements upon removal from such establishments; (2) drugs which conform to
applicable standards of identity, strength, quality, and purity prescribed by
these regulations and are intended for use in manufacturing other drugs; and (3)
drugs which are intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and efficacy of
drugs. Such regulations may, within the discretion of the Secretary, among other
conditions relating to the protection of the public health, provide for
conditioning the exemption under clause (3) of this subsection upon -
- (1) the submission to the Secretary, before any clinical testing of a
new drug is undertaken, of reports, by the manufacturer or the sponsor of the
investigation of such drug, of preclinical tests (including tests on animals) of
such drug adequate to justify the proposed clinical testing;
- (2) the manufacturer or the sponsor of the investigation of a new drug
proposed to be distributed to investigators for clinical testing obtaining a
signed agreement from each of such investigators that patients to whom the drug
is administered will be under his personal supervision, or under the supervision
of investigators responsible to him, and that he will not supply such drug to
any other investigator, or to clinics, for administration to human beings; and
- (3) the establishment and maintenance of such records, and the making of
such reports to the Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not limited to analytical
reports by investigators) obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to evaluate the safety and
effectiveness of such drug in the event of the filing of an application for
certification or release pursuant to subsection (a) of this section.
Such regulations shall provide that such exemption shall be conditioned
upon the manufacturer, or the sponsor of the investigation, requiring that
experts using such drugs for investigational purposes certify to such
manufacturer or sponsor that they will inform any human beings to whom such
drugs, or any controls used in connection therewith, are being administered, or
their representatives, that such drugs are being used for investigational
purposes and will obtain the consent of such human beings or their
representatives, except where they deem it not feasible or, in their
professional judgment, contrary to the best interests of such human beings.
Nothing in this subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the investigational
use of drugs.
- (e) Exempted new drugs subject to section 355 of this title;
request for certification of exempted drug; determination of compliance with
sections 351(b) and 352(g) of this title
No drug which is subject to this section shall be deemed to be subject to
any provision of section 355 of this title except a new drug exempted from the
requirements of this section and of section 352(l) of this title pursuant to
regulations promulgated by the Secretary. For purposes of section 355 of this
title, the initial request for certification, as thereafter duly amended,
pursuant to this section, of a new drug so exempted shall be considered a part
of the application filed pursuant to section 355(b) of this title with respect
to the person filing such request and to such drug as of the date of the
exemption. Compliance of any drug subject to section 352(l) of this title or
this section with sections 351(b) and 352(g) of this title shall be determined
by the application of the standards of strength, quality, and purity, the tests
and methods of assay, and the requirements of packaging and labeling,
respectively, prescribed by regulations promulgated under this section.
- (f) Filing of petitions; contents; notice; answer; public hearing;
orders
Any interested person may file with the Administrator (FOOTNOTE 2) a
petition proposing the issuance, amendment, or repeal of any regulation
contemplated by this section. The petition shall set forth the proposal in
general terms and shall state reasonable grounds therefor. The Administrator
(FOOTNOTE 2) shall give public notice of the proposal and an opportunity for all
interested persons to present their views thereon, orally or in writing, and as
soon as practicable thereafter shall make public his action upon such proposal.
At any time prior to the thirtieth day after such action is made public any
interested person may file objections to such action, specifying with
particularity the changes desired, stating reasonable grounds therefor, and
requesting a public hearing upon such objections. The Administrator (FOOTNOTE 2)
shall thereupon, after due notice, hold such public hearing. As soon as
practicable after completion of the hearing, the Administrator (FOOTNOTE 2)
shall by order make public his action on such objections. The Administrator
(FOOTNOTE 2) shall base his order only on substantial evidence of record at the
hearing and shall set forth as part of the order detailed findings of fact on
which the order is based. The order shall be subject to the provisions of
section 371(f) and (g) of this title. (FOOTNOTE 2) See Transfer of Functions
note below.
- (g) Records and reports; professional ethics and interests of
patients; examination of data; access to records
- (1) Every person engaged in manufacturing, compounding, or processing any
drug within the purview of this section with respect to which a certificate or
release has been issued pursuant to this section shall establish and maintain
such records, and make such reports to the Secretary, of data relating to
clinical experience and other data or information, received or otherwise
obtained by such person with respect to such drug, as the Secretary may by
general regulation, or by order with respect to such certification or release,
prescribe on the basis of a finding that such records and reports are necessary
in order to enable the Secretary to make, or to facilitate, a determination as
to whether such certification or release should be rescinded or whether any
regulation issued under this section should be amended or repealed. Regulations
and orders issued under this subsection and under clause (3) of subsection (d)
of this section shall have due regard for the professional ethics of the medical
profession and the interests of patients and shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request, by the persons to
whom such regulations or orders are applicable, of similar information received
or otherwise obtained by the Secretary.
- (2) Every person required under this section to maintain records, and every
person having charge or custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or employee at all
reasonable times to have access to and copy and verify such records.
- (h) Issuance of regulations; conditions; amendment or repeal of
regulations; effective date; procedure; lack of substantial evidence
In the case of a drug for which, on the day immediately preceding May 1,
1963, a prior approval of an application under section 355 of this title had not
been withdrawn under section 355(e) of this title, the initial issuance of
regulations providing for certification or exemption of such drug under this
section shall, with respect to the conditions of use prescribed, recommended, or
suggested in the labeling covered by such application, not be conditioned upon
an affirmative finding of the efficacy of such drug. Any subsequent amendment or
repeal of such regulations so as no longer to provide for such certification or
exemption on the ground of a lack of efficacy of such drug for use under such
conditions of use may be effected only on or after May 1, 1963, which would be
applicable to such drug under such conditions of use if such drug were subject
to section 355(e) of this title, and then only if (1) such amendment or repeal
is made in accordance with the procedure specified in subsection (f) of this
section (except that such amendment or repeal may be initiated either by a
proposal of the Secretary or by a petition of any interested person) and (2) the
Secretary finds, on the basis of new information with respect to such drug
evaluated together with the information before him when the application under
section 355 of this title became effective or was approved, that there is a lack
of substantial evidence (as defined in section 355(d) of this title) that the
drug has the effect it purports or is represented to have under such conditions
of use.
§ 358. Authority to designate official names.
- (a) Necessity or desirability; use in official compendiums;
infringement of trademarks
The Secretary may designate an official name for any drug or device if he
determines that such action is necessary or desirable in the interest of
usefulness and simplicity. Any official name designated under this section for
any drug or device shall be the only official name of that drug or device used
in any official compendium published after such name has been prescribed or for
any other purpose of this chapter. In no event, however, shall the Secretary
establish an official na |
