Senate Study Bill 3073 - Introduced SENATE/HOUSE FILE _____ BY (PROPOSED BOARD OF PHARMACY BILL) A BILL FOR An Act relating to controlled substances and precursor 1 substances, including provisions relating to the 2 registration of persons who manufacture, distribute, 3 or dispense controlled substances, adding substances 4 to the controlled substance schedules, expanding the 5 list of precursor substances for which reporting is 6 required, providing penalties, and including effective date 7 provisions. 8 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 9 TLSB 5274DP (8) 87 jm/rh

S.F. _____ H.F. _____ DIVISION I 1 REGISTRATION AND DISCIPLINE 2 Section 1. Section 124.302, subsections 1 and 4, Code 2018, 3 are amended to read as follows: 4 1. Every person who manufactures, distributes, or dispenses 5 any controlled substance within in this state or who proposes 6 to engage in the manufacture, distribution, or dispensing 7 of any controlled substance within this state, shall obtain 8 and maintain a biennial registration issued by the board in 9 accordance with its rules. 10 4. A separate registration is required for each principal 11 place of business or professional practice where the applicant 12 manufactures, distributes, or dispenses , or conducts research 13 with controlled substances. 14 Sec. 2. Section 124.304, subsection 1, Code 2018, is amended 15 to read as follows: 16 1. The board may suspend, revoke, or restrict a registration 17 under section 124.303 to manufacture, distribute, or dispense 18 a controlled substance , or otherwise discipline a registrant, 19 upon a finding that any of the following apply to the 20 registrant: 21 a. The registrant has furnished false or fraudulent material 22 information in any application filed under this chapter or 23 any other chapter which applies to the registrant or the 24 registrant’s practice . 25 b. The registrant has had the registrant’s federal 26 registration to manufacture, distribute, or dispense , or 27 conduct research with controlled substances suspended, revoked, 28 or restricted. 29 c. The registrant has been convicted of a public offense 30 under any state or federal law relating to any controlled 31 substance. For the purpose of this section only, a conviction 32 shall include a plea of guilty, a forfeiture of bail or 33 collateral deposited to secure a defendant’s appearance in 34 court which forfeiture has not been vacated, or a finding 35 -1- LSB 5274DP (8) 87 jm/rh 1/ 9

S.F. _____ H.F. _____ of guilt in a criminal action even though the entry of the 1 judgment or sentence has been withheld and the individual 2 placed on probation. 3 d. The registrant has committed such acts as would 4 render the registrant’s registration under section 124.303 5 inconsistent with the public interest as determined under that 6 section. 7 e. If the registrant is a licensed health care professional, 8 the registrant has had the registrant’s professional license 9 revoked or suspended or has been otherwise disciplined in a 10 way that restricts the registrant’s authority to handle or 11 prescribe controlled substances. 12 Sec. 3. Section 124.304, subsections 2, 3, and 4, Code 2018, 13 are amended to read as follows: 14 2. The board may limit revocation , or suspension , or 15 restriction of a registration or discipline of a registrant 16 to the particular controlled substance with respect to 17 which grounds for revocation , or suspension , restriction, or 18 discipline exist. 19 3. If the board suspends , or revokes , or restricts a 20 registration, or otherwise disciplines a registrant, all 21 controlled substances owned or possessed by the registrant 22 at the time of the suspension , revocation, restriction, 23 or discipline, or at the time of the effective date of the 24 revocation order , may be placed under seal. No disposition 25 may be made of substances under seal until the time for taking 26 an appeal has elapsed or until all appeals have been concluded 27 unless a court, upon application, orders the sale of perishable 28 substances and the deposit of the proceeds of the sale with the 29 court. Upon a revocation an order becoming final, all such 30 controlled substances may be forfeited to the state. 31 4. The board shall promptly notify the bureau and 32 the department of all orders suspending , or revoking , or 33 restricting a registration and all forfeitures of controlled 34 substances , or otherwise disciplining a registrant . 35 -2- LSB 5274DP (8) 87 jm/rh 2/ 9

