House Study Bill 158 - Introduced HOUSE FILE _____ BY (PROPOSED COMMITTEE ON HUMAN RESOURCES BILL BY CHAIRPERSON MILLER) A BILL FOR An Act relating to drug product selection. 1 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 2 TLSB 2093HC (3) 85 pf/nh
H.F. _____ Section 1. Section 155A.13A, Code 2013, is amended to read 1 as follows: 2 155A.13A Nonresident pharmacy license —— required, renewal, 3 drug product selection, discipline. 4 1. License required. A pharmacy located outside of this 5 state which delivers, dispenses, or distributes by any method, 6 prescription drugs or devices to an ultimate user in this state 7 shall obtain a nonresident pharmacy license from the board. 8 The board shall make available an application form for a 9 nonresident pharmacy license and shall require such information 10 it deems necessary to fulfill the purposes of this section . A 11 nonresident pharmacy shall do all of the following in order to 12 obtain a nonresident pharmacy license from the board: 13 a. Submit a completed application form and an application 14 fee as determined by the board. 15 b. Submit evidence of possession of a valid license, permit, 16 or registration as a pharmacy in compliance with the laws of 17 the state in which it is located, a copy of the most recent 18 inspection report resulting from an inspection conducted by 19 the regulatory or licensing agency of the state in which it is 20 located, and evidence of compliance with all legal directions 21 and requests for information issued by the regulatory or 22 licensing agency of the state in which it is located. 23 c. Submit a list of the names, titles, and locations of 24 all principal owners, partners, or officers of the nonresident 25 pharmacy, all pharmacists employed by the nonresident pharmacy 26 who deliver, dispense, or distribute by any method prescription 27 drugs to an ultimate user in this state, and of the pharmacist 28 in charge of the nonresident pharmacy. A nonresident pharmacy 29 shall update the list within thirty days of any addition, 30 deletion, or other change to the list. 31 d. Submit evidence that the nonresident pharmacy maintains 32 records of the controlled substances delivered, dispensed, or 33 distributed to ultimate users in this state. 34 e. Submit evidence that the nonresident pharmacy provides, 35 -1- LSB 2093HC (3) 85 pf/nh 1/ 4
H.F. _____ during its regular hours of operation for at least six days and 1 for at least forty hours per week, toll-free telephone service 2 to facilitate communication between ultimate users in this 3 state and a pharmacist who has access to the ultimate user’s 4 records in the nonresident pharmacy, and that the toll-free 5 number is printed on the label affixed to each container of 6 prescription drugs delivered, dispensed, or distributed in this 7 state. 8 2. License renewal. A nonresident pharmacy shall renew its 9 license on or before January 1 annually. In order to renew 10 a nonresident pharmacy license, a nonresident pharmacy shall 11 submit a renewal fee as determined by the board, and shall 12 fulfill all of the requirements of subsection 1 , paragraphs “b” 13 through “e” . A nonresident pharmacy shall pay an additional fee 14 for late renewal as determined by the board. 15 3. Drug product selection. A nonresident pharmacy is 16 subject to the drug product selection requirements specified 17 in section 155A.32. 18 3. 4. Discipline. The board may deny, suspend, or revoke a 19 nonresident pharmacy license for any violation of this section , 20 section 155A.15, subsection 2 , paragraph “a” , “b” , “d” , “e” , 21 “f” , “g” , “h” , or “i” , chapter 124 , 124A , 124B , 126 , or 205 , or 22 a rule of the board. 23 Sec. 2. Section 155A.32, subsection 2, Code 2013, is amended 24 to read as follows: 25 2. The pharmacist shall not exercise the drug product 26 selection described in this section if either any of the 27 following is true: 28 a. The prescriber specifically indicates that no drug 29 product selection shall be made. 30 b. The person presenting the prescription indicates that 31 only the specific drug product prescribed should be dispensed. 32 However, this paragraph does not apply if the cost of the 33 prescription or any part of it will be paid by expenditure of 34 public funds authorized under chapter 249A . 35 -2- LSB 2093HC (3) 85 pf/nh 2/ 4
H.F. _____ c. The prescriber indicates that a specific drug product 1 should be dispensed and a diagnosis of epilepsy is written on 2 the prescription. For the purposes of this paragraph, “drug 3 product selection” includes dispensing a drug product of another 4 manufacturer instead of the specific drug product the patient 5 is currently prescribed, and substituting a generic version 6 for a brand version, a brand version for a generic version, 7 or a generic version for a generic version of a different 8 manufacturer. For the purposes of this paragraph, a “specific 9 drug product” means a specific drug, strength, dosage form, or 10 dosing regimen from a specific manufacturer. 11 Sec. 3. Section 155A.32, Code 2013, is amended by adding the 12 following new subsections: 13 NEW SUBSECTION . 4. If drug product selection is prohibited 14 pursuant to subsection 2, paragraph “c” , but the specific 15 drug indicated is not available, the pharmacist may dispense 16 a seventy-two-hour emergency supply of a bioequivalent of 17 a specific generic manufacturer’s product. If a pharmacist 18 dispenses a bioequivalent drug product under this subsection, 19 the pharmacist shall notify the patient and the prescriber 20 of the substitution and shall resolve the shortage within 21 seventy-two hours of dispensing the substitute drug product. 22 The board shall adopt rules regarding notification of the 23 patient and prescriber under this subsection. 24 NEW SUBSECTION . 5. If drug product selection is prohibited 25 under subsection 2, paragraph “c” , any differential in cost to 26 the pharmacy or patient resulting from the prohibition shall be 27 covered by the patient’s health carrier as defined in section 28 514J.102. 29 EXPLANATION 30 This bill relates to drug product selection. 31 The bill amends provisions relating to nonresident 32 pharmacies to provide that a nonresident pharmacy is subject 33 to the drug product selection requirements that are currently 34 applicable to resident pharmacies. 35 -3- LSB 2093HC (3) 85 pf/nh 3/ 4
H.F. _____ The bill also amends the list of exceptions to a pharmacist 1 exercising drug product selection to provide that a pharmacist 2 shall not exercise drug product selection if the prescriber 3 indicates that a specific drug product should be dispensed and 4 a diagnosis of epilepsy is written on the prescription. The 5 bill also specifies that for the purposes of the exception, 6 drug product selection includes dispensing a drug product of 7 another manufacturer instead of the specific drug product the 8 patient is currently prescribed, and substituting a generic 9 version for a brand version, a brand version for a generic 10 version, or a generic version for a generic version of a 11 different manufacturer. Additionally, for the purposes of 12 the exception, a specific drug product means a specific drug, 13 strength, dosage form, or dosing regimen from a specific 14 manufacturer. 15 The bill also addresses substitutions made when a pharmacy 16 does not have a specific drug product available when drug 17 product selection is prohibited. In those instances, the bill 18 provides that the pharmacist may dispense a 72-hour emergency 19 supply of a bioequivalent of a specific generic manufacturer’s 20 product. If a substitute is dispensed, the pharmacist is 21 required to notify the patient and the prescriber of the 22 substitution and to resolve the shortage within 72 hours of 23 dispensing the substitute drug product. The bill directs the 24 board of pharmacy to adopt rules regarding notification of the 25 patient and prescriber. 26 The bill also provides that if drug product selection 27 is prohibited relating to a diagnosis of epilepsy, any 28 differential in cost to the pharmacy or patient resulting 29 from the prohibition shall be covered by the patient’s health 30 carrier. 31 -4- LSB 2093HC (3) 85 pf/nh 4/ 4