House File 2377 - Introduced HOUSE FILE 2377 BY COMMITTEE ON HUMAN RESOURCES (SUCCESSOR TO HF 2299) A BILL FOR An Act relating to the regulation of the practice of pharmacy, 1 providing penalties, and including effective date 2 provisions. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 6028HV (3) 87 ss/rh

H.F. 2377 DIVISION I 1 REGULATION OF THE PRESCRIPTION MONITORING PROGRAM 2 Section 1. Section 124.550, Code 2018, is amended by adding 3 the following new subsection: 4 NEW SUBSECTION . 3. “Program” means the information program 5 for drug prescribing and dispensing. 6 Sec. 2. Section 124.551, subsection 2, Code 2018, is amended 7 to read as follows: 8 2. The program shall collect from pharmacies dispensing 9 information for controlled substances identified pursuant 10 to section 124.554, subsection 1 , paragraph “g” , and from 11 first responders as defined in section 147A.1 administration 12 information for opioid antagonists . The information collected 13 shall be used by prescribing practitioners and pharmacists on 14 a need-to-know basis for purposes of improving patient health 15 care by facilitating early identification of patients who may 16 be at risk for addiction, or who may be using, abusing, or 17 diverting drugs for unlawful or otherwise unauthorized purposes 18 at risk to themselves and others, or who may be appropriately 19 using controlled substances lawfully prescribed for them but 20 unknown to the practitioner. 21 Sec. 3. NEW SECTION . 124.551A Prescribing practitioner 22 program registration. 23 A prescribing practitioner shall register for the program 24 at the same time the practitioner applies to the board to 25 register or renews registration to prescribe controlled 26 substances as required by the board. Once the prescribing 27 practitioner registers for the program, the practitioner 28 shall utilize the program database as prescribed by rule to 29 assist the prescribing practitioner in determining appropriate 30 treatment options and to improve the quality of patient care. 31 A prescribing practitioner shall not be required to utilize 32 the program database to assist in the treatment of a patient 33 receiving inpatient hospice care or long-term residential 34 facility patient care. 35 -1- LSB 6028HV (3) 87 ss/rh 1/ 29

H.F. 2377 Sec. 4. Section 124.552, Code 2018, is amended to read as 1 follows: 2 124.552 Information reporting. 3 1. Each Unless otherwise prohibited by federal or state law, 4 each licensed pharmacy that dispenses controlled substances 5 identified pursuant to section 124.554, subsection 1 , paragraph 6 “g” , to patients in the state, and each licensed pharmacy 7 located in the state that dispenses such controlled substances 8 identified pursuant to section 124.554, subsection 1 , 9 paragraph “g” , to patients inside or outside the state, unless 10 specifically excepted in this section or by rule, and each 11 prescribing practitioner furnishing, dispensing, or supplying 12 controlled substances to the prescribing practitioner’s 13 patient, shall submit the following prescription information 14 to the program: 15 a. Pharmacy identification. 16 b. Patient identification. 17 c. Prescribing practitioner identification. 18 d. The date the prescription was issued by the prescribing 19 practitioner. 20 e. The date the prescription was dispensed. 21 f. An indication of whether the prescription dispensed is 22 new or a refill. 23 g. Identification of the drug dispensed. 24 h. Quantity of the drug dispensed. 25 i. The number of days’ supply of the drug dispensed. 26 j. Serial or prescription number assigned by the pharmacy. 27 k. Type of payment for the prescription. 28 l. Other information identified by the board and advisory 29 council by rule. 30 2. Information shall be submitted electronically in a 31 secure format specified by the board unless the board has 32 granted a waiver and approved an alternate secure format. 33 3. Information shall be timely transmitted as designated 34 by the board and advisory council by rule within twenty-four 35 -2- LSB 6028HV (3) 87 ss/rh 2/ 29