S.F. _____ H.F. _____ Sec. 4. Section 124.305, Code 2018, is amended to read as 1 follows: 2 124.305 Order to show cause Contested case proceedings . 3 1. Before denying, Prior to suspending , restricting, or 4 revoking a registration, or refusing a renewal of registration, 5 or otherwise disciplining a registrant, the board shall serve 6 upon the applicant or registrant an order to show cause why 7 registration should not be denied, revoked, or suspended, or 8 why the renewal should not be refused. The order to show 9 cause shall contain a statement of the basis therefor and 10 shall call upon the applicant or registrant to appear before 11 the board at a time and place not less than thirty days after 12 the date of service of the order, but in the case of a denial 13 or renewal of registration the show cause order shall be 14 served not later than thirty days before the expiration of 15 the registration a notice in accordance with section 17A.12, 16 subsection 1 . The proceedings shall comply with the contested 17 case procedures in accordance with chapter 17A. These The 18 proceedings shall also be conducted without regard to any 19 criminal prosecution or other proceeding. Proceedings to 20 refuse renewal of registration shall not abate the existing 21 registration which shall remain in effect pending the outcome 22 of the administrative hearing. 23 2. The board , without an order to show cause , may suspend 24 any registration while simultaneously with the institution 25 of proceedings under section 124.304 , or where renewal of 26 registration is refused, pursuing emergency adjudicative 27 proceedings in accordance with section 17A.18A, if it finds 28 that there is an imminent danger to the public health or 29 safety which warrants this action. The suspension shall 30 continue in effect until the conclusion of the proceedings, 31 including judicial review thereof, under the provisions of 32 the Iowa administrative procedure Act, chapter 17A , unless 33 sooner withdrawn by the board or dissolved by the order of the 34 district court or an appellate court. 35 -3- LSB 5274DP (8) 87 jm/rh 3/ 9

S.F. _____ H.F. _____ DIVISION II 1 ADDITIONAL CONTROLLED SUBSTANCES AND PRECURSOR SUBSTANCES 2 Sec. 5. Section 124.204, subsection 9, Code 2018, is amended 3 by adding the following new paragraphs: 4 NEW PARAGRAPH . t. Methyl 2-(1-(5-fluoropentyl)- 5 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 6 positional, and geometric isomers, salts, and salts of isomers. 7 Other names: 5F-ADB; 5F-MDMB-PINACA. 8 NEW PARAGRAPH . u. Methyl 2-(1-(5-fluoropentyl)-1H- 9 indazole-3-carboxamido)-3-methylbutanoate, its optical, 10 positional, and geometric isomers, salts, and salts of isomers. 11 Other name: 5F-AMB. 12 NEW PARAGRAPH . v. N-(adamantan-1-yl)-1-(5- 13 fluoropentyl)-1H-indazole-3-carboxamide, its optical, 14 positional, and geometric isomers, salts, and salts of isomers. 15 Other names: 5F-APINACA, 5F-AKB48. 16 NEW PARAGRAPH . w. N-(1-amino-3,3-dimethyl-1- 17 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, 18 its optical, positional, and geometric isomers, salts, and 19 salts of isomers. Other name: ADB-FUBINACA. 20 NEW PARAGRAPH . x. Methyl 2-(1-(cyclohexylmethyl)-1H- 21 indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 22 positional, and geometric isomers, salts, and salts of isomers. 23 Other names: MDMB-CHMICA, MMB-CHMINACA 24 NEW PARAGRAPH . y. Methyl 2-(1-(4-fluorobenzyl)-1H- 25 indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 26 positional, and geometric isomers, salts, and salts of 27 isomers. Other name: MDMB-FUBINACA. 28 NEW PARAGRAPH . z. N-(4-fluorophenyl)-N-(1- 29 phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, 30 ethers, salts, and salts of isomers, esters, and ethers. Other 31 names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl 32 fentanyl. 33 NEW PARAGRAPH . aa. N-(2-fluorophenyl)-N-(1- 34 phenethylpiperidin-4-yl) propionamide. Other names: ortho- 35 -4- LSB 5274DP (8) 87 jm/rh 4/ 9

