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From the U.S. House of Representatives Downloadable U.S. Code
[uscode.house.gov]
[Laws in effect as of January 5, 1999]

[CITE: 42USC262]

 
TITLE 42 - THE PUBLIC HEALTH AND WELFARE
    CHAPTER 6A - PUBLIC HEALTH SERVICE
    SUBCHAPTER II - GENERAL POWERS AND DUTIES
    Part F - Licensing of Biological Products and Clinical Laboratories
    subpart 1 - biological products
 
-HEAD-
    Sec. 262. Regulation of biological products
 
-STATUTE-
    (a) Biologics license
      (1) No person shall introduce or deliver for introduction into
    interstate commerce any biological product unless -
        (A) a biologics license is in effect for the biological
      product; and
        (B) each package of the biological product is plainly marked
      with -
          (i) the proper name of the biological product contained in
        the package;
          (ii) the name, address, and applicable license number of the
        manufacturer of the biological product; and
          (iii) the expiration date of the biological product.
      (2)(A) The Secretary shall establish, by regulation, requirements
    for the approval, suspension, and revocation of biologics licenses.
      (B) The Secretary shall approve a biologics license application -
        (i) on the basis of a demonstration that -
          (I) the biological product that is the subject of the
        application is safe, pure, and potent; and
          (II) the facility in which the biological product is
        manufactured, processed, packed, or held meets standards
        designed to assure that the biological product continues to be
        safe, pure, and potent; and
        (ii) if the applicant (or other appropriate person) consents to
      the inspection of the facility that is the subject of the
      application, in accordance with subsection (c) of this section.
      (3) The Secretary shall prescribe requirements under which a
    biological product undergoing investigation shall be exempt from
    the requirements of paragraph (1).
    (b) Falsely labeling or marking package or container; altering
        label or mark
      No person shall falsely label or mark any package or container of
    any biological product or alter any label or mark on the package or
    container of the biological product so as to falsify the label or
    mark.
    (c) Inspection of establishment for propagation and preparation
      Any officer, agent, or employee of the Department of Health and
    Human Services, authorized by the Secretary for the purpose, may
    during all reasonable hours enter and inspect any establishment for
    the propagation or manufacture and preparation of any biological
    product.
    (d) Recall of product presenting imminent hazard; violations
      (1) Upon a determination that a batch, lot, or other quantity of
    a product licensed under this section presents an imminent or
    substantial hazard to the public health, the Secretary shall issue
    an order immediately ordering the recall of such batch, lot, or
    other quantity of such product.  An order under this paragraph
    shall be issued in accordance with section 554 of title 5.
      (2) Any violation of paragraph (1) shall subject the violator to
    a civil penalty of up to $100,000 per day of violation.  The amount
    of a civil penalty under this paragraph shall, effective December 1
    of each year beginning 1 year after the effective date of this
    paragraph, be increased by the percent change in the Consumer Price
    Index for the base quarter of such year over the Consumer Price
    Index for the base quarter of the preceding year, adjusted to the
    nearest 1/10 of 1 percent.  For purposes of this paragraph, the
    term ''base quarter'', as used with respect to a year, means the
    calendar quarter ending on September 30 of such year and the price
    index for a base quarter is the arithmetical mean of such index for
    the 3 months comprising such quarter.
    (e) Interference with officers
      No person shall interfere with any officer, agent, or employee of
    the Service in the performance of any duty imposed upon him by this
    section or by regulations made by authority thereof.
    (f) Penalties for offenses
      Any person who shall violate, or aid or abet in violating, any of
    the provisions of this section shall be punished upon conviction by
    a fine not exceeding $500 or by imprisonment not exceeding one
    year, or by both such fine and imprisonment, in the discretion of
    the court.
    (g) Construction with other laws
      Nothing contained in this chapter shall be construed as in any
    way affecting, modifying, repealing, or superseding the provisions
    of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
    seq.).
    (h) Exportation of partially processed biological products
      A partially processed biological product which -
        (1) is not in a form applicable to the prevention, treatment,
      or cure of diseases or injuries of man;
        (2) is not intended for sale in the United States; and
        (3) is intended for further manufacture into final dosage form
      outside the United States,
    shall be subject to no restriction on the export of the product
    under this chapter or the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 301 et. seq.) if the product is manufactured, processed,
    packaged, and held in conformity with current good manufacturing
    practice requirements or meets international manufacturing
    standards as certified by an international standards organization
    recognized by the Secretary and meets the requirements of section
    801(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    381(e)).
    (i) ''Biological product'' defined
      In this section, the term ''biological product'' means a virus,
    therapeutic serum, toxin, antitoxin, vaccine, blood, blood
    component or derivative, allergenic product, or analogous product,
    or arsphenamine or derivative of arsphenamine (or any other
    trivalent organic arsenic compound), applicable to the prevention,
    treatment, or cure of a disease or condition of human beings.
    (j) Application of Federal Food, Drug, and Cosmetic Act
      The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
    applies to a biological product subject to regulation under this
    section, except that a product for which a license has been
    approved under subsection (a) shall not be required to have an
    approved application under section 505 of such Act (21 U.S.C. 355).
 
