S.F. 453 Section 1. Section 147.107, subsection 2, paragraph a, Code 1 2015, is amended to read as follows: 2 a. A pharmacist, physician, dentist, or podiatric physician 3 who dispenses prescription drugs, including but not limited 4 to controlled substances, for human use, may delegate 5 nonjudgmental dispensing functions to staff assistants only 6 when verification of the accuracy and completeness of the 7 dispensing is determined by the pharmacist or practitioner 8 in the pharmacist’s or practitioner’s physical presence. 9 However, the physical presence requirement does not apply 10 when a pharmacist or practitioner is utilizing an automated 11 dispensing system ; or when a pharmacist is utilizing a 12 tech-check-tech program, as defined in section 155A.3 ; or when 13 a pharmacist is remotely supervising a certified pharmacy 14 technician practicing at a telepharmacy site approved by the 15 board of pharmacy . When using an automated dispensing system 16 the pharmacist or practitioner shall utilize an internal 17 quality control assurance plan that ensures accuracy for 18 dispensing. When using a tech-check-tech program or when 19 remotely supervising a certified pharmacy technician practicing 20 at an approved telepharmacy site, the pharmacist shall utilize 21 an internal quality control assurance plan, in accordance 22 with rules adopted by the board of pharmacy, that ensures 23 accuracy for dispensing. Verification of automated dispensing , 24 and tech-check-tech , and telepharmacy practice accuracy and 25 completeness remains the responsibility of the pharmacist or 26 practitioner and shall be determined in accordance with rules 27 adopted by the board of pharmacy, the board of medicine, the 28 dental board, and the board of podiatry for their respective 29 licensees. 30 Sec. 2. Section 155A.3, Code 2015, is amended by adding the 31 following new subsection: 32 NEW SUBSECTION . 40A. “Telepharmacy” means the practice of 33 pharmacy via telecommunications as provided by the board by 34 rule. 35 -1- LSB 1217SV (2) 86 tr/nh 1/ 10

S.F. 453 Sec. 3. Section 155A.13A, Code 2015, is amended to read as 1 follows: 2 155A.13A Nonresident pharmacy license —— required, renewal, 3 discipline. 4 1. License required. A pharmacy located outside of this 5 state which that delivers, dispenses, or distributes by any 6 method, prescription drugs or devices to an ultimate user in 7 this state shall obtain a nonresident pharmacy license from 8 the board. The board shall make available an application form 9 for a nonresident pharmacy license and shall require such 10 information it deems necessary to fulfill the purposes of this 11 section . A nonresident pharmacy shall do all of the following 12 in order to obtain a nonresident pharmacy license from the 13 board: 14 a. Submit a completed application form and an application 15 fee as determined by the board. 16 b. Submit evidence of possession of a valid pharmacy 17 license, permit, or registration as a pharmacy in compliance 18 with the laws of the state in which it is located, a copy of 19 the most recent inspection report resulting from an inspection 20 conducted by the regulatory or licensing agency of the state 21 in which it is located, and evidence of compliance with all 22 legal directions and requests for information issued by the 23 regulatory or licensing agency of the state in which it is 24 located issued by the home state licensing authority . 25 c. (1) Submit a list of the names, titles, and locations of 26 all principal owners, partners, or officers of the nonresident 27 pharmacy, all pharmacists employed by the nonresident pharmacy 28 who deliver, dispense, or distribute by any method prescription 29 drugs to an ultimate user in this state, and of the pharmacist 30 in charge of the nonresident pharmacy. A nonresident pharmacy 31 shall update the list within thirty days of any addition, 32 deletion, or other change to the list. Submit an inspection 33 report that satisfies all of the following requirements: 34 (a) Less than two years have passed since the date of 35 -2- LSB 1217SV (2) 86 tr/nh 2/ 10

S.F. 453 inspection. 1 (b) The inspection occurred while the pharmacy was in 2 operation. An inspection prior to the initial opening of the 3 pharmacy shall not satisfy this requirement. 4 (c) The inspection report addresses all aspects of the 5 pharmacy’s business that will be utilized in Iowa. 6 (d) The inspection was performed by or on behalf of the home 7 state licensing authority, if available. 8 (e) The inspection report is the most recent report 9 available that satisfies the requirements of this paragraph 10 “c” . 11 (2) If the home state licensing authority has not conducted 12 an inspection satisfying the requirements of this paragraph 13 “c” , the pharmacy may submit an inspection report from the 14 national association of boards of pharmacy’s verified pharmacy 15 program, or the pharmacy may submit an inspection report from 16 another qualified entity if preapproved by the board, if the 17 inspection report satisfies all of the other requirements of 18 this paragraph “c” . 19 (3) The board may recover from a nonresident pharmacy, prior 20 to the issuance of a license or renewal, the costs associated 21 with conducting an inspection by or on behalf of the board 22 for purposes of satisfying the requirement in subparagraph 23 (1), subparagraph division (d). In addition, the nonresident 24 pharmacy shall submit evidence of corrective actions for all 25 deficiencies noted in the inspection report and shall submit 26 evidence of compliance with all legal directives of the home 27 state regulatory or licensing authority. 28 d. Submit evidence that the nonresident pharmacy maintains 29 records of the controlled substances delivered, dispensed, or 30 distributed to ultimate users in this state. 31 e. Submit evidence that the nonresident pharmacy provides , 32 during its regular hours of operation for at least six days 33 and for at least forty hours per week, a toll-free telephone 34 service to facilitate communication between ultimate users in 35 -3- LSB 1217SV (2) 86 tr/nh 3/ 10

S.F. 453 this state and , the telephone number of which is printed on the 1 label affixed to each prescription dispensed or distributed 2 in Iowa, that allows patients to speak with a pharmacist who 3 has access to the ultimate user’s patient records in the 4 nonresident pharmacy, and that the toll-free number is printed 5 on the label affixed to each container of prescription drugs 6 delivered, dispensed, or distributed in this state at least six 7 days per week for a total of at least forty hours . 8 2. Pharmacist license requirement. The pharmacist who is 9 the pharmacist in charge of the nonresident pharmacy shall 10 be designated as such on the nonresident pharmacy license 11 application or renewal. Any change in the pharmacist in charge 12 shall be reported to the board within ten days of the change. 13 The pharmacist in charge must be registered, not licensed, 14 according to rules established by the board of pharmacy. 15 2. 3. License renewal. A nonresident pharmacy shall renew 16 its license on or before January 1 annually. In order to renew 17 a nonresident pharmacy license, a nonresident pharmacy shall 18 submit a renewal completed application and fee as determined 19 by the board, and shall fulfill all of the requirements of 20 subsection 1 , paragraphs “b” through “e” . A nonresident 21 pharmacy shall pay an additional fee for late renewal as 22 determined by the board. 23 4. License denial. The board shall refuse to issue 24 a nonresident pharmacy license for failure to meet the 25 requirements of subsection 1. The board may refuse to issue 26 or renew a license for any grounds under which the board 27 may impose discipline. License or renewal denials shall be 28 considered contested cases governed by chapter 17A. 29 3. 5. Discipline. The board may deny fine , suspend, or 30 revoke , or impose other disciplinary sanctions on a nonresident 31 pharmacy license for any violation of this section , section 32 155A.15, subsection 2 , paragraph “a” , “b” , “d” , “e” , “f” , “g” , 33 “h” , or “i” , chapter 124 , 124A , 124B , 126 , or 205 , or a rule of 34 the board. of the following: 35 -4- LSB 1217SV (2) 86 tr/nh 4/ 10

S.F. 453 a. Any violation of the federal Food, Drug, and Cosmetic Act 1 or federal regulations promulgated under the Act. A warning 2 letter issued by the United States food and drug administration 3 shall be conclusive evidence of a violation. 4 b. Any conviction of a crime related to prescription drugs 5 or the practice of pharmacy committed by the nonresident 6 pharmacy, pharmacist in charge, or individual owner, or if the 7 pharmacy is an association, joint stock company, partnership, 8 or corporation, by any managing officer. 9 c. Refusing access to the pharmacy or pharmacy records to an 10 agent of the board for the purpose of conducting an inspection 11 or investigation. 12 d. Any violation of this chapter or chapter 124, 124A, 124B, 13 126, or 205, or rule of the board. 14 Sec. 4. NEW SECTION . 155A.13C Outsourcing facility license 15 —— renewal, cancellation, denial, discipline. 16 1. License required. Any compounding facility that is 17 registered as an outsourcing facility, as defined in 21 18 U.S.C. §353b, that distributes sterile compounded human 19 drug products without a patient-specific prescription to an 20 authorized agent or practitioner in this state shall obtain an 21 outsourcing facility license from the board prior to engaging 22 in such distribution. If an outsourcing facility dispenses 23 prescription drugs pursuant to patient-specific prescriptions 24 to patients in Iowa, the outsourcing facility shall obtain and 25 maintain a valid Iowa pharmacy license or Iowa nonresident 26 pharmacy license under this chapter. The board shall make 27 available an application form for an outsourcing facility 28 license and shall require such information it deems necessary 29 to fulfill the purposes of this section. An outsourcing 30 facility shall do all of the following in order to obtain an 31 outsourcing facility license from the board: 32 a. Submit a completed application form and application fee 33 as determined by the board. 34 b. Submit evidence of possession of a valid registration as 35 -5- LSB 1217SV (2) 86 tr/nh 5/ 10

