House File 2377 - Reprinted HOUSE FILE 2377 BY COMMITTEE ON HUMAN RESOURCES (SUCCESSOR TO HF 2299) (As Amended and Passed by the House February 26, 2018 ) A BILL FOR An Act relating to the regulation of certain substances, 1 including the regulation of the practice of pharmacy, 2 providing penalties, and including effective date 3 provisions. 4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 5 HF 2377 (4) 87 ss/rh/md
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. a. The program shall collect from pharmacies dispensing 9 information for controlled substances identified pursuant to 10 section 124.554, subsection 1, paragraph “g” , and from first 11 responders as defined in section 147A.1, subsection 7, with 12 the exception of emergency medical care providers as defined 13 in section 147A.1, subsection 4, administration information 14 for opioid antagonists. The department of public health 15 shall provide information for the administration of opioid 16 antagonists to the board as prescribed by rule for emergency 17 medical care providers as defined in section 147A.1, subsection 18 4. The board shall adopt rules requiring the following 19 information to be provided regarding the administration of 20 opioid antagonists: 21 (1) Patient identification. 22 (2) Identification of the person administering opioid 23 antagonists. 24 (3) The date of administration. 25 (4) The quantity of opioid antagonists administered. 26 b. The information collected shall be used by prescribing 27 practitioners and pharmacists on a need-to-know basis for 28 purposes of improving patient health care by facilitating early 29 identification of patients who may be at risk for addiction, 30 or who may be using, abusing, or diverting drugs for unlawful 31 or otherwise unauthorized purposes at risk to themselves and 32 others, or who may be appropriately using controlled substances 33 lawfully prescribed for them but unknown to the practitioner. 34 Sec. 3. NEW SECTION . 124.551A Prescribing practitioner 35 -1- HF 2377 (4) 87 ss/rh/md 1/ 23
H.F. 2377 program registration. 1 A prescribing practitioner shall register for the program at 2 the same time the practitioner applies to the board to register 3 or renews registration to prescribe controlled substances as 4 required by the board. Once the prescribing practitioner 5 registers for the program, the practitioner or the prescribing 6 practitioner's designated agent shall utilize the program 7 database prior to issuing an opioid prescription as prescribed 8 by rule to assist the prescribing practitioner in determining 9 appropriate treatment options and to improve the quality of 10 patient care. A prescribing practitioner shall not be required 11 to utilize the program database to assist in the treatment 12 of a patient receiving inpatient hospice care or long-term 13 residential facility patient care. 14 Sec. 4. Section 124.552, Code 2018, is amended to read as 15 follows: 16 124.552 Information reporting. 17 1. Each Unless otherwise prohibited by federal or state law, 18 each licensed pharmacy that dispenses controlled substances 19 identified pursuant to section 124.554, subsection 1 , paragraph 20 “g” , to patients in the state, and each licensed pharmacy 21 located in the state that dispenses such controlled substances 22 identified pursuant to section 124.554, subsection 1 , 23 paragraph “g” , to patients inside or outside the state, unless 24 specifically excepted in this section or by rule, and each 25 prescribing practitioner furnishing, dispensing, or supplying 26 controlled substances to the prescribing practitioner’s 27 patient, shall submit the following prescription information 28 to the program: 29 a. Pharmacy identification. 30 b. Patient identification. 31 c. Prescribing practitioner identification. 32 d. The date the prescription was issued by the prescribing 33 practitioner. 34 e. The date the prescription was dispensed. 35 -2- HF 2377 (4) 87 ss/rh/md 2/ 23
H.F. 2377 f. An indication of whether the prescription dispensed is 1 new or a refill. 2 g. Identification of the drug dispensed. 3 h. Quantity of the drug dispensed. 4 i. The number of days’ supply of the drug dispensed. 5 j. Serial or prescription number assigned by the pharmacy. 6 k. Type of payment for the prescription. 7 l. Other information identified by the board and advisory 8 council by rule. 9 2. Information shall be submitted electronically in a 10 secure format specified by the board unless the board has 11 granted a waiver and approved an alternate secure format. 12 3. Information shall be timely transmitted as designated 13 by the board and advisory council by rule within one business 14 day of the dispensing of the controlled substance , unless the 15 board grants an extension. The board may grant an extension if 16 either of the following occurs: 17 a. The pharmacy or prescribing practitioner suffers 18 a mechanical or electronic failure, or cannot meet the 19 deadline established by the board for other reasons beyond the 20 pharmacy’s or practitioner’s control. 21 b. The board is unable to receive electronic submissions. 22 4. This section shall not apply to a prescribing 23 practitioner furnishing, dispensing, supplying, or 24 administering drugs to the prescribing practitioner’s patient, 25 or to dispensing by a licensed pharmacy for the purposes of 26 inpatient hospital care, inpatient hospice care , or long-term 27 residential facility patient care. 28 Sec. 5. Section 124.553, subsection 4, Code 2018, is amended 29 by striking the subsection. 30 Sec. 6. Section 124.554, subsection 1, paragraphs b, c, d, 31 and g, Code 2018, are amended to read as follows: 32 b. An electronic format for the submission of information 33 from pharmacies and prescribing practitioners . 34 c. A waiver to submit information in another format for 35 -3- HF 2377 (4) 87 ss/rh/md 3/ 23
H.F. 2377 a pharmacy or prescribing practitioner unable to submit 1 information electronically. 2 d. An application by a pharmacy or prescribing practitioner 3 for an extension of time for transmitting information to the 4 program. 5 g. Including all schedule II controlled substances , and 6 those substances in schedules III and IV that the advisory 7 council and board determine can be addictive or fatal if not 8 taken under the proper care and direction of a prescribing 9 practitioner , and opioid antagonists . 10 Sec. 7. Section 124.557, Code 2018, is amended to read as 11 follows: 12 124.557 Drug information program fund. 13 The drug information program fund is established to be used 14 by the board to fund or assist in funding the program. The 15 board may make deposits into the fund from any source, public 16 or private, including grants or contributions of money or other 17 items of value, which it determines necessary to carry out the 18 purposes of this subchapter . The board may add a surcharge 19 of not more than twenty-five percent to the applicable fee 20 for a registration issued pursuant to section 124.302 and the 21 surcharge shall be deposited into the fund. Moneys received 22 by the board to establish and maintain the program must 23 be used for the expenses of administering this subchapter . 24 Notwithstanding section 8.33 , amounts contained in the fund 25 that remain unencumbered or unobligated at the close of the 26 fiscal year shall not revert but shall remain available for 27 expenditure for the purposes designated in future years. 28 Sec. 8. Section 124.558, subsection 1, Code 2018, is amended 29 to read as follows: 30 1. Failure to comply with requirements. A pharmacist, 31 pharmacy, prescribing practitioner, or agent of a pharmacist 32 or prescribing practitioner who knowingly fails to comply 33 with the confidentiality requirements of this subchapter 34 or who delegates program information access to another 35 -4- HF 2377 (4) 87 ss/rh/md 4/ 23
H.F. 2377 individual except as provided in section 124.553 , is subject to 1 disciplinary action by the appropriate professional licensing 2 board. A pharmacist , or pharmacy , or prescribing practitioner 3 that knowingly fails to comply with other requirements of this 4 subchapter is subject to disciplinary action by the board. 5 Each licensing board may adopt rules in accordance with chapter 6 17A to implement the provisions of this section . 7 DIVISION II 8 ELECTRONIC PRESCRIPTIONS 9 Sec. 9. Section 124.308, Code 2018, is amended by striking 10 the section and inserting in lieu thereof the following: 11 124.308 Prescriptions. 12 1. Except when dispensed directly by a practitioner to an 13 ultimate user, a prescription drug as defined in section 155A.3 14 that is a controlled substance shall not be dispensed without 15 a prescription, unless such prescription is authorized by a 16 practitioner and complies with this section, section 155A.27, 17 applicable federal law and regulation, and rules of the board. 18 2. a. Beginning January 1, 2020, every prescription issued 19 for a controlled substance shall be transmitted electronically 20 as an electronic prescription pursuant to the requirements in 21 subsection 2, paragraph “b” , unless exempt under subsection 2, 22 paragraph “c” . 23 b. Except for prescriptions identified in paragraph “c” , 24 a prescription that is transmitted pursuant to paragraph “a” 25 shall be transmitted to a pharmacy by a practitioner or the 26 practitioner’s authorized agent in compliance with federal 27 law and regulation for electronic prescriptions of controlled 28 substances. The practitioner’s electronic prescription system 29 and the receiving pharmacy’s dispensing system shall comply 30 with federal law and regulation for electronic prescriptions of 31 controlled substances. 32 c. Paragraph “b” shall not apply to any of the following: 33 (1) A prescription for a patient residing in a nursing home, 34 long-term care facility, correctional facility, or jail. 35 -5- HF 2377 (4) 87 ss/rh/md 5/ 23
H.F. 2377 (2) A prescription authorized by a licensed veterinarian. 1 (3) A prescription dispensed by a department of veterans 2 affairs pharmacy. 3 (4) A prescription requiring information that makes 4 electronic submission impractical, such as complicated or 5 lengthy directions for use or attachments. 6 (5) A prescription for a compounded preparation containing 7 two or more components. 8 (6) A prescription issued in response to a public health 9 emergency in a situation where a non-patient specific 10 prescription would be permitted. 11 (7) A prescription issued pursuant to an established and 12 valid collaborative practice agreement, standing order, or drug 13 research protocol. 14 (8) A prescription issued during a temporary technical 15 or electronic failure at the practitioner’s or pharmacy’s 16 location, provided that a prescription issued pursuant to 17 this subparagraph shall indicate on the prescription that the 18 practitioner or pharmacy is experiencing a temporary technical 19 or electronic failure. 20 (9) A prescription issued in an emergency situation 21 pursuant to federal law and regulation rules of the board. 22 d. A practitioner, as defined in section 124.101, subsection 23 27, paragraph “a” , who violates paragraph “a” is subject 24 to an administrative penalty of two hundred fifty dollars 25 per violation, up to a maximum of five thousand dollars per 26 calendar year. The assessment of an administrative penalty 27 pursuant to this paragraph by the appropriate licensing board 28 of the practitioner alleged to have violated paragraph “a” 29 shall not be considered a disciplinary action or reported 30 as discipline. A practitioner may appeal the assessment of 31 an administrative penalty pursuant to this paragraph, which 32 shall initiate a contested case proceeding under chapter 33 17A. A penalty collected pursuant to this paragraph shall be 34 deposited into the drug information program fund established 35 -6- HF 2377 (4) 87 ss/rh/md 6/ 23
H.F. 2377 pursuant to section 124.557. The board shall be notified 1 of any administrative penalties assessed by the appropriate 2 professional licensing board and deposited into the drug 3 information program fund under this paragraph. 4 e. A pharmacist who receives a written, oral, or facsimile 5 prescription shall not be required to verify that the 6 prescription is subject to an exception under paragraph “c” 7 and may dispense a prescription drug pursuant to an otherwise 8 valid written, oral, or facsimile prescription. However, a 9 pharmacist shall exercise professional judgment in identifying 10 and reporting suspected violations of this section to the 11 board or the appropriate professional licensing board of the 12 practitioner. 13 3. A prescription issued prior to January 1, 2020, or a 14 prescription that is exempt from the electronic prescription 15 requirement in subsection 2, paragraph “c” , may be transmitted 16 by a practitioner or the practitioner’s authorized agent to a 17 pharmacy in any of the following ways: 18 a. Electronically, if transmitted in accordance with 19 the requirements for electronic prescriptions pursuant to 20 subsection 2. 21 b. By facsimile for a schedule III, IV, or V controlled 22 substance, or for a schedule II controlled substance only 23 pursuant to federal law and regulation and rules of the board. 24 c. Orally for a schedule III, IV, or V controlled substance, 25 or for a schedule II controlled substance only in an emergency 26 situation pursuant to federal regulation and rules of the 27 board. 28 d. By providing an original signed prescription to a patient 29 or a patient’s authorized representative. 30 4. If permitted by federal law and in accordance with 31 federal requirements, an electronic or facsimile prescription 32 shall serve as the original signed prescription and the 33 practitioner shall not provide a patient, a patient’s 34 authorized representative, or the dispensing pharmacy with a 35 -7- HF 2377 (4) 87 ss/rh/md 7/ 23
H.F. 2377 signed, written prescription. An original signed prescription 1 shall be retained for a minimum of two years from the date of 2 the latest dispensing or refill of the prescription. 3 5. A prescription for a schedule II controlled substance 4 shall not be filled more than six months after the date 5 of issuance. A prescription for a schedule II controlled 6 substance shall not be refilled. 7 6. A prescription for a schedule III, IV, or V controlled 8 substance shall not be filled or refilled more than six months 9 after the date on which the prescription was issued or be 10 refilled more than five times. 11 7. A controlled substance shall not be distributed or 12 dispensed other than for a medical purpose. 13 8. A practitioner, medical group, or pharmacy that is unable 14 to timely comply with the electronic prescribing requirements 15 in subsection 2, paragraph “b” , may petition the board for an 16 exemption from the requirements based upon economic hardship, 17 technical limitations that the practitioner, medical group, or 18 pharmacy cannot control, or other exceptional circumstances. 19 The board shall adopt rules establishing the form and specific 20 information to be included in a request for an exemption 21 and the specific criteria to be considered by the board in 22 determining whether to approve a request for an exemption. The 23 board may approve an exemption for a period of time determined 24 by the board not to exceed one year from the date of approval, 25 and may be renewed annually upon request subject to board 26 approval. 27 Sec. 10. Section 155A.27, Code 2018, is amended by striking 28 the section and inserting in lieu thereof the following: 29 155A.27 Requirements for prescription. 30 1. Except when dispensed directly by a prescriber to an 31 ultimate user, a prescription drug shall not be dispensed 32 without a prescription, authorized by a prescriber, and based 33 on a valid patient-prescriber relationship. 34 2. a. Beginning January 1, 2020, every prescription issued 35 -8- HF 2377 (4) 87 ss/rh/md 8/ 23
