House File 2299 - Introduced HOUSE FILE 2299 BY LUNDGREN 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 6028YH (10) 87 ss/rh

H.F. 2299 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 at 24 the same time the practitioner applies to the board to register 25 or renews registration to prescribe controlled substances as 26 required by the board. Once the prescribing practitioner 27 registers for the program, the practitioner shall utilize 28 the program database as prescribed by rule to assist the 29 prescribing practitioner in determining appropriate treatment 30 options and to improve the quality of patient care. 31 Sec. 4. Section 124.552, Code 2018, is amended to read as 32 follows: 33 124.552 Information reporting. 34 1. Each Unless otherwise prohibited by federal or state law, 35 -1- LSB 6028YH (10) 87 ss/rh 1/ 29

H.F. 2299 each licensed pharmacy that dispenses controlled substances 1 identified pursuant to section 124.554, subsection 1 , paragraph 2 “g” , to patients in the state, and each licensed pharmacy 3 located in the state that dispenses such controlled substances 4 identified pursuant to section 124.554, subsection 1 , 5 paragraph “g” , to patients inside or outside the state, unless 6 specifically excepted in this section or by rule, and each 7 prescribing practitioner furnishing, dispensing, or supplying 8 controlled substances to the prescribing practitioner’s 9 patient, shall submit the following prescription information 10 to the program: 11 a. Pharmacy identification. 12 b. Patient identification. 13 c. Prescribing practitioner identification. 14 d. The date the prescription was issued by the prescribing 15 practitioner. 16 e. The date the prescription was dispensed. 17 f. An indication of whether the prescription dispensed is 18 new or a refill. 19 g. Identification of the drug dispensed. 20 h. Quantity of the drug dispensed. 21 i. The number of days’ supply of the drug dispensed. 22 j. Serial or prescription number assigned by the pharmacy. 23 k. Type of payment for the prescription. 24 l. Other information identified by the board and advisory 25 council by rule. 26 2. Information shall be submitted electronically in a 27 secure format specified by the board unless the board has 28 granted a waiver and approved an alternate secure format. 29 3. Information shall be timely transmitted as designated 30 by the board and advisory council by rule within twenty-four 31 hours of the dispensing of the controlled substance , unless the 32 board grants an extension. The board may grant an extension if 33 either of the following occurs: 34 a. The pharmacy or prescribing practitioner suffers 35 -2- LSB 6028YH (10) 87 ss/rh 2/ 29

H.F. 2299 a mechanical or electronic failure, or cannot meet the 1 deadline established by the board for other reasons beyond the 2 pharmacy’s or practitioner’s control. 3 b. The board is unable to receive electronic submissions. 4 4. This section shall not apply to a prescribing 5 practitioner furnishing, dispensing, supplying, or 6 administering drugs to the prescribing practitioner’s patient, 7 or to dispensing by a licensed pharmacy for the purposes of 8 inpatient hospital care, inpatient hospice care , or long-term 9 residential facility patient care. 10 Sec. 5. Section 124.553, subsection 4, Code 2018, is amended 11 by striking the subsection. 12 Sec. 6. Section 124.554, subsection 1, paragraphs b, c, d, 13 and g, Code 2018, are amended to read as follows: 14 b. An electronic format for the submission of information 15 from pharmacies and prescribing practitioners . 16 c. A waiver to submit information in another format for 17 a pharmacy or prescribing practitioner unable to submit 18 information electronically. 19 d. An application by a pharmacy or prescribing practitioner 20 for an extension of time for transmitting information to the 21 program. 22 g. Including all schedule II controlled substances , and 23 those substances in schedules III and IV that the advisory 24 council and board determine can be addictive or fatal if not 25 taken under the proper care and direction of a prescribing 26 practitioner , and opioid antagonists . 27 Sec. 7. Section 124.557, Code 2018, is amended to read as 28 follows: 29 124.557 Drug information program fund. 30 The drug information program fund is established to be used 31 by the board to fund or assist in funding the program. The 32 board may make deposits into the fund from any source, public 33 or private, including grants or contributions of money or other 34 items of value, which it determines necessary to carry out the 35 -3- LSB 6028YH (10) 87 ss/rh 3/ 29

