S.F. _____ H.F. _____ DIVISION I 1 CONTROLLED SUBSTANCES 2 Section 1. Section 124.204, subsection 2, Code 2017, is 3 amended by adding the following new paragraph: 4 NEW PARAGRAPH . bd. AH-7921 (3,4-dichloro-N- 5 [(1-dimethylamino) cyclohexylmethyl]benzamide. 6 Sec. 2. Section 124.204, subsection 9, Code 2017, is amended 7 by adding the following new paragraphs: 8 NEW PARAGRAPH . p. N-(1-phenethylpiperidin-4-yl)-N- 9 phenylfuran-2-carboxamide, its isomers, esters, ethers, salts 10 and salts of isomers, esters and ethers. Other names: Furanyl 11 fentanyl. 12 NEW PARAGRAPH . q. N-(1-phenethylpiperidin-4-yl)-N- 13 phenylbutyramide, its isomers, esters, ethers, salts and salts 14 of isomers, esters and ethers. Other names: Butyryl fentanyl. 15 NEW PARAGRAPH . r. N-[1-[2-hydroxy-2-(thiophen-2- 16 yl)ethyl]piperidin-4-yl]-N-phenylpropionamide, its isomers, 17 esters, ethers, salts and salts of isomers, esters and ethers. 18 Other names: beta-hydroxythiofentanyl. 19 NEW PARAGRAPH . s. 3,4-Dichloro-N-[2- 20 (dimethylamino)cyclohexyl]-N-methylbenzamide, its isomers, 21 esters, ethers, salts and salts of isomers, esters and ethers. 22 Other names: U-47700. 23 Sec. 3. Section 124.206, subsection 2, paragraph a, 24 unnumbered paragraph 1, Code 2017, is amended to read as 25 follows: 26 Opium and opiate, and any salt, compound, derivative, 27 or preparation of opium or opiate, excluding apomorphine, 28 thebaine-derived butorphanol, dextrorphan, nalbuphine, 29 nalmefene, naloxegol, naloxone, and naltrexone, and their 30 respective salts, but including the following: 31 Sec. 4. Section 124.206, subsection 2, paragraph d, Code 32 2017, is amended to read as follows: 33 d. Coca leaves and any salt, compound, derivative, or 34 preparation of coca leaves . Decocainized coca leaves or 35 -1- LSB 1287DP (16) 87 jm/nh 1/ 8

S.F. _____ H.F. _____ extractions of coca leaves, which extractions do not contain 1 cocaine or ecgonine, are excluded from this paragraph. The 2 following substances and their salts, optical and geometric 3 isomers, derivatives, and salts of derivatives and optical 4 and geometric isomers including cocaine and ecgonine and 5 their salts, isomers, derivatives and salts of isomers and 6 derivatives , and any salt, compound, derivative, or preparation 7 thereof that is chemically equivalent or identical to any of 8 such substances, are included in this paragraph except that the 9 substances shall not include : 10 (1) Cocaine Decocainized coca leaves or extractions of coca 11 leaves, which extractions do not contain cocaine or ecgonine . 12 (2) Ecgonine [\123\I]ioflupane . 13 Sec. 5. Section 124.206, subsection 3, Code 2017, is amended 14 by adding the following new paragraph: 15 NEW PARAGRAPH . ac. Thiafentanil. 16 Sec. 6. Section 124.208, subsection 5, paragraph a, 17 subparagraphs (3) and (4), Code 2017, are amended by striking 18 the subparagraphs. 19 Sec. 7. Section 124.210, subsection 2, Code 2017, is amended 20 by adding the following new paragraph: 21 NEW PARAGRAPH . c. 2-[(dimethylamino)methyl]-1- 22 (3-methoxyphenyl)cyclohexanol, its salts, optical and geometric 23 isomers and salts of these isomers (including tramadol). 24 Sec. 8. Section 124.210, subsection 3, Code 2017, is amended 25 by adding the following new paragraphs: 26 NEW PARAGRAPH . bb. Alfaxalone. 27 NEW PARAGRAPH . bc. Suvorexant. 28 Sec. 9. Section 124.210, subsection 7, Code 2017, is amended 29 by adding the following new paragraph: 30 NEW PARAGRAPH . c. Eluxadoline (5-[[[(2S)-2-amino-3- 31 [4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1- 32 (4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2- 33 methoxybenzoic acid) (including its optical isomers) and its 34 salts, isomers, and salts of isomers. 35 -2- LSB 1287DP (16) 87 jm/nh 2/ 8

