House File 555 - Enrolled House File 555 AN ACT RELATING TO THE PRACTICE OF PHARMACY, AND PROVIDING FOR ADMINISTRATIVE PENALTIES. BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: Section 1. NEW SECTION . 155A.2B Practice of pharmacy —— general principles. To evaluate whether an act by a licensee or registrant under this chapter violates the appropriate standard of care, a licensee or registrant of the board must consider all of the following: 1. Whether performance of the act is expressly prohibited by a provision of this chapter. 2. Whether performance of the act is expressly prohibited by a rule adopted by the board. 3. Whether performance of the act is consistent with the education, training, and experience of a licensee or registrant. 4. Whether performance of the act is within the accepted standard of care that would be provided in a similar setting by a reasonable and prudent licensee or registrant with similar education, training, and experience. Sec. 2. Section 155A.3, subsection 39, Code 2024, is amended to read as follows: 39. “Practitioner” means a physician, dentist, podiatric physician, prescribing psychologist, veterinarian, optometrist, pharmacist, physician assistant, advanced registered nurse

House File 555, p. 2 practitioner, or other person licensed or registered to prescribe, distribute, or dispense a prescription drug or device in the course of professional practice in this state or a person licensed by another state in a health field in which, under Iowa law, licensees in this state may legally prescribe drugs. Sec. 3. Section 155A.3, Code 2024, is amended by adding the following new subsection: NEW SUBSECTION . 49A. “Therapeutic substitution” means the replacement of a prescribed drug, biological product, or device with an alternative molecule or device with assumed equivalent therapeutic effect. The alternative drug, biological product, or device may be within the same class or from another class with assumed therapeutic equivalence. Sec. 4. Section 155A.7, Code 2024, is amended by striking the section and inserting in lieu thereof the following: 155A.7 Pharmacist-intern, pharmacy technician, and pharmacy support person registration. 1. Registration programs for pharmacist-interns, pharmacy technicians, and pharmacy support persons are established for the purposes of identification, tracking, and disciplinary action for the violation of federal drug laws or regulations, state drug or pharmacy laws, or rules of the board. 2. A person who is or desires to be a pharmacist-intern, pharmacy technician, or pharmacy support person in this state shall apply to the board for registration on a form prescribed by the board. a. A pharmacist-intern shall be registered during internship training and thereafter pursuant to rules adopted by the board. b. An applicant for a new pharmacy technician registration or for a pharmacy technician renewal shall provide proof of current certification by a national technician certification authority approved by the board. A person who is in the process of acquiring national certification as a pharmacy technician and who is in training to become a pharmacy technician shall register with the board as a pharmacy technician. 3. The board shall adopt rules pursuant to chapter 17A on matters pertaining to pharmacist-intern, pharmacy technician,

House File 555, p. 3 and pharmacy support person registration, renewals, fees, training, national certification for pharmacy technicians, approval of preceptors for pharmacist-interns, and other relevant matters. a. The board shall establish standards for pharmacist-intern registration. b. The board shall not adopt rules pertaining to pharmacy support person registration which include any determination of the competency of the registered person and, notwithstanding section 272C.2, subsection 1, shall not require continuing education for renewal. 4. The board may deny, suspend, or revoke the registration of a pharmacist-intern, pharmacy technician, or pharmacy support person, or otherwise impose disciplinary penalties upon the registration of a pharmacy technician or pharmacy support person, for any violation of the laws of this state, another state, or the United States relating to prescription drugs, controlled substances, or nonprescription drugs, or for any violation of this chapter or chapter 124, 124B, 126, 147, 205, or 272C, or any rule of the board. The board may deny, suspend, or revoke a pharmacist-intern registration for failure to meet the standards prescribed by the board pursuant to subsection 3. 5. Responsibility for the actions of a pharmacist-intern, pharmacy technician, or pharmacy support person working under a licensed pharmacist’s delegated functions and reasonable professional oversight shall remain with the licensed pharmacist. Sec. 5. Section 155A.8, Code 2024, is amended to read as follows: 155A.8 Requirements for pharmacist Pharmacist license. 1. A person shall not engage in the practice of pharmacy in this state without a license. The license shall be identified as a pharmacist license. 2. A pharmacist may dispense, administer, monitor, and issue prescription drugs, biological products, and medication orders commensurate with the pharmacist’s training and education and in accordance with the appropriate standard of care. 3. To qualify for a pharmacist license, an applicant shall

