Senate Study Bill 1165 - Introduced SENATE FILE _____ BY (PROPOSED COMMITTEE ON STATE GOVERNMENT BILL BY CHAIRPERSON SCHULTZ) A BILL FOR An Act relating to the practice of pharmacy, and providing for 1 administrative penalties. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 1831XC (6) 90 ss/rh
S.F. _____ Section 1. NEW SECTION . 155A.2B Practice of pharmacy 1 general principles. 2 To evaluate whether an act by a licensee or registrant under 3 this chapter violates the appropriate standard of care, a 4 licensee or registrant of the board must consider all of the 5 following: 6 1. Whether performance of the act is expressly prohibited 7 by a provision of this chapter. 8 2. Whether performance of the act is expressly prohibited 9 by a rule adopted by the board. 10 3. Whether performance of the act is expressly prohibited by 11 another applicable state or federal law or regulation. 12 4. Whether performance of the act is consistent with 13 the education, training, and experience of a licensee or 14 registrant. 15 5. Whether performance of the act is within the accepted 16 standard of care that would be provided in a similar setting by 17 a reasonable and prudent licensee or registrant with similar 18 education, training, and experience. 19 Sec. 2. Section 155A.3, subsection 39, Code 2023, is amended 20 to read as follows: 21 39. Practitioner means a physician, dentist, podiatric 22 physician, prescribing psychologist, veterinarian, optometrist, 23 pharmacist, physician assistant, advanced registered nurse 24 practitioner, or other person licensed or registered to 25 prescribe, distribute, or dispense a prescription drug or 26 device in the course of professional practice in this state or 27 a person licensed by another state in a health field in which, 28 under Iowa law, licensees in this state may legally prescribe 29 drugs. 30 Sec. 3. Section 155A.3, Code 2023, is amended by adding the 31 following new subsection: 32 NEW SUBSECTION . 49A. Therapeutic substitution means the 33 replacement of a prescribed drug with an alternative molecule 34 with assumed equivalent therapeutic effect. The alternative 35 -1- LSB 1831XC (6) 90 ss/rh 1/ 13
S.F. _____ drug may be within the same class or from another class with 1 assumed therapeutic equivalence. 2 Sec. 4. Section 155A.7, Code 2023, is amended by striking 3 the section and inserting in lieu thereof the following: 4 155A.7 Pharmacist-intern, pharmacy technician, and pharmacy 5 support person registration. 6 1. Registration programs for pharmacist-interns, pharmacy 7 technicians, and pharmacy support persons are established for 8 the purposes of identification, tracking, and disciplinary 9 action for the violation of federal drug laws or regulations, 10 state drug or pharmacy laws, or rules of the board. 11 2. A person who is or desires to be a pharmacist-intern, 12 pharmacy technician, or pharmacy support person in this state 13 shall apply to the board for registration on a form prescribed 14 by the board. 15 a. A pharmacist-intern shall be registered during internship 16 training and thereafter pursuant to rules adopted by the board. 17 b. An applicant for a new pharmacy technician registration 18 or for a pharmacy technician renewal shall provide proof of 19 current certification by a national technician certification 20 authority approved by the board. A person who is in the 21 process of acquiring national certification as a pharmacy 22 technician and who is in training to become a pharmacy 23 technician shall register with the board as a pharmacy 24 technician. 25 3. The board shall adopt rules pursuant to chapter 17A on 26 matters pertaining to pharmacist-intern, pharmacy technician, 27 and pharmacy support person registration, renewals, fees, 28 training, national certification for pharmacy technicians, 29 approval of preceptors for pharmacist-interns, and other 30 relevant matters. 31 a. The board shall establish standards for pharmacist-intern 32 registration. 33 b. The board shall not adopt rules pertaining to pharmacy 34 support person registration which include any determination of 35 -2- LSB 1831XC (6) 90 ss/rh 2/ 13
