As used in this part, unless the context otherwise requires:
(1) “Biological product” has the same meaning as defined in 42 U.S.C. § 262(i);
(2) “Brand name” means the registered trademark name of a drug or drug product given by its manufacturer, labeler or distributor;
(3) “Finished dosage form” means that form of a drug that is, or is intended to be, dispensed or administered to a patient and requires no further manufacturing or processing other than packaging, reconstitution or labeling;
(4) “Generic equivalent” means a drug product that has the same established name, active ingredients, strength or concentration, dosage form, and route of administration and that is formulated to contain the same amount of active ingredients, in the same dosage form, and to meet the same compendial or other applicable standards, i.e. strength, quality, purity, and identity, but that may differ in characteristics, such as shape, scoring, configuration, packaging, excipients, including colors, flavors, preservatives, and expiration time;
(5) “Interchangeable biological product” means:
(A) A biological product licensed by the federal food and drug administration and determined to meet the safety standards for determining interchangeability pursuant to 42 U.S.C. § 262(k)(4); or
(B) A biological product determined by the federal food and drug administration to be therapeutically equivalent as set forth in the latest edition or supplement of the federal food and drug administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the “Orange Book”; and
(6) “Prescriber” means an individual authorized by law to prescribe drugs.
