All Agencies, Latest Month All Agencies, Current FY Geographic Distribution
of Convictions for
All Agencies, FY 2014
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4 Prosecutions
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Conviction Report
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1 Conviction
in Fiscal Year 2014

CITE

    21 USC Sec. 353                                             01/05/2009

EXPCITE

    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

HEAD

    Sec. 353. Exemptions and consideration for certain drugs, devices,
      and biological products

STATUTE

    (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, a conditionally-approved
      application under section 360ccc of this title, or an index
      listing under section 360ccc-1 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, 360ccc, or 360ccc-1 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.

SOURCE

    (June 25, 1938, ch. 675, Sec. 503, 52 Stat. 1051; Oct. 26, 1951,
    ch. 578, Sec. 1, 65 Stat. 648; Pub. L. 87-781, title I, Sec.
    104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91-601, Sec. 6(e),
    formerly Sec. 7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
    L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
    Pub. L. 100-293, Secs. 4-6, Apr. 22, 1988, 102 Stat. 96-98; Pub. L.
    100-670, title I, Sec. 105, Nov. 16, 1988, 102 Stat. 3983; Pub. L.
    101-629, Sec. 16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-
    108, Sec. 2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102-300,
    Sec. 6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102-353, Secs.
    2(a)-(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104-250,
    Sec. 5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105-115, title I,
    Secs. 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324,
    2327, 2328; Pub. L. 107-250, title II, Sec. 204, Oct. 26, 2002, 116
    Stat. 1611; Pub. L. 108-282, title I, Sec. 102(b)(5)(F), Aug. 2,
    2004, 118 Stat. 903.)

REFERENCES IN TEXT

      Section 357 of this title, referred to in subsec. (g)(5)(C)(i),
    was repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,
    1997, 111 Stat. 2325.

CODIFICATION

      In subsec. (b)(5), "sections 4721, 6001, and 6151 of title 26"
    and "section 4761 of title 26" substituted for "section 3220 of the
    Internal Revenue Code (26 U.S.C. 3220)" and "section 3238(b) of the
    Internal Revenue Code (26 U.S.C. 3238(b))", respectively, on
    authority of section 7852(b) of Title 26, Internal Revenue Code.

