Foods, Drugs, Oils, and Compounds Chapter 183 FOODS, DRUGS, OILS, AND COMPOUNDS CHAPTER 183 HOUSE BILL NO. 1469 (Representatives Mock, Devlin, Kasper, Louser, D. Ruby) (Senators Anderson, Dever, Heckaman, J. Lee) AN ACT to create and enact section 19-02.1-16.3 of the North Dakota Century Code, relating to pharmacy benefits manager step therapy protocols. BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA: SECTION 1. Section 19-02.1-16.3 of the North Dakota Century Code is created and enacted as follows: 19 - 02.1 - 16.3. Pharmacy benefits managers - Step therapy protocols - Limitations. 1. As used in this section: a. "Metastatic cancer" means cancer that has spread from the primary or original site to lymph nodes, nearby tissues, or other parts of the body. b. "Pharmacy benefits manager" has the same meaning as in section 19 - 03.6 - 01. c. "Step therapy protocol" means a protocol requiring an individual use a drug, or sequence of drugs, other than the prescription drug, or sequence of prescription drugs, the individual's health care provider recommends for the individual's treatment, before the pharmacy benefits manager or health plan allows coverage for the recommended prescription drug, or sequence of prescription drugs. 2. A pharmacy benefits manager or a health plan may not require a step therapy protocol for coverage of a recommended prescription drug, or sequence of prescription drugs, approved by the United States food and drug administration if: a. The recommended prescription drug, or sequence of prescription drugs, is prescribed to treat the individual's diagnosis of metastatic cancer; and b. The use of the recommended prescription drug, or sequence of prescription drugs, is consistent with the United States food and drug administration-approved indications or is supported by peer-reviewed medical literature. 3. This section does not require coverage of a nonformulary prescription drug. Approved April 23, 2019 Filed April 24, 2019 Chapter 184 Foods, Drugs, Oils, and Compounds CHAPTER 184 HOUSE BILL NO. 1382 (Representatives Keiser, Kasper) AN ACT to create and enact section 19-02.1-16.3 of the North Dakota Century Code, relating to pharmacy mail order and home delivery services; and to provide an effective date. BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA: SECTION 1. Section 19-02.1-16.3 of the North Dakota Century Code is created and enacted as follows: Mail order and home delivery - Prior consent - Refund. 1. If a pharmacy offers a prescription through home delivery or mail order delivery services, the pharmacy may not initiate delivery of a refill unless: a. The pharmacy obtains prior consent from the patient or the patient's authorized representative; or b. The pharmacy provides the patient with notice of the upcoming delivery through more than one communication attempt, by different means, and the patient or the patient's authorized representative does not respond indicating the patient does not want the refill. 2. If a pharmacy delivers a refill in violation of subsection 1: a. Within thirty days of the patient's or the patient's authorized representative's notification of the pharmacy of the unwanted refill, the pharmacy shall refund all payments received by the pharmacy relating to the unwanted refill. b. Within thirty days of the pharmacy's, patient's, or patient's authorized representative's notification of the health plan or the pharmacy benefits manager of the unwanted refill, the health plan and pharmacy benefits manager shall refund all payments received relating to the unwanted refill. SECTION 2. EFFECTIVE DATE. This Act becomes effective January 1, 2020. Approved April 24, 2019 Filed April 24, 2019 Foods, Drugs, Oils, and Compounds Chapter 185 CHAPTER 185 HOUSE BILL NO. 1113 (Judiciary Committee) (At the request of the State Board of Pharmacy) AN ACT to amend and reenact subsection 18 of section 19-03.1-01, section 19-03.1-05, subsection 7 of section 19-03.1-07, subsection 4 of section 19-03.1-09, subsection 7 of section 19-03.1-11, and subsection 5 of section 19-03.1-13 of the North Dakota Century Code, relating to the definition of marijuana and the scheduling of controlled substances; and to declare an emergency. BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA: SECTION 1. AMENDMENT. Subsection 18 of section 19-03.1-01 of the North Dakota Century Code is amended and reenacted as follows: 18. "Marijuana" means all parts of the plant cannabis sativa L., whether growing or not; the seeds thereof; the resinous product of the combustionresin extracted from any part of the plant cannabis; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant or, its seeds, or resin. The term does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of mature stalks, except the resin extracted therefrom, fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination. The term marijuana does not include hemp as defined in title 4.1. SECTION 2. AMENDMENT. Section 19-03.1-05 of the North Dakota Century Code is amended and reenacted as follows: 19-03.1-05. Schedule I. 1. The controlled substances listed in this section are included in schedule I. 2. Schedule I consists of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. 3. Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of those isomers, esters, ethers, and salts is possible within the specific chemical designation: a. Acetylmethadol. b. Allylprodine. c. Alphacetylmethadol. d. Alphameprodine. Chapter 185 Foods, Drugs, Oils, and Compounds e. Alphamethadol. f. Benzethidine. g. Betacetylmethadol. h. Betameprodine. i. Betamethadol. j. Betaprodine. k. Clonitazene. l. Dextromoramide. m. Diampromide. n. Diethylthiambutene. o. Difenoxin. p. Dimenoxadol. q. Dimepheptanol. r. Dimethylthiambutene. s. Dioxaphetyl butyrate. t. Dipipanone. u. Ethylmethylthiambutene. v. Etonitazene. w. Etoxeridine. x. Furethidine. y. Hydroxypethidine. z. Ketobemidone. aa. Levomoramide. bb. Levophenacylmorphan. cc. Morpheridine. dd. MPPP (also known as 1-methyl-4-phenyl-4-propionoxypiperidine). ee. Noracymethadol. ff. Norlevorphanol. Foods, Drugs, Oils, and Compounds Chapter 185 gg. Normethadone. hh. Norpipanone. ii. PEPAP (1-(2-Phenylethyl)-4-Phenyl-4-acetoxypiperidine). jj. Phenadoxone. kk. Phenampromide. ll. Phenomorphan. mm. Phenoperidine. nn. Piritramide. oo. Proheptazine. pp. Properidine. qq. Propiram. rr. Racemoramide. ss. Tilidine. tt. Trimeperidine. uu. 3,4-dichloro-N-[2-(dimethylamino)cyclbhexylcyclohexyl]-N- methylbenzamide (also known as U-47700). vv. 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (also know as MT-45). ww. 3,4-dichloro-N-{[1-(dimethylamino)cyclohexyl]methyl}benzamide (also known as AH-7921). xx. Fentanyl derivatives. Unless specifically excepted or unless listed in another schedule or are not FDA approved drugs, and are derived from N- (1-(2-Phenylethyl)-4-piperidinyl)-N-phenylpropanamide (Fentanyl) by any substitution on or replacement of the phenethyl group, any substitution on the piperidine ring, any substitution on or replacement of the propanamide group, any substitution on the anilido phenyl group, or any combination of the above. Examples include: (1) N-[1-(1-methyl-2-phenethyl)-4-piperidinyl]-N-phenylacetamide (also known as Acetyl-alpha-methylfentanyl). (2) N-[1-(alpha-methyl-beta-phenyl)ethyl-4-piperidyl]propionanilide; 1-(1- methyl-2-phenylethyl)-4-(N-propanilido)piperidine (also known as Alpha-methylfentanyl). (3) N-[1-methyl-2-(2-thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide (also known as Alpha-methylthiofentanyl). (4) N-[1-(2-hydroxy-2-phenethyl)-4-piperidinyl]-N-phenylpropanamide (also known as Beta-hydroxyfentanyl). Chapter 185 Foods, Drugs, Oils, and Compounds (5) N-[1-(2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl]-N- phenylpropanamide (also known as Beta-hydroxy-3-methylfentanyl). (6) N-[3-methyl-1-(2-phenylethyl)-4-piperidyl]-N-phenylpropanamide (also known as 3-Methylfentanyl). (7) N-[3-methyl-1-(2-thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide (also known as 3-Methylthiofentanyl). (8) N-(4-fluorophenyl)-N-[1-(2-phenethyl)-4-piperidinyl]propanamide (also known as Para-fluorofentanyl). (9) N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]propanamide (also known as Thiofentanyl). (10) N-(1-phenylethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide (also known as Furanyl Fentanyl). (11) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide; N-(1- phenethylpiperidin-4-yl)-N-phenylbutanamide (also known as Butyryl Fentanyl). (12) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N- phenylpropionamide; N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-piperidinyl]- N-phenylpropanamide (also known as Beta-Hydroxythiofentanyl). (13) N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (also known as Acetyl Fentanyl). (14) N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]prop-2-enamide N-(1 - phene thylpiperidin-4-yl)-N-phenylacrylamide (also known as AcrylfentanylAcryl Fentanyl). (15) N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-pentanamide N-(1 - pheneth ylpiperidin-4-yl)-N-phenylpentanamide (also known as Valeryl Fentanyl). (16) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide