0458 US CODE Title 42,262_ Regulation of biological products

US CODE: Title 42,262. Regulation of biological products US CODE

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262. Regulation of biological products

Release date: 2003-07-24

(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]. Search this title:

Notes

Updates

Parallel authorities (CFR)

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