PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.

SEC. 2104. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS. Subsection (h) of section 351 of the Public Health Service Act (42 U.S.C. 262) is amended to read as follows: “(h) 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 Act or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 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)).”