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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