S.F. _____ the competency of the registered person and, notwithstanding 1 section 272C.2, subsection 1, shall not require continuing 2 education for renewal. 3 4. The board may deny, suspend, or revoke the registration 4 of a pharmacist-intern, pharmacy technician, or pharmacy 5 support person, or otherwise impose disciplinary penalties upon 6 the registration of a pharmacy technician or pharmacy support 7 person, for any violation of the laws of this state, another 8 state, or the United States relating to prescription drugs, 9 controlled substances, or nonprescription drugs, or for any 10 violation of this chapter or chapter 124, 124B, 126, 147, 205, 11 or 272C, or any rule of the board. The board may deny, suspend, 12 or revoke a pharmacist-intern registration for failure to meet 13 the standards prescribed by the board pursuant to subsection 3. 14 5. Responsibility for the actions of a pharmacist-intern, 15 pharmacy technician, or pharmacy support person working under 16 a licensed pharmacists delegated functions and reasonable 17 professional oversight shall remain with the licensed 18 pharmacist. 19 Sec. 5. Section 155A.8, Code 2023, is amended to read as 20 follows: 21 155A.8 Requirements for pharmacist Pharmacist license. 22 1. A person shall not engage in the practice of pharmacy in 23 this state without a license. The license shall be identified 24 as a pharmacist license. 25 2. A pharmacist may dispense, administer, manage, and 26 prescribe immunizations, prescription drugs, or devices 27 commensurate with the pharmacists training and education and 28 in accordance with the appropriate standard of care. 29 3. To qualify for a pharmacist license, an applicant shall 30 meet the following requirements: 31 1. a. Be a graduate of a school or college of pharmacy 32 or of a department of pharmacy of a university recognized and 33 approved by the board. 34 2. b. File proof, satisfactory to the board, of internship 35 -3- LSB 1831XC (6) 90 ss/rh 3/ 13
S.F. _____ for a period of time fixed by the board. 1 3. c. Pass an examination prescribed by the board. 2 4. The board shall specify by rule procedures and fees to 3 renew a pharmacist license and penalties for late renewal or 4 failure to renew a pharmacist license. 5 Sec. 6. Section 155A.9, subsection 2, Code 2023, is amended 6 to read as follows: 7 2. An applicant who is a graduate of a school or college of 8 pharmacy located outside the United States but who is otherwise 9 qualified to apply for a pharmacist license in this state may 10 be deemed to have satisfied the requirements of section 155A.8, 11 subsection 1 section 155A.8, subsection 3, paragraph a , by 12 verification to the board of the applicants academic record 13 and graduation and by meeting other requirements established 14 by rule of the board. The board may require the applicant 15 to pass an examination or examinations given or approved by 16 the board to establish proficiency in English and equivalency 17 of education as a prerequisite for taking the licensure 18 examination required in section 155A.8, subsection 3 . 19 Sec. 7. Section 155A.12, subsection 1, Code 2023, is amended 20 to read as follows: 21 1. Violated any provision of this chapter or any rules of 22 the board adopted under this chapter , the pharmacy or drug 23 laws or rules of the United States, or any other state laws 24 or rules of the United States while under the other states 25 jurisdiction . 26 Sec. 8. Section 155A.12, subsections 8, 9, and 10, Code 27 2023, are amended by striking the subsections. 28 Sec. 9. Section 155A.12, Code 2023, is amended by adding the 29 following new subsections: 30 NEW SUBSECTION . 11. Engaged in conduct outside the accepted 31 standard of care that would be provided in a similar setting by 32 a reasonable and prudent applicant or licensee. 33 NEW SUBSECTION . 12. Displayed incapacity of a nature 34 preventing engagement in the practice of pharmacy with 35 -4- LSB 1831XC (6) 90 ss/rh 4/ 13
S.F. _____ reasonable skill, competence, and safety to the public. 1 Sec. 10. Section 155A.13, subsection 3, paragraph b, Code 2 2023, is amended by striking the paragraph and inserting in 3 lieu thereof the following: 4 b. The board shall adopt rules for the issuance of a special 5 or limited-use pharmacy license to a telepharmacy site. 6 Sec. 11. Section 155A.13, subsection 3, paragraphs c, d, and 7 e, Code 2023, are amended by striking the paragraphs. 8 Sec. 12. Section 155A.13, subsection 8, Code 2023, is 9 amended by striking the subsection. 10 Sec. 13. Section 155A.13A, Code 2023, is amended by adding 11 the following new subsection: 12 NEW SUBSECTION . 6. Nonresident pharmacy license. The 13 board shall specify by rule procedures and fees to renew a 14 nonresident pharmacy license and the penalties for late renewal 15 or failure to renew a nonresident pharmacy license. 16 Sec. 14. Section 155A.18, Code 2023, is amended to read as 17 follows: 18 155A.18 Penalties. 19 1. The board shall impose penalties as allowed under section 20 272C.3 . In addition, civil penalties not to exceed twenty-five 21 thousand dollars, may be imposed. 22 2. The board may impose an administrative penalty of up to 23 five hundred dollars on a licensee or registrant who does any 24 of the following: 25 a. Engages in a practice regulated by this chapter without a 26 current license or registration. 27 b. Employs a person without a current license or 28 registration to engage in a practice regulated by this chapter. 29 c. Fails to complete the continuing education required for 30 renewal of a license or registration. 31 d. Fails any component of a routine inspection conducted by 32 the board. 33 e. The assessment and payment of a penalty imposed pursuant 34 to this subsection shall not be considered a disciplinary 35 -5- LSB 1831XC (6) 90 ss/rh 5/ 13
S.F. _____ action or reported as discipline and shall be confidential. 1 Sec. 15. Section 155A.19, Code 2023, is amended by striking 2 the section and inserting in lieu thereof the following: 3 155A.19 Notifications to board. 4 Individuals and businesses licensed or registered pursuant 5 to this chapter shall notify the board of pertinent changes 6 related to activities performed pursuant to a license or 7 registration issued under this chapter, pursuant to rules of 8 the board. 9 Sec. 16. Section 155A.23, Code 2023, is amended by adding 10 the following new subsection: 11 NEW SUBSECTION . 4. a. A person found in possession of a 12 drug or device limited to dispensation by prescription, unless 13 the drug or device was so lawfully dispensed, commits a serious 14 misdemeanor. 15 b. Paragraph a does not apply to a licensed pharmacy, 16 licensed wholesaler, physician, veterinarian, dentist, 17 podiatric physician, optometrist, advanced registered nurse 18 practitioner, physician assistant, pharmacist, a nurse 19 acting under the direction of a physician, staff acting 20 under the direction of a person licensed to prescribe, or 21 the board of pharmacy, its officers, agents, inspectors, 22 and representatives, or to a common carrier, manufacturers 23 representative, or messenger when transporting the drug or 24 device in the same unbroken package in which the drug or device 25 was delivered to that person for transportation. 26 Sec. 17. Section 155A.26, unnumbered paragraph 1, Code 27 2023, is amended to read as follows: 28 The board, its officers, agents, inspectors compliance 29 officers , and representatives, and all peace officers 30 within the state, and all county attorneys shall enforce 31 all provisions of this chapter , except those specifically 32 delegated, and shall cooperate with all agencies charged 33 with the enforcement of the laws of the United States, of 34 this state, and of all other states relating to prescription 35 -6- LSB 1831XC (6) 90 ss/rh 6/ 13
S.F. _____ drugs. Officers, agents, inspectors compliance officers , and 1 representatives of the board shall have the powers and status 2 of peace officers when enforcing the provisions of this chapter 3 and chapters 124 , 126 , and 205 . Officers, agents, inspectors 4 compliance officers , and representatives of the board of 5 pharmacy may: 6 Sec. 18. Section 155A.26, subsection 3, Code 2023, is 7 amended to read as follows: 8 3. Conduct routine and unannounced inspections of 9 pharmacies, drug wholesalers, and the offices or business 10 locations of all individuals and institutions authorized to 11 have possession of prescription drugs including any entity 12 licensed by the board or location authorized to possess 13 controlled substances or prescription devices, regardless of 14 the location of the office or business. 