Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 720.000 - List Of Interchangeable Drug Products
Standards
Section 720.050 - List of Interchangeable Drug Products

Universal Citation: 105 CMR 720.000 MA Code of Regs 720.050

Current through Register 1531, September 27, 2024

The Massachusetts List of Interchangeable Drug Products (MLID) shall consist of:

(1) drug products which are considered by FDA to be therapeutically equivalent to other pharmaceutically equivalent products listed with the same generic or chemical name according to the most recent edition of "Approved Drug Products with Therapeutic Equivalence Evaluations" and its supplements as published by the United States Department of Health and Human Services:

(2) drug products specified on a list established by the Department and set forth in 105 CMR 720.200, for which the Commission has determined that the bioequivalence is not essential, or if the Commission has determined that the bioequivalence may be essential, bioequivalence has been established. The list may include the following categories of drug products:

(a) drug products which hold New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) approved by the FDA, which FDA does not consider to be therapeutically equivalent to other pharmaceutically equivalent products listed with the same generic or chemical name; and

(b) drug products exempt from the Food, Drug and Cosmetic Act of 1962, and included in the Drug Efficacy Study Implementation (DESI) done by the National Academy of Sciences/National Research Council; and

(c) frequently prescribed drug products which were manufactured prior to 1938 and meet the FDA Good Manufacturing Practices Requirements; and

(d) frequently prescribed over-the-counter drug products which contain the same amounts of active ingredients, in the same dosage forms, as other drug products with the same general or chemical name.

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