S.F. 453 an outsourcing facility with the United States food and drug 1 administration. 2 c. If one or more inspections have been conducted by the 3 United States food and drug administration in the five-year 4 period immediately preceding the application, submit a copy 5 of any correspondence from the United States food and drug 6 administration as a result of the inspection, including but 7 not limited to any form 483s, warning letters, or formal 8 responses, and all correspondence from the applicant to the 9 United States food and drug administration related to such 10 inspections, including but not limited to formal responses and 11 corrective action plans. In addition, the applicant shall 12 submit evidence of correction of all deficiencies discovered in 13 such inspections and evidence of compliance with all directives 14 from the United States food and drug administration. 15 d. Submit evidence that the supervising pharmacist, as 16 described in 21 U.S.C. §353b(a), holds a valid pharmacist 17 license in the state in which the facility is located and that 18 such license is in good standing. 19 2. License renewal. An outsourcing facility shall renew 20 its license on or before January 1 annually. In order to renew 21 an outsourcing facility license, an outsourcing facility shall 22 submit a completed application and fee as determined by the 23 board, and shall fulfill all of the requirements of subsection 24 1. An outsourcing facility shall pay an additional fee for 25 late renewal as determined by the board. 26 3. License cancellation. If a facility ceases to be 27 registered as an outsourcing facility with the United States 28 food and drug administration, the facility shall notify the 29 board in writing and shall surrender its Iowa outsourcing 30 facility license to the board within thirty days of such 31 occurrence. Upon receipt, the board shall administratively 32 cancel the outsourcing facility license. 33 4. License denial. The board shall refuse to issue 34 an outsourcing facility license for failure to meet the 35 -6- LSB 1217SV (2) 86 tr/nh 6/ 10

S.F. 453 requirements of subsection 1. The board may refuse to issue 1 or renew a license for any grounds under which the board 2 may impose discipline. License or renewal denials shall be 3 considered contested cases governed by chapter 17A. 4 5. Discipline. The board may fine, suspend, revoke, or 5 impose other disciplinary sanctions on an outsourcing facility 6 license for any of the following: 7 a. Any violation of the federal Food, Drug, and Cosmetic Act 8 or federal regulations promulgated under the Act. A warning 9 letter issued by the United States food and drug administration 10 shall be conclusive evidence of a violation. 11 b. Any conviction of a crime related to prescription drugs 12 or the practice of pharmacy committed by the outsourcing 13 facility, supervising pharmacist, or individual owner, or 14 if the outsourcing facility is an association, joint stock 15 company, partnership, or corporation, by any managing officer. 16 c. Refusing access to the outsourcing facility or facility 17 records to an agent of the board for the purpose of conducting 18 an inspection or investigation. 19 d. Any violation of this chapter or chapter 124, 124A, 124B, 20 126, or 205, or rule of the board. 21 Sec. 5. Section 155A.26, subsections 2, 3, and 4, Code 2015, 22 are amended to read as follows: 23 2. Make audits of the supply and inventory of controlled 24 substances and prescription drugs in the possession of any and 25 all individuals or institutions authorized to have possession 26 of any controlled substances or prescription drugs , regardless 27 of the location of the individual or institution . 28 3. Conduct routine and unannounced inspections of 29 pharmacies, drug wholesalers, and the offices or business 30 locations of all individuals and institutions authorized to 31 have possession of prescription drugs including controlled 32 substances or prescription devices , regardless of the location 33 of the office or business . 34 4. Conduct inspections and investigations related to the 35 -7- LSB 1217SV (2) 86 tr/nh 7/ 10