H.F. 2299 purposes of this subchapter . The board may add a surcharge 1 of not more than twenty-five percent to the applicable fee 2 for a registration issued pursuant to section 124.302 and the 3 surcharge shall be deposited into the fund. Moneys received 4 by the board to establish and maintain the program must 5 be used for the expenses of administering this subchapter . 6 Notwithstanding section 8.33 , amounts contained in the fund 7 that remain unencumbered or unobligated at the close of the 8 fiscal year shall not revert but shall remain available for 9 expenditure for the purposes designated in future years. 10 Sec. 8. Section 124.558, subsection 1, Code 2018, is amended 11 to read as follows: 12 1. Failure to comply with requirements. A pharmacist, 13 pharmacy, prescribing practitioner, or agent of a pharmacist 14 or prescribing practitioner who knowingly fails to comply 15 with the confidentiality requirements of this subchapter 16 or who delegates program information access to another 17 individual except as provided in section 124.553 , is subject to 18 disciplinary action by the appropriate professional licensing 19 board. A pharmacist , or pharmacy , or prescribing practitioner 20 that knowingly fails to comply with other requirements of this 21 subchapter is subject to disciplinary action by the board. 22 Each licensing board may adopt rules in accordance with chapter 23 17A to implement the provisions of this section . 24 Sec. 9. Section 147A.4, Code 2018, is amended by adding the 25 following new subsection: 26 NEW SUBSECTION . 5. The department shall adopt rules 27 requiring first responders to report to the program the 28 following information regarding the administration of opioid 29 antagonists by first responders: 30 a. Patient identification. 31 b. Identification of the person administering opioid 32 antagonists. 33 c. The date of administration. 34 d. The quantity of opioid antagonists administered. 35 -4- LSB 6028YH (10) 87 ss/rh 4/ 29

H.F. 2299 DIVISION II 1 ELECTRONIC PRESCRIPTIONS 2 Sec. 10. Section 124.308, Code 2018, is amended by striking 3 the section and inserting in lieu thereof the following: 4 124.308 Prescriptions. 5 1. Except when dispensed directly by a practitioner to an 6 ultimate user, a prescription drug as defined in section 155A.3 7 that is a controlled substance shall not be dispensed without 8 a prescription, unless such prescription is authorized by a 9 practitioner and complies with this section, section 155A.27, 10 applicable federal law and regulation, and rules of the board. 11 2. a. Beginning July 1, 2019, every prescription issued 12 for a controlled substance shall be transmitted electronically 13 as an electronic prescription pursuant to the requirements in 14 subsection 2, paragraph “b” , unless exempt under subsection 2, 15 paragraph “c” . 16 b. Except for prescriptions identified in paragraph “c” , 17 a prescription that is transmitted pursuant to paragraph “a” 18 shall be transmitted to a pharmacy by a practitioner or the 19 practitioner’s authorized agent in compliance with federal 20 law and regulation for electronic prescriptions of controlled 21 substances. The practitioner’s electronic prescription system 22 and the receiving pharmacy’s dispensing system shall comply 23 with federal law and regulation for electronic prescriptions of 24 controlled substances. 25 c. Paragraph “b” shall not apply to any of the following: 26 (1) A prescription for a patient residing in a nursing home, 27 long-term care facility, correctional facility, or jail. 28 (2) A prescription authorized by a licensed veterinarian. 29 (3) A prescription dispensed by a department of veterans 30 affairs pharmacy. 31 (4) A prescription requiring information that makes 32 electronic submission impractical, such as complicated or 33 lengthy directions for use or attachments. 34 (5) A prescription for a compounded preparation containing 35 -5- LSB 6028YH (10) 87 ss/rh 5/ 29

H.F. 2299 two or more components. 1 (6) 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 (7) A prescription issued pursuant to an established and 5 valid collaborative practice agreement, standing order, or drug 6 research protocol, except for a standing order for an opioid 7 antagonist. 8 (8) A prescription issued during a temporary technical or 9 electronic failure at the prescriber’s or pharmacy’s location. 10 (9) A prescription issued in an emergency situation 11 pursuant to federal law and regulation rules of the board. 12 d. A practitioner, as defined in section 124.101, subsection 13 27, paragraph “a” , who violates paragraph “a” is subject 14 to an administrative penalty of two hundred fifty dollars 15 per violation, up to a maximum of five thousand dollars per 16 calendar year. The assessment of an administrative penalty 17 pursuant to this paragraph by the appropriate licensing board 18 of the practitioner alleged to have violated paragraph “a” 19 shall not be considered a disciplinary action and shall not be 20 released or reported as discipline. A practitioner may appeal 21 the assessment of an administrative penalty pursuant to this 22 paragraph, which shall initiate a contested case proceeding 23 under chapter 17A. A penalty collected pursuant to this 24 paragraph shall be deposited into the drug information program 25 fund established pursuant to section 124.557. The board shall 26 be notified of any administrative penalties assessed by the 27 appropriate professional licensing board and deposited into the 28 drug information program fund under this paragraph. 29 3. A prescription issued prior to July 1, 2019, or a 30 prescription that is exempt from the electronic prescription 31 requirement in subsection 2, paragraph “c” , may be transmitted 32 by a practitioner or the practitioner’s authorized agent to a 33 pharmacy in any of the following ways: 34 a. Electronically, if transmitted in accordance with 35 -6- LSB 6028YH (10) 87 ss/rh 6/ 29

H.F. 2299 the requirements for electronic prescriptions pursuant to 1 subsection 2. 2 b. By facsimile for a schedule III, IV, or V controlled 3 substance, or for a schedule II controlled substance only 4 pursuant to federal law and regulation and rules of the board. 5 c. Orally for a schedule III, IV, or V controlled substance, 6 or for a schedule II controlled substance only in an emergency 7 situation pursuant to federal regulation and rules of the 8 board. 9 d. By providing an original signed prescription to a patient 10 or a patient’s authorized representative. 11 4. If permitted by federal law and in accordance with 12 federal requirements, an electronic or facsimile prescription 13 shall serve as the original signed prescription and the 14 practitioner shall not provide a patient, a patient’s 15 authorized representative, or the dispensing pharmacy with a 16 signed, written prescription. An original signed prescription 17 shall be retained for a minimum of two years from the date of 18 the latest dispensing or refill of the prescription. 19 5. A prescription for a schedule II controlled substance 20 shall not be filled more than six months after the date 21 of issuance. A prescription for a schedule II controlled 22 substance shall not be refilled. 23 6. A prescription for a schedule III, IV, or V controlled 24 substance shall not be filled or refilled more than six months 25 after the date on which the prescription was issued or be 26 refilled more than five times. 27 7. A controlled substance shall not be distributed or 28 dispensed other than for a medical purpose. 29 8. A practitioner, medical group, or pharmacy that is unable 30 to timely comply with the electronic prescribing requirements 31 in subsection 2, paragraph “b” , may petition the board for an 32 exemption from the requirements based upon economic hardship, 33 technical limitations that the practitioner, medical group, or 34 pharmacy cannot control, or other exceptional circumstances. 35 -7- LSB 6028YH (10) 87 ss/rh 7/ 29

H.F. 2299 The board shall adopt rules establishing the form and specific 1 information to be included in a request for an exemption 2 and the specific criteria to be considered by the board in 3 determining whether to approve a request for an exemption. The 4 board may approve an exemption for a period of time determined 5 by the board not to exceed one year from the date of approval, 6 and may be renewed annually upon request subject to board 7 approval. 8 Sec. 11. Section 155A.27, Code 2018, is amended by striking 9 the section and inserting in lieu thereof the following: 10 155A.27 Requirements for prescription. 11 1. Except when dispensed directly by a prescriber to an 12 ultimate user, a prescription drug shall not be dispensed 13 without a prescription, authorized by a prescriber, and based 14 on a valid patient-prescriber relationship. 15 2. a. Beginning July 1, 2019, every prescription issued for 16 a prescription drug shall be transmitted electronically as an 17 electronic prescription to a pharmacy by a prescriber or the 18 prescriber’s authorized agent unless exempt under paragraph 19 “b” . 20 b. Paragraph “a” shall not apply to any of the following: 21 (1) A prescription for a patient residing in a nursing home, 22 long-term care facility, correctional facility, or jail. 23 (2) A prescription authorized by a licensed veterinarian. 24 (3) A prescription for a device. 25 (4) A prescription dispensed by a department of veterans 26 affairs pharmacy. 27 (5) A prescription requiring information that makes 28 electronic transmission impractical, such as complicated or 29 lengthy directions for use or attachments. 30 (6) A prescription for a compounded preparation containing 31 two or more components. 32 (7) A prescription issued in response to a public health 33 emergency in a situation where a non-patient specific 34 prescription would be permitted. 35 -8- LSB 6028YH (10) 87 ss/rh 8/ 29

H.F. 2299 (8) A prescription issued for epinephrine pursuant to 1 section 135.185. 2 (9) A prescription issued pursuant to an established and 3 valid collaborative practice agreement, standing order, or drug 4 research protocol except for a standing order for an opioid 5 antagonist. 6 (10) A prescription issued during a temporary technical 7 or electronic failure at the location of the prescriber or 8 pharmacy. 9 (11) A prescription issued in an emergency situation 10 pursuant to federal law and regulation and rules of the board. 11 c. A practitioner, as defined in section 124.101, subsection 12 27, paragraph “a” , who violates paragraph “a” is subject 13 to an administrative penalty of two hundred fifty dollars 14 per violation, up to a maximum of five thousand dollars per 15 calendar year. The assessment of an administrative penalty 16 pursuant to this paragraph by the appropriate licensing board 17 of the practitioner alleged to have violated paragraph “a” 18 shall not be considered a disciplinary action and shall not be 19 released or reported as discipline. A practitioner may appeal 20 the assessment of an administrative penalty pursuant to this 21 paragraph, which shall initiate a contested case proceeding 22 under chapter 17A. A penalty collected pursuant to this 23 paragraph shall be deposited into the drug information program 24 fund established pursuant to section 124.557. The board shall 25 be notified of any administrative penalties assessed by the 26 appropriate professional licensing board and deposited into the 27 drug information program fund under this paragraph. 28 3. For prescriptions issued prior to July 1, 2019, or 29 for prescriptions exempt from the electronic prescription 30 requirement in subsection 2, paragraph “b” , a prescriber or the 31 prescriber’s authorized agent may transmit a prescription for a 32 prescription drug to a pharmacy by any of the following means: 33 a. Electronically. 34 b. By facsimile. 35 -9- LSB 6028YH (10) 87 ss/rh 9/ 29

H.F. 2299 c. Orally. 1 d. By providing an original signed prescription to a patient 2 or a patient’s authorized representative. 3 4. A prescription shall be issued in compliance with 4 this subsection. Regardless of the means of transmission, a 5 prescriber shall provide verbal verification of a prescription 6 upon request of the pharmacy. 7 a. If written, electronic, or facsimile, each prescription 8 shall contain all of the following: 9 (1) The date of issue. 10 (2) The name and address of the patient for whom, or the 11 owner of the animal for which, the drug is dispensed. 12 (3) The name, strength, and quantity of the drug prescribed. 13 (4) The directions for use of the drug, medicine, or device 14 prescribed. 15 (5) The name, address, and written or electronic signature 16 of the prescriber issuing the prescription. 17 (6) The federal drug enforcement administration number, if 18 required under chapter 124. 19 b. If electronic, each prescription shall comply with all 20 of the following: 21 (1) The prescriber shall ensure that the electronic system 22 used to transmit the electronic prescription has adequate 23 security and safeguards designed to prevent and detect 24 unauthorized access, modification, or manipulation of the 25 prescription. 26 (2) Notwithstanding paragraph “a” , subparagraph (5), 27 for prescriptions that are not controlled substances, if 28 transmitted by an authorized agent, the electronic prescription 29 shall not require the written or electronic signature of the 30 prescriber issuing the prescription. 31 c. If facsimile, in addition to the requirements of 32 paragraph “a” , each prescription shall contain all of the 33 following: 34 (1) The identification number of the facsimile machine 35 -10- LSB 6028YH (10) 87 ss/rh 10/ 29

H.F. 2299 which is used to transmit the prescription. 1 (2) The date and time of transmission of the prescription. 2 (3) The name, address, telephone number, and facsimile 3 number of the pharmacy to which the prescription is being 4 transmitted. 5 d. If oral, the prescriber issuing the prescription 6 shall furnish the same information required for a written 7 prescription, except for the written signature and address 8 of the prescriber. Upon receipt of an oral prescription, 9 the recipient shall promptly reduce the oral prescription to 10 a written format by recording the information required in a 11 written prescription. 12 e. A prescription transmitted by electronic, facsimile, 13 or oral means by a prescriber’s agent shall also include 14 the name and title of the prescriber’s agent completing the 15 transmission. 16 5. An electronic, facsimile, or oral prescription 17 shall serve as the original signed prescription and the 18 prescriber shall not provide a patient, a patient’s authorized 19 representative, or the dispensing pharmacist with a signed 20 written prescription. Prescription records shall be retained 21 pursuant to rules of the board. 22 6. This section shall not prohibit a pharmacist, 23 in exercising the pharmacist’s professional judgment, 24 from dispensing, at one time, additional quantities of a 25 prescription drug, with the exception of a prescription drug 26 that is a controlled substance as defined in section 124.101, 27 up to the total number of dosage units authorized by the 28 prescriber on the original prescription and any refills of 29 the prescription, not to exceed a ninety-day supply of the 30 prescription drug as specified on the prescription. 31 7. A prescriber, medical group, institution, or pharmacy 32 that is unable to timely comply with the electronic prescribing 33 requirements in subsection 2, paragraph “a” , may petition 34 the board for an exemption from the requirements based upon 35 -11- LSB 6028YH (10) 87 ss/rh 11/ 29

H.F. 2299 economic hardship, technical limitations that the prescriber, 1 medical group, institution, or pharmacy cannot control, or 2 other exceptional circumstances. The board shall adopt rules 3 establishing the form and specific information to be included 4 in a request for an exemption and the specific criteria to be 5 considered by the board in determining whether to approve a 6 request for an exemption. The board may approve an exemption 7 for a period of time determined by the board, not to exceed one 8 year from the date of approval, and may be annually renewed 9 subject to board approval upon request. 10 Sec. 12. Section 155A.29, subsection 4, Code 2018, is 11 amended to read as follows: 12 4. An authorization to refill a prescription drug order may 13 shall be transmitted to a pharmacist pharmacy by a prescriber 14 or the prescriber’s authorized agent through word of mouth, 15 note, telephone, facsimile, or other means of communication 16 initiated by or directed by the practitioner. The transmission 17 shall include the information required pursuant to section 18 155A.27 , except that prescription drug orders for controlled 19 substances shall be transmitted pursuant to section 124.308, 20 and, if not transmitted directly by the practitioner, 21 shall identify by also include the name and title of the 22 practitioner’s agent completing the transmission. 23 DIVISION III 24 PRESCRIBER ACTIVITY REPORTS 25 Sec. 13. Section 124.553, subsection 1, Code 2018, is 26 amended by adding the following new paragraph: 27 NEW PARAGRAPH . g. A prescribing practitioner for the 28 issuance of a required report pursuant to section 124.554, 29 subsection 3. 30 Sec. 14. Section 124.554, subsection 1, Code 2018, is 31 amended by adding the following new paragraph: 32 NEW PARAGRAPH . j. The issuance annually of a prescribing 33 practitioner activity report compiled from information from the 34 program pursuant to subsection 3. 35 -12- LSB 6028YH (10) 87 ss/rh 12/ 29

H.F. 2299 Sec. 15. Section 124.554, Code 2018, is amended by adding 1 the following new subsection: 2 NEW SUBSECTION . 3. a. Beginning February 1, 2019, 3 and annually by February 1 thereafter, the board shall 4 electronically, and at as low a cost as possible, issue each 5 prescribing practitioner who prescribed a controlled substance 6 reported to the program as dispensed in the preceding calendar 7 year in this state a prescribing practitioner activity report 8 which shall include but not be limited to the following: 9 (1) A cover letter. 10 (2) A summary of the prescribing practitioner’s history of 11 prescribing controlled substances. 12 (3) A comparison of the prescribing practitioner’s history 13 of prescribing controlled substances with the history of other 14 prescribing practitioners of the same profession or specialty. 15 (4) The prescribing practitioner’s history of program use. 16 (5) General patient risk factors. 17 (6) Educational updates. 18 (7) Other pertinent information identified by the board and 19 advisory council by rule. 20 b. Information provided to a prescribing practitioner in a 21 report required under this subsection is privileged and shall 22 be kept confidential pursuant to section 124.553, subsection 3. 23 Sec. 16. Section 124.556, Code 2018, is amended to read as 24 follows: 25 124.556 Education and treatment. 26 The program for drug prescribing and dispensing shall 27 include education initiatives and outreach to consumers, 28 prescribing practitioners, and pharmacists, and shall also 29 include assistance for identifying substance abuse treatment 30 programs and providers. The program shall also include 31 educational updates and information on general patient risk 32 factors for prescribing practitioners. The board and advisory 33 council shall adopt rules, as provided under section 124.554 , 34 to implement this section . 35 -13- LSB 6028YH (10) 87 ss/rh 13/ 29