H.F. 2377 for a prescription drug shall be transmitted electronically as 1 an electronic prescription to a pharmacy by a prescriber or the 2 prescriber’s authorized agent unless exempt under paragraph 3 “b” . 4 b. Paragraph “a” shall not apply to any of the following: 5 (1) A prescription for a patient residing in a nursing home, 6 long-term care facility, correctional facility, or jail. 7 (2) A prescription authorized by a licensed veterinarian. 8 (3) A prescription for a device. 9 (4) A prescription dispensed by a department of veterans 10 affairs pharmacy. 11 (5) A prescription requiring information that makes 12 electronic transmission impractical, such as complicated or 13 lengthy directions for use or attachments. 14 (6) A prescription for a compounded preparation containing 15 two or more components. 16 (7) A prescription issued in response to a public health 17 emergency in a situation where a non-patient specific 18 prescription would be permitted. 19 (8) A prescription issued for an opioid antagonist pursuant 20 to section 135.190 or a prescription issued for epinephrine 21 pursuant to section 135.185. 22 (9) A prescription issued during a temporary technical 23 or electronic failure at the location of the prescriber or 24 pharmacy, provided that a prescription issued pursuant to 25 this subparagraph shall indicate on the prescription that the 26 prescriber or pharmacy is experiencing a temporary technical 27 or electronic failure. 28 (10) A prescription issued pursuant to an established and 29 valid collaborative practice agreement, standing order, or drug 30 research protocol. 31 (11) A prescription issued in an emergency situation 32 pursuant to federal law and regulation and rules of the board. 33 c. A practitioner, as defined in section 124.101, subsection 34 27, paragraph “a” , who violates paragraph “a” is subject 35 -9- HF 2377 (4) 87 ss/rh/md 9/ 23
H.F. 2377 to an administrative penalty of two hundred fifty dollars 1 per violation, up to a maximum of five thousand dollars per 2 calendar year. The assessment of an administrative penalty 3 pursuant to this paragraph by the appropriate licensing board 4 of the practitioner alleged to have violated paragraph “a” 5 shall not be considered a disciplinary action or reported 6 as discipline. A practitioner may appeal the assessment of 7 an administrative penalty pursuant to this paragraph, which 8 shall initiate a contested case proceeding under chapter 9 17A. A penalty collected pursuant to this paragraph shall be 10 deposited into the drug information program fund established 11 pursuant to section 124.557. The board shall be notified 12 of any administrative penalties assessed by the appropriate 13 professional licensing board and deposited into the drug 14 information program fund under this paragraph. 15 d. A pharmacist who receives a written, oral, or facsimile 16 prescription shall not be required to verify that the 17 prescription is subject to an exception under paragraph “b” 18 and may dispense a prescription drug pursuant to an otherwise 19 valid written, oral, or facsimile prescription. However, a 20 pharmacist shall exercise professional judgment in identifying 21 and reporting suspected violations of this section to the 22 board or the appropriate professional licensing board of the 23 prescriber. 24 3. For prescriptions issued prior to January 1, 2020, 25 or for prescriptions exempt from the electronic prescription 26 requirement in subsection 2, paragraph “b” , a prescriber or the 27 prescriber’s authorized agent may transmit a prescription for a 28 prescription drug to a pharmacy by any of the following means: 29 a. Electronically. 30 b. By facsimile. 31 c. Orally. 32 d. By providing an original signed prescription to a patient 33 or a patient’s authorized representative. 34 4. A prescription shall be issued in compliance with 35 -10- HF 2377 (4) 87 ss/rh/md 10/ 23
H.F. 2377 this subsection. Regardless of the means of transmission, a 1 prescriber shall provide verbal verification of a prescription 2 upon request of the pharmacy. 3 a. If written, electronic, or facsimile, each prescription 4 shall contain all of the following: 5 (1) The date of issue. 6 (2) The name and address of the patient for whom, or the 7 owner of the animal for which, the drug is dispensed. 8 (3) The name, strength, and quantity of the drug prescribed. 9 (4) The directions for use of the drug, medicine, or device 10 prescribed. 11 (5) The name, address, and written or electronic signature 12 of the prescriber issuing the prescription. 13 (6) The federal drug enforcement administration number, if 14 required under chapter 124. 15 b. If electronic, each prescription shall comply with all 16 of the following: 17 (1) The prescriber shall ensure that the electronic system 18 used to transmit the electronic prescription has adequate 19 security and safeguards designed to prevent and detect 20 unauthorized access, modification, or manipulation of the 21 prescription. 22 (2) Notwithstanding paragraph “a” , subparagraph (5), 23 for prescriptions that are not controlled substances, if 24 transmitted by an authorized agent, the electronic prescription 25 shall not require the written or electronic signature of the 26 prescriber issuing the prescription. 27 c. If facsimile, in addition to the requirements of 28 paragraph “a” , each prescription shall contain all of the 29 following: 30 (1) The identification number of the facsimile machine 31 which is used to transmit the prescription. 32 (2) The date and time of transmission of the prescription. 33 (3) The name, address, telephone number, and facsimile 34 number of the pharmacy to which the prescription is being 35 -11- HF 2377 (4) 87 ss/rh/md 11/ 23