S.F. 453 practice of pharmacy and the distribution of prescription drugs 1 and devices in and into this state. 2 Sec. 6. Section 155A.33, Code 2015, is amended to read as 3 follows: 4 155A.33 Delegation of technical functions. 5 A pharmacist may delegate technical dispensing functions 6 to pharmacy technicians, but only if the pharmacist is 7 physically present to verify the accuracy and completeness 8 of the patient’s prescription prior to the delivery of the 9 prescription to the patient or the patient’s representative. 10 However, the physical presence requirement does not apply when 11 a pharmacist is utilizing an automated dispensing system or 12 a tech-check-tech program or when a pharmacist is remotely 13 supervising a certified pharmacy technician practicing at 14 a telepharmacy site approved by the board . When using an 15 automated dispensing system or a tech-check-tech program , or 16 when remotely supervising a certified pharmacy technician 17 practicing at an approved telepharmacy site , the pharmacist 18 shall utilize an internal quality control assurance plan that 19 ensures accuracy for dispensing. Verification of automated 20 dispensing , and tech-check-tech , and telepharmacy practice 21 accuracy and completeness remains the responsibility of the 22 pharmacist and shall be determined in accordance with rules 23 adopted by the board. 24 Sec. 7. NEW SECTION . 155A.45 Inspection reports —— 25 disclosure. 26 Notwithstanding section 272C.6, subsection 4, paragraph “a” , 27 an inspection report in possession of the board, regardless 28 of whether the report is based on a routine inspection or an 29 inspection prompted by one or more complaints, may be disclosed 30 to the national association of boards of pharmacy’s inspection 31 network. 32 EXPLANATION 33 The inclusion of this explanation does not constitute agreement with 34 the explanation’s substance by the members of the general assembly. 35 -8- LSB 1217SV (2) 86 tr/nh 8/ 10

S.F. 453 This bill relates to the operation of, and persons and 1 activities regulated by, the board of pharmacy. 2 The bill provides for remote pharmacist supervision of 3 a certified pharmacy technician practicing at an approved 4 telepharmacy practice site, pursuant to rules of the board. 5 The bill defines the term “telepharmacy” as it relates to the 6 practice of pharmacy. 7 The bill amends provisions relating to the licensure of 8 nonresident pharmacies that provide prescription pharmaceutical 9 products to patients located in Iowa. The bill requires the 10 pharmacist in charge of a nonresident pharmacy to be identified 11 as such on the nonresident pharmacy license application or 12 renewal, report any change in the pharmacist in charge to the 13 board within 10 days, and be registered in accordance with 14 board rules. The bill clarifies the information required for 15 license application, including evidence of recent inspection 16 of the pharmacy and defining the elements of an acceptable 17 inspection. The bill describes and identifies various entities 18 that may be employed to perform an inspection acceptable for 19 Iowa licensure. The bill authorizes the board to recoup from 20 a nonresident pharmacy any costs incurred by the board in 21 completing an inspection of the nonresident pharmacy if the 22 nonresident pharmacy cannot provide an acceptable inspection 23 report. 24 The bill eliminates the requirement that a nonresident 25 pharmacy maintain minimum hours and days of operation, 26 requiring in lieu thereof that a pharmacist with access to 27 patient records be readily available to speak to patients via 28 a toll-free telephone number at least six days per week for a 29 total of at least 40 hours. 30 The bill authorizes the board to deny an application for a 31 nonresident pharmacy license if the applicant fails to meet the 32 application requirements and authorizes the board to refuse to 33 issue or renew a nonresident pharmacy license for any grounds 34 under which the board may impose discipline. 35 -9- LSB 1217SV (2) 86 tr/nh 9/ 10

S.F. 453 The bill amends the grounds for disciplining nonresident 1 pharmacies. The board may impose discipline for any violation 2 of the federal Food, Drug, and Cosmetic Act or regulations 3 promulgated under the Act including the issuance by the United 4 States food and drug administration of a warning letter; 5 conviction of a crime related to prescription drugs or the 6 practice of pharmacy by the owner, managing officer, or the 7 pharmacy; refusal to provide the board’s agent access to the 8 pharmacy or pharmacy records for purposes of inspection or 9 investigation; and any violation of Iowa law or rule of the 10 board relating to the practice of pharmacy and the distribution 11 of prescription products in Iowa. For nonresident pharmacies, 12 the bill adds that the board has the option to fine the 13 nonresident pharmacy, in addition to license suspension, 14 revocation, and other sanctions. 15 The bill adds a new license classification for outsourcing 16 facilities, for the purpose of licensing and regulating any 17 compounding facility that is registered under federal law as an 18 outsourcing facility. The bill establishes the requirements 19 for application and licensure; license renewal, cancellation, 20 and denial; and establishes grounds for discipline of the 21 outsourcing facility license identical to the disciplinary 22 procedure available regarding nonresident pharmacies. 23 The bill clarifies that the officers, agents, inspectors, 24 and representatives of the board may perform functions and 25 activities relating to authorized enforcement activities 26 regardless of the location of the office or business that is 27 the subject of the enforcement activities. The bill authorizes 28 the board to provide reports of inspections of board licensees 29 to the national association of boards of pharmacy’s inspection 30 network, a closed network of information regarding individual 31 states’ licensees that compiles information and makes that 32 information available to other state boards of pharmacy for 33 purposes of regulating the subject licensees. 34 -10- LSB 1217SV (2) 86 tr/nh 10/ 10