105 Cmr 720.000: Drug Formulary Commission List of Interchangeable Drug Products

105 CMR 720.000: DRUG FORMULARY COMMISSION LIST OF INTERCHANGEABLE DRUG PRODUCTS Section 720.001: Purpose 720.002: Citation 720.010: Scope and Application 720.00120: Definitions Standards 720:040: Commission Review of Relevant Drug Products Interchangeable Abuse-Deterrent Drug Products 720.050: List of Interchangeable Drug Products 720.060: Drug Products Excluded From the List of Interchangeable Drug Products 720.070: Formulary of Chemically Equivalent Substitutions for Opioids with Heightened Public Health Risk 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 Chemically Equivalent Substitutions for Opioids with Heightened Public Health Risk 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. 720.00120: 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 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. Abuse-deterrent property (ADP) means those properties of a drug formulation shown to meaningfully deter abuse, even if they do not fully prevent abuse. ADP efficacy means the capacity of an abuse deterrent technology to produce the desired result of effectively deterring the abuse of an opioid with a heightened public health risk. There are three categories of ADP efficacy: Category I: There is evidence, supported by scientifically sound outcome data, which demonstrates a reduction in the abuse of the product in the community setting compared to levels of abuse, overdose, and death that occurred when only formulations of the same opioid without abuse-deterrent properties were available. Category II: Evidence is based on physical/chemical property, clinical abuse potential studies or laboratory manipulation studies and is not yet supported by scientifically sound outcome data which demonstrates a reduction in the abuse of the product in the community setting compared to levels of abuse, overdose, and death that occurred when only formulations of the same opioid without abuse- deterrent properties were available. Category III: Evidence is based on physical/chemical property, theoretical assumptions or manufacturer’s claims and is not yet supported by scientifically sound outcome data which demonstrates a reduction in the abuse of the product in the community setting compared to levels of abuse, overdose, and death that occurred when only formulations of the same opioid without abuse-deterrent properties were available. Chemically equivalent substitution means a drug product which contains the same active ingredients and is equivalent in strength or concentration, dosage form, and route of administration, and produces a comparable biologic effect as an opioid with heightened public health risk. Prodrugs or ingredients without analgesic effect that are used solely for abuse deterrent formulations need not be equivalent. Commissioner means the commissioner of public health appointed under M.G.L. c. 17, § 2. or his or her duly authorized agent. 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. Extended release (ER) means the drug product has a mechanism to prolong absorption of a drug to allow longer dosing intervals and to minimize fluctuations in serum drug levels. FDA means the Food and Drug Administration of the United States Department of Health and Human Services. Generic drug product means a drug product that is comparable to a brand or reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. Generic name means a non-proprietary (common) name given used to identify a drug product, pharmaceutical substance, or biologic product that may be used by all who wish to refer to this substance, as listed by the United States Adopted Names Council and the United States Pharmacopeia in the USAN/USP Dictionary of Drug Names. Immediate release (IR) means the active ingredient in the drug product is released within a small period of time, typically less than 30 minutes. 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. Interchangeable abuse-deterrent (IAP) drug product means an opioid drug product that has either FDA-approved labeling for having abuse-deterrent properties or has manufacturer claims of abuse-deterrent properties and there is sufficient evidence of the efficacy of those abuse-deterrent properties. Opioid means substances, both natural and synthetic, that act on opioid receptors to produce morphine-like effects, most often used medically to relieve pain. Opioids include opiates, an older term that refers to such drugs derived from opium, including morphine itself. Opioids with a heightened public health risk (HPHR) means opioids that have an increased risk to the public health due to their potential for abuse and misuse. 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. Prodrug means a medication or compound, typically paired with a primary drug, that is converted within the body after administration into active form to improve (1) how a primary drug is absorbed, distributed, metabolized, and excreted, (2) the bioavailability of a poorly absorbed primary drug, or (3) the selective interaction with targeted cells or processes to reduce adverse or unintended effects of the primary drug, especially in treatments with severe side effects, like chemotherapy. 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. 720.040: Commission Review of Interchangeable Abuse-Deterrent Drug Products 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 Commission shall assess and evaluate pertinent data,

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