H.F. 2377 hours of the dispensing of the controlled substance , unless the 1 board grants an extension. The board may grant an extension if 2 either of the following occurs: 3 a. The pharmacy or prescribing practitioner suffers 4 a mechanical or electronic failure, or cannot meet the 5 deadline established by the board for other reasons beyond the 6 pharmacy’s or practitioner’s control. 7 b. The board is unable to receive electronic submissions. 8 4. This section shall not apply to a prescribing 9 practitioner furnishing, dispensing, supplying, or 10 administering drugs to the prescribing practitioner’s patient, 11 or to dispensing by a licensed pharmacy for the purposes of 12 inpatient hospital care, inpatient hospice care , or long-term 13 residential facility patient care. 14 Sec. 5. Section 124.553, subsection 4, Code 2018, is amended 15 by striking the subsection. 16 Sec. 6. Section 124.554, subsection 1, paragraphs b, c, d, 17 and g, Code 2018, are amended to read as follows: 18 b. An electronic format for the submission of information 19 from pharmacies and prescribing practitioners . 20 c. A waiver to submit information in another format for 21 a pharmacy or prescribing practitioner unable to submit 22 information electronically. 23 d. An application by a pharmacy or prescribing practitioner 24 for an extension of time for transmitting information to the 25 program. 26 g. Including all schedule II controlled substances , and 27 those substances in schedules III and IV that the advisory 28 council and board determine can be addictive or fatal if not 29 taken under the proper care and direction of a prescribing 30 practitioner , and opioid antagonists . 31 Sec. 7. Section 124.557, Code 2018, is amended to read as 32 follows: 33 124.557 Drug information program fund. 34 The drug information program fund is established to be used 35 -3- LSB 6028HV (3) 87 ss/rh 3/ 29

H.F. 2377 by the board to fund or assist in funding the program. The 1 board may make deposits into the fund from any source, public 2 or private, including grants or contributions of money or other 3 items of value, which it determines necessary to carry out the 4 purposes of this subchapter . The board may add a surcharge 5 of not more than twenty-five percent to the applicable fee 6 for a registration issued pursuant to section 124.302 and the 7 surcharge shall be deposited into the fund. Moneys received 8 by the board to establish and maintain the program must 9 be used for the expenses of administering this subchapter . 10 Notwithstanding section 8.33 , amounts contained in the fund 11 that remain unencumbered or unobligated at the close of the 12 fiscal year shall not revert but shall remain available for 13 expenditure for the purposes designated in future years. 14 Sec. 8. Section 124.558, subsection 1, Code 2018, is amended 15 to read as follows: 16 1. Failure to comply with requirements. A pharmacist, 17 pharmacy, prescribing practitioner, or agent of a pharmacist 18 or prescribing practitioner who knowingly fails to comply 19 with the confidentiality requirements of this subchapter 20 or who delegates program information access to another 21 individual except as provided in section 124.553 , is subject to 22 disciplinary action by the appropriate professional licensing 23 board. A pharmacist , or pharmacy , or prescribing practitioner 24 that knowingly fails to comply with other requirements of this 25 subchapter is subject to disciplinary action by the board. 26 Each licensing board may adopt rules in accordance with chapter 27 17A to implement the provisions of this section . 28 Sec. 9. Section 147A.4, Code 2018, is amended by adding the 29 following new subsection: 30 NEW SUBSECTION . 5. The department shall adopt rules 31 requiring first responders to report to the program the 32 following information regarding the administration of opioid 33 antagonists by first responders: 34 a. Patient identification. 35 -4- LSB 6028HV (3) 87 ss/rh 4/ 29

H.F. 2377 b. Identification of the person administering opioid 1 antagonists. 2 c. The date of administration. 3 d. The quantity of opioid antagonists administered. 4 DIVISION II 5 ELECTRONIC PRESCRIPTIONS 6 Sec. 10. Section 124.308, Code 2018, is amended by striking 7 the section and inserting in lieu thereof the following: 8 124.308 Prescriptions. 9 1. Except when dispensed directly by a practitioner to an 10 ultimate user, a prescription drug as defined in section 155A.3 11 that is a controlled substance shall not be dispensed without 12 a prescription, unless such prescription is authorized by a 13 practitioner and complies with this section, section 155A.27, 14 applicable federal law and regulation, and rules of the board. 15 2. a. Beginning January 1, 2020, every prescription issued 16 for a controlled substance shall be transmitted electronically 17 as an electronic prescription pursuant to the requirements in 18 subsection 2, paragraph “b” , unless exempt under subsection 2, 19 paragraph “c” . 20 b. Except for prescriptions identified in paragraph “c” , 21 a prescription that is transmitted pursuant to paragraph “a” 22 shall be transmitted to a pharmacy by a practitioner or the 23 practitioner’s authorized agent in compliance with federal 24 law and regulation for electronic prescriptions of controlled 25 substances. The practitioner’s electronic prescription system 26 and the receiving pharmacy’s dispensing system shall comply 27 with federal law and regulation for electronic prescriptions of 28 controlled substances. 29 c. Paragraph “b” shall not apply to any of the following: 30 (1) A prescription for a patient residing in a nursing home, 31 long-term care facility, correctional facility, or jail. 32 (2) A prescription authorized by a licensed veterinarian. 33 (3) A prescription dispensed by a department of veterans 34 affairs pharmacy. 35 -5- LSB 6028HV (3) 87 ss/rh 5/ 29

