Definitions

The terms used herein shall have the meanings set forth below. Terms defined in M.G.L. c. 112, § 12D and c. 94C, § 1, and not defined herein shallhave the meanings set forth therein when used in 105 CMR 720.000, unless the context clearly requires a different interpretation. Bioequivalent Drug Products means drug products whose rate and extent ofabsorptiondo not show a significant difference when administered at the same molar dose of therapeutic moiety under similar conditions. Some drug products may be equivalent in the extent of their absorption but not in their rate of absorption and yet may beconsideredtherapeutically equivalent because such differences in the rate ofabsorption are not essential to the attainment of effective body drugconcentrationsorare considered medically insignificant for the particular drug product studies. Drug products for which bioequivalence is considered essentialare those whose bioinequivalence would have therapeutic significance, i.e. use ofdifferent brands of the same drug product or different batches of the same drug product would result in therapeutic failure or a hazard to the patient. This is most critical in a drug product that has a narrow therapeutic-toxicity range which requires careful patient titration and monitoring for safe and effective use. Commissioner means the commissioner of public health appointed under M.G.L. c. 17, § 2. Department means the Department of Public Health established under M.G.L. c. 17 as an agency within the Executive Department of the Commonwealth of Massachusetts. Drug Product means a product whichcontains an active drug ingredient and is in a dosage form, e.g. tablet, capsule, orsolution, generally, but not necessarily in combination with other substances included in the manufacturing process. An active drug ingredient is that portion of a drug product intended to produce a therapeutic effect. FDA means the Food and Drug Administration of the United States Department of Health and Human Services. Generic name means a non-proprietary (common) name used to identify a drug product as listed by the United States Adopted Names Council and the United States Pharmacopeia in the USAN/USP Dictionary of Drug Names. Interchangeable Drug Product means a product containing a drug in the same amounts of the same active ingredients in the same dosage form as other drug products with the same generic or chemical name. Pharmaceutically equivalent drug products means drug products which contain the same active ingredients, and are identical in strength or concentration, dosage form, and route of administration. Public HealthCouncil means the Department's governing body established under M.G.L. c. 17, § 3. See also M.G.L. c. 111, § 3. Therapeutically equivalent drug products means drug products which are pharmaceutically equivalent; meet applicable standards for strength, quality, purity and identity; are bioequivalent in that: (a) they do not present a known or potential bioequivalence problem, and they do meet an acceptable in vitro standard; or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standards matching both rate and extent of absorption; are adequately labeled; and are manufactured in compliance with current Good Manufacturing Practice regulations.