TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

PART A—RESEARCH AND INVESTIGATION

IN GENERAL

SEC. 301. [241] (a) The Secretary shall conduct in the Service, and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man, including water purification, sewage treatment, and pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to [Omitted]

PART F—LICENSING—BIOLOGICAL PRODUCTS AND CLINICAL LABORATORIES

Subpart 1—Biological Products

REGULATION OF BIOLOGICAL PRODUCTS

SEC. 351. [262] (a)(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—

  • (A) a biologics license under this subsection or subsection (k) 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.
  • (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…[Further omitted]

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Last Updated: 2015-11-18