H.F. 2377 (4) A prescription requiring information that makes 1 electronic submission impractical, such as complicated or 2 lengthy directions for use or attachments. 3 (5) A prescription for a compounded preparation containing 4 two or more components. 5 (6) A prescription issued in response to a public health 6 emergency in a situation where a non-patient specific 7 prescription would be permitted. 8 (7) A prescription issued pursuant to an established and 9 valid collaborative practice agreement, standing order, or drug 10 research protocol, except for a standing order for an opioid 11 antagonist. 12 (8) A prescription issued during a temporary technical or 13 electronic failure at the prescriber’s or pharmacy’s location. 14 (9) A prescription issued in an emergency situation 15 pursuant to federal law and regulation rules of the board. 16 d. A practitioner, as defined in section 124.101, subsection 17 27, paragraph “a” , who violates paragraph “a” is subject 18 to an administrative penalty of two hundred fifty dollars 19 per violation, up to a maximum of five thousand dollars per 20 calendar year. The assessment of an administrative penalty 21 pursuant to this paragraph by the appropriate licensing board 22 of the practitioner alleged to have violated paragraph “a” 23 shall not be considered a disciplinary action and shall not be 24 released or reported as discipline. A practitioner may appeal 25 the assessment of an administrative penalty pursuant to this 26 paragraph, which shall initiate a contested case proceeding 27 under chapter 17A. A penalty collected pursuant to this 28 paragraph shall be deposited into the drug information program 29 fund established pursuant to section 124.557. The board shall 30 be notified of any administrative penalties assessed by the 31 appropriate professional licensing board and deposited into the 32 drug information program fund under this paragraph. 33 3. A prescription issued prior to January 1, 2020, or a 34 prescription that is exempt from the electronic prescription 35 -6- LSB 6028HV (3) 87 ss/rh 6/ 29

H.F. 2377 requirement in subsection 2, paragraph “c” , may be transmitted 1 by a practitioner or the practitioner’s authorized agent to a 2 pharmacy in any of the following ways: 3 a. Electronically, if transmitted in accordance with 4 the requirements for electronic prescriptions pursuant to 5 subsection 2. 6 b. By facsimile for a schedule III, IV, or V controlled 7 substance, or for a schedule II controlled substance only 8 pursuant to federal law and regulation and rules of the board. 9 c. Orally for a schedule III, IV, or V controlled substance, 10 or for a schedule II controlled substance only in an emergency 11 situation pursuant to federal regulation and rules of the 12 board. 13 d. By providing an original signed prescription to a patient 14 or a patient’s authorized representative. 15 4. If permitted by federal law and in accordance with 16 federal requirements, an electronic or facsimile prescription 17 shall serve as the original signed prescription and the 18 practitioner shall not provide a patient, a patient’s 19 authorized representative, or the dispensing pharmacy with a 20 signed, written prescription. An original signed prescription 21 shall be retained for a minimum of two years from the date of 22 the latest dispensing or refill of the prescription. 23 5. A prescription for a schedule II controlled substance 24 shall not be filled more than six months after the date 25 of issuance. A prescription for a schedule II controlled 26 substance shall not be refilled. 27 6. A prescription for a schedule III, IV, or V controlled 28 substance shall not be filled or refilled more than six months 29 after the date on which the prescription was issued or be 30 refilled more than five times. 31 7. A controlled substance shall not be distributed or 32 dispensed other than for a medical purpose. 33 8. A practitioner, medical group, or pharmacy that is unable 34 to timely comply with the electronic prescribing requirements 35 -7- LSB 6028HV (3) 87 ss/rh 7/ 29

H.F. 2377 in subsection 2, paragraph “b” , may petition the board for an 1 exemption from the requirements based upon economic hardship, 2 technical limitations that the practitioner, medical group, or 3 pharmacy cannot control, or other exceptional circumstances. 4 The board shall adopt rules establishing the form and specific 5 information to be included in a request for an exemption 6 and the specific criteria to be considered by the board in 7 determining whether to approve a request for an exemption. The 8 board may approve an exemption for a period of time determined 9 by the board not to exceed one year from the date of approval, 10 and may be renewed annually upon request subject to board 11 approval. 12 Sec. 11. Section 155A.27, Code 2018, is amended by striking 13 the section and inserting in lieu thereof the following: 14 155A.27 Requirements for prescription. 15 1. Except when dispensed directly by a prescriber to an 16 ultimate user, a prescription drug shall not be dispensed 17 without a prescription, authorized by a prescriber, and based 18 on a valid patient-prescriber relationship. 19 2. a. Beginning January 1, 2020, every prescription issued 20 for a prescription drug shall be transmitted electronically as 21 an electronic prescription to a pharmacy by a prescriber or the 22 prescriber’s authorized agent unless exempt under paragraph 23 “b” . 24 b. Paragraph “a” shall not apply to any of the following: 25 (1) A prescription for a patient residing in a nursing home, 26 long-term care facility, correctional facility, or jail. 27 (2) A prescription authorized by a licensed veterinarian. 28 (3) A prescription for a device. 29 (4) A prescription dispensed by a department of veterans 30 affairs pharmacy. 31 (5) A prescription requiring information that makes 32 electronic transmission impractical, such as complicated or 33 lengthy directions for use or attachments. 34 (6) A prescription for a compounded preparation containing 35 -8- LSB 6028HV (3) 87 ss/rh 8/ 29

H.F. 2377 two or more components. 1 (7) A prescription issued in response to a public health 2 emergency in a situation where a non-patient specific 3 prescription would be permitted. 4 (8) A prescription issued for epinephrine pursuant to 5 section 135.185. 6 (9) A prescription issued pursuant to an established and 7 valid collaborative practice agreement, standing order, or drug 8 research protocol except for a standing order for an opioid 9 antagonist. 10 (10) A prescription issued during a temporary technical 11 or electronic failure at the location of the prescriber or 12 pharmacy. 13 (11) A prescription issued in an emergency situation 14 pursuant to federal law and regulation and rules of the board. 15 c. A practitioner, as defined in section 124.101, subsection 16 27, paragraph “a” , who violates paragraph “a” is subject 17 to an administrative penalty of two hundred fifty dollars 18 per violation, up to a maximum of five thousand dollars per 19 calendar year. The assessment of an administrative penalty 20 pursuant to this paragraph by the appropriate licensing board 21 of the practitioner alleged to have violated paragraph “a” 22 shall not be considered a disciplinary action and shall not be 23 released or reported as discipline. A practitioner may appeal 24 the assessment of an administrative penalty pursuant to this 25 paragraph, which shall initiate a contested case proceeding 26 under chapter 17A. A penalty collected pursuant to this 27 paragraph shall be deposited into the drug information program 28 fund established pursuant to section 124.557. The board shall 29 be notified of any administrative penalties assessed by the 30 appropriate professional licensing board and deposited into the 31 drug information program fund under this paragraph. 32 3. For prescriptions issued prior to January 1, 2020, 33 or for prescriptions exempt from the electronic prescription 34 requirement in subsection 2, paragraph “b” , a prescriber or the 35 -9- LSB 6028HV (3) 87 ss/rh 9/ 29

H.F. 2377 prescriber’s authorized agent may transmit a prescription for a 1 prescription drug to a pharmacy by any of the following means: 2 a. Electronically. 3 b. By facsimile. 4 c. Orally. 5 d. By providing an original signed prescription to a patient 6 or a patient’s authorized representative. 7 4. A prescription shall be issued in compliance with 8 this subsection. Regardless of the means of transmission, a 9 prescriber shall provide verbal verification of a prescription 10 upon request of the pharmacy. 11 a. If written, electronic, or facsimile, each prescription 12 shall contain all of the following: 13 (1) The date of issue. 14 (2) The name and address of the patient for whom, or the 15 owner of the animal for which, the drug is dispensed. 16 (3) The name, strength, and quantity of the drug prescribed. 17 (4) The directions for use of the drug, medicine, or device 18 prescribed. 19 (5) The name, address, and written or electronic signature 20 of the prescriber issuing the prescription. 21 (6) The federal drug enforcement administration number, if 22 required under chapter 124. 23 b. If electronic, each prescription shall comply with all 24 of the following: 25 (1) The prescriber shall ensure that the electronic system 26 used to transmit the electronic prescription has adequate 27 security and safeguards designed to prevent and detect 28 unauthorized access, modification, or manipulation of the 29 prescription. 30 (2) Notwithstanding paragraph “a” , subparagraph (5), 31 for prescriptions that are not controlled substances, if 32 transmitted by an authorized agent, the electronic prescription 33 shall not require the written or electronic signature of the 34 prescriber issuing the prescription. 35 -10- LSB 6028HV (3) 87 ss/rh 10/ 29

H.F. 2377 c. If facsimile, in addition to the requirements of 1 paragraph “a” , each prescription shall contain all of the 2 following: 3 (1) The identification number of the facsimile machine 4 which is used to transmit the prescription. 5 (2) The date and time of transmission of the prescription. 6 (3) The name, address, telephone number, and facsimile 7 number of the pharmacy to which the prescription is being 8 transmitted. 9 d. If oral, the prescriber issuing the prescription 10 shall furnish the same information required for a written 11 prescription, except for the written signature and address 12 of the prescriber. Upon receipt of an oral prescription, 13 the recipient shall promptly reduce the oral prescription to 14 a written format by recording the information required in a 15 written prescription. 16 e. A prescription transmitted by electronic, facsimile, 17 or oral means by a prescriber’s agent shall also include 18 the name and title of the prescriber’s agent completing the 19 transmission. 20 5. An electronic, facsimile, or oral prescription 21 shall serve as the original signed prescription and the 22 prescriber shall not provide a patient, a patient’s authorized 23 representative, or the dispensing pharmacist with a signed 24 written prescription. Prescription records shall be retained 25 pursuant to rules of the board. 26 6. This section shall not prohibit a pharmacist, 27 in exercising the pharmacist’s professional judgment, 28 from dispensing, at one time, additional quantities of a 29 prescription drug, with the exception of a prescription drug 30 that is a controlled substance as defined in section 124.101, 31 up to the total number of dosage units authorized by the 32 prescriber on the original prescription and any refills of 33 the prescription, not to exceed a ninety-day supply of the 34 prescription drug as specified on the prescription. 35 -11- LSB 6028HV (3) 87 ss/rh 11/ 29

H.F. 2377 7. A prescriber, medical group, institution, or pharmacy 1 that is unable to timely comply with the electronic prescribing 2 requirements in subsection 2, paragraph “a” , may petition 3 the board for an exemption from the requirements based upon 4 economic hardship, technical limitations that the prescriber, 5 medical group, institution, or pharmacy cannot control, or 6 other exceptional circumstances. The board shall adopt rules 7 establishing the form and specific information to be included 8 in a request for an exemption and the specific criteria to be 9 considered by the board in determining whether to approve a 10 request for an exemption. The board may approve an exemption 11 for a period of time determined by the board, not to exceed one 12 year from the date of approval, and may be annually renewed 13 subject to board approval upon request. 14 Sec. 12. Section 155A.29, subsection 4, Code 2018, is 15 amended to read as follows: 16 4. An authorization to refill a prescription drug order may 17 shall be transmitted to a pharmacist pharmacy by a prescriber 18 or the prescriber’s authorized agent through word of mouth, 19 note, telephone, facsimile, or other means of communication 20 initiated by or directed by the practitioner. The transmission 21 shall include the information required pursuant to section 22 155A.27 , except that prescription drug orders for controlled 23 substances shall be transmitted pursuant to section 124.308, 24 and, if not transmitted directly by the practitioner, 25 shall identify by also include the name and title of the 26 practitioner’s agent completing the transmission. 27 DIVISION III 28 PRESCRIBER ACTIVITY REPORTS 29 Sec. 13. Section 124.553, subsection 1, Code 2018, is 30 amended by adding the following new paragraph: 31 NEW PARAGRAPH . g. A prescribing practitioner for the 32 issuance of a required report pursuant to section 124.554, 33 subsection 3. 34 Sec. 14. Section 124.554, subsection 1, Code 2018, is 35 -12- LSB 6028HV (3) 87 ss/rh 12/ 29

H.F. 2377 amended by adding the following new paragraph: 1 NEW PARAGRAPH . j. The issuance annually of a prescribing 2 practitioner activity report compiled from information from the 3 program pursuant to subsection 3. 4 Sec. 15. Section 124.554, Code 2018, is amended by adding 5 the following new subsection: 6 NEW SUBSECTION . 3. a. Beginning February 1, 2019, 7 and annually by February 1 thereafter, the board shall 8 electronically, and at as low a cost as possible, issue each 9 prescribing practitioner who prescribed a controlled substance 10 reported to the program as dispensed in the preceding calendar 11 year in this state a prescribing practitioner activity report 12 which shall include but not be limited to the following: 13 (1) A cover letter. 14 (2) A summary of the prescribing practitioner’s history of 15 prescribing controlled substances. 16 (3) A comparison of the prescribing practitioner’s history 17 of prescribing controlled substances with the history of other 18 prescribing practitioners of the same profession or specialty. 19 (4) The prescribing practitioner’s history of program use. 20 (5) General patient risk factors. 21 (6) Educational updates. 22 (7) Other pertinent information identified by the board and 23 advisory council by rule. 24 b. Information provided to a prescribing practitioner in a 25 report required under this subsection is privileged and shall 26 be kept confidential pursuant to section 124.553, subsection 3. 27 Sec. 16. Section 124.556, Code 2018, is amended to read as 28 follows: 29 124.556 Education and treatment. 30 The program for drug prescribing and dispensing shall 31 include education initiatives and outreach to consumers, 32 prescribing practitioners, and pharmacists, and shall also 33 include assistance for identifying substance abuse treatment 34 programs and providers. The program shall also include 35 -13- LSB 6028HV (3) 87 ss/rh 13/ 29

H.F. 2377 educational updates and information on general patient risk 1 factors for prescribing practitioners. The board and advisory 2 council shall adopt rules, as provided under section 124.554 , 3 to implement this section . 4 DIVISION IV 5 SUBSTANCE ABUSE PREVENTION 6 Sec. 17. Section 124.550, Code 2018, is amended by adding 7 the following new subsection: 8 NEW SUBSECTION . 3. “Proactive notification” means 9 a notification by the board, generated based on factors 10 determined by the board and issued to a specific prescribing 11 practitioner or pharmacist, indicating that a patient may 12 be practitioner shopping or pharmacy shopping or at risk of 13 abusing or misusing a controlled substance. 14 Sec. 18. Section 124.553, subsection 1, Code 2018, is 15 amended by adding the following new paragraph: 16 NEW PARAGRAPH . g. A prescribing practitioner or pharmacist 17 through the use of a targeted distribution of proactive 18 notifications. 19 Sec. 19. Section 124.553, subsections 2 and 3, Code 2018, 20 are amended to read as follows: 21 2. The board shall maintain a record of each person that 22 requests information from the program and of all proactive 23 notifications distributed to prescribing practitioners and 24 dispensing pharmacists as provided in subsection 1, paragraph 25 “g” . Pursuant to rules adopted by the board and advisory 26 council under section 124.554 , the board may use the records 27 to document and report statistical information, and may 28 provide program information for statistical, public research, 29 public policy, or educational purposes, after removing 30 personal identifying information of a patient, prescribing 31 practitioner, dispenser, or other person who is identified in 32 the information. 33 3. Information contained in the program and any information 34 obtained from it, and information contained in the records 35 -14- LSB 6028HV (3) 87 ss/rh 14/ 29

H.F. 2377 of requests for information from the program and information 1 distributed to prescribing practitioners and dispensing 2 pharmacists as provided in subsection 1, paragraph “g” , 3 is privileged and strictly confidential information. Such 4 information is a confidential public record pursuant to section 5 22.7 , and is not subject to discovery, subpoena, or other 6 means of legal compulsion for release except as provided in 7 this subchapter . Information from the program shall not be 8 released, shared with an agency or institution, or made public 9 except as provided in this subchapter . 10 Sec. 20. Section 124.554, subsection 1, Code 2018, is 11 amended by adding the following new paragraph: 12 NEW PARAGRAPH . j. The establishment of thresholds or other 13 criteria or measures to be used in identifying an at-risk 14 patient as provided in section 124.553, subsection 1, paragraph 15 “g” , and the targeted distribution of proactive notifications 16 suggesting review of the patient’s prescription history. 17 Sec. 21. NEW SECTION . 147.162 Rules and directives relating 18 to controlled substances. 19 1. Any board created under this chapter that licenses a 20 prescribing practitioner shall adopt rules under chapter 17A 21 establishing penalties for prescribing practitioners that 22 prescribe controlled substances in dosage amounts exceeding 23 what would be prescribed by a reasonably prudent prescribing 24 practitioner engaged in the same practice. 25 2. For the purposes of this section, “prescribing 26 practitioner” means a licensed health care professional with the 27 authority to prescribe prescription drugs including controlled 28 substances. 29 DIVISION V 30 REGISTRATION 31 Sec. 22. Section 124.302, subsections 1 and 4, Code 2018, 32 are amended to read as follows: 33 1. Every person who manufactures, distributes, or dispenses 34 any controlled substance within in this state or who proposes 35 -15- LSB 6028HV (3) 87 ss/rh 15/ 29

H.F. 2377 to engage in the manufacture, distribution, or dispensing 1 of any controlled substance within this state, shall obtain 2 and maintain a biennial registration issued by the board in 3 accordance with its rules. 4 4. A separate registration is required for each principal 5 place of business or professional practice where the applicant 6 manufactures, distributes, or dispenses , or conducts research 7 with controlled substances. 8 Sec. 23. Section 124.304, subsection 1, Code 2018, is 9 amended to read as follows: 10 1. The board may suspend, revoke, or restrict a registration 11 under section 124.303 to manufacture, distribute, or dispense 12 a controlled substance , or otherwise discipline a registrant, 13 upon a finding that any of the following apply to the 14 registrant: 15 a. The registrant has furnished false or fraudulent material 16 information in any application filed under this chapter or 17 any other chapter which applies to the registrant or the 18 registrant’s practice . 19 b. The registrant has had the registrant’s federal 20 registration to manufacture, distribute, or dispense , or 21 conduct research with controlled substances suspended, revoked, 22 or restricted. 23 c. The registrant has been convicted of a public offense 24 under any state or federal law relating to any controlled 25 substance. For the purpose of this section only, a conviction 26 shall include a plea of guilty, a forfeiture of bail or 27 collateral deposited to secure a defendant’s appearance in 28 court which forfeiture has not been vacated, or a finding 29 of guilt in a criminal action even though the entry of the 30 judgment or sentence has been withheld and the individual 31 placed on probation. 32 d. The registrant has committed such acts as would 33 render the registrant’s registration under section 124.303 34 inconsistent with the public interest as determined under that 35 -16- LSB 6028HV (3) 87 ss/rh 16/ 29

H.F. 2377 section. 1 e. If the registrant is a licensed health care professional, 2 the registrant has had the registrant’s professional license 3 revoked or suspended or has been otherwise disciplined in a 4 way that restricts the registrant’s authority to handle or 5 prescribe controlled substances. 6 Sec. 24. Section 124.304, subsections 2, 3, and 4, Code 7 2018, are amended to read as follows: 8 2. The board may limit revocation , or suspension , or 9 restriction of a registration or discipline of a registrant 10 to the particular controlled substance with respect to 11 which grounds for revocation , or suspension , restriction, or 12 discipline exist. 13 3. If the board suspends , or revokes , or restricts a 14 registration, or otherwise disciplines a registrant, all 15 controlled substances owned or possessed by the registrant 16 at the time of the suspension , revocation, restriction, 17 or discipline, or at the time of the effective date of the 18 revocation order , may be placed under seal. No disposition 19 may be made of substances under seal until the time for taking 20 an appeal has elapsed or until all appeals have been concluded 21 unless a court, upon application, orders the sale of perishable 22 substances and the deposit of the proceeds of the sale with the 23 court. Upon a revocation an order becoming final, all such 24 controlled substances may be forfeited to the state. 25 4. The board shall promptly notify the bureau and 26 the department of all orders suspending , or revoking , or 27 restricting a registration and all forfeitures of controlled 28 substances , or otherwise disciplining a registrant . 29 Sec. 25. Section 124.305, Code 2018, is amended to read as 30 follows: 31 124.305 Order to show cause Contested case proceedings . 32 1. Before denying, Prior to suspending , restricting, or 33 revoking a registration, or refusing a renewal of registration, 34 or otherwise disciplining a registrant, the board shall serve 35 -17- LSB 6028HV (3) 87 ss/rh 17/ 29

H.F. 2377 upon the applicant or registrant an order to show cause why 1 registration should not be denied, revoked, or suspended, or 2 why the renewal should not be refused. The order to show 3 cause shall contain a statement of the basis therefor and 4 shall call upon the applicant or registrant to appear before 5 the board at a time and place not less than thirty days after 6 the date of service of the order, but in the case of a denial 7 or renewal of registration the show cause order shall be 8 served not later than thirty days before the expiration of 9 the registration a notice in accordance with section 17A.12, 10 subsection 1 . The proceedings shall comply with the contested 11 case procedures in accordance with chapter 17A. These The 12 proceedings shall also be conducted without regard to any 13 criminal prosecution or other proceeding. Proceedings to 14 refuse renewal of registration shall not abate the existing 15 registration which shall remain in effect pending the outcome 16 of the administrative hearing. 17 2. The board , without an order to show cause, may suspend 18 any registration while simultaneously with the institution 19 of proceedings under section 124.304 , or where renewal of 20 registration is refused, pursuing emergency adjudicative 21 proceedings in accordance with section 17A.18A, if it finds 22 that there is an imminent danger to the public health or 23 safety which warrants this action. The suspension shall 24 continue in effect until the conclusion of the proceedings, 25 including judicial review thereof, under the provisions of 26 the Iowa administrative procedure Act, chapter 17A , unless 27 sooner withdrawn by the board or dissolved by the order of the 28 district court or an appellate court. 29 DIVISION VI 30 CONTROLLED SUBSTANCES —— PRECURSOR SUBSTANCES 31 Sec. 26. Section 124.204, subsection 9, Code 2018, is 32 amended by adding the following new paragraphs: 33 NEW PARAGRAPH . t. Methyl 2-(1-(5-fluoropentyl)- 34 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 35 -18- LSB 6028HV (3) 87 ss/rh 18/ 29