S.F. _____ H.F. _____ Sec. 10. Section 124.212, subsection 5, Code 2017, is 1 amended by adding the following new paragraph: 2 NEW PARAGRAPH . d. Brivaracetam ((2S)-2-[(4R)-2-oxo-4- 3 propylpyrrolidin-1-yl] butanamide), including its salts. Other 4 names: BRV, UCB-34714, Briviact. 5 DIVISION II 6 CODE CHAPTER 124B (PRECURSOR SUBSTANCES) REPEAL 7 Sec. 11. Section 124.401, subsection 5, unnumbered 8 paragraph 1, Code 2017, is amended to read as follows: 9 It is unlawful for any person knowingly or intentionally 10 to possess a controlled substance unless such substance was 11 obtained directly from, or pursuant to, a valid prescription 12 or order of a practitioner while acting in the course of the 13 practitioner’s professional practice, or except as otherwise 14 authorized by this chapter . Any person who violates this 15 subsection is guilty of a serious misdemeanor for a first 16 offense. A person who commits a violation of this subsection 17 and who has previously been convicted of violating this chapter 18 or chapter 124A , 124B , or 453B , or chapter 124B as it existed 19 prior to the effective date of this Act, is guilty of an 20 aggravated misdemeanor. A person who commits a violation of 21 this subsection and has previously been convicted two or more 22 times of violating this chapter or chapter 124A , 124B , or 453B , 23 or chapter 124B as it existed prior to the effective date of 24 this Act, is guilty of a class “D” felony. 25 Sec. 12. Section 155A.6, subsection 3, Code 2017, is amended 26 to read as follows: 27 3. The board shall establish standards for 28 pharmacist-intern registration and may deny, suspend, 29 or revoke a pharmacist-intern registration for failure to meet 30 the standards or for any violation of the laws of this state, 31 another state, or the United States relating to prescription 32 drugs, controlled substances, or nonprescription drugs, or for 33 any violation of this chapter or chapter 124 , 124A , 124B , 126 , 34 147 , or 205 , or any rule of the board. 35 -3- LSB 1287DP (16) 87 jm/nh 3/ 8

S.F. _____ H.F. _____ Sec. 13. Section 155A.6A, subsection 5, Code 2017, is 1 amended to read as follows: 2 5. The board may deny, suspend, or revoke the registration 3 of, or otherwise discipline, a registered pharmacy technician 4 for any violation of the laws of this state, another state, or 5 the United States relating to prescription drugs, controlled 6 substances, or nonprescription drugs, or for any violation of 7 this chapter or chapter 124 , 124A , 124B , 126 , 147 , 205 , or 8 272C , or any rule of the board. 9 Sec. 14. Section 155A.6B, subsection 5, Code 2017, is 10 amended to read as follows: 11 5. The board may deny, suspend, or revoke the registration 12 of a pharmacy support person or otherwise discipline the 13 pharmacy support person for any violation of the laws of 14 this state, another state, or the United States relating to 15 prescription drugs, controlled substances, or nonprescription 16 drugs, or for any violation of this chapter or chapter 124 , 17 124A , 124B , 126 , 147 , 205 , or 272C , or any rule of the board. 18 Sec. 15. Section 155A.13A, subsection 5, paragraph d, Code 19 2017, is amended to read as follows: 20 d. Any violation of this chapter or chapter 124 , 124A , 124B , 21 126 , or 205 , or rule of the board. 22 Sec. 16. Section 155A.13C, subsection 5, paragraph d, Code 23 2017, is amended to read as follows: 24 d. Any violation of this chapter or chapter 124 , 124A , 124B , 25 126 , or 205 , or rule of the board. 26 Sec. 17. Section 155A.17, subsection 2, Code 2017, is 27 amended to read as follows: 28 2. The board shall establish standards for drug wholesaler 29 licensure and may define specific types of wholesaler licenses. 30 The board may deny, suspend, or revoke a drug wholesale license 31 for failure to meet the applicable standards or for a violation 32 of the laws of this state, another state, or the United 33 States relating to prescription drugs, devices, or controlled 34 substances, or for a violation of this chapter , chapter 124 , 35 -4- LSB 1287DP (16) 87 jm/nh 4/ 8

S.F. _____ H.F. _____ 124A , 124B , 126 , or 205 , or a rule of the board. 1 Sec. 18. Section 155A.42, subsection 4, Code 2017, is 2 amended to read as follows: 3 4. The board may deny, suspend, or revoke a limited drug and 4 device distributor’s license for failure to meet the applicable 5 standards or for a violation of the laws of this state, another 6 state, or the United States relating to prescription drugs or 7 controlled substances, or for a violation of this chapter , 8 chapter 124 , 124A , 124B , 126 , 205 , or 272C , or a rule of the 9 board. 10 Sec. 19. REPEAL. Chapter 124B, Code 2017, is repealed. 11 DIVISION III 12 EFFECTIVE DATE 13 Sec. 20. EFFECTIVE UPON ENACTMENT. This Act, being deemed 14 of immediate importance, takes effect upon enactment. 15 EXPLANATION 16 The inclusion of this explanation does not constitute agreement with 17 the explanation’s substance by the members of the general assembly. 18 This bill makes changes to the controlled substance 19 schedules and modifies the regulation of precursor substances. 20 DIVISION I —— CONTROLLED SUBSTANCES. The bill classifies 21 four synthetic opioids as schedule I controlled substances in 22 conformance with scheduling actions taken by the United States 23 department of justice, drug enforcement administration. The 24 bill also classifies as a schedule I controlled substance a 25 micro-opioid receptor agonist with analgesic activity similar 26 to morphine. 27 The bill classifies thiafentanil, an opioid and analogue of 28 fentanyl, as a schedule II controlled substance. 29 The bill removes hydrocodone-combination products from 30 the list of substances classified as schedule III controlled 31 substances. Currently, hydrocodone, as a single-entity 32 substance, is classified as a schedule II controlled 33 substance. The change under the bill effectively makes all 34 hydrocodone-containing products subject to the controls, 35 -5- LSB 1287DP (16) 87 jm/nh 5/ 8

