S.F. _____ H.F. _____ 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. NEW SECTION . 155A.2A Board of pharmacy —— alternate 31 members. 32 Notwithstanding sections 17A.11, 69.16, 69.16A, 147.12, 33 147.14, and 147.19, the board may have a pool of up to seven 34 alternate members, including members licensed to practice under 35 -1- LSB 1217DP (3) 86 tr/nh 1/ 13

S.F. _____ H.F. _____ this chapter and members not licensed to practice under this 1 chapter, to substitute for board members who are disqualified 2 or become unavailable for any other reason for contested case 3 hearings. 4 1. The board may recommend, subject to approval by the 5 governor, up to seven people to serve in a pool of alternate 6 members. 7 2. A person serves in the pool of alternate members at 8 the discretion of the board; however, the length of time an 9 alternate member may serve in the pool shall not exceed nine 10 years. A person who serves as an alternate member may later be 11 appointed to the board and may serve nine years, in accordance 12 with sections 147.12 and 147.19. A former board member may 13 serve in the pool of alternate members. 14 3. An alternate member licensed under this chapter shall 15 hold an active license and shall have been actively engaged in 16 the practice of pharmacy in the preceding three years, with the 17 two most recent years of practice being in Iowa. 18 4. When a sufficient number of board members are unavailable 19 to hear a contested case, the board may request alternate 20 members to serve. 21 5. Notwithstanding section 17A.11, section 147.14, 22 subsection 2, and section 272C.6, subsection 5: 23 a. An alternate member is deemed a member of the board only 24 for the hearing panel for which the alternate member serves. 25 b. A hearing panel containing alternate members must include 26 at least five people. 27 c. The majority of a hearing panel containing alternate 28 members shall be current members of the board. 29 d. The majority of a hearing panel containing alternate 30 members shall be licensed to practice under this chapter. 31 e. A decision of a hearing panel containing alternate 32 members is considered a final decision of the board. 33 6. An alternate member shall not receive compensation in 34 excess of that authorized by law for a board member. 35 -2- LSB 1217DP (3) 86 tr/nh 2/ 13

S.F. _____ H.F. _____ Sec. 3. Section 155A.3, subsections 10 and 11, Code 2015, 1 are amended to read as follows: 2 10. “Device” means an instrument, apparatus, implement, 3 machine, contrivance, implant, in vitro reagent, or other 4 similar or related article, including any component part or 5 accessory of any of these , that is required under federal or 6 state law to be ordered or prescribed by a practitioner. which 7 is any of the following: 8 a. Recognized as a device in the official United States 9 pharmacopoeia national formulary or any supplement thereto. 10 b. Intended for use in the diagnosis of diseases or 11 other conditions, or in the cure, mitigation, treatment, or 12 prevention of diseases or other conditions in a human. 13 c. Intended to affect the structure or any function of 14 the body of a human, and which does not achieve any of its 15 principal intended purposes through chemical action within 16 or on the body of a human and which is not dependent upon 17 being metabolized for the achievement of any of its principal 18 intended purposes. 19 11. “Dispense” means to deliver a prescription drug, 20 device, or controlled substance to an ultimate user or research 21 subject by or pursuant to the lawful prescription drug order or 22 medication order of a practitioner, including the prescribing, 23 administering, packaging, labeling, or compounding necessary 24 to prepare the a substance for that delivery , or measuring, 25 fitting, adjusting, or otherwise facilitating the use of a 26 medical device or equipment by the patient . 27 Sec. 4. Section 155A.3, Code 2015, is amended by adding the 28 following new subsections: 29 NEW SUBSECTION . 17A. “Equipment” means any durable or 30 nondurable medical product or article, including but not 31 limited to medical products or articles for personal use. 32 NEW SUBSECTION . 40A. “Telepharmacy” means the practice of 33 pharmacy via telecommunications as provided by the board by 34 rule. 35 -3- LSB 1217DP (3) 86 tr/nh 3/ 13

S.F. _____ H.F. _____ Sec. 5. 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 -4- LSB 1217DP (3) 86 tr/nh 4/ 13

S.F. _____ H.F. _____ 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 has submitted an 31 application to register with the Iowa prescription monitoring 32 program, except as otherwise provided in this paragraph . The 33 prescription monitoring program registration shall be issued 34 if the nonresident pharmacy license application is granted. 35 -5- LSB 1217DP (3) 86 tr/nh 5/ 13

S.F. _____ H.F. _____ If the nonresident pharmacy does not intend to dispense or 1 distribute controlled substances in Iowa, the pharmacy may, in 2 lieu of registering with the prescription monitoring program, 3 submit an application for exemption from reporting to the 4 prescription monitoring program. 5 e. Submit evidence that the nonresident pharmacy provides , 6 during its regular hours of operation for at least six days 7 and for at least forty hours per week, a toll-free telephone 8 service to facilitate communication between ultimate users in 9 this state and , the telephone number of which is printed on the 10 label affixed to each prescription dispensed or distributed 11 in Iowa, that allows patients to speak with a pharmacist who 12 has access to the ultimate user’s patient records in the 13 nonresident pharmacy, and that the toll-free number is printed 14 on the label affixed to each container of prescription drugs 15 delivered, dispensed, or distributed in this state at least six 16 days per week for a total of at least forty hours . 17 2. Pharmacist license requirement. At least one pharmacist 18 employed by the nonresident pharmacy, who shall be the 19 pharmacist in charge of the nonresident pharmacy, shall 20 maintain a current license to practice pharmacy in Iowa during 21 any period that the nonresident pharmacy is licensed by the 22 board. 23 2. 3. License renewal. A nonresident pharmacy shall renew 24 its license on or before January 1 annually. In order to renew 25 a nonresident pharmacy license, a nonresident pharmacy shall 26 submit a renewal completed application and fee as determined 27 by the board, and shall fulfill all of the requirements of 28 subsection 1 , paragraphs “b” through “e” . A nonresident 29 pharmacy shall pay an additional fee for late renewal as 30 determined by the board. 31 4. License denial. The board shall refuse to issue 32 a nonresident pharmacy license for failure to meet the 33 requirements of subsection 1. The board may refuse to issue 34 or renew a license for any grounds under which the board 35 -6- LSB 1217DP (3) 86 tr/nh 6/ 13

S.F. _____ H.F. _____ may impose discipline. License or renewal denials shall be 1 considered contested cases governed by chapter 17A. 2 3. 5. Discipline. The board may deny fine , suspend, or 3 revoke , or impose other disciplinary sanctions on a nonresident 4 pharmacy license for any violation of this section , section 5 155A.15, subsection 2 , paragraph “a” , “b” , “d” , “e” , “f” , “g” , 6 “h” , or “i” , chapter 124 , 124A , 124B , 126 , or 205 , or a rule of 7 the board. of the following: 8 a. Any violation of the federal Food, Drug, and Cosmetic Act 9 or federal regulations promulgated under the Act. A warning 10 letter issued by the United States food and drug administration 11 shall be conclusive evidence of a violation. 12 b. Any conviction of a crime related to prescription drugs 13 or the practice of pharmacy committed by the nonresident 14 pharmacy, pharmacist in charge, or individual owner, or if the 15 pharmacy is an association, joint stock company, partnership, 16 or corporation, by any managing officer. 17 c. Refusing access to the pharmacy or pharmacy records to an 18 agent of the board for the purpose of conducting an inspection 19 or investigation. 20 d. Any violation of this chapter or chapter 124, 124A, 124B, 21 126, or 205, or rule of the board. 22 Sec. 6. NEW SECTION . 155A.13C Outsourcing facility license 23 —— renewal, cancellation, denial, discipline. 24 1. License required. Any compounding facility that is 25 registered as an outsourcing facility, as defined in 21 26 U.S.C. §353b, that distributes sterile compounded human 27 drug products without a patient-specific prescription to an 28 authorized agent or practitioner in this state shall obtain an 29 outsourcing facility license from the board prior to engaging 30 in such distribution. If an outsourcing facility dispenses 31 prescription drugs pursuant to patient-specific prescriptions 32 to patients in Iowa, the outsourcing facility shall obtain and 33 maintain a valid Iowa pharmacy license or Iowa nonresident 34 pharmacy license under this chapter. The board shall make 35 -7- LSB 1217DP (3) 86 tr/nh 7/ 13

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

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

S.F. _____ H.F. _____ of the location of the individual or institution . 1 3. Conduct routine and unannounced inspections of 2 pharmacies, drug wholesalers, and the offices or business 3 locations of all individuals and institutions authorized to 4 have possession of prescription drugs including controlled 5 substances or prescription devices , regardless of the location 6 of the office or business . 7 4. Conduct inspections and investigations related to the 8 practice of pharmacy and the distribution of prescription drugs 9 and devices in and into this state. 10 Sec. 8. Section 155A.33, Code 2015, is amended to read as 11 follows: 12 155A.33 Delegation of technical functions. 13 A pharmacist may delegate technical dispensing functions 14 to pharmacy technicians, but only if the pharmacist is 15 physically present to verify the accuracy and completeness 16 of the patient’s prescription prior to the delivery of the 17 prescription to the patient or the patient’s representative. 18 However, the physical presence requirement does not apply when 19 a pharmacist is utilizing an automated dispensing system or 20 a tech-check-tech program or when a pharmacist is remotely 21 supervising a certified pharmacy technician practicing at 22 a telepharmacy site approved by the board . When using an 23 automated dispensing system or a tech-check-tech program , or 24 when remotely supervising a certified pharmacy technician 25 practicing at an approved telepharmacy site , the pharmacist 26 shall utilize an internal quality control assurance plan that 27 ensures accuracy for dispensing. Verification of automated 28 dispensing , and tech-check-tech , and telepharmacy practice 29 accuracy and completeness remains the responsibility of the 30 pharmacist and shall be determined in accordance with rules 31 adopted by the board. 32 Sec. 9. NEW SECTION . 155A.45 Inspection reports —— 33 disclosure. 34 Notwithstanding section 272C.6, subsection 4, paragraph “a” , 35 -10- LSB 1217DP (3) 86 tr/nh 10/ 13

