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U.S. Code as of:
01/19/04
Section 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) 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
(B) 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
section 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) A drug that is subject to paragraph (1) shall be deemed to
be misbranded if at any time prior to dispensing the label of the
drug fails to bear, at a minimum, the symbol "Rx only".
(B) A drug to which paragraph (1) does not apply shall be deemed
to be misbranded if at any time prior to dispensing the label of
the drug bears the symbol described in subparagraph (A).
(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, other
than a veterinary feed directive drug intended for use in animal
feed or an animal feed bearing or containing a veterinary feed
directive drug, 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 in accordance with this subsection assign
an agency center 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 agency center
charged with premarket review of drugs shall have primary
jurisdiction,
(B) a device, the agency center charged with premarket review
of devices shall have primary jurisdiction, or
(C) a biological product, the agency center 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)(A) Not later than 60 days after October 26, 2002, the
Secretary shall establish within the Office of the Commissioner of
Food and Drugs an office to ensure the prompt assignment of
combination products to agency centers, the timely and effective
premarket review of such products, and consistent and appropriate
postmarket regulation of like products subject to the same
statutory requirements to the extent permitted by law.
Additionally, the office shall, in determining whether a product is
to be designated a combination product, consult with the component
within the Office of the Commissioner of Food and Drugs that is
responsible for such determinations. Such office (referred to in
this paragraph as the "Office") shall have appropriate scientific
and medical expertise, and shall be headed by a director.
(B) In carrying out this subsection, the Office shall, for each
combination product, promptly assign an agency center with primary
jurisdiction in accordance with paragraph (1) for the premarket
review of such product.
(C)(i) In carrying out this subsection, the Office shall ensure
timely and effective premarket reviews by overseeing the timeliness
of and coordinating reviews involving more than one agency center.
(ii) In order to ensure the timeliness of the premarket review of
a combination product, the agency center with primary jurisdiction
for the product, and the consulting agency center, shall be
responsible to the Office with respect to the timeliness of the
premarket review.
(D) In carrying out this subsection, the Office shall ensure the
consistency and appropriateness of postmarket regulation of like
products subject to the same statutory requirements to the extent
permitted by law.
(E)(i) Any dispute regarding the timeliness of the premarket
review of a combination product may be presented to the Office for
resolution, unless the dispute is clearly premature.
(ii) During the review process, any dispute regarding the
substance of the premarket review may be presented to the
Commissioner of Food and Drugs after first being considered by the
agency center with primary jurisdiction of the premarket review,
under the scientific dispute resolution procedures for such center.
The Commissioner of Food and Drugs shall consult with the Director
of the Office in resolving the substantive dispute.
(F) The Secretary, acting through the Office, shall review each
agreement, guidance, or practice of the Secretary that is specific
to the assignment of combination products to agency centers and
shall determine whether the agreement, guidance, or practice is
consistent with the requirements of this subsection. In carrying
out such review, the Secretary shall consult with stakeholders and
the directors of the agency centers. After such consultation, the
Secretary shall determine whether to continue in effect, modify,
revise, or eliminate such agreement, guidance, or practice, and
shall publish in the Federal Register a notice of the availability
of such modified or revised agreement, guidance or practice.
Nothing in this paragraph shall be construed as preventing the
Secretary from following each agreement, guidance, or practice
until continued, modified, revised, or eliminated.
(G) Not later than one year after October 26, 2002, and annually
thereafter, the Secretary shall report to the appropriate
committees of Congress on the activities and impact of the Office.
The report shall include provisions -
(i) describing the numbers and types of combination products
under review and the timeliness in days of such assignments,
reviews, and dispute resolutions;
(ii) identifying the number of premarket reviews of such
products that involved a consulting agency center; and
(iii) describing improvements in the consistency of postmarket
regulation of combination products.
(H) Nothing in this paragraph shall be construed to limit the
regulatory authority of any agency center.
(5) As used in this subsection:
(A) The term "agency center" means a center or alternative
organizational component of the Food and Drug Administration.
(B) The term "biological product" has the meaning given the
term in section 262(i) of title 42.
(C) The term "market clearance" includes -
(i) approval of an application under section 355, 357,(!1)
360e, or 360j(g) of this title,
(ii) a finding of substantial equivalence under this part,
and
(iii) approval of a biologics license application under
subsection (a) of section 262 of title 42.
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