H.F. 2377 transmitted. 1 d. If oral, the prescriber issuing the prescription 2 shall furnish the same information required for a written 3 prescription, except for the written signature and address 4 of the prescriber. Upon receipt of an oral prescription, 5 the recipient shall promptly reduce the oral prescription to 6 a written format by recording the information required in a 7 written prescription. 8 e. A prescription transmitted by electronic, facsimile, 9 or oral means by a prescriber’s agent shall also include 10 the name and title of the prescriber’s agent completing the 11 transmission. 12 5. An electronic, facsimile, or oral prescription 13 shall serve as the original signed prescription and the 14 prescriber shall not provide a patient, a patient’s authorized 15 representative, or the dispensing pharmacist with a signed 16 written prescription. Prescription records shall be retained 17 pursuant to rules of the board. 18 6. This section shall not prohibit a pharmacist, 19 in exercising the pharmacist’s professional judgment, 20 from dispensing, at one time, additional quantities of a 21 prescription drug, with the exception of a prescription drug 22 that is a controlled substance as defined in section 124.101, 23 up to the total number of dosage units authorized by the 24 prescriber on the original prescription and any refills of 25 the prescription, not to exceed a ninety-day supply of the 26 prescription drug as specified on the prescription. 27 7. A prescriber, medical group, institution, or pharmacy 28 that is unable to timely comply with the electronic prescribing 29 requirements in subsection 2, paragraph “a” , may petition 30 the board for an exemption from the requirements based upon 31 economic hardship, technical limitations that the prescriber, 32 medical group, institution, or pharmacy cannot control, or 33 other exceptional circumstances. The board shall adopt rules 34 establishing the form and specific information to be included 35 -12- HF 2377 (4) 87 ss/rh/md 12/ 23
H.F. 2377 in a request for an exemption and the specific criteria to be 1 considered by the board in determining whether to approve a 2 request for an exemption. The board may approve an exemption 3 for a period of time determined by the board, not to exceed one 4 year from the date of approval, and may be annually renewed 5 subject to board approval upon request. 6 Sec. 11. Section 155A.29, subsection 4, Code 2018, is 7 amended to read as follows: 8 4. An authorization to refill a prescription drug order may 9 shall be transmitted to a pharmacist pharmacy by a prescriber 10 or the prescriber’s authorized agent through word of mouth, 11 note, telephone, facsimile, or other means of communication 12 initiated by or directed by the practitioner. The transmission 13 shall include the information required pursuant to section 14 155A.27 , except that prescription drug orders for controlled 15 substances shall be transmitted pursuant to section 124.308, 16 and, if not transmitted directly by the practitioner, 17 shall identify by also include the name and title of the 18 practitioner’s agent completing the transmission. 19 DIVISION III 20 PRESCRIBER ACTIVITY REPORTS 21 Sec. 12. Section 124.553, subsection 1, Code 2018, is 22 amended by adding the following new paragraph: 23 NEW PARAGRAPH . g. A prescribing practitioner for the 24 issuance of a required report pursuant to section 124.554, 25 subsection 3. 26 Sec. 13. Section 124.554, subsection 1, Code 2018, is 27 amended by adding the following new paragraph: 28 NEW PARAGRAPH . j. The issuance annually of a prescribing 29 practitioner activity report compiled from information from the 30 program pursuant to subsection 3. 31 Sec. 14. Section 124.554, Code 2018, is amended by adding 32 the following new subsection: 33 NEW SUBSECTION . 3. a. Beginning February 1, 2019, 34 and annually by February 1 thereafter, the board shall 35 -13- HF 2377 (4) 87 ss/rh/md 13/ 23
H.F. 2377 electronically, and at as low a cost as possible, issue each 1 prescribing practitioner who prescribed a controlled substance 2 reported to the program as dispensed in the preceding calendar 3 year in this state a prescribing practitioner activity report 4 which shall include but not be limited to the following: 5 (2) A summary of the prescribing practitioner’s history of 6 prescribing controlled substances. 7 (3) A comparison of the prescribing practitioner’s history 8 of prescribing controlled substances with the history of other 9 prescribing practitioners of the same profession or specialty. 10 (4) The prescribing practitioner’s history of program use. 11 (5) General patient risk factors. 12 (6) Educational updates. 13 (7) Other pertinent information identified by the board and 14 advisory council by rule. 15 b. Information provided to a prescribing practitioner in a 16 report required under this subsection is privileged and shall 17 be kept confidential pursuant to section 124.553, subsection 3. 18 Sec. 15. Section 124.556, Code 2018, is amended to read as 19 follows: 20 124.556 Education and treatment. 21 The program for drug prescribing and dispensing shall 22 include education initiatives and outreach to consumers, 23 prescribing practitioners, and pharmacists, and shall also 24 include assistance for identifying substance abuse treatment 25 programs and providers. The program shall also include 26 educational updates and information on general patient risk 27 factors for prescribing practitioners. The board and advisory 28 council shall adopt rules, as provided under section 124.554 , 29 to implement this section . 30 DIVISION IV 31 SUBSTANCE ABUSE PREVENTION 32 Sec. 16. Section 124.550, Code 2018, is amended by adding 33 the following new subsection: 34 NEW SUBSECTION . 3. “Proactive notification” means 35 -14- HF 2377 (4) 87 ss/rh/md 14/ 23
H.F. 2377 a notification by the board, generated based on factors 1 determined by the board and issued to a specific prescribing 2 practitioner or pharmacist, indicating that a patient may 3 be practitioner shopping or pharmacy shopping or at risk of 4 abusing or misusing a controlled substance. 5 Sec. 17. Section 124.553, subsection 1, Code 2018, is 6 amended by adding the following new paragraph: 7 NEW PARAGRAPH . g. A prescribing practitioner or pharmacist 8 through the use of a targeted distribution of proactive 9 notifications. 10 Sec. 18. Section 124.553, subsections 2 and 3, Code 2018, 11 are amended to read as follows: 12 2. The board shall maintain a record of each person that 13 requests information from the program and of all proactive 14 notifications distributed to prescribing practitioners and 15 dispensing pharmacists as provided in subsection 1, paragraph 16 “g” . Pursuant to rules adopted by the board and advisory 17 council under section 124.554 , the board may use the records 18 to document and report statistical information, and may 19 provide program information for statistical, public research, 20 public policy, or educational purposes, after removing 21 personal identifying information of a patient, prescribing 22 practitioner, dispenser, or other person who is identified in 23 the information. 24 3. Information contained in the program and any information 25 obtained from it, and information contained in the records 26 of requests for information from the program and information 27 distributed to prescribing practitioners and dispensing 28 pharmacists as provided in subsection 1, paragraph “g” , 29 is privileged and strictly confidential information. Such 30 information is a confidential public record pursuant to section 31 22.7 , and is not subject to discovery, subpoena, or other 32 means of legal compulsion for release except as provided in 33 this subchapter . Information from the program shall not be 34 released, shared with an agency or institution, or made public 35 -15- HF 2377 (4) 87 ss/rh/md 15/ 23
H.F. 2377 except as provided in this subchapter . 1 Sec. 19. Section 124.554, subsection 1, Code 2018, is 2 amended by adding the following new paragraph: 3 NEW PARAGRAPH . j. The establishment of thresholds or other 4 criteria or measures to be used in identifying an at-risk 5 patient as provided in section 124.553, subsection 1, paragraph 6 “g” , and the targeted distribution of proactive notifications 7 suggesting review of the patient’s prescription history. 8 Sec. 20. NEW SECTION . 147.162 Rules and directives relating 9 to opioids. 10 1. Any board created under this chapter that licenses a 11 prescribing practitioner shall adopt rules under chapter 17A 12 establishing penalties for prescribing practitioners that 13 prescribe opioids in dosage amounts exceeding what would be 14 prescribed by a reasonably prudent prescribing practitioner 15 engaged in the same practice. 16 2. For the purposes of this section, “prescribing 17 practitioner” means a licensed health care professional with the 18 authority to prescribe prescription drugs including opioids. 19 Sec. 21. NEW SECTION . 272C.2C Continuing education minimum 20 requirements —— medicine and surgery and osteopathic medicine and 21 surgery, nursing, and dentistry. 22 The board of medicine, board of nursing, and board 23 of dentistry shall establish rules requiring a person 24 licensed pursuant to section 148.3 or 152.6, or chapter 153, 25 respectively, to receive continuing education credits regarding 26 the United States centers for disease control and prevention 27 guideline for prescribing opioids for chronic pain, including 28 recommendations on limitations on dosages and the length 29 of prescriptions, risk factors for abuse, and nonopiod and 30 nonpharmacologic therapy options, as a condition of license 31 renewal. 32 DIVISION V 33 REGISTRATION 34 Sec. 22. Section 124.302, subsections 1 and 4, Code 2018, 35 -16- HF 2377 (4) 87 ss/rh/md 16/ 23
H.F. 2377 are amended to read as follows: 1 1. Every person who manufactures, distributes, or dispenses 2 any controlled substance within in this state or who proposes 3 to engage in the manufacture, distribution, or dispensing 4 of any controlled substance within this state, shall obtain 5 and maintain a biennial registration issued by the board in 6 accordance with its rules. 7 4. A separate registration is required for each principal 8 place of business or professional practice where the applicant 9 manufactures, distributes, or dispenses , or conducts research 10 with controlled substances. 11 Sec. 23. Section 124.304, subsection 1, Code 2018, is 12 amended to read as follows: 13 1. The board may suspend, revoke, or restrict a registration 14 under section 124.303 to manufacture, distribute, or dispense 15 a controlled substance , or otherwise discipline a registrant, 16 upon a finding that any of the following apply to the 17 registrant: 18 a. The registrant has furnished false or fraudulent material 19 information in any application filed under this chapter or 20 any other chapter which applies to the registrant or the 21 registrant’s practice . 22 b. The registrant has had the registrant’s federal 23 registration to manufacture, distribute, or dispense , or 24 conduct research with controlled substances suspended, revoked, 25 or restricted. 26 c. The registrant has been convicted of a public offense 27 under any state or federal law relating to any controlled 28 substance. For the purpose of this section only, a conviction 29 shall include a plea of guilty, a forfeiture of bail or 30 collateral deposited to secure a defendant’s appearance in 31 court which forfeiture has not been vacated, or a finding 32 of guilt in a criminal action even though the entry of the 33 judgment or sentence has been withheld and the individual 34 placed on probation. 35 -17- HF 2377 (4) 87 ss/rh/md 17/ 23