S.F. _____ H.F. _____ an inspection report in possession of the board, regardless 1 of whether the report is based on a routine inspection or an 2 inspection prompted by one or more complaints, may be disclosed 3 to the national association of boards of pharmacy’s inspection 4 network. 5 EXPLANATION 6 The inclusion of this explanation does not constitute agreement with 7 the explanation’s substance by the members of the general assembly. 8 This bill relates to the operation of, and persons and 9 activities regulated by, the board of pharmacy. 10 The bill provides for remote pharmacist supervision of 11 a certified pharmacy technician practicing at an approved 12 telepharmacy practice site, pursuant to rules of the board. 13 The bill permits the board to recommend, subject to approval 14 by the governor, a pool of up to seven qualified individuals 15 to serve as alternate board members to ensure the availability 16 of an unbiased quorum of board members to hear a contested 17 case. The bill identifies the maximum term for an alternate 18 board member, provides that an individual who previously served 19 on the board may serve as an alternate board member, provides 20 for compensation when the alternate member serves on a hearing 21 panel, establishes requirements for the composition of a 22 hearing panel containing alternate board members, and provides 23 that the decision of a hearing panel containing alternate board 24 members is considered a final decision of the board. 25 The bill amends the definitions of “device” and “dispense” 26 to more closely align with industry standard definitions and to 27 clarify the activities that may be included as a function of 28 dispensing. The bill also defines the terms “equipment” and 29 “telepharmacy” as they relate to the practice of pharmacy. 30 The bill amends provisions relating to the licensure of 31 nonresident pharmacies that provide prescription pharmaceutical 32 products to patients located in Iowa. The bill requires the 33 pharmacist in charge of a nonresident pharmacy to maintain 34 a license to practice pharmacy in Iowa. The bill clarifies 35 -11- LSB 1217DP (3) 86 tr/nh 11/ 13

S.F. _____ H.F. _____ the information required for license application, including 1 evidence of recent inspection of the pharmacy and defining the 2 elements of an acceptable inspection. The bill describes and 3 identifies various entities that may be employed to perform an 4 inspection acceptable for Iowa licensure. The bill authorizes 5 the board to recoup from a nonresident pharmacy any costs 6 incurred by the board in completing an inspection of the 7 nonresident pharmacy if the nonresident pharmacy cannot provide 8 an acceptable inspection report. 9 The bill requires that an applicant for a nonresident 10 pharmacy license must include with the application either 11 evidence that the nonresident pharmacy has registered to 12 submit controlled substances prescription records to the 13 Iowa prescription monitoring program (PMP) or has requested 14 exemption from reporting to the PMP based on exemption criteria 15 established by the board pursuant to Code section 124.552. The 16 bill eliminates the requirement that a nonresident pharmacy 17 maintain minimum hours and days of operation, requiring in 18 lieu thereof that a pharmacist with access to patient records 19 be readily available to speak to patients via a toll-free 20 telephone number at least six days per week for a total of at 21 least 40 hours. 22 The bill authorizes the board to deny an application for a 23 nonresident pharmacy license if the applicant fails to meet the 24 application requirements and authorizes the board to refuse to 25 issue or renew a nonresident pharmacy license for any grounds 26 under which the board may impose discipline. 27 The bill amends the grounds for disciplining nonresident 28 pharmacies. The board may impose discipline for any violation 29 of the federal Food, Drug, and Cosmetic Act or regulations 30 promulgated under the Act including the issuance by the United 31 States food and drug administration of a warning letter; 32 conviction of a crime related to prescription drugs or the 33 practice of pharmacy by the owner, managing officer, or the 34 pharmacy; refusal to provide the board’s agent access to the 35 -12- LSB 1217DP (3) 86 tr/nh 12/ 13

S.F. _____ H.F. _____ pharmacy or pharmacy records for purposes of inspection or 1 investigation; and any violation of Iowa law or rule of the 2 board relating to the practice of pharmacy and the distribution 3 of prescription products in Iowa. For nonresident pharmacies, 4 the bill adds that the board has the option to fine the 5 nonresident pharmacy, in addition to license suspension, 6 revocation, and other sanctions. 7 The bill adds a new license classification for outsourcing 8 facilities, for the purpose of licensing and regulating any 9 compounding facility that is registered under federal law as an 10 outsourcing facility. The bill establishes the requirements 11 for application and licensure; license renewal, cancellation, 12 and denial; and establishes grounds for discipline of the 13 outsourcing facility license identical to the disciplinary 14 procedure available regarding nonresident pharmacies. 15 The bill clarifies that the officers, agents, inspectors, 16 and representatives of the board may perform functions and 17 activities relating to authorized enforcement activities 18 regardless of the location of the office or business that is 19 the subject of the enforcement activities. The bill authorizes 20 the board to provide reports of inspections of board licensees 21 to the national association of boards of pharmacy’s inspection 22 network, a closed network of information regarding individual 23 states’ licensees that compiles information and makes that 24 information available to other state boards of pharmacy for 25 purposes of regulating the subject licensees. 26 -13- LSB 1217DP (3) 86 tr/nh 13/ 13