Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Section 720.020 - Definitions

Current through Register 1525, July 5, 2024
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 shall have 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 of absorption do 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 be considered
				therapeutically equivalent because such differences in the rate of absorption
				are not essential to the attainment of effective body drug concentrations or
				are considered medically insignificant for the particular drug product
				studies.
Drug products for which bioequivalence is considered essential
				are those whose bioinequivalence would have therapeutic significance,
i.e.
use of different 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 which
				contains an active drug ingredient and is in a dosage form,
e.g.
tablet, capsule, or solution, 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 Health Council
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.