New York § 497 - 497Definitions

§ 497. 497Definitions

§ 497. Definitions. The following terms shall have the following meanings when used in this article. (a) "Opioid" shall mean an "opiate" as defined by subdivision twenty-three of section thirty-three hundred two of the public health law and any natural, synthetic, or semisynthetic "narcotic drug" as defined by subdivision twenty-two of such section that has agonist, partial agonist, or agonist/antagonist morphine-like activities or effects similar to natural opium alkaloids, and any derivative, congener, or combination thereof listed in schedules II-V of section thirty-three hundred six of the public health law. The term "opioid" shall not mean buprenorphine, methadone, or morphine. (b) "Unit" shall mean a single finished dosage form of an opioid, such as a pill, tablet, capsule, suppository, transdermal patch, buccal film, milliliter of liquid, milligram of topical preparation, or any other form. (c) "Strength per unit" shall mean the amount of opioid in a unit, as measured by weight, volume, concentration or other metric. (d) "Morphine milligram equivalent conversion factor" shall mean that reference standard of a particular opioid as it relates in potency to morphine as determined by the commissioner of health. (e) "Morphine milligram equivalent" shall mean a unit multiplied by its strength per unit multiplied by the morphine milligram equivalent conversion factor. (f) "Registrant" shall mean: (1) any person, firm, corporation or association that: (i) is required to be registered with the education department as a wholesaler, manufacturer, or outsourcing facility pursuant to section six thousand eight hundred eight or section six thousand eight hundred eight-b of the education law and (ii) holds and transfers title to an opioid unit; (2) any person, firm, corporation or association that: (i) would be required to be registered with the education department as a wholesaler, manufacturer, or outsourcing facility pursuant to such section six thousand eight hundred eight-b but for the exception in subdivision two of such section and (ii) holds and transfers title to an opioid unit; or (3) any person, firm, corporation or association that: (i) is required to be registered with the health department as a manufacturer or distributor of a controlled substance pursuant to section thirty-three hundred ten of the public health law and (ii) holds and transfers title to an opioid unit. (g) "Wholesale acquisition cost" shall mean the manufacturer's list price for an opioid unit to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological pricing data. (h) "Sale" shall mean any transfer of title to an opioid unit for a consideration where actual or constructive possession of such opioid unit is transferred by a registrant holding title to such opioid unit to a purchaser or its designee in this state. A sale shall not include either the dispensing of an opioid unit pursuant to a prescription to an ultimate consumer or the transfer of title to an opioid unit from a manufacturer in this state to a purchaser outside this state when such opioid unit will be used or consumed outside this state.