H.F. 2299 DIVISION IV 1 SUBSTANCE ABUSE PREVENTION 2 Sec. 17. Section 124.550, Code 2018, is amended by adding 3 the following new subsection: 4 NEW SUBSECTION . 3. “Proactive notification” means 5 a notification by the board, generated based on factors 6 determined by the board and issued to a specific prescribing 7 practitioner or pharmacist, indicating that a patient may 8 be practitioner shopping or pharmacy shopping or at risk of 9 abusing or misusing a controlled substance. 10 Sec. 18. Section 124.553, subsection 1, Code 2018, is 11 amended by adding the following new paragraph: 12 NEW PARAGRAPH . g. A prescribing practitioner or pharmacist 13 through the use of a targeted distribution of proactive 14 notifications. 15 Sec. 19. Section 124.553, subsections 2 and 3, Code 2018, 16 are amended to read as follows: 17 2. The board shall maintain a record of each person that 18 requests information from the program and of all proactive 19 notifications distributed to prescribing practitioners and 20 dispensing pharmacists as provided in subsection 1, paragraph 21 “g” . Pursuant to rules adopted by the board and advisory 22 council under section 124.554 , the board may use the records 23 to document and report statistical information, and may 24 provide program information for statistical, public research, 25 public policy, or educational purposes, after removing 26 personal identifying information of a patient, prescribing 27 practitioner, dispenser, or other person who is identified in 28 the information. 29 3. Information contained in the program and any information 30 obtained from it, and information contained in the records 31 of requests for information from the program and information 32 distributed to prescribing practitioners and dispensing 33 pharmacists as provided in subsection 1, paragraph “g” , 34 is privileged and strictly confidential information. Such 35 -14- LSB 6028YH (10) 87 ss/rh 14/ 29

H.F. 2299 information is a confidential public record pursuant to section 1 22.7 , and is not subject to discovery, subpoena, or other 2 means of legal compulsion for release except as provided in 3 this subchapter . Information from the program shall not be 4 released, shared with an agency or institution, or made public 5 except as provided in this subchapter . 6 Sec. 20. Section 124.554, subsection 1, Code 2018, is 7 amended by adding the following new paragraph: 8 NEW PARAGRAPH . j. The establishment of thresholds or other 9 criteria or measures to be used in identifying an at-risk 10 patient as provided in section 124.553, subsection 1, paragraph 11 “g” , and the targeted distribution of proactive notifications 12 suggesting review of the patient’s prescription history. 13 Sec. 21. NEW SECTION . 147.162 Rules and directives relating 14 to controlled substances. 15 1. Any board created under this chapter that licenses a 16 prescribing practitioner shall adopt rules under chapter 17A 17 establishing penalties for prescribing practitioners that 18 prescribe controlled substances in dosage amounts exceeding 19 what would be prescribed by a reasonably prudent prescribing 20 practitioner engaged in the same practice. 21 2. For the purposes of this section, “prescribing 22 practitioner” means a licensed health care professional with the 23 authority to prescribe prescription drugs including controlled 24 substances. 25 DIVISION V 26 REGISTRATION 27 Sec. 22. Section 124.302, subsections 1 and 4, Code 2018, 28 are amended to read as follows: 29 1. Every person who manufactures, distributes, or dispenses 30 any controlled substance within in this state or who proposes 31 to engage in the manufacture, distribution, or dispensing 32 of any controlled substance within this state, shall obtain 33 and maintain a biennial registration issued by the board in 34 accordance with its rules. 35 -15- LSB 6028YH (10) 87 ss/rh 15/ 29

H.F. 2299 4. A separate registration is required for each principal 1 place of business or professional practice where the applicant 2 manufactures, distributes, or dispenses , or conducts research 3 with controlled substances. 4 Sec. 23. Section 124.304, subsection 1, Code 2018, is 5 amended to read as follows: 6 1. The board may suspend, revoke, or restrict a registration 7 under section 124.303 to manufacture, distribute, or dispense 8 a controlled substance , or otherwise discipline a registrant, 9 upon a finding that any of the following apply to the 10 registrant: 11 a. The registrant has furnished false or fraudulent material 12 information in any application filed under this chapter or 13 any other chapter which applies to the registrant or the 14 registrant’s practice . 15 b. The registrant has had the registrant’s federal 16 registration to manufacture, distribute, or dispense , or 17 conduct research with controlled substances suspended, revoked, 18 or restricted. 19 c. The registrant has been convicted of a public offense 20 under any state or federal law relating to any controlled 21 substance. For the purpose of this section only, a conviction 22 shall include a plea of guilty, a forfeiture of bail or 23 collateral deposited to secure a defendant’s appearance in 24 court which forfeiture has not been vacated, or a finding 25 of guilt in a criminal action even though the entry of the 26 judgment or sentence has been withheld and the individual 27 placed on probation. 28 d. The registrant has committed such acts as would 29 render the registrant’s registration under section 124.303 30 inconsistent with the public interest as determined under that 31 section. 32 e. If the registrant is a licensed health care professional, 33 the registrant has had the registrant’s professional license 34 revoked or suspended or has been otherwise disciplined in a 35 -16- LSB 6028YH (10) 87 ss/rh 16/ 29