-SOURCE-
    (July 1, 1944, ch. 373, title III, Sec. 351, 58 Stat. 702; 1953
    Reorg. Plan No. 1, Sec. 5, 8, eff.  Apr. 11, 1953, 18 F.R. 2053, 67
    Stat. 631; Pub. L. 85-881, Sec. 2, Sept. 2, 1958, 72 Stat. 1704;
    Pub. L. 91-515, title II, Sec. 291, Oct. 30, 1970, 84 Stat. 1308;
    Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695;
    Pub. L. 99-660, title I, Sec. 105(a), title III, Sec. 315, Nov. 14,
    1986, 100 Stat. 3751, 3783; Pub. L. 102-300, Sec. 6(b)(1), June 16,
    1992, 106 Stat. 240; Pub. L. 104-134, title II, Sec. 2102(d)(2),
    2104, Apr. 26, 1996, 110 Stat. 1321-319, 1321-320; Pub. L. 105-115,
    title I, Sec. 123(a)-(d), (g), Nov. 21, 1997, 111 Stat. 2323,
    2324.)
 
-REFTEXT-
                             REFERENCES IN TEXT
      The effective date of this paragraph, referred to in subsec.
    (d)(2), is the effective date of section 315 of Pub. L. 99-660
    which added subsec. (d)(2). See Effective Date of 1986 Amendment
    note set out below.
      The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
    (g), (h), and (j), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of Title 21, Food and Drugs. For complete classification of
    this Act to the Code, see section 301 of Title 21 and Tables.
 
