Page:United States Statutes at Large Volume 106 Part 5.djvu/854

 106 STAT. 4492 PUBLIC LAW 102-571—OCT. 29, 1992 "(A) approval of a new drug submitted under section 505(b)(l), "(B) approval of a new drug submitted under section 505(b)(2) after September 30, 1992, which requests approval of— "(i) a molecular entity which is an active ingredient (inclu(Ung any salt or ester of an active ingredient), or "(ii) an indication for a use, that had not been approved under an application submitted under section 505(b), "(C) initial certification or initial approval of an antibiotic drug under section 507, or "(D) licensure of a biological product under section 351 of the Public Health Service Act. Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic biologic product licensed under section 351 of the Public Health Service Act, and does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992. "(2) The term 'supplement' means a request to the Secretary to approve a change in a human drug application which has been approved. ''(3) The term 'prescription drug product' means a specific strength or potency of a drug in final dosage form— "(A) for which a human drug application has been approved, and "(B) which may be dispensed only under prescription pursuant to section 503(b). Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic biologic product licensed under section 351 of the Public Health Service Act, and does not include a large volume parenteral drug product approved before September 1, 1992. "(4) The term 'final dosage form' means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without further manufacturing. "(5) The term 'prescription drug establishment' means a foreign or domestic place of business which is— "(A) at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more prescription drug products are manufactured in final dosage form, and "(B) under the management of a person that is listed as the applicant in a human drug application for a prescription drug product with respect to at least one such product. For purposes of this paragraph, the term 'manufactured' does not include packaging.

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