H.F. 2377 positional, and geometric isomers, salts, and salts of isomers. 1 Other names: 5F-ADB; 5F-MDMB-PINACA. 2 NEW PARAGRAPH . u. Methyl 2-(1-(5-fluoropentyl)-1H- 3 indazole-3-carboxamido)-3-methylbutanoate, its optical, 4 positional, and geometric isomers, salts, and salts of isomers. 5 Other name: 5F-AMB. 6 NEW PARAGRAPH . v. N-(adamantan-1-yl)-1-(5- 7 fluoropentyl)-1H-indazole-3-carboxamide, its optical, 8 positional, and geometric isomers, salts, and salts of isomers. 9 Other names: 5F-APINACA, 5F-AKB48. 10 NEW PARAGRAPH . w. N-(1-amino-3,3-dimethyl-1- 11 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, 12 its optical, positional, and geometric isomers, salts, and 13 salts of isomers. Other name: ADB-FUBINACA. 14 NEW PARAGRAPH . x. Methyl 2-(1-(cyclohexylmethyl)-1H- 15 indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 16 positional, and geometric isomers, salts, and salts of isomers. 17 Other names: MDMB-CHMICA, MMB-CHMINACA. 18 NEW PARAGRAPH . y. Methyl 2-(1-(4-fluorobenzyl)-1H- 19 indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 20 positional, and geometric isomers, salts, and salts of 21 isomers. Other name: MDMB-FUBINACA. 22 NEW PARAGRAPH . z. N-(4-fluorophenyl)-N-(1- 23 phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, 24 ethers, salts, and salts of isomers, esters, and ethers. Other 25 names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl 26 fentanyl. 27 NEW PARAGRAPH . aa. N-(2-fluorophenyl)-N-(1- 28 phenethylpiperidin-4-yl) propionamide. Other names: ortho- 29 fluorofentanyl or 2-fluorofentanyl. 30 NEW PARAGRAPH . ab. N-(1-phenethylpiperidin-4-yl)-N- 31 phenyltetrahydrofuran-2-carboxamide. Other name: 32 tetrahydrofuranyl fentanyl. 33 NEW PARAGRAPH . ac. 2-methoxy-N-(1-phenethylpiperidin-4- 34 yl)-N-phenylacetamide. Other name: methoxyacetyl fentanyl. 35 -19- LSB 6028HV (3) 87 ss/rh 19/ 29

H.F. 2377 NEW PARAGRAPH . ad. N-(1-phenethylpiperidin-4-yl)-N- 1 phenylacrylamide. Other names: acryl fentanyl or 2 acryloylfentanyl. 3 NEW PARAGRAPH . ae. Methyl 2-(1-(4-fluorobenzyl)-1H- 4 indazole-3-carboxamido)-3-methylbutanoate, its optical, 5 positional, and geometric isomers, salts, and salts of isomers. 6 Other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA. 7 Sec. 27. Section 124.206, subsection 7, Code 2018, is 8 amended by adding the following new paragraph: 9 NEW PARAGRAPH . c. Dronabinol [(-)-delta-9-trans- 10 tetrahydrocannabinol] in an oral solution in a drug product 11 approved for marketing by the United States food and drug 12 administration. 13 Sec. 28. Section 124B.2, subsection 1, Code 2018, is amended 14 by adding the following new paragraph: 15 NEW PARAGRAPH . ab. Alpha-phenylacetoacetonitrile and its 16 salts, optical isomers, and salts of optical isomers. Other 17 name: APAAN. 18 Sec. 29. EFFECTIVE DATE. This division of this Act, being 19 deemed of immediate importance, takes effect upon enactment. 20 DIVISION VII 21 GOOD SAMARITAN IMMUNITY 22 Sec. 30. NEW SECTION . 124.418 Persons seeking medical 23 assistance for drug-related overdose. 24 1. As used in this section, unless the context otherwise 25 requires: 26 a. “Drug-related overdose” means a condition of a person for 27 which each of the following is true: 28 (1) The person is in need of medical assistance. 29 (2) The person displays symptoms including but not limited 30 to extreme physical illness, pinpoint pupils, decreased level 31 of consciousness including coma, or respiratory depression. 32 (3) The person’s condition is the result of, or a prudent 33 layperson would reasonably believe such condition to be the 34 result of, the consumption or use of a controlled substance. 35 -20- LSB 6028HV (3) 87 ss/rh 20/ 29