Senate Study Bill 1111 - Introduced SENATE/HOUSE FILE _____ BY (PROPOSED BOARD OF PHARMACY BILL) A BILL FOR An Act relating to the practice of pharmacy, and providing for 1 a repeal. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 1318DP (4) 89 pf/rh
S.F. _____ H.F. _____ DIVISION I 1 PHARMACY TECHNICIANS AND PHARMACY SUPPORT PERSONS —— 2 REGISTRATION AND DELEGATION OF FUNCTIONS 3 Section 1. Section 147.107, subsection 2, paragraph d, Code 4 2021, is amended to read as follows: 5 d. A pharmacist who dispenses prescription drugs, including 6 but not limited to controlled substances, for human use, 7 may delegate nonjudgmental dispensing functions only when 8 verification of the accuracy and completeness of the dispensing 9 is determined by the pharmacist in the pharmacist’s physical 10 presence. The pharmacist’s verification of the accuracy of the 11 prescription drug dispensed shall not be required when verified 12 by a certified pharmacy technician in a technician product 13 verification program or a tech-check-tech program as defined 14 in section 155A.3 . The pharmacist’s physical presence shall 15 not be required when the pharmacist is remotely supervising 16 pharmacy personnel operating in an approved a licensed 17 telepharmacy site or when utilizing an automated dispensing 18 system that utilizes an internal quality control assurance 19 plan. When utilizing a technician product verification program 20 or tech-check-tech program , or when remotely supervising 21 pharmacy personnel operating at an approved a licensed 22 telepharmacy site, the pharmacist shall utilize an internal 23 quality control assurance plan, in accordance with rules 24 adopted by the board of pharmacy, that ensures accuracy for 25 dispensing. Automated dispensing verification, technician 26 product verification, and telepharmacy practice accuracy and 27 completeness remains the responsibility of the pharmacist and 28 shall be determined in accordance with rules adopted by the 29 board of pharmacy. 30 Sec. 2. Section 155A.3, Code 2021, is amended by adding the 31 following new subsection: 32 NEW SUBSECTION . 35A. “Pharmacy support person” means 33 a person, other than a licensed pharmacist, a registered 34 pharmacist-intern, or a registered pharmacy technician, who 35 -1- LSB 1318DP (4) 89 pf/rh 1/ 5
S.F. _____ H.F. _____ may perform nontechnical duties assigned by a supervising 1 pharmacist under the pharmacist’s responsibility and 2 supervision. 3 Sec. 3. Section 155A.3, subsection 46, Code 2021, is amended 4 by striking the subsection. 5 Sec. 4. Section 155A.6A, subsections 3 and 4, Code 2021, are 6 amended to read as follows: 7 3. A person who is in the process of acquiring national 8 certification as a pharmacy technician and who is in training 9 to become a pharmacy technician shall register with the board 10 as a pharmacy technician. The registration shall be issued for 11 a period not to exceed one year and shall not be renewable. 12 4. The board shall adopt rules in accordance with 13 chapter 17A on matters pertaining to pharmacy technician 14 registration, application, forms, renewals, fees, termination 15 of registration, tech-check-tech programs, technician product 16 verification programs, national certification, training, and 17 any other relevant matters. 18 Sec. 5. Section 155A.33, Code 2021, is amended to read as 19 follows: 20 155A.33 Delegation of technical functions. 21 A pharmacist may delegate any technical dispensing functions 22 to pharmacy technicians and any nontechnical functions to 23 pharmacy support persons , but only if the pharmacist is 24 physically present available to verify the accuracy and 25 completeness provide professional oversight of the patient’s 26 prescription prior to the delivery of the prescription to the 27 patient or the patient’s representative delegated functions 28 performed by the pharmacy technician or pharmacy support 29 person . However, the physical presence requirement does not 30 apply when a pharmacist is utilizing an automated dispensing 31 system or a technician product verification program or when 32 a pharmacist is remotely supervising a certified pharmacy 33 technician practicing at a telepharmacy site approved by 34 the board. When using an automated dispensing system or a 35 -2- LSB 1318DP (4) 89 pf/rh 2/ 5
S.F. _____ H.F. _____ technician product verification program, or when remotely 1 supervising a certified pharmacy technician practicing at 2 an approved telepharmacy site, the pharmacist shall utilize 3 an internal quality control assurance plan that ensures 4 accuracy for dispensing. Verification of automated dispensing, 5 technician product verification, and telepharmacy practice 6 accuracy and completeness remains the responsibility of the 7 pharmacist and shall be determined in accordance with rules 8 adopted by the board. 