S.F. _____ H.F. _____ security, reporting, and penalty provisions for schedule II 1 controlled substances. 2 The bill removes naloxegol, a new molecular entity and 3 derivative of naloxone, from control as a schedule III 4 controlled substance. The federal food and drug administration 5 approved naloxegol for the treatment of opioid-induced 6 constipation in adults with chronic non-cancer pain. 7 The bill also removes [\123\I]ioflupane from control as 8 a schedule II controlled substance. This substance is a new 9 molecular entity and is the active pharmaceutical ingredient 10 in the drug DaTscan, approved by the federal food and drug 11 administration for use in diagnosis of patients suspected of 12 having Parkinson’s disease. 13 The bill classifies the substance commonly known as 14 tramadol, a centrally acting opioid analgesic, as a schedule 15 IV controlled substance. This substance was previously 16 marketed and distributed as a noncontrolled prescription 17 drug. Effective August 18, 2014, the federal drug enforcement 18 administration classified tramadol as a schedule IV controlled 19 substance under federal law. 20 The bill classifies alfaxalone, a neurosteroid with central 21 nervous system depressant properties, as a schedule IV 22 controlled substance. The federal food and drug administration 23 approved this intravenous injectable anesthetic for use by or 24 on the order of a licensed veterinarian. Alfaxalone is not 25 available by prescription and is approved for use in veterinary 26 practice. 27 The bill classifies suvorexant, an insomnia treatment 28 approved by the federal food and drug administration, 29 as a schedule IV controlled substance. This is a novel, 30 first-in-class, chemical substance and information on actual 31 abuse data is not available. However, data from clinical 32 studies supports the classification in schedule IV. 33 The bill classifies eluxadoline, a new entity with central 34 nervous system opioid properties approved by the federal food 35 -6- LSB 1287DP (16) 87 jm/nh 6/ 8

S.F. _____ H.F. _____ and drug administration for the treatment of irritable bowel 1 syndrome with diarrhea, as a schedule IV controlled substance. 2 The bill classifies brivaracetam, also known as briviact 3 or BRV, as a schedule V controlled substance. Briviact is a 4 new molecular entity with central nervous system depressant 5 properties and has been approved as an add-on treatment to 6 other medications to treat partial onset seizures in patients 7 age 16 years and older with epilepsy. 8 It is a class “C” felony pursuant to Code section 9 124.401(1)(c)(8) for any unauthorized person to violate a 10 provision of Code section 124.401 involving a classified 11 substance placed on schedule I, II, or III pursuant to the 12 bill. A class “C” felony for this particular offense is 13 punishable by confinement for no more than 10 years and a fine 14 of at least $1,000 but not more than $50,000. 15 It is an aggravated misdemeanor pursuant to Code section 16 124.401(1)(d) for any unauthorized person to violate a 17 provision of Code section 124.401 involving a classified 18 substance placed on schedule IV pursuant to the bill. An 19 aggravated misdemeanor is punishable by confinement for no more 20 than two years and a fine of at least $625 but not more than 21 $6,250. 22 If a person possesses a controlled substance in violation of 23 Code section 124.401(5) as a first offense, the person commits 24 a serious misdemeanor. A serious misdemeanor is punishable by 25 confinement for no more than one year and a fine of at least 26 $315 but not more than $1,875. 27 DIVISION II —— PRECURSOR SUBSTANCES. The bill repeals 28 Code chapter 124B relating to the regulation of precursor 29 substances. Code section 124B.1 defines “precursor substance” 30 to mean a substance which may be used as a precursor in 31 the illegal production of a controlled substance and is 32 specified in Code section 124B.2. Under Code section 124B.2, a 33 manufacturer, retailer, or other person who sells, transfers, 34 or otherwise furnishes to any person in this state a substance 35 -7- LSB 1287DP (16) 87 jm/nh 7/ 8

S.F. _____ H.F. _____ listed in Code section 124B.2 is required to file a report with 1 the board of pharmacy unless certain exceptions apply under 2 Code section 124B.6. A person who commits a violation of Code 3 chapter 124B is subject to criminal penalties ranging from a 4 simple misdemeanor to a class “C” felony. 5 DIVISION III —— EFFECTIVE DATE. The bill takes effect upon 6 enactment. 7 -8- LSB 1287DP (16) 87 jm/nh 8/ 8