
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[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
 
Sec. 262. Regulation of biological products


(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].

(July 1, 1944, ch. 373, title III, Sec. 351, 58 Stat. 702; 1953 Reorg. 
Plan No. 1, Secs. 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, Secs. 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.)

                       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.


                               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.

                          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.


           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 References

    Regulation of biological products for use in treatment of domestic 
animals, see sections 151 to 159 of Title 21, Food and Drugs.

                  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.