House File 555, p. 4 meet the following requirements: 1. a. Be a graduate of a school or college of pharmacy or of a department of pharmacy of a university recognized and approved by the board. 2. b. File proof, satisfactory to the board, of internship for a period of time fixed by the board. 3. c. Pass an examination prescribed by the board. 4. The board shall specify by rule procedures and fees to renew a pharmacist license and penalties for late renewal or failure to renew a pharmacist license. Sec. 6. Section 155A.9, subsection 2, Code 2024, is amended to read as follows: 2. An applicant who is a graduate of a school or college of pharmacy located outside the United States but who is otherwise qualified to apply for a pharmacist license in this state may be deemed to have satisfied the requirements of section 155A.8, subsection 1 section 155A.8, subsection 3, paragraph “a” , by verification to the board of the applicant’s academic record and graduation and by meeting other requirements established by rule of the board. The board may require the applicant to pass an examination or examinations given or approved by the board to establish proficiency in English and equivalency of education as a prerequisite for taking the licensure examination required in section 155A.8, subsection 3 . Sec. 7. Section 155A.12, Code 2024, is amended by adding the following new subsections: NEW SUBSECTION . 11. Engaged in conduct outside the accepted standard of care that would be provided in a similar setting by a reasonable and prudent applicant or licensee. NEW SUBSECTION . 12. Displayed incapacity of a nature preventing engagement in the practice of pharmacy with reasonable skill, competence, and safety to the public. Sec. 8. Section 155A.13, subsection 3, paragraph b, Code 2024, is amended by striking the paragraph and inserting in lieu thereof the following: b. The board shall adopt rules for the issuance of a special or limited-use pharmacy license to a telepharmacy site. Sec. 9. Section 155A.13, subsection 3, paragraphs c, d, and e, Code 2024, are amended by striking the paragraphs.

House File 555, p. 5 Sec. 10. Section 155A.13, subsection 8, Code 2024, is amended by striking the subsection. Sec. 11. Section 155A.18, Code 2024, is amended to read as follows: 155A.18 Penalties. 1. The board shall impose penalties as allowed under section 272C.3 . In addition, civil penalties not to exceed twenty-five thousand dollars, may be imposed. 2. The board may impose an administrative penalty of up to five hundred dollars on a licensee or registrant who does any of the following: a. Engages in a practice regulated by this chapter without a current license or registration. b. Employs a person without a current license or registration to engage in a practice regulated by this chapter. c. Fails to complete the continuing education required for renewal of a license or registration. d. Fails any component of a routine inspection conducted by the board. e. The assessment and payment of a penalty imposed pursuant to this subsection shall not be considered a disciplinary action or reported as discipline and shall be confidential. Sec. 12. Section 155A.19, Code 2024, is amended by striking the section and inserting in lieu thereof the following: 155A.19 Notifications to board. Individuals and businesses licensed or registered pursuant to this chapter shall notify the board of pertinent changes related to activities performed pursuant to a license or registration issued under this chapter, pursuant to rules of the board. Sec. 13. Section 155A.23, Code 2024, is amended by adding the following new subsection: NEW SUBSECTION . 4. a. A person found in possession of a drug or device limited to dispensation by prescription, unless the drug or device was so lawfully dispensed, commits a serious misdemeanor. b. Paragraph “a” does not apply to a licensed pharmacy, licensed wholesaler, physician, veterinarian, dentist, podiatric physician, optometrist, advanced registered nurse

House File 555, p. 6 practitioner, physician assistant, pharmacist, a nurse acting under the direction of a physician, staff acting under the direction of a person licensed to prescribe, or the board of pharmacy, its officers, agents, inspectors, and representatives, or to a common carrier, manufacturer’s representative, or messenger when transporting the drug or device in the same unbroken package in which the drug or device was delivered to that person for transportation. Sec. 14. Section 155A.26, unnumbered paragraph 1, Code 2024, is amended to read as follows: The board, its officers, agents, inspectors compliance officers , and representatives, and all peace officers within the state, and all county attorneys shall enforce all provisions of this chapter , except those specifically delegated, and shall cooperate with all agencies charged with the enforcement of the laws of the United States, of this state, and of all other states relating to prescription drugs. Officers, agents, inspectors compliance officers , and representatives of the board shall have the powers and status of peace officers when enforcing the provisions of this chapter and chapters 124 , 126 , and 205 . Officers, agents, inspectors compliance officers , and representatives of the board of pharmacy may: Sec. 15. Section 155A.26, subsection 3, Code 2024, is amended to read as follows: 3. Conduct routine and unannounced inspections of pharmacies, drug wholesalers, and the offices or business locations of all individuals and institutions authorized to have possession of prescription drugs including any entity licensed by the board or location authorized to possess controlled substances or prescription devices, regardless of the location of the office or business. Sec. 16. Section 155A.27, subsection 2, paragraph a, Code 2024, is amended to read as follows: a. Beginning January 1, 2020, every Every prescription issued for a prescription drug shall be transmitted electronically as an electronic prescription to a pharmacy by a prescriber or the prescriber’s authorized agent unless exempt under paragraph “b” .