AMENDMENTS

      2004 - Subsec. (f)(1)(A)(ii). Pub. L. 108-282, Sec.
    102(b)(5)(F)(i), substituted "360b of this title, a conditionally-
    approved application under section 360ccc of this title, or an
    index listing under section 360ccc-1 of this title" for "360b of
    this title".
      Subsec. (f)(3). Pub. L. 108-282, Sec. 102(b)(5)(F)(ii),
    substituted "section 360b, 360ccc, or 360ccc-1" for "section 360b".
      2002 - Subsec. (g)(1). Pub. L. 107-250, Sec. 204(1)(A),
    substituted "shall in accordance with this subsection assign an
    agency center" for "shall designate a component of the Food and
    Drug Administration" in first sentence of introductory provisions.
      Subsec. (g)(1)(A) to (C). Pub. L. 107-250, Sec. 204(1)(B),
    substituted "the agency center charged" for "the persons charged".
      Subsec. (g)(4). Pub. L. 107-250, Sec. 204(3), added par. (4).
    Former par. (4) redesignated (5).
      Subsec. (g)(5). Pub. L. 107-250, Sec. 204(2), (4), redesignated
    par. (4) as (5), added subpar. (A), and redesignated former
    subpars. (A) and (B) as (B) and (C), respectively.
      1997 - Subsec. (b)(1)(A) to (C). Pub. L. 105-115, Sec. 126(c)(1),
    redesignated subpars. (B) and (C) as (A) and (B), respectively, and
    struck out former subpar. (A), which read as follows: "is a habit-
    forming drug to which section 352(d) of this title applies; or".
      Subsec. (b)(3). Pub. L. 105-115, Sec. 126(c)(2), struck out
    reference to section 352(d) of this title before "355".
      Subsec. (b)(4). Pub. L. 105-115, Sec. 126(a), amended par. (4)
    generally. Prior to amendment, par. (4) read as follows: "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."
      Subsec. (g)(4)(A). Pub. L. 105-115, Sec. 123(e)(1), substituted
    "section 262(i) of title 42" for "section 262(a) of title 42".
      Subsec. (g)(4)(B)(iii). Pub. L. 105-115, Sec. 123(e)(2),
    substituted "biologics license application under subsection (a)"
    for "product or establishment license under subsection (a) or (d)".
      1996 - Subsec. (f)(1)(A). Pub. L. 104-250 inserted ", 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," after "other than man" in introductory provisions.
      1992 - Subsec. (d)(1). Pub. L. 102-353, Sec. 4(1), amended par.
    (1) generally. Prior to amendment, par. (1) read as follows:
    "Except as provided in paragraphs (2) and (3), no representative of
    a drug manufacturer or distributor may distribute any drug sample."
      Subsec. (d)(2). Pub. L. 102-353, Sec. 4(2), substituted
    "authorized distributor of record" for "distributor" wherever
    appearing.
      Subsec. (d)(3). Pub. L. 102-353, Sec. 4(2), substituted
    "authorized distributor of record" for "distributor" and
    "authorized distributors of record" for "distributors" wherever
    appearing.
      Subsec. (e)(1). Pub. L. 102-353, Sec. 4(3), amended par. (1)
    generally. Prior to amendment, par. (1) read as follows: "Each
    person who is engaged in the wholesale distribution of drugs
    subject to subsection (b) of this section and who is not an
    authorized distributor of record of such drugs shall provide to
    each wholesale distributor of such drugs a statement identifying
    each sale of the drug (including the date of the sale) before the
    sale to such wholesale distributor. Each manufacturer shall
    maintain at its corporate offices a current list of such authorized
    distributors."
      Subsec. (e)(2)(A). Pub. L. 102-353, Sec. 2(a), (d), temporarily
    inserted "or has registered with the Secretary in accordance with
    paragraph (3)". See Termination Date of 1992 Amendment note below.
      Subsec. (e)(3). Pub. L. 102-353, Sec. 2(b), (d), temporarily
    added par. (3). Former par. (3) redesignated (4). See Termination
    Date of 1992 Amendment note below.
      Subsec. (e)(4). Pub. L. 102-353, Sec. 4(4), inserted "and
    subsection (d) of this section" after "For the purposes of this
    subsection".
      Pub. L. 102-353, Sec. 2(b), (d), temporarily redesignated par.
    (3) as (4). See Termination Date of 1992 Amendment note below.
      Subsec. (f)(1)(B). Pub. L. 102-353, Sec. 2(c), which directed the
    substitution of "an order" for "and order", could not be executed