H.F. 2299 way that restricts the registrant’s authority to handle or 1 prescribe controlled substances. 2 Sec. 24. Section 124.304, subsections 2, 3, and 4, Code 3 2018, are amended to read as follows: 4 2. The board may limit revocation , or suspension , or 5 restriction of a registration or discipline of a registrant 6 to the particular controlled substance with respect to 7 which grounds for revocation , or suspension , restriction, or 8 discipline exist. 9 3. If the board suspends , or revokes , or restricts a 10 registration, or otherwise disciplines a registrant, all 11 controlled substances owned or possessed by the registrant 12 at the time of the suspension , revocation, restriction, 13 or discipline, or at the time of the effective date of the 14 revocation order , may be placed under seal. No disposition 15 may be made of substances under seal until the time for taking 16 an appeal has elapsed or until all appeals have been concluded 17 unless a court, upon application, orders the sale of perishable 18 substances and the deposit of the proceeds of the sale with the 19 court. Upon a revocation an order becoming final, all such 20 controlled substances may be forfeited to the state. 21 4. The board shall promptly notify the bureau and 22 the department of all orders suspending , or revoking , or 23 restricting a registration and all forfeitures of controlled 24 substances , or otherwise disciplining a registrant . 25 Sec. 25. Section 124.305, Code 2018, is amended to read as 26 follows: 27 124.305 Order to show cause Contested case proceedings . 28 1. Before denying, Prior to suspending , restricting, or 29 revoking a registration, or refusing a renewal of registration, 30 or otherwise disciplining a registrant, the board shall serve 31 upon the applicant or registrant an order to show cause why 32 registration should not be denied, revoked, or suspended, or 33 why the renewal should not be refused. The order to show 34 cause shall contain a statement of the basis therefor and 35 -17- LSB 6028YH (10) 87 ss/rh 17/ 29

H.F. 2299 shall call upon the applicant or registrant to appear before 1 the board at a time and place not less than thirty days after 2 the date of service of the order, but in the case of a denial 3 or renewal of registration the show cause order shall be 4 served not later than thirty days before the expiration of 5 the registration a notice in accordance with section 17A.12, 6 subsection 1 . The proceedings shall comply with the contested 7 case procedures in accordance with chapter 17A. These The 8 proceedings shall also be conducted without regard to any 9 criminal prosecution or other proceeding. Proceedings to 10 refuse renewal of registration shall not abate the existing 11 registration which shall remain in effect pending the outcome 12 of the administrative hearing. 13 2. The board , without an order to show cause, may suspend 14 any registration while simultaneously with the institution 15 of proceedings under section 124.304 , or where renewal of 16 registration is refused, pursuing emergency adjudicative 17 proceedings in accordance with section 17A.18A, if it finds 18 that there is an imminent danger to the public health or 19 safety which warrants this action. The suspension shall 20 continue in effect until the conclusion of the proceedings, 21 including judicial review thereof, under the provisions of 22 the Iowa administrative procedure Act, chapter 17A , unless 23 sooner withdrawn by the board or dissolved by the order of the 24 district court or an appellate court. 25 DIVISION VI 26 CONTROLLED SUBSTANCES —— PRECURSOR SUBSTANCES 27 Sec. 26. Section 124.204, subsection 9, Code 2018, is 28 amended by adding the following new paragraphs: 29 NEW PARAGRAPH . t. Methyl 2-(1-(5-fluoropentyl)- 30 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 31 positional, and geometric isomers, salts, and salts of isomers. 32 Other names: 5F-ADB; 5F-MDMB-PINACA. 33 NEW PARAGRAPH . u. Methyl 2-(1-(5-fluoropentyl)-1H- 34 indazole-3-carboxamido)-3-methylbutanoate, its optical, 35 -18- LSB 6028YH (10) 87 ss/rh 18/ 29