House File 555, p. 7 Sec. 17. Section 155A.27, subsection 3, unnumbered paragraph 1, Code 2024, is amended to read as follows: For prescriptions issued prior to January 1, 2020, or for prescriptions exempt from the electronic prescription requirement in subsection 2 , paragraph “b” , a prescriber or the prescriber’s authorized agent may transmit a prescription for a prescription drug to a pharmacy by any of the following means: Sec. 18. Section 155A.27, Code 2024, is amended by adding the following new subsections: NEW SUBSECTION . 8. Except as specified in subsection 9, a prescription for any prescription drug or device which is not a controlled substance shall not be filled or refilled more than eighteen months after the date on which the prescription was issued and a prescription which is authorized to be refilled shall not be refilled more than twelve times. NEW SUBSECTION . 9. A pharmacist may exercise professional judgment by refilling a prescription drug order without prescriber authorization in accordance with the appropriate standard of care and pursuant to rules established by the board. NEW SUBSECTION . 10. An authorization to refill a prescription drug order shall be transmitted to a pharmacy by a prescriber or the prescriber’s authorized agent pursuant to this section, except that prescription drug orders for controlled substances shall be transmitted pursuant to section 124.308, and, if not transmitted directly by the practitioner, shall also include the name and title of the practitioner’s agent completing the transmission. Sec. 19. Section 155A.32, Code 2024, is amended by striking the section and inserting in lieu thereof the following: 155A.32 Drug product selection —— restrictions. 1. If an authorized practitioner prescribes a drug, the pharmacist may exercise professional judgment in the interest of the patient by providing a therapeutic substitution for dispensing and sale to the patient. 2. The pharmacist shall not provide a therapeutic substitution if “dispense as written” is indicated on the prescription. 3. The board shall adopt rules on proper recording and

House File 555, p. 8 notification when a therapeutic substitution is made under this section. Sec. 20. Section 155A.39, subsection 6, Code 2024, is amended to read as follows: 6. Funds and surcharges collected under this section shall be deposited in an account and may be used by the board to administer a program authorized by this section , but shall not be used for costs incurred for a participant’s initial evaluation, referral services, treatment, or rehabilitation subsequent to intervention and to assist licensees and registrants with costs incurred for participation in the program . Sec. 21. Section 155A.40, subsection 1, Code 2024, is amended to read as follows: 1. The board may request and obtain, notwithstanding section 692.2, subsection 5 , criminal history data for any applicant for an initial or renewal license or registration issued pursuant to this chapter or chapter 147 , any applicant for reinstatement of a license or registration issued pursuant to this chapter or chapter 147 , or any licensee or registrant who is being monitored as a result of a board order or agreement resolving an administrative disciplinary action, for the purpose of evaluating the applicant’s, licensee’s, or registrant’s eligibility for licensure, registration, or suitability for continued practice of the profession. Criminal history data may be requested for all owners, managers, and principal employees of a pharmacy , third-party logistics provider, or drug wholesaler wholesale distributor licensed pursuant to this chapter . The board shall adopt rules pursuant to chapter 17A to implement this section . The board shall inform the applicant, licensee, or registrant of the criminal history requirement and obtain a signed waiver from the applicant, licensee, or registrant prior to submitting a criminal history data request. Sec. 22. Section 155A.46, Code 2024, is amended by adding the following new subsection: NEW SUBSECTION . 01. A pharmacist may, pursuant to statewide protocols developed and approved by the board in consultation with the department of health and human services,

