Print
House Study Bill 38 - IntroducedA Bill ForAn Act 1relating to the prescribing of biological products and
2making penalties applicable.
3BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. Section 155A.3, Code 2017, is amended by adding
2the following new subsections:
3 NEW SUBSECTION. 2A. “Biological product” means the same as
4defined in 42 U.S.C. §262.
5 NEW SUBSECTION. 19A. “Interchangeable biological product”
6means either of the following:
7a. A biological product that the United States food and
8drug administration has licensed and has determined meets
9the standards for interchangeability pursuant to 42 U.S.C.
10§262(k)(4).
11b. A biological product that the United States food and
12drug administration has determined to be therapeutically
13equivalent to another biological product as set forth in the
14latest edition or supplement of the United States food and
15drug administration approved drug products with therapeutic
16equivalence evaluations publication.
17 Sec. 2. Section 155A.28, Code 2017, is amended to read as
18follows:
19155A.28 Label of prescription drugs — interchangeable
20biological product list.
211. The label of any drug, biological product, or device sold
22and dispensed on the prescription of a practitioner shall be in
23compliance with rules adopted by the board.
242. The board shall maintain a link on its internet site to
25the current list of all biological products that the United
26States food and drug administration has determined to be
27interchangeable biological products.
28 Sec. 3. Section 155A.32, Code 2017, is amended to read as
29follows:
30155A.32 Drug product selection — restrictions.
311. a. If an authorized