105 CMR: DEPARTMENT OF PUBLIC HEALTH 105 CMR 720.000: LIST OF INTERCHANGEABLE DRUG PRODUCTS Section 720.001: Purpose 720.002: Citation 720.010: Scope and Application 720.020: Definitions Standards 720:040: Commission Review of Relevant Drug Products 720.050: List of Interchangeable Drug Products 720.060: Drug Products Excluded 720.070: Amendments to the Massachusetts List of Interchangeable Drugs Procedures for Amending List of Interchangeable Drug Products 720.080: Procedures for Amending the Massachusetts List of Interchangeable Drugs 720.081: Petition to Amend List of Interchangeable Drug Products 720.082: Commission Review of Petition 720.083: Notice of Public Comment Period 720.084: Commission Recommendation of Amendments to Department 720.090: Department Adoption of Amendments 720.100: Severability 720.200: Appendix A: List of Interchangeable Drugs 720.001: Purpose The purpose of 105 CMR 720.000 is to establish a drug formulary, or list of interchangeable drug products, for use by physicians, other practitioners, and pharmacists licensed to practice within the commonwealth, so that consumers of prescription drug products may realize cost savings by buying less expensive, safe drug products. 720.002: Citation 105 CMR 720.000 shall be known as the 105 CMR 720.000: Massachusetts List of Interchangeable Drug Products. 720.010: Scope and Application 105 CMR 720.000 establishes the list of interchangeable drug products from which a pharmacist must interchange a reasonably available less expensive drug product than that written, when a prescription written by a practitioner indicates "interchange". 105 CMR 720.000 also establishes criteria and procedures for inclusion of drug products on this list. 720.020: 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 be considered therapeutically 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. 105 CMR: DEPARTMENT OF PUBLIC HEALTH 720.020: continued 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. 720.040: Commission Review of Relevant Drug Products In preparing the List of Interchangeable Drug Products and amendments thereto, the Drug Formulary Commission shall determine whether drug products meet the standards set forth in 105 CMR 720.050. In making this determination, the Commissionshallassess and evaluate pertinent data, including, but not limited to, the United States Pharmacopeia and its supplements, additional pertinent listings of the FDA, other state formularies, formularies of various hospitals of the commonwealth, and data submitted by manufacturers and other interested persons, including chemical and laboratory listing data and clinical evidence concerning bioequivalence and therapeutic equivalence where available. In reviewing this material, the Commission shall utilize the pharmaceutical and medical expertise of its members. 105 CMR: DEPARTMENT OF PUBLIC HEALTH 720.050: List of Interchangeable Drug Products 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. 720.060: Drug Products Excluded The following categories of drug products are excluded from the list of interchangeable drug products: (a) drug products for which the Commonwealth has determined that bioequivalence may be essential, but for which bioequivalence has not been established; and (b) drug products which are the subject matter of patent rights issued by the U.S. Patent Office, for which provision by other than the patent-holder would violate the patent; and (c) drug products available from only one manufacturer at one price. 720.070: Amendments to the Massachusetts List of Interchangeable Drugs (1) Drug products which meet the criteria specified in 105 CMR 720.050(1) shall be deemed interchangeable and added to the Massachusetts List of Drugs upon publication by the United States Department of Health and Human Services of the most recent edition of "Approved Drug Products with Therapeutic Equivalence Evaluations" and its supplements. (2) Drug products which meet criteria specified in 105 CMR 720.050(2) shall be deemed interchangeable and added to the Massachusetts List of Interchangeable Drugs in accordance with procedures set forth in 105 CMR 720.080. 720.080: Procedures for Amending the Massachusetts List of Interchangeable Drugs The Department, working with the Commission, shall review at least one a year and revise as necessary the list of interchangeable drug products adopted pursuant to 105 CMR 720.050(2), and shall have the authority to review and revise the list of interchangeable drug products adopted pursuant to 105 CMR 720.050(1) as necessary. The revisions to 105 CMR 720.050(1) shall be specified on an exception list established by the Department and set forth in 105 CMR 720.200. The revisions will add and delete drug products, based on current information concerning therapeutic efficacy and interchangeability of drug products.