House File 555, p. 9 order and administer prescription drugs, products, tests, or treatments. Each protocol, as established by rule, may define the prescription drugs, products, tests, or treatments allowed to be ordered and administered, any training or qualification required to implement the protocol, and any additional requirements deemed appropriate by the board. The board shall not develop or approve a statewide protocol permitting a pharmacist to order and administer any drug intended to induce an abortion as defined in section 146.l. Sec. 23. Section 155A.46, subsection 1, Code 2024, is amended to read as follows: 1. A pharmacist may, pursuant to statewide protocols developed and approved by the board in consultation with the department of health and human services and consistent with subsection 2, order and administer an immunization or vaccination. Each protocol, as established by rule, may define the immunization or vaccination allowed to be ordered and administered, any training or qualification required to implement the protocol, and any additional requirements deemed appropriate by the board. a. A pharmacist may , pursuant to statewide protocols developed by the board in consultation with the department of health and human services and consistent with subsection 2 , order and administer the following to patients ages eighteen years and older: (1) Opioid antagonists for overdose reversals. (2) Nicotine replacement tobacco cessation products. (3) (1) An immunization or vaccination recommended by the United States centers for disease control and prevention advisory committee on immunization practices in its approved vaccination schedule for adults. (4) (2) An immunization or vaccination recommended by the United States centers for disease control and prevention for international travel. (5) (3) A Tdap (tetanus, diphtheria, acellular pertussis) vaccination in a booster application. (6) (4) Other emergency immunizations or vaccinations in response to a public health emergency. (7) (5) An immunization or vaccination for COVID-19 as

House File 555, p. 10 defined in section 686D.2 . b. A pharmacist may , pursuant to statewide protocols developed by the board in consultation with the department of health and human services and consistent with subsection 2 , order and administer the following to patients ages six months and older: (1) A vaccine An immunization or immunization vaccination for influenza. (2) Other emergency immunizations or vaccines in response to a public health emergency. c. A pharmacist may, pursuant to statewide protocols developed by the board in consultation with the department of health and human services and consistent with subsection 2 , order and administer the final two doses in a course of vaccinations for HPV to patients ages eleven years and older. d. Prior to the ordering and administration of a vaccination an immunization or immunization vaccination authorized by this subsection , pursuant to statewide protocols, a licensed pharmacist shall consult and review the statewide immunization registry or health information network. The board shall adopt rules requiring the reporting of the administration of vaccines and immunizations and vaccinations authorized by this subsection to a patient’s primary health care provider, primary physician, and a statewide immunization registry or health information network. e. A pharmacist may, pursuant to statewide protocols developed by the board in consultation with the department of health and human services and consistent with subsection 2 , order and administer the following to patients ages six years and older: (1) Point-of-care testing and treatment for influenza, streptococcus A, and COVID-19 as defined in section 686D.2 at the point of interaction between a pharmacist and a patient. (2) Point-of-care testing at the point of interaction between a pharmacist and a patient in response to a public health emergency. Sec. 24. Section 155A.46, subsection 2, Code 2024, is amended by striking the subsection and inserting in lieu thereof the following:

House File 555, p. 11 2. Notwithstanding any provision of law to the contrary, a pharmacist may develop policies, procedures, and protocols to carry out the practices identified in section 155A.8, subsection 2. Sec. 25. Section 155A.47, subsection 1, Code 2024, is amended to read as follows: 1. Notwithstanding any provision of section 147.107, subsection 2 , or section 155A.33 this chapter to the contrary, the board may approve a pilot or demonstration research project of innovative applications in the practice of pharmacy to provide enhanced patient care. Sec. 26. Section 514F.7, subsection 4, paragraph a, Code 2024, is amended to read as follows: a. Prevent a health carrier, health benefit plan, or utilization review organization from requiring a covered person to try a prescription drug with the same generic name and demonstrated bioavailability or a biological product that is an interchangeable biological product pursuant to section 155A.32 as defined in section 155A.3 prior to providing coverage for the equivalent branded prescription drug. Sec. 27. REPEAL. Sections 155A.6, 155A.6A, 155A.6B, 155A.11, 155A.21, 155A.28, and 155A.29, Code 2024, are repealed. ______________________________ PAT GRASSLEY Speaker of the House ______________________________ AMY SINCLAIR President of the Senate I hereby certify that this bill originated in the House and is known as House File 555, Ninetieth General Assembly. ______________________________ MEGHAN NELSON Chief Clerk of the House Approved _______________, 2024 ______________________________ KIM REYNOLDS Governor