H.F. 2377 d. The registrant has committed such acts as would 1 render the registrant’s registration under section 124.303 2 inconsistent with the public interest as determined under that 3 section. 4 e. If the registrant is a licensed health care professional, 5 the registrant has had the registrant’s professional license 6 revoked or suspended or has been otherwise disciplined in a 7 way that restricts the registrant’s authority to handle or 8 prescribe controlled substances. 9 Sec. 24. Section 124.304, subsections 2, 3, and 4, Code 10 2018, are amended to read as follows: 11 2. The board may limit revocation , or suspension , or 12 restriction of a registration or discipline of a registrant 13 to the particular controlled substance with respect to 14 which grounds for revocation , or suspension , restriction, or 15 discipline exist. 16 3. If the board suspends , or revokes , or restricts a 17 registration, or otherwise disciplines a registrant, all 18 controlled substances owned or possessed by the registrant 19 at the time of the suspension , revocation, restriction, 20 or discipline, or at the time of the effective date of the 21 revocation order , may be placed under seal. No disposition 22 may be made of substances under seal until the time for taking 23 an appeal has elapsed or until all appeals have been concluded 24 unless a court, upon application, orders the sale of perishable 25 substances and the deposit of the proceeds of the sale with the 26 court. Upon a revocation an order becoming final, all such 27 controlled substances may be forfeited to the state. 28 4. The board shall promptly notify the bureau and 29 the department of all orders suspending , or revoking , or 30 restricting a registration and all forfeitures of controlled 31 substances , or otherwise disciplining a registrant . 32 Sec. 25. Section 124.305, Code 2018, is amended to read as 33 follows: 34 124.305 Order to show cause Contested case proceedings . 35 -18- HF 2377 (4) 87 ss/rh/md 18/ 23
H.F. 2377 1. Before denying, Prior to suspending , restricting, or 1 revoking a registration, or refusing a renewal of registration, 2 or otherwise disciplining a registrant, the board shall serve 3 upon the applicant or registrant an order to show cause why 4 registration should not be denied, revoked, or suspended, or 5 why the renewal should not be refused. The order to show 6 cause shall contain a statement of the basis therefor and 7 shall call upon the applicant or registrant to appear before 8 the board at a time and place not less than thirty days after 9 the date of service of the order, but in the case of a denial 10 or renewal of registration the show cause order shall be 11 served not later than thirty days before the expiration of 12 the registration a notice in accordance with section 17A.12, 13 subsection 1 . The proceedings shall comply with the contested 14 case procedures in accordance with chapter 17A. These The 15 proceedings shall also be conducted without regard to any 16 criminal prosecution or other proceeding. Proceedings to 17 refuse renewal of registration shall not abate the existing 18 registration which shall remain in effect pending the outcome 19 of the administrative hearing. 20 2. The board , without an order to show cause, may suspend 21 any registration while simultaneously with the institution 22 of proceedings under section 124.304 , or where renewal of 23 registration is refused, pursuing emergency adjudicative 24 proceedings in accordance with section 17A.18A, if it finds 25 that there is an imminent danger to the public health or 26 safety which warrants this action. The suspension shall 27 continue in effect until the conclusion of the proceedings, 28 including judicial review thereof, under the provisions of 29 the Iowa administrative procedure Act, chapter 17A , unless 30 sooner withdrawn by the board or dissolved by the order of the 31 district court or an appellate court. 32 DIVISION VI 33 CONTROLLED SUBSTANCES —— PRECURSOR SUBSTANCES 34 Sec. 26. Section 124.204, subsection 9, Code 2018, is 35 -19- HF 2377 (4) 87 ss/rh/md 19/ 23
H.F. 2377 amended by adding the following new paragraphs: 1 NEW PARAGRAPH . t. Methyl 2-(1-(5-fluoropentyl)- 2 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 3 positional, and geometric isomers, salts, and salts of isomers. 4 Other names: 5F-ADB; 5F-MDMB-PINACA. 5 NEW PARAGRAPH . u. Methyl 2-(1-(5-fluoropentyl)-1H- 6 indazole-3-carboxamido)-3-methylbutanoate, its optical, 7 positional, and geometric isomers, salts, and salts of isomers. 8 Other name: 5F-AMB. 9 NEW PARAGRAPH . v. N-(adamantan-1-yl)-1-(5- 10 fluoropentyl)-1H-indazole-3-carboxamide, its optical, 11 positional, and geometric isomers, salts, and salts of isomers. 12 Other names: 5F-APINACA, 5F-AKB48. 13 NEW PARAGRAPH . w. N-(1-amino-3,3-dimethyl-1- 14 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, 15 its optical, positional, and geometric isomers, salts, and 16 salts of isomers. Other name: ADB-FUBINACA. 17 NEW PARAGRAPH . x. Methyl 2-(1-(cyclohexylmethyl)-1H- 18 indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 19 positional, and geometric isomers, salts, and salts of isomers. 20 Other names: MDMB-CHMICA, MMB-CHMINACA. 21 NEW PARAGRAPH . y. Methyl 2-(1-(4-fluorobenzyl)-1H- 22 indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, 23 positional, and geometric isomers, salts, and salts of 24 isomers. Other name: MDMB-FUBINACA. 25 NEW PARAGRAPH . z. N-(4-fluorophenyl)-N-(1- 26 phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, 27 ethers, salts, and salts of isomers, esters, and ethers. Other 28 names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl 29 fentanyl. 30 NEW PARAGRAPH . aa. N-(2-fluorophenyl)-N-(1- 31 phenethylpiperidin-4-yl) propionamide. Other names: ortho- 32 fluorofentanyl or 2-fluorofentanyl. 33 NEW PARAGRAPH . ab. N-(1-phenethylpiperidin-4-yl)-N- 34 phenyltetrahydrofuran-2-carboxamide. Other name: 35 -20- HF 2377 (4) 87 ss/rh/md 20/ 23