    because "and order" did not appear in subpar. (B).
      Subsec. (g)(3). Pub. L. 102-300 substituted "clearance" for
    "approval".
      1991 - Subsec. (c). Pub. L. 102-108, Sec. 2(d)(3), redesignated
    subsec. (c), relating to veterinary prescription drugs, as (f).
    Former subsec. (f) redesignated (g).
      Subsec. (c)(2), (3)(B)(v). Pub. L. 102-108, Sec. 2(d)(1), made
    technical amendment to reference to subsection (b) of this section
    involving corresponding provision of original act.
      Subsec. (d)(3)(E). Pub. L. 102-108, Sec. 2(d)(2), made technical
    amendment to reference to subsection (c)(1) of this section
    involving corresponding provision of original act.
      Subsec. (f). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
    (f), relating to regulation of combination products, as (g).
      Pub. L. 102-108, Sec. 2(d)(3), redesignated subsec. (c), relating
    to veterinary prescription drugs, as (f).
      Subsec. (g). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
    (f), relating to regulation of combination products, as (g).
      1990 - Pub. L. 101-629, Sec. 16(a)(1), substituted "Exemptions
    and consideration for certain drugs, devices, and biological
    products" for "Exemptions in case of drugs and devices" in section
    catchline.
      Subsec. (f). Pub. L. 101-629, Sec. 16(a)(2), added subsec. (f).
      1988 - Subsec. (c). Pub. L. 100-670 added subsec. (c) relating to
    veterinary prescription drugs.
      Pub. L. 100-293, Sec. 4, added subsec. (c) relating to sales
    restrictions.
      Subsec. (d). Pub. L. 100-293, Sec. 5, added subsec. (d).
      Subsec. (e). Pub. L. 100-293, Sec. 6, added subsec. (e).
      1970 - Subsec. (b)(2). Pub. L. 91-601 included exemption from
    packaging requirements of subsec. (p) of section 352 of this title.
      1962 - Subsec. (b)(1)(C). Pub. L. 87-781 substituted "approved"
    for "effective".
      1951 - Subsec. (b). Act Oct. 26, 1951, amended subsec. (b)
    generally to protect the public from abuses in the sale of potent
    prescription drugs, and to relieve retail pharmacists and the
    public from unnecessary restrictions on the dispensation of drugs
    that are safe to use without supervision of a doctor.
                     EFFECTIVE DATE OF 1997 AMENDMENT
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.
                    TERMINATION DATE OF 1992 AMENDMENT
      Section 2(d) of Pub. L. 102-353 provided that: "Effective
    September 14, 1994, the amendments made by subsections (a) and (b)
    [amending this section] shall no longer be in effect."
                     EFFECTIVE DATE OF 1988 AMENDMENT
      Section 8 of Pub. L. 100-293 provided that:
      "(a) General Rule. - Except as provided in subsection (b), this
    Act and the amendments made by this Act [amending this section and
    sections 331, 333, and 381 of this title and enacting provisions
    set out as notes under this section and section 301 of this title]
    shall take effect upon the expiration of 90 days after the date of
    the enactment of this Act [Apr. 22, 1988].
      "(b) Exception. -
        "(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take
      effect upon the expiration of 180 days after the date of the
      enactment of this Act [Apr. 22, 1988].
        "(2) The Secretary of Health and Human Services shall by
      regulation issue the guidelines required by section 503(e)(2)(B)
      of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
      353(e)(2)(B)] (as added by section 6 of this Act) not later than
      180 days after the date of the enactment of this Act. Section
      503(e)(2)(A) of such Act shall take effect upon the expiration of
      2 years after the date such regulations are promulgated and take
      effect."
                     EFFECTIVE DATE OF 1970 AMENDMENT
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.
                     EFFECTIVE DATE OF 1962 AMENDMENT
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    107 of Pub. L. 87-781, set out as a note under section 321 of this
    title.
                     EFFECTIVE DATE OF 1951 AMENDMENT
      Amendment by act Oct. 26, 1951, effective six months after Oct.
    26, 1951, see section 3 of act Oct. 26, 1951, set out as a note
    under section 333 of this title.