-MISC2-
                                 AMENDMENTS
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 123(a)(1), amended
    subsec. (a) generally.  Prior to amendment, subsec. (a) related to
    intrastate and interstate traffic in biological products and
    suspension or revocation of licenses as affecting prior sales.
      Subsec. (b). Pub. L. 105-115, Sec. 123(b), amended subsec. (b)
    generally.  Prior to amendment, subsec. (b) read as follows: ''No
    person shall falsely label or mark any package or container of any
    virus, serum, toxin, antitoxin, vaccine, blood, blood component or
    derivative, allergenic product, or other product aforesaid; nor
    alter any label or mark on any package or container of any virus,
    serum, toxin, antitoxin, vaccine, blood, blood component or
    derivative, allergenic product, or other product aforesaid so as to
    falsify such label or mark.''
      Subsec. (c). Pub. L. 105-115, Sec. 123(c), substituted
    ''biological product.'' for ''virus, serum, toxin, antitoxin,
    vaccine, blood, blood component or derivative, allergenic product,
    or other product aforesaid for sale, barter, or exchange in the
    District of Columbia, or to be sent, carried, or brought from any
    State or possession into any other State or possession or into any
    foreign country, or from any foreign country into any State or
    possession.''
      Subsec. (d). Pub. L. 105-115, Sec. 123(a)(2), designated par. (2)
    as subsec. (d), redesignated subpars. (A) and (B) of par. (2) as
    pars. (1) and (2), respectively, in par. (2), substituted ''Any
    violation of paragraph (1)'' for ''Any violation of subparagraph
    (A)'' and substituted ''this paragraph'' for ''this subparagraph''
    wherever appearing, and struck out former par. (1) which read as
    follows: ''Licenses for the maintenance of establishments for the
    propagation or manufacture and preparation of products described in
    subsection (a) of this section may be issued only upon a showing
    that the establishment and the products for which a license is
    desired meet standards, designed to insure the continued safety,
    purity, and potency of such products, prescribed in regulations,
    and licenses for new products may be issued only upon a showing
    that they meet such standards.  All such licenses shall be issued,
    suspended, and revoked as prescribed by regulations and all
    licenses issued for the maintenance of establishments for the
    propagation or manufacture and preparation, in any foreign country,
    of any such products for sale, barter, or exchange in any State or
    possession shall be issued upon condition that the licensees will
    permit the inspection of their establishments in accordance with
    subsection (c) of this section.''
      Subsec. (i). Pub. L. 105-115, Sec. 123(d), added subsec. (i).
      Subsec. (j). Pub. L. 105-115, Sec. 123(g), added subsec. (j).
      1996 - Subsec. (h). Pub. L. 104-134, Sec. 2104, amended subsec.
    (h) generally, revising and restating former provisions, which also
    related to exportation of partially processed biological products.
      Subsec. (h)(1)(A). Pub. L. 104-134, Sec. 2102(d)(2), substituted
    ''in a country listed under section 802(b)(1)'' for ''in a country
    listed under section 802(b)(A)'' and ''to a country listed under
    section 802(b)(1)'' for ''to a country listed under section
    802(b)(4)''.
      1992 - Subsec. (c). Pub. L. 102-300, which directed substitution
    of ''Health and Human Services'' for ''Health, Education, and
    Welfare'', could not be executed because the words ''Health,
    Education, and Welfare'' did not appear in original statutory
    text.  Previously, references to Department and Secretary of Health
    and Human Services were substituted for references to Federal
    Security Agency and its Administrator pursuant to provisions cited
    in Transfer of Functions note below.
      1986 - Subsec. (d). Pub. L. 99-660, Sec. 315, designated existing
    provisions as par. (1) and added par. (2).
      Subsec. (h). Pub. L. 99-660, Sec. 105(a), added subsec. (h).
      1970 - Subsecs. (a) to (c). Pub. L. 91-515 inserted ''vaccine,
    blood, blood component or derivative, allergenic product,'' after
    ''antitoxin'' wherever appearing.
      1958 - Subsec. (d). Pub. L. 85-881 struck out ''made jointly by
    the Surgeon General, the Surgeon General of the Army, and the
    Surgeon General of the Navy, and approved by the Secretary'' after
    ''regulations'' in first sentence.
                      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 Title 21, Food and
    Drugs.
                      EFFECTIVE DATE OF 1986 AMENDMENT
      Section 105(b) of Pub. L. 99-660 provided that: ''Paragraph (1)
    of section 351(h) of the Public Health Service Act (former subsec.
    (h)(1) of this section) as added by subsection (a) shall take
    effect upon the expiration of 90 days after the date of the
    enactment of this Act (Nov. 14, 1986).''
      Amendment by section 315 of Pub. L. 99-660 effective Dec. 22,
    1987, see section 323 of Pub. L. 99-660, as amended, set out as an
    Effective Date note under section 300aa-1 of this title.
 
-TRANS-
                           TRANSFER OF FUNCTIONS
      Functions of Public Health Service, Surgeon General of Public
    Health Service, and all other officers and employees of Public
    Health Service, and functions of all agencies of or in Public
    Health Service transferred to Secretary of Health, Education, and
    Welfare by Reorg. Plan No. 3 of 1966, eff.  June 25, 1966, 31 F.R.
    8855, 80 Stat. 1610, set out as a note under section 202 of this
    title.  Secretary of Health, Education, and Welfare redesignated
    Secretary of Health and Human Services by section 509(b) of Pub. L.
    96-88 which is classified to section 3508(b) of Title 20,
    Education.
      References to Secretary and Department of Health, Education, and
    Welfare substituted for references to Federal Security
    Administrator and Federal Security Agency, respectively, pursuant
    to Reorg. Plan No. 1 of 1953, Sec. 5, set out as a note under
    section 3501 of this title, which transferred all functions of
    Federal Security Administrator to Secretary of Health, Education,
    and Welfare and all agencies of Federal Security Agency to
    Department of Health, Education, and Welfare. Federal Security
    Agency and office of Administrator abolished by section 8 of Reorg.
    Plan No. 1 of 1953. Secretary and Department of Health, Education,
    and Welfare redesignated Secretary and Department of Health and
    Human Services by section 509(b) of Pub. L. 96-88 which is
    classified to section 3508(b) of Title 20.
 