S.F. _____ H.F. _____ fluorofentanyl or 2-fluorofentanyl. 1 NEW PARAGRAPH . ab. N-(1-phenethylpiperidin-4-yl)-N- 2 phenyltetrahydrofuran-2-carboxamide. Other name: 3 tetrahydrofuranyl fentanyl. 4 NEW PARAGRAPH . ac. 2-methoxy-N-(1-phenethylpiperidin-4- 5 yl)-N-phenylacetamide. Other name: methoxyacetyl fentanyl. 6 NEW PARAGRAPH . ad. N-(1-phenethylpiperidin-4-yl)-N- 7 phenylacrylamide. Other names: acryl fentanyl or 8 acryloylfentanyl. 9 NEW PARAGRAPH . ae. Methyl 2-(1-(4-fluorobenzyl)-1H- 10 indazole-3-carboxamido)-3-methylbutanoate, its optical, 11 positional, and geometric isomers, salts, and salts of isomers. 12 Other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA. 13 Sec. 6. Section 124.206, subsection 7, Code 2018, is amended 14 by adding the following new paragraph: 15 NEW PARAGRAPH . c. Dronabinol [(-)-delta-9-trans- 16 tetrahydrocannabinol] in an oral solution in a drug product 17 approved for marketing by the United States food and drug 18 administration. 19 Sec. 7. Section 124B.2, subsection 1, Code 2018, is amended 20 by adding the following new paragraph: 21 NEW PARAGRAPH . ab. Alpha-phenylacetoacetonitrile and its 22 salts, optical isomers, and salts of optical isomers. Other 23 name: APAAN. 24 Sec. 8. EFFECTIVE DATE. This division of this Act, being 25 deemed of immediate importance, takes effect upon enactment. 26 EXPLANATION 27 The inclusion of this explanation does not constitute agreement with 28 the explanation’s substance by the members of the general assembly. 29 This bill relates to controlled substances and precursor 30 substances including provisions relating to the registration 31 of persons who manufacture, distribute, or dispense controlled 32 substances, adding substances to the controlled substance 33 schedules, and expanding the list of precursor substances for 34 which reporting is required. 35 -5- LSB 5274DP (8) 87 jm/rh 5/ 9

S.F. _____ H.F. _____ DIVISION I. The bill provides that a person who 1 manufactures, distributes, or dispenses any controlled 2 substance in this state or who proposes to engage in such 3 activities in this state (registrant), obtain and maintain 4 a registration issued by the board of pharmacy. Currently, 5 a registrant is required to obtain and maintain a biennial 6 registration issued by the board of pharmacy. 7 The bill requires a separate registration for each principal 8 place of business of a registrant, when the registrant is 9 conducting research with controlled substances. Currently, 10 a separate registration is required for each principal place 11 of business where a registrant manufactures, distributes, or 12 dispenses controlled substances. 13 The bill permits the board of pharmacy to take disciplinary 14 action against a registrant who manufactures, distributes, 15 or dispenses any controlled substance within this state, 16 without restricting, suspending, or revoking the registration. 17 Currently, the board of pharmacy does not have the option to 18 take disciplinary action against a registrant. 19 The bill provides that the board of pharmacy may discipline 20 a registrant when the registrant has furnished false or 21 fraudulent material information in any application under any 22 Code chapter which applies to the registrant. Currently, the 23 board of pharmacy may take action against a registrant when 24 the registrant has furnished false or fraudulent material 25 information in any application under only Code chapter 124 26 (controlled substances). 27 The bill provides that the board of pharmacy may limit the 28 restriction of a registrant’s registration or discipline of a 29 registrant to a particular controlled substance when grounds 30 exist for such restriction or discipline. Currently, the 31 board of pharmacy may impose such limits only when revoking or 32 suspending a registrant’s registration. 33 Under the bill, if the board of pharmacy restricts a 34 registrant’s registration or disciplines a registrant, all 35 -6- LSB 5274DP (8) 87 jm/rh 6/ 9

