to engage in the business of insurance in a State and which is subject to State law which regulates insurance (within the meaning of section 514(b)(2) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1144(b)(2) )). Such term does not include a group health plan. (3) Health maintenance organization The term health maintenance organization means— (A) a Federally qualified health maintenance organization (as defined in section 300e(a) of title 42 of the United States Code), (B) an organization recognized under State law as a health maintenance organization, or (C) a similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization. (4) Manufacturer The term manufacturer means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug. (5) Prescription drug The term prescription drug means any human drug required by Federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b) ). (c) Effective date This section shall take effect on the date of the enactment of this Act but shall not apply with respect to conduct that occurs before such date. 353. Biological product innovation Section 351(j) of the Public Health Service Act ( 42 U.S.C. 262(j) ) is amended— (1) by striking except that a product and inserting “except that— (1) a product