TRANSFER OF FUNCTIONS

      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

EFFECTIVE MEDICATION GUIDES

      Pub. L. 104-180, title VI, Sec. 601, Aug. 6, 1996, 110 Stat.
    1593, provided that:
      "(a) In General. - Not later than 30 days after the date of
    enactment of this Act [Aug. 6, 1996], the Secretary of the
    Department of Health and Human Services shall request that national
    organizations representing health care professionals, consumer
    organizations, voluntary health agencies, the pharmaceutical
    industry, drug wholesalers, patient drug information database
    companies, and other relevant parties collaborate to develop a long-
    range comprehensive action plan to achieve goals consistent with
    the goals of the proposed rule of the Food and Drug Administration
    on 'Prescription Drug Product Labeling: Medication Guide
    Requirements' (60 Fed. Reg. 44182; relating to the provision of
    oral and written prescription information to consumers).
      "(b) Goals. - Goals consistent with the proposed rule described
    in subsection (a) are the distribution of useful written
    information to 75 percent of individuals receiving new precriptions
    [sic] by the year 2000 and to 95 percent by the year 2006.
      "(c) Plan. - The plan described in subsection (a) shall -
        "(1) identify the plan goals;
        "(2) assess the effectiveness of the current private-sector
      approaches used to provide oral and written prescription
      information to consumers;
        "(3) develop guidelines for providing effective oral and
      written prescription information consistent with the findings of
      any such assessment;
        "(4) contain elements necessary to ensure the transmittal of
      useful information to the consuming public, including being
      scientifically accurate, non-promotional in tone and content,
      sufficiently specific and comprehensive as to adequately inform
      consumers about the use of the product, and in an understandable,
      legible format that is readily comprehensible and not confusing
      to consumers expected to use the product.[;]
        "(5) develop a mechanism to assess periodically the quality of
      the oral and written prescription information and the frequency
      with which the information is provided to consumers; and
        "(6) provide for compliance with relevant State board
      regulations.
      "(d) Limitation on the Authority of the Secretary. - The
    Secretary of the Department of Health and Human Services shall have
    no authority to implement the proposed rule described in subsection
    (a), or to develop any similar regulation, policy statement, or
    other guideline specifying a uniform content or format for written
    information voluntarily provided to consumers about prescription
    drugs if, (1) not later than 120 days after the date of enactment
    of this Act [Aug. 6, 1996], the national organizations described in
    subsection (a) develop and submit to the Secretary for Health and
    Human Services a comprehensive, long-range action plan (as
    described in subsection (a)) which shall be acceptable to the
    Secretary of Health and Human Services; (2) the aforementioned plan
    is submitted to the Secretary of Health and Human Services for
    review and acceptance: Provided, That the Secretary shall give due
    consideration to the submitted plan and that any such acceptance
    shall not be arbitrarily withheld; and (3) the implementation of
    (a) a plan accepted by the Secretary commences within 30 days of
    the Secretary's acceptance of such plan, or (b) the plan submitted
    to the Secretary commences within 60 days of the submission of such
    plan if the Secretary fails to take any action on the plan within
    30 days of the submission of the plan. The Secretary shall accept,
    reject or suggest modifications to the plan submitted within 30
    days of its submission. The Secretary may confer with and assist
    private parties in the development of the plan described in
    subsections (a) and (b).
      "(e) Secretary Review. - Not later than January 1, 2001, the
    Secretary of the Department of Health and Human Services shall
    review the status of private-sector initiatives designed to achieve
    the goals of the plan described in subsection (a), and if such
    goals are not achieved, the limitation in subsection (d) shall not
    apply, and the Secretary shall seek public comment on other
    initiatives that may be carried out to meet such goals."
                          CONGRESSIONAL FINDINGS
      Section 2 of Pub. L. 100-293 provided that: "The Congress finds
    the following:
        "(1) American consumers cannot purchase prescription drugs with
      the certainty that the products are safe and effective.
        "(2) The integrity of the distribution system for prescription
      drugs is insufficient to prevent the introduction and eventual
      retail sale of substandard, ineffective, or even counterfeit
      drugs.
        "(3) The existence and operation of a wholesale submarket,
      commonly known as the 'diversion market', prevents effective
      control over or even routine knowledge of the true sources of
      prescription drugs in a significant number of cases.
        "(4) Large amounts of drugs are being reimported to the United
      States as American goods returned. These imports are a health and
      safety risk to American consumers because they may have become
      subpotent or adulterated during foreign handling and shipping.
        "(5) The ready market for prescription drug reimports has been
      the catalyst for a continuing series of frauds against American
      manufacturers and has provided the cover for the importation of
      foreign counterfeit drugs.
        "(6) The existing system of providing drug samples to
      physicians through manufacturer's representatives has been abused
      for decades and has resulted in the sale to consumers of
      misbranded, expired, and adulterated pharmaceuticals.
        "(7) The bulk resale of below wholesale priced prescription
      drugs by health care entities, for ultimate sale at retail, helps
      fuel the diversion market and is an unfair form of competition to
      wholesalers and retailers that must pay otherwise prevailing
      market prices.
        "(8) The effect of these several practices and conditions is to
      create an unacceptable risk that counterfeit, adulterated,
      misbranded, subpotent, or expired drugs will be sold to American
      consumers."

FOOTNOTE

    (!1) See References in Text note below.
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