9 DIVISION II 10 OUTSOURCING FACILITY LICENSE 11 Sec. 6. Section 155A.13C, subsection 1, Code 2021, is 12 amended by adding the following new paragraph: 13 NEW PARAGRAPH . e. Submit evidence of a satisfactory 14 inspection conducted by the home state regulatory authority 15 or an entity approved by the board in the two-year period 16 immediately preceding the application which demonstrates 17 compliance with current good manufacturing practices. In 18 addition, the applicant shall submit evidence of correction of 19 all deficiencies discovered in such inspections and evidence of 20 compliance with all directives from the home state regulatory 21 authority or entity approved by the board. The board may 22 recover from an outsourcing facility, prior to the issuance 23 of a license or license renewal, the costs associated with 24 conducting an inspection by or on behalf of the board for 25 purposes of satisfying the requirements of this paragraph. 26 DIVISION III 27 INFORMATION SHARING 28 Sec. 7. Section 155A.45, Code 2021, is amended to read as 29 follows: 30 155A.45 Inspection reports Reports —— disclosure. 31 1. Notwithstanding section 272C.6, subsection 4 , paragraph 32 “a” , an inspection report in possession of the board, regardless 33 of whether the report is based on a routine inspection or an 34 inspection prompted by one or more complaints, may be disclosed 35 -3- LSB 1318DP (4) 89 pf/rh 3/ 5
S.F. _____ H.F. _____ to the national association of boards of pharmacy’s inspection 1 network. 2 2. Notwithstanding section 272C.6, subsection 4, paragraph 3 “a” , any complaints, investigative information, or data 4 collected pertaining to compounded human drug products may be 5 disclosed to the United States food and drug administration, 6 including through the use of an information sharing network, in 7 order to comply with any memorandum of understanding with the 8 United States food and drug administration. 9 DIVISION IV 10 PHARMACY PILOT OR DEMONSTRATION RESEARCH PROJECTS 11 Sec. 8. NEW SECTION . 155A.47 Pilot or demonstration 12 research projects. 13 1. Notwithstanding any provision of section 147.107, 14 subsection 2, or section 155A.33 to the contrary, the board may 15 approve a pilot or demonstration research project of innovative 16 applications in the practice of pharmacy to provide enhanced 17 patient care. 18 2. The board shall adopt rules pursuant to chapter 17A for 19 application for and approval of such projects. The rules may 20 include exceptions to any existing rules under the purview 21 of the board as necessary for completion of the project, 22 limited to the duration of the project. The board may approve 23 a project for no more than eighteen months. The board may 24 extend or renew a project in accordance with board rules. All 25 projects shall comply with the rules adopted for such projects. 26 3. The board shall not approve any project that expands the 27 practice of pharmacy as defined in section 155A.3. 28 Sec. 9. REPEAL. 2011 Iowa Acts, chapter 63, section 36, is 29 repealed. 30 EXPLANATION 31 The inclusion of this explanation does not constitute agreement with 32 the explanation’s substance by the members of the general assembly. 33 This bill relates to pharmacy practice. 34 Division I of the bill eliminates the tech-check-tech 35 -4- LSB 1318DP (4) 89 pf/rh 4/ 5
S.F. _____ H.F. _____ program. The board of pharmacy (board) adopted administrative 1 rules to implement and establish a technician product 2 verification program as authorized by 2018 Iowa Acts, 3 chapter 1142, enacting Code section 155A.33A. Division I 4 eliminates the one-year registration limitation for a person in 5 training to become a pharmacy technician and makes conforming 6 terminology changes. Division I also amends provisions 7 relating to the delegation of technical functions between 8 a pharmacist and a pharmacy technician or pharmacy support 9 person. 10 Division II of the bill requires a drug compounding 11 outsourcing facility seeking licensure in the state to 12 have been inspected by the facility’s home state regulatory 13 authority or other entity approved by the board in the two-year 14 period immediately preceding the application, which inspection 15 demonstrates compliance with federal current good manufacturing 16 practices. Division II also allows the board to recover from 17 an outsourcing facility costs associated with conducting an 18 inspection to satisfy the inspection requirement. 19 Division III of the bill authorizes the board of pharmacy to 20 share information collected relating to compounded human drug 21 products with the United States food and drug administration 22 (FDA) pursuant to any memorandum of understanding between the 23 board of pharmacy and the FDA. 24 Division IV of the bill codifies the provisions of 2011 Iowa 25 Acts, chapter 63, section 36, relating to pharmacy pilot or 26 demonstration research projects. The language in Division IV 27 differs from these provisions by eliminating language limiting 28 the projects to those based solely on prescription verification 29 and by eliminating the requirement that the board report the 30 approval or denial of projects to the chairpersons and ranking 31 members of the joint appropriations subcommittee on health and 32 human services. 33 -5- LSB 1318DP (4) 89 pf/rh 5/ 5