E Public Health Service Act (1944)

PUBLIC LAWS-CH. 373-JULY 1, 1944 PART F-BIOLOGICAL PRODUCTS Regulation of Biological Products

Sale, barter or exchange in D.C., etc.

Manufacturers of virus, etc. License requirements.

Sec. 351. (a) No person shall sell, barter, or offer for sale, barter, or exchange in the District of Columbia, or send, carry, or bring for sale, barter, or exchange 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, any virus, therapeutic serum, toxin, antitoxin, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention,

treatment, or cure of diseases or injuries of man, unless (1) such virus, serum, toxin, antitoxin, or other product has been propogated or manufactured and prepared at an establishment holding an unsuspended and unrevoked license, issued by the Administrator as hereinafter authorized, to propogate or manufacture, and prepare such virus, serum, toxin, antitoxin, or other product for sale in the District of Columbia, or for sending, bringing



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The Children's Vaccine Initiative: Achieving the Vision E Public Health Service Act (1944) PUBLIC LAWS-CH. 373-JULY 1, 1944 PART F-BIOLOGICAL PRODUCTS Regulation of Biological Products Sale, barter or exchange in D.C., etc. Manufacturers of virus, etc. License requirements. Sec. 351. (a) No person shall sell, barter, or offer for sale, barter, or exchange in the District of Columbia, or send, carry, or bring for sale, barter, or exchange 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, any virus, therapeutic serum, toxin, antitoxin, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man, unless (1) such virus, serum, toxin, antitoxin, or other product has been propogated or manufactured and prepared at an establishment holding an unsuspended and unrevoked license, issued by the Administrator as hereinafter authorized, to propogate or manufacture, and prepare such virus, serum, toxin, antitoxin, or other product for sale in the District of Columbia, or for sending, bringing

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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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The Children's Vaccine Initiative: Achieving the Vision 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, or 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. Interference With Officers (e) 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. Penalties for Offenses (f) 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) Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug and Cosmetic Act (U.S.C., 1940 edition, title 21, ch. 9). (h)(1)(A)1 A partially processed biological product which is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man, which is not intended for sale in the United States, and which is intended for further manufacture into final dosage form outside the United States in a country listed under section 1   Added by sec. 105 of P.L. 99–660.

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The Children's Vaccine Initiative: Achieving the Vision 802(b)(A) of the Federal Food, Drug, and Cosmetic Act may, upon approval of an application meeting the requirements of subparagraph (B), be exported to a country listed under section 802(b)(4) of the Federal Food, Drug, and Cosmetic Act. The Secretary may not approve an application to export such a product unless the Secretary  determines  that  the  product  is manufactured, processed, packaged, and held in conformity  with  current  good  manufacturing practice and the outside of the shipping package is labeled  with  the  following  statement:   ''This product may be sold or offered for sale only in the following countries:    ," the blank space being filled with a list of the countries to which export of the drug is authorized. (B) An application for the export of a partially processed biological product shall— (i) describe the partially processed biological product to be exported, (ii) list each country to which the product is to be exported, (iii) contain a certification by the applicant that the product will not be exported to a country not listed under clause (ii), (iv) identify the establishments in which the product is manufactured, and (v) contain a certification by the applicant that the final product to be developed from the partially processed product is approved in the country to which it is to be exported or approval of the final product is being sought in such country. (2) A product described in paragraph (1) is not subject to licensure under this section. (3) If the Secretary determines that prohibiting the export of a product described in paragraph (1) is necessary for protection of the public health in the United States or the country to which it is to be exported, the Secretary may not approve an application under paragraph (1) for the export of

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The Children's Vaccine Initiative: Achieving the Vision such product. Preparation of Biological Products by Service Sec. 352. [263] (a) The Service may prepare for its own use any product described in section 351 and any product necessary to carrying out any of the purposes of section 301. (b) The Service may prepare any product described in section 351 for the use of other Federal departments or agencies, and public or private agencies and individuals engaged in work in the field of medicine when such product is not available from establishments licensed under such section.