S.F. _____ H.F. _____ controlled substances owned or possessed by the registrant at 1 the time of the restriction or at the time of the effective 2 date of the order may be place under seal. Currently, if 3 the board of pharmacy suspends or revokes a registrant’s 4 registration, all controlled substances owned or possessed by 5 the registrant at the time of the suspension or revocation or 6 at the time of the effective date of the order may be placed 7 under seal. 8 The bill requires the board of pharmacy to notify the 9 federal bureau of narcotics and dangerous drugs, United States 10 department of justice, or its successor agency, of all orders 11 restricting a registrant’s registration or disciplining a 12 registrant. Under current law, the board shall notify the 13 federal agency when suspending or revoking the registration 14 of a registrant including all forfeitures of controlled 15 substances. 16 If the board of pharmacy decides to suspend, restrict, or 17 revoke a registrant’s registration or discipline a registrant, 18 the bill requires the board to serve upon the registrant a 19 notice in accordance with Code section 17A.12. Currently, the 20 board of pharmacy institutes such proceedings by serving an 21 order to show cause why the registrant should not be denied, 22 revoked, or suspended, or why the registration should not be 23 refused. 24 The bill permits the board of pharmacy to suspend a 25 registrant’s registration while simultaneously pursuing an 26 emergency adjudicative proceeding in accordance with Code 27 section 17A.18A, if the board finds there is an immediate 28 danger to the public health, safety, or welfare. Currently, 29 the board of pharmacy may suspend a registrant’s registration 30 without an order to show cause, if the board finds there is an 31 imminent danger to the public health or safety. 32 DIVISION II. The bill classifies nine substances as 33 schedule I controlled substances and one substance as a 34 schedule II controlled substance in conformance with scheduling 35 -7- LSB 5274DP (8) 87 jm/rh 7/ 9

S.F. _____ H.F. _____ actions taken by the United States department of justice, drug 1 enforcement administration. 2 For the nine schedule I controlled substances added in Code 3 section 124.204(9) under the bill, the penalties under Code 4 section 124.401(1)(a),(b), and (c) range, depending upon the 5 amount of the controlled substance involved, from a class “B” 6 felony punishable by confinement for not more than 50 years 7 and a fine of not more than $1 million, to a class “C” felony 8 punishable by confinement of not more than 10 years and a fine 9 of at least $1,000 and not more than $50,000. If a person 10 unlawfully possesses any such controlled substance in violation 11 of Code section 124.401(5), the person commits a serious 12 misdemeanor for a first offense. A serious misdemeanor is 13 punishable by confinement for no more than one year and a fine 14 of at least $315 but not more than $1,875. 15 For the schedule II controlled substance added under Code 16 section 124.206, it is a class “C” felony pursuant to Code 17 section 124.401(1)(c)(9) for any unauthorized person to violate 18 a provision of Code section 124.401(1) involving a schedule II 19 controlled substance. A class “C” felony for this particular 20 offense is punishable by confinement for no more than 10 years 21 and a fine of at least $1,000 but not more than $50,000. If a 22 person unlawfully possesses a schedule II controlled substance 23 in violation of Code section 124.401(5), the person commits a 24 serious misdemeanor for a first offense. A serious misdemeanor 25 is punishable by confinement for no more than one year and a 26 fine of at least $315 but not more than $1,875. 27 The bill also classifies a substance as a precursor 28 substance for purposes of certain reporting requirements. A 29 “precursor substance” is defined in Code section 124B.1 to 30 mean a substance which may be used as a precursor in the 31 illegal production of a controlled substance. A person who 32 sells, transfers, or otherwise furnishes a precursor substance 33 with knowledge or the intent that the recipient will use the 34 precursor substance to unlawfully manufacture a controlled 35 -8- LSB 5274DP (8) 87 jm/rh 8/ 9

S.F. _____ H.F. _____ substance commits a class “C” felony under Code section 1 124B.9(1). A person who receives a precursor substance with 2 the intent that the substance be used unlawfully to manufacture 3 a controlled substance commits a class “C” felony under 4 Code section 124B.9(2). A class “C” felony is punishable by 5 confinement for no more than 10 years and a fine of at least 6 $1,000 but not more than $10,000. 7 This division takes effect upon enactment. 8 -9- LSB 5274DP (8) 87 jm/rh 9/ 9