is appropriately harmonized, in terms of terminology or cross-references, with the applicable provisions of this Act (and regulations thereunder) and any other orders issued under this section. (c) Procedure for minor changes (1) In general Minor changes in the dosage form of a drug that is described in paragraph (1) or (2) of subsection (a) or the subject of an order issued under subsection (b) may be made by a requestor without the issuance of an order under subsection (b) if— (A) the requestor maintains such information as is necessary to demonstrate that the change— (i) will not affect the safety or effectiveness of the drug