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The Children's Vaccine Initiative: Achieving the Vision (1993)
Institute of Medicine (IOM)

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. "Appendix E: Public Health Service Act (1944)." The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press, 1993.

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The Children's Vaccine Initiative: Achieving the Vision

Package marking requirement.

or carrying from place to place aforesaid; and (2) each package of such virus, serum, toxin, antitoxin, or other product is plainly marked with the proper name of THE article contained therein, the name, address, and license number of the manufacturer, and the date beyond which the specific results. The

Effect of license suspension, etc.

suspension or revocation of any license shall not prevent the sale, barter, or exchange of any virus, serum, toxin, antitoxin, or other product aforesaid which has been sold and delivered by the licensee prior to such suspension or revocation, unless the owner or custodian of such virus, serum, toxin, antitoxin, or other product aforesaid has been notified by the Administrator not to sell, barter, or exchange the same.

False labels, etc.

(b) No person shall falsely label or mark any package or container of any virus, serum, toxin, antitoxin, or other product aforesaid; nor alter any label or mark on any package or container or any virus, serum, toxin, antitoxin, or other product aforesaid so as to falsify such label or mark.

Inspection of establishments for manufacture of virus, etc.

(c) Any officer, agent, or employee or the Federal Security Agency, authorized by the Administrator for the purpose, may during all reasonable hours enter and inspect any establishment for the propagation or manufacture and preparation of any virus, serum, toxin, antitoxin, 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.

Issuance of licenses, standards required.

(d) 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 desired meet standards, designed to insure the continued safety, purity, and potency of such products, prescribed in regulations made jointly by the Surgeon General, the Surgeon General of the Army, and the Surgeon General of the Navy, and approved by the Administrator, and licenses for new products may be issued only upon a showing that

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