Coop guidance 42 USC 262

From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 3, 2005]
[Document not affected by Public Laws enacted between
January 3, 2005 and January 18, 2007]
[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) Pediatric studies.--A person that submits an application for a
license under this paragraph shall submit to the Secretary as part of
the application any assessments required under section 505B of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c].
(C) 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; Pub. L. 108-155, Sec. 2(b)(3), Dec. 3,
2003, 117 Stat. 1941.)

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

2003--Subsec. (a)(2)(B), (C). Pub. L. 108-155 added subpar. (B) and
redesignated former subpar. (B) as (C).
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 2003 Amendment

Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
otherwise provided, see section 4 of Pub. L. 108-155, set out as an
Effective Date note under section 355c of Title 21, Food and Drugs.

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,
as amended by Pub. L. 107-188, title II, Sec. 204, June 12, 2002, 116
Stat. 647, 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.]''