HCV Final Rule - 42USC262

42 USCA § 262
42 U.S.C.A. § 262

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UNITED STATES CODE ANNOTATED
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
Copr. © West Group 2002. No claim to Orig. U.S. Govt. Works.
Current through P.L. 107-305 (excluding P.L. 107-273, 107-279,
107-295 to 107-297) approved 11-27-02

§ 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

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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) Regulations governing licenses; 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.A. § 301 et seq.].

(h) Exportation of partially processed biological products

A partially processed biological product which-Copr. © West 2002 No Claim to Orig. U.S. Govt. Works

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(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. 321 et. [FN1] 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) Definition; application

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 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 355 of Title 21.

CREDIT(S)
2002 Electronic Update
(July 1, 1944, c. 373, Title III, § 351, 58 Stat. 702; 1953 Reorg. Plan No. 1, § § 5, 8, eff. Apr. 11, 1953, 18 F.R.
2053, 67 Stat. 631; Sept. 2, 1958, Pub.L. 85-881, § 2, 72 Stat. 1704; Oct. 30, 1970, Pub.L. 91-515, Title II, § 291,
84 Stat. 1308; Oct. 17, 1979, Pub.L. 96-88, Title V, § 509(b), 93 Stat. 695; Nov. 14, 1986, Pub.L. 99-660, Title I,
§ 105(a), Title III, § 315, 100 Stat. 3751, 3783; June 16, 1992, Pub.L. 102-300, § 6(b)(1), 106 Stat. 240; Apr. 26,
1996, Pub.L. 104-134, Title II, § § 2102(d)(2), 2104, 110 Stat. 1321-319, 1321-320; Nov. 21, 1997, Pub.L. 105115, Title I, § § 123(a) to (d), (g), 111 Stat. 2323, 2324.)

[FN1] So in original.

42 U.S.C.A. § 262
42 USCA § 262
END OF DOCUMENT

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