15 Sec. 19. Section 155A.27, subsection 2, paragraph a, Code 16 2023, is amended to read as follows: 17 a. Beginning January 1, 2020, every Every prescription 18 issued for a prescription drug shall be transmitted 19 electronically as an electronic prescription to a pharmacy by a 20 prescriber or the prescribers authorized agent unless exempt 21 under paragraph b . 22 Sec. 20. Section 155A.27, subsection 3, unnumbered 23 paragraph 1, Code 2023, is amended to read as follows: 24 For prescriptions issued prior to January 1, 2020, or 25 for prescriptions exempt from the electronic prescription 26 requirement in subsection 2 , paragraph b , a prescriber or the 27 prescribers authorized agent may transmit a prescription for a 28 prescription drug to a pharmacy by any of the following means: 29 Sec. 21. Section 155A.27, Code 2023, is amended by adding 30 the following new subsections: 31 NEW SUBSECTION . 8. Except as specified in subsection 9, a 32 prescription for any prescription drug or device which is not a 33 controlled substance shall not be filled or refilled more than 34 eighteen months after the date on which the prescription was 35 -7- LSB 1831XC (6) 90 ss/rh 7/ 13
S.F. _____ issued and a prescription which is authorized to be refilled 1 shall not be refilled more than twelve times. 2 NEW SUBSECTION . 9. A pharmacist may exercise professional 3 judgment by refilling a prescription drug order without 4 prescriber authorization in accordance with the appropriate 5 standard of care and pursuant to rules established by the 6 board. 7 NEW SUBSECTION . 10. An authorization to refill a 8 prescription drug order shall be transmitted to a pharmacy by 9 a prescriber or the prescribers authorized agent pursuant 10 to this section, except that prescription drug orders for 11 controlled substances shall be transmitted pursuant to section 12 124.308, and, if not transmitted directly by the practitioner, 13 shall also include the name and title of the practitioners 14 agent completing the transmission. 15 Sec. 22. Section 155A.32, Code 2023, is amended by striking 16 the section and inserting in lieu thereof the following: 17 155A.32 Drug product selection restrictions. 18 1. If an authorized practitioner prescribes a drug, the 19 pharmacist may exercise professional judgment in the interest 20 of the patient by providing a therapeutic substitution for 21 dispensing and sale to the patient. 22 2. The pharmacist shall not provide a therapeutic 23 substitution if dispense as written is indicated on the 24 prescription. 25 3. The board shall adopt rules on proper recording and 26 notification when a therapeutic substitution is made under this 27 section. 28 Sec. 23. Section 155A.39, subsection 6, Code 2023, is 29 amended to read as follows: 30 6. Funds and surcharges collected under this section shall 31 be deposited in an account and may be used by the board to 32 administer a program authorized by this section , but shall 33 not be used for costs incurred for a participants initial 34 evaluation, referral services, treatment, or rehabilitation 35 -8- LSB 1831XC (6) 90 ss/rh 8/ 13
S.F. _____ subsequent to intervention and to assist licensees and 1 registrants with costs incurred for participation in the 2 program . 3 Sec. 24. Section 155A.40, subsection 1, Code 2023, is 4 amended to read as follows: 5 1. The board may request and obtain, notwithstanding 6 section 692.2, subsection 5 , criminal history data for any 7 applicant for an initial or renewal license or registration 8 issued pursuant to this chapter or chapter 147 , any applicant 9 for reinstatement of a license or registration issued pursuant 10 to this chapter or chapter 147 , or any licensee or registrant 11 who is being monitored as a result of a board order or 12 agreement resolving an administrative disciplinary action, 13 for the purpose of evaluating the applicants, licensees, 14 or registrants eligibility for licensure, registration, or 15 suitability for continued practice of the profession. Criminal 16 history data may be requested for all owners, managers, and 17 principal employees of a pharmacy , third-party logistics 18 provider, or drug wholesaler wholesale distributor licensed 19 pursuant to this chapter . The board shall adopt rules 20 pursuant to chapter 17A to implement this section . The board 21 shall inform the applicant, licensee, or registrant of the 22 criminal history requirement and obtain a signed waiver from 23 the applicant, licensee, or registrant prior to submitting a 24 criminal history data request. 