H.F. 2299 positional, and geometric isomers, salts, and salts of isomers. 1 Other name: 5F-AMB. 2 NEW PARAGRAPH . v. N-(adamantan-1-yl)-1-(5- 3 fluoropentyl)-1H-indazole-3-carboxamide, its optical, 4 positional, and geometric isomers, salts, and salts of isomers. 5 Other names: 5F-APINACA, 5F-AKB48. 6 NEW PARAGRAPH . w. N-(1-amino-3,3-dimethyl-1- 7 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, 8 its optical, positional, and geometric isomers, salts, and 9 salts of isomers. Other name: ADB-FUBINACA. 10 NEW PARAGRAPH . x. Methyl 2-(1-(cyclohexylmethyl)-1H- 11 indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 12 positional, and geometric isomers, salts, and salts of isomers. 13 Other names: MDMB-CHMICA, MMB-CHMINACA. 14 NEW PARAGRAPH . y. Methyl 2-(1-(4-fluorobenzyl)-1H- 15 indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 16 positional, and geometric isomers, salts, and salts of 17 isomers. Other name: MDMB-FUBINACA. 18 NEW PARAGRAPH . z. N-(4-fluorophenyl)-N-(1- 19 phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, 20 ethers, salts, and salts of isomers, esters, and ethers. Other 21 names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl 22 fentanyl. 23 NEW PARAGRAPH . aa. N-(2-fluorophenyl)-N-(1- 24 phenethylpiperidin-4-yl) propionamide. Other names: ortho- 25 fluorofentanyl or 2-fluorofentanyl. 26 NEW PARAGRAPH . ab. N-(1-phenethylpiperidin-4-yl)-N- 27 phenyltetrahydrofuran-2-carboxamide. Other name: 28 tetrahydrofuranyl fentanyl. 29 NEW PARAGRAPH . ac. 2-methoxy-N-(1-phenethylpiperidin-4- 30 yl)-N-phenylacetamide. Other name: methoxyacetyl fentanyl. 31 NEW PARAGRAPH . ad. N-(1-phenethylpiperidin-4-yl)-N- 32 phenylacrylamide. Other names: acryl fentanyl or 33 acryloylfentanyl. 34 NEW PARAGRAPH . ae. Methyl 2-(1-(4-fluorobenzyl)-1H- 35 -19- LSB 6028YH (10) 87 ss/rh 19/ 29

H.F. 2299 indazole-3-carboxamido)-3-methylbutanoate, its optical, 1 positional, and geometric isomers, salts, and salts of isomers. 2 Other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA. 3 Sec. 27. Section 124.206, subsection 7, Code 2018, is 4 amended by adding the following new paragraph: 5 NEW PARAGRAPH . c. Dronabinol [(-)-delta-9-trans- 6 tetrahydrocannabinol] in an oral solution in a drug product 7 approved for marketing by the United States food and drug 8 administration. 9 Sec. 28. Section 124B.2, subsection 1, Code 2018, is amended 10 by adding the following new paragraph: 11 NEW PARAGRAPH . ab. Alpha-phenylacetoacetonitrile and its 12 salts, optical isomers, and salts of optical isomers. Other 13 name: APAAN. 14 Sec. 29. EFFECTIVE DATE. This division of this Act, being 15 deemed of immediate importance, takes effect upon enactment. 16 DIVISION VII 17 GOOD SAMARITAN IMMUNITY 18 Sec. 30. NEW SECTION . 124.418 Persons seeking medical 19 assistance for drug-related overdose. 20 1. As used in this section, unless the context otherwise 21 requires: 22 a. “Drug-related overdose” means a condition of a person for 23 which each of the following is true: 24 (1) The person is in need of medical assistance. 25 (2) The person displays symptoms including but not limited 26 to extreme physical illness, pinpoint pupils, decreased level 27 of consciousness including coma, or respiratory depression. 28 (3) The person’s condition is the result of, or a prudent 29 layperson would reasonably believe such condition to be the 30 result of, the consumption or use of a controlled substance. 31 b. “Overdose patient” means a person who is, or would 32 reasonably be perceived to be, suffering a drug-related 33 overdose and who has not previously received immunity under 34 this section. 35 -20- LSB 6028YH (10) 87 ss/rh 20/ 29