H.F. 2377 tetrahydrofuranyl fentanyl. 1 NEW PARAGRAPH . ac. 2-methoxy-N-(1-phenethylpiperidin-4- 2 yl)-N-phenylacetamide. Other name: methoxyacetyl fentanyl. 3 NEW PARAGRAPH . ad. N-(1-phenethylpiperidin-4-yl)-N- 4 phenylacrylamide. Other names: acryl fentanyl or 5 acryloylfentanyl. 6 NEW PARAGRAPH . ae. Methyl 2-(1-(4-fluorobenzyl)-1H- 7 indazole-3-carboxamido)-3-methylbutanoate, its optical, 8 positional, and geometric isomers, salts, and salts of isomers. 9 Other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA. 10 Sec. 27. Section 124.206, subsection 7, Code 2018, is 11 amended by adding the following new paragraph: 12 NEW PARAGRAPH . c. Dronabinol [(-)-delta-9-trans- 13 tetrahydrocannabinol] in an oral solution in a drug product 14 approved for marketing by the United States food and drug 15 administration. 16 Sec. 28. Section 124B.2, subsection 1, Code 2018, is amended 17 by adding the following new paragraph: 18 NEW PARAGRAPH . ab. Alpha-phenylacetoacetonitrile and its 19 salts, optical isomers, and salts of optical isomers. Other 20 name: APAAN. 21 Sec. 29. EFFECTIVE DATE. This division of this Act, being 22 deemed of immediate importance, takes effect upon enactment. 23 DIVISION VII 24 GOOD SAMARITAN IMMUNITY 25 Sec. 30. NEW SECTION . 124.418 Persons seeking medical 26 assistance for drug-related overdose. 27 1. As used in this section, unless the context otherwise 28 requires: 29 a. “Drug-related overdose” means a condition of a person for 30 which each of the following is true: 31 (1) The person is in need of medical assistance. 32 (2) The person displays symptoms including but not limited 33 to extreme physical illness, pinpoint pupils, decreased level 34 of consciousness including coma, or respiratory depression. 35 -21- HF 2377 (4) 87 ss/rh/md 21/ 23
H.F. 2377 (3) The person’s condition is the result of, or a prudent 1 layperson would reasonably believe such condition to be the 2 result of, the consumption or use of a controlled substance. 3 b. “Overdose patient” means a person who is, or would 4 reasonably be perceived to be, suffering a drug-related 5 overdose and who has not previously received immunity under 6 this section. 7 c. “Overdose reporter” means a person who seeks medical 8 assistance for an overdose patient and who has not previously 9 received immunity under this section. 10 d. “Protected information” means information or evidence 11 collected or derived as a result of any of the following: 12 (1) An overdose patient’s good-faith actions to seek 13 medical assistance while experiencing a drug-related overdose. 14 (2) An overdose reporter’s good-faith actions to seek 15 medical assistance for an overdose patient experiencing a 16 drug-related overdose if all of the following are true: 17 (a) The overdose patient is in need of medical assistance 18 for an immediate health or safety concern. 19 (b) The overdose reporter is the first person to seek 20 medical assistance for the overdose patient. 21 (c) The overdose reporter provides the overdose reporter’s 22 name and contact information to medical or law enforcement 23 personnel. 24 (d) The overdose reporter remains on the scene until 25 assistance arrives or is provided. 26 (e) The overdose reporter cooperates with medical and law 27 enforcement personnel. 28 (f) Medical assistance was not sought during the execution 29 of an arrest warrant, search warrant, or other lawful search. 30 2. Protected information shall not be considered to support 31 probable cause and shall not be admissible as evidence against 32 an overdose patient or overdose reporter for any of the 33 following offenses: 34 a. Delivery of a controlled substance under section 124.401, 35 -22- HF 2377 (4) 87 ss/rh/md 22/ 23
H.F. 2377 subsection 1, if such delivery involved the sharing of the 1 controlled substance without profit. 2 b. Possession of a controlled substance under section 3 124.401, subsection 5. 4 c. Violation of section 124.407. 5 d. Violation of section 124.414. 6 3. A person’s pretrial release, probation, supervised 7 release, or parole shall not be revoked based on protected 8 information. 9 4. Notwithstanding any other provision of law to the 10 contrary, a court may consider the act of providing first aid 11 or other medical assistance to someone who is experiencing a 12 drug-related overdose as a mitigating factor in a criminal 13 prosecution. 14 5. Nothing in this section shall do any of the following: 15 a. Preclude or prevent an investigation by law enforcement 16 of the drug-related overdose where medical assistance was 17 provided. 18 b. Be construed to limit or bar the use or admissibility 19 of any evidence or information obtained in connection with the 20 investigation of the drug-related overdose in the investigation 21 or prosecution of other crimes or violations which do not 22 qualify for immunity under this section and which are committed 23 by any person, including the overdose patient or overdose 24 reporter. 25 c. Preclude the investigation or prosecution of any person 26 on the basis of evidence obtained from sources other than the 27 specific drug-related overdose where medical assistance was 28 provided. 29 -23- HF 2377 (4) 87 ss/rh/md 23/ 23