S.F. 326 Section 1. Section 155A.3, Code 2017, is amended by adding 1 the following new subsections: 2 NEW SUBSECTION . 2A. “Biological product” means the same as 3 defined in 42 U.S.C. §262. 4 NEW SUBSECTION . 19A. “Interchangeable biological product” 5 means either of the following: 6 a. A biological product that the United States food and 7 drug administration has licensed and has determined meets 8 the standards for interchangeability pursuant to 42 U.S.C. 9 §262(k)(4). 10 b. A biological product that the United States food and 11 drug administration has determined to be therapeutically 12 equivalent to another biological product as set forth in the 13 latest edition or supplement of the United States food and 14 drug administration approved drug products with therapeutic 15 equivalence evaluations publication. 16 Sec. 2. Section 155A.28, Code 2017, is amended to read as 17 follows: 18 155A.28 Label of prescription drugs —— interchangeable 19 biological product list . 20 1. The label of any drug , biological product, or device sold 21 and dispensed on the prescription of a practitioner shall be in 22 compliance with rules adopted by the board. 23 2. The board shall maintain a link on its internet site to 24 the current list of all biological products that the United 25 States food and drug administration has determined to be 26 interchangeable biological products. 27 Sec. 3. Section 155A.32, Code 2017, is amended to read as 28 follows: 29 155A.32 Drug product selection —— restrictions. 30 1. a. If an authorized prescriber prescribes, in 31 writing, electronically, by facsimile, or orally, a drug 32 by its brand or trade name, the pharmacist may exercise 33 professional judgment in the economic interest of the patient 34 by selecting a drug product with the same generic name 35 -1- LSB 1076SV (2) 87 tr/nh/rh 1/ 5

S.F. 326 and demonstrated bioavailability as the one drug product 1 prescribed for dispensing and sale to the patient. If the 2 cost of the prescription or any part of it will be paid by 3 expenditure of public funds authorized under chapter 249A , the 4 pharmacist shall exercise professional judgment by selecting 5 a drug product with the same generic name and demonstrated 6 bioavailability as the one drug product prescribed for 7 dispensing and sale. If the pharmacist exercises drug product 8 selection, the pharmacist shall inform the patient of the 9 savings which the patient will obtain as a result of the drug 10 product selection and pass on to the patient no less than fifty 11 percent of the difference in actual acquisition costs between 12 the drug prescribed and the drug substituted. 13 b. If an authorized prescriber prescribes a biological 14 product, the pharmacist may exercise professional judgment in 15 the economic interest of the patient by selecting a biological 16 product that is an interchangeable biological product for the 17 biological product prescribed for dispensing and sale to the 18 patient. If the cost of the prescription or any part of it will 19 be paid by expenditure of public funds authorized under chapter 20 249A, the pharmacist shall exercise professional judgment by 21 selecting a biological product that is an interchangeable 22 biological product for the biological product prescribed for 23 dispensing and sale. 24 2. The pharmacist shall not exercise the drug or biological 25 product selection described in this section if either any of 26 the following is true: 27 a. The prescriber specifically indicates that no drug or 28 biological product selection shall be made. 29 b. The person presenting the prescription indicates that 30 only the specific drug product prescribed should be dispensed. 31 However, this paragraph does not apply if the cost of the 32 prescription or any part of it will be paid by expenditure of 33 public funds authorized under chapter 249A . 34 3. If selection of a generically equivalent drug product 35 -2- LSB 1076SV (2) 87 tr/nh/rh 2/ 5

S.F. 326 or an interchangeable biological product is made under this 1 section , the pharmacist making the selection shall inform the 2 patient and note that fact and the name of the manufacturer of 3 the selected drug on the prescription presented by the patient 4 or the patient’s adult representative or transmitted by the 5 prescriber or the prescriber’s authorized agent. 6 4. a. Within five business days following the dispensing 7 of a biological product, the dispensing pharmacist or the 8 pharmacist’s designee shall make an entry of the specific 9 biological product provided to the patient, including the name 10 of the biological product and the manufacturer. The entry 11 shall be electronically accessible to the prescriber through 12 one of the following means: 13 (1) An interoperable electronic medical records system. 14 (2) An electronic prescribing technology. 15 (3) A pharmacy benefit management system. 16 (4) A pharmacy record. 17 b. An entry into an electronic records system as described 18 in this subsection is presumed to provide notice to the 19 prescriber. If the entry is not made electronically, the 20 pharmacist shall communicate the name and manufacturer of the 21 biological product dispensed to the prescriber using facsimile, 22 telephone, electronic transmission, or other prevailing means. 23 c. Communication under this subsection shall not be required 24 in either of the following circumstances: 25 (1) There is no federal food and drug 26 administration-approved interchangeable biological product for 27 the product prescribed. 28 (2) A refill prescription is not changed from the product 29 dispensed on the prior filling of the prescription. 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 adopts by reference to federal law a definition of 34 “biological product” and defines “interchangeable biological 35 -3- LSB 1076SV (2) 87 tr/nh/rh 3/ 5

S.F. 326 product”. As described by the United States food and drug 1 administration, a “biological product” is a medical product, 2 often made from a variety of natural sources, used for a broad 3 range of diseases or conditions, particularly chronic, serious, 4 or life-threatening conditions such as cancer and rheumatoid 5 arthritis. 6 The bill provides that pharmacists may use professional 7 judgment to distribute an interchangeable biological product 8 when an authorized prescriber prescribes a biological product. 9 The bill requires the board of pharmacy to maintain a link 10 on its internet site to the current list of all biological 11 products that the United States food and drug administration 12 has determined to be interchangeable biological products. 13 The bill provides that a pharmacist may not dispense 14 an interchangeable biological product if the prescriber 15 specifically indicates that no product selection shall be made 16 or the person presenting the prescription indicates that only 17 the specific biological product prescribed should be dispensed. 18 The bill removes a provision that requires a pharmacist 19 to pass on to the patient no less than 50 percent of the 20 difference in actual acquisition costs between the drug 21 prescribed and the drug substituted and inform a patient of 22 those savings if the pharmacist makes a drug product selection. 23 The bill requires a pharmacist to notify a patient whenever 24 the pharmacist selects a generically equivalent drug product or 25 an interchangeable biological product. 26 The bill requires that within five days of dispensing an 27 interchangeable biological product, a pharmacist must make 28 an entry into one of a specified type of electronic records 29 systems noting the name and manufacturer of the biological 30 product. According to the bill, such an entry is deemed to 31 provide notice to the prescriber if done electronically. If 32 it is not done electronically, the pharmacist must otherwise 33 provide the name and manufacturer of the biological product to 34 the prescriber. Such communication is not required if a refill 35 -4- LSB 1076SV (2) 87 tr/nh/rh 4/ 5

S.F. 326 prescription is not changed from the product dispensed on the 1 prior filling of the prescription. 2 A person who violates these provisions with regard to 3 a noncontrolled substance shall be guilty of a serious 4 misdemeanor for a first violation, an aggravated misdemeanor 5 for a second offense or if the person has been convicted with 6 a violation of laws relating to prescription drugs or devices 7 in other jurisdictions, or a class “D” felony for a third 8 offense or a second offense with prior conviction in another 9 jurisdiction. A person who violates these provisions with 10 regard to a controlled substance shall be punished pursuant to 11 Code section 124.401, subsection 1, and other provisions of 12 Code chapter 124, division IV. 13 -5- LSB 1076SV (2) 87 tr/nh/rh 5/ 5