-MISC5-
            ENHANCED PENALTIES AND CONTROL OF BIOLOGICAL AGENTS
      Pub. L. 104-132, title V, Sec. 511, Apr. 24, 1996, 110 Stat.
    1284, provided that:
      ''(a) Findings. - The Congress finds that -
        ''(1) certain biological agents have the potential to pose a
      severe threat to public health and safety;
        ''(2) such biological agents can be used as weapons by
      individuals or organizations for the purpose of domestic or
      international terrorism or for other criminal purposes;
        ''(3) the transfer and possession of potentially hazardous
      biological agents should be regulated to protect public health
      and safety; and
        ''(4) efforts to protect the public from exposure to such
      agents should ensure that individuals and groups with legitimate
      objectives continue to have access to such agents for clinical
      and research purposes.
      ''(b) Criminal Enforcement. - (Amended sections 175, 177, and 178
    of Title 18, Crimes and Criminal Procedure.)
      ''(c) Terrorism. - (Amended section 2332a of Title 18.)
      ''(d) Regulatory Control of Biological Agents. -
        ''(1) List of biological agents. -
          ''(A) In general. - The Secretary shall, through regulations
        promulgated under subsection (f), establish and maintain a list
        of each biological agent that has the potential to pose a
        severe threat to public health and safety.
          ''(B) Criteria. - In determining whether to include an agent
        on the list under subparagraph (A), the Secretary shall -
            ''(i) consider -
     ''(I) the effect on human health of exposure to the agent;
     ''(II) the degree of contagiousness of the agent and the methods
            by which the agent is transferred to humans;
     ''(III) the availability and effectiveness of immunizations to
            prevent and treatments for any illness resulting from
            infection by the agent; and
     ''(IV) any other criteria that the Secretary considers
            appropriate; and
            ''(ii) consult with scientific experts representing
          appropriate professional groups.
      ''(e) Regulation of Transfers of Listed Biological Agents. - The
    Secretary shall, through regulations promulgated under subsection
    (f), provide for -
        ''(1) the establishment and enforcement of safety procedures
      for the transfer of biological agents listed pursuant to
      subsection (d)(1), including measures to ensure -
          ''(A) proper training and appropriate skills to handle such
        agents; and
          ''(B) proper laboratory facilities to contain and dispose of
        such agents;
        ''(2) safeguards to prevent access to such agents for use in
      domestic or international terrorism or for any other criminal
      purpose;
        ''(3) the establishment of procedures to protect the public
      safety in the event of a transfer or potential transfer of a
      biological agent in violation of the safety procedures
      established under paragraph (1) or the safeguards established
      under paragraph (2); and
        ''(4) appropriate availability of biological agents for
      research, education, and other legitimate purposes.
      ''(f) Regulations. - The Secretary shall carry out this section
    by issuing -
        ''(1) proposed rules not later than 60 days after the date of
      enactment of this Act (Apr. 24, 1996); and
        ''(2) final rules not later than 120 days after the date of
      enactment of this Act.
      ''(g) Definitions. - For purposes of this section -
        ''(1) the term 'biological agent' has the same meaning as in
      section 178 of title 18, United States Code; and
        ''(2) the term 'Secretary' means the Secretary of Health and
      Human Services.''
 
-CROSS-
                              CROSS REFERENCES
      Regulation of biological products for use in treatment of
    domestic animals, see sections 151 to 159 of Title 21, Food and
    Drugs.
 
-SECREF-
                   SECTION REFERRED TO IN OTHER SECTIONS
      This section is referred to in sections 236, 263, 300aa-22,
    300aa-23, 1396r-8 of this title; title 21 sections 321, 331, 352,
    353, 355, 356, 356a, 360aa, 360bb, 360cc, 360ee, 360aaa, 360bbb-1,
    379g, 381, 382, 392, 397; title 26 section 45C; title 35 section
    156.



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