25 Sec. 25. Section 155A.46, Code 2023, is amended by striking 26 the section and inserting in lieu thereof the following: 27 155A.46 Statewide protocols. 28 1. A pharmacist may, pursuant to statewide protocols 29 developed and approved by the board in consultation with the 30 department of health and human services, order and administer 31 prescription drugs, products, tests, or treatments. Each 32 protocol, as established by rule, may define the prescription 33 drugs, products, tests, or treatment allowed to be ordered 34 and administered, any training or qualification required to 35 -9- LSB 1831XC (6) 90 ss/rh 9/ 13
S.F. _____ implement the protocol, and any additional requirements deemed 1 appropriate. 2 2. Notwithstanding any provision of law to the contrary, 3 a pharmacist may develop policies, procedures, and protocols 4 to carry out the practices identified in section 155A.8, 5 subsection 2. 6 Sec. 26. Section 155A.47, subsection 1, Code 2023, is 7 amended to read as follows: 8 1. Notwithstanding any provision of section 147.107, 9 subsection 2 , or section 155A.33 this chapter to the contrary, 10 the board may approve a pilot or demonstration research project 11 of innovative applications in the practice of pharmacy to 12 provide enhanced patient care. 13 Sec. 27. REPEAL. Sections 155A.6, 155A.6A, 155A.6B, 14 155A.21, 155A.28, and 155A.29, Code 2023, are repealed. 15 EXPLANATION 16 The inclusion of this explanation does not constitute agreement with 17 the explanations substance by the members of the general assembly. 18 This bill relates to the practice of pharmacy. The bill 19 creates general principles that licensees and registrants of 20 the board of pharmacy (board) must consider when determining 21 whether an act violates the appropriate standard of care. The 22 bill also reorganizes Code chapter 155A (pharmacy) by combining 23 and repealing certain Code sections, and makes conforming Code 24 changes. The bill combines Code section 155A.21 (unlawful 25 possession of prescription drug or device penalty) into Code 26 section 155A.23 (prohibited acts) and Code section 155A.29 27 (prescription refills) into Code section 155A.27 (requirements 28 for prescriptions). 29 The bill adds pharmacists to the definition of 30 practitioner for the purposes of Code chapter 155A and 31 defines therapeutic substitution as the replacement of a 32 prescribed drug with an alternative molecule with assumed 33 equivalent therapeutic effect. 34 The bill repeals and amends current Code provisions 35 -10- LSB 1831XC (6) 90 ss/rh 10/ 13
S.F. _____ regarding the registration of pharmacist-interns, pharmacy 1 technicians, and pharmacy support persons. The bill requires 2 the board to adopt rules regarding the registration and 3 practice of pharmacist-interns, pharmacy technicians, and 4 pharmacy support persons. The bill prohibits the board 5 from adopting rules pertaining to pharmacy support person 6 registration which include any determination of the competency 7 of the registered person or requiring continuing education. 8 The bill allows the board to deny, suspend, or revoke a 9 registration of a pharmacist-intern, pharmacy technician, 10 or pharmacy support person based on a violation of certain 11 laws and regulations. Responsibility for the actions of a 12 pharmacist-intern, pharmacy technician, or pharmacy support 13 person working under a pharmacist remains with the pharmacist. 14 The bill allows a pharmacist to dispense, administer, 15 manage, and prescribe immunizations, prescription drugs, or 16 devices according to the pharmacists training and education 17 and in accordance with the appropriate standard of care. The 18 bill requires the board to specify by rule the procedures and 19 fees to renew a pharmacist license and the penalties for late 20 renewal or failure to renew a pharmacist license. 21 The bill allows the board to discipline a pharmacist or 22 refuse to issue a pharmacist license to a person for engaging 23 in conduct outside the accepted standard of care that would 24 be provided in a similar setting by a reasonable and prudent 25 applicant or licensee and for displaying incapacity of a 26 nature preventing engagement in the practice of pharmacy with 27 reasonable skill, competence, and safety to the public. 28 The bill strikes provisions regarding the issuance of a 29 telepharmacy license and requires the board to adopt rules for 30 the issuance of a telepharmacy license. The bill also strikes 31 a requirement that a pharmacy license be issued in the name of 32 the pharmacist in charge and not be transferable or assignable. 33 The bill requires the board to adopt rules regarding the 34 renewal of a nonresident pharmacy license and the penalties 35 -11- LSB 1831XC (6) 90 ss/rh 11/ 13
S.F. _____ for a late renewal or failure to renew a nonresident pharmacy 1 license. 2 The bill allows the board to impose an administrative 3 penalty of up to $500 on a licensee or registrant who engages 4 in a practice regulated by Code chapter 155A without a current 5 license or registration, employs a person without a current 6 license or registration to engage in a practice regulated by 7 Code chapter 155A, fails to complete the continuing education 8 required for renewal of a license or registration, or fails any 9 component of a routine inspection conducted by the board. An 10 administrative penalty shall not be considered a disciplinary 11 action or reported as discipline and shall be confidential. 12 Under current law, the board can impose civil penalties not to 13 exceed $25,000. 14 The bill strikes current law regarding notifications 15 submitted by a pharmacy to the board and requires the board 16 to adopt rules for the reporting of pertinent changes related 17 to activities performed pursuant to a license or registration 18 issued under Code chapter 155A to the board by a licensed or 19 registered person or business. 20 The bill changes references to inspectors of the board 21 to compliance officers of the board. The bill allows the 22 board to conduct routine and unannounced inspections of any 23 entity licensed by the board or location authorized to possess 24 controlled substances or prescription devices. 25 The bill strikes provisions allowing prescriptions issued 26 before January 1, 2020, to be issued by nonelectronic means. 27 The bill allows a pharmacist to exercise professional judgment 28 by refilling a prescription without prescriber authorization in 29 accordance with the appropriate standard of care and pursuant 30 to rules established by the board. 31 The bill allows a pharmacist to dispense a therapeutic 32 substitution in lieu of a prescribed drug according to the 33 professional judgment of the pharmacist unless the prescription 34 states dispense as written. The board shall adopt rules on 35 -12- LSB 1831XC (6) 90 ss/rh 12/ 13
S.F. _____ proper recording and notification of therapeutic substitutions. 1 The bill allows funds and surcharges collected for a 2 program to monitor impaired pharmacists, pharmacist-interns, 3 or pharmacy technicians to be used to assist licensees and 4 registrants with costs incurred for participation in the 5 program. 6 The bill allows the board to request criminal history 7 data for all owners, managers, and principal employees and 8 third-party logistics providers and wholesale distributors. 9 The bill strikes current provisions regarding statewide 10 protocols under which a pharmacist can order and administer 11 certain drugs. The bill allows the board to develop statewide 12 protocols for the ordering and administration of prescription 13 drugs, products, tests, or treatments in consultation with the 14 department of health and human services. 15 The bill allows the board to approve a pilot or demonstration 16 research project of innovative applications in the practice of 17 pharmacy to provide enhanced patient care, notwithstanding any 18 provision of Code chapter 155A to the contrary. Current law 19 allows the board to approve such a project notwithstanding Code 20 section 155A.33 (delegation of functions). 21 -13- LSB 1831XC (6) 90 ss/rh 13/ 13