; or (ii) with respect to a drug for which there is no average manufacturer price as so defined, such term shall mean the wholesale acquisition cost of the drug. (C) Commerce The term commerce has the meaning given such term in section 4 of the Federal Trade Commission Act ( 15 U.S.C. 44 ). (D) Inspector General The term Inspector General means the Inspector General of the Department of Health and Human Services. (E) Prescription drug (i) In general The term prescription drug means any drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g) )), including a combination product whose primary mode of action is determined under section 503(g) of such Act ( 21 U.S.C. 353(g) ) to be that of a drug, and that— (I) is subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b)(1) ); and (II) is covered by a Federal health care program (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(f))). (ii) Treatment of reformulated drugs For purposes of this subsection, a prescription drug with respect to which the Secretary of Health and Human Services has approved any minor reformulation that does not produce a meaningful therapeutic benefit, the drug that was approved prior to any such reformulation and the drug with any such reformulation shall be considered one prescription drug. (F) Price spike (i) In general The term price spike means an increase in the average manufacturer price in commerce of a prescription drug for which the price spike percentage is equal to or greater than applicable price increase allowance. (ii) Price spike percentage The price spike percentage is the percentage (if any) by which— (I) the average manufacturer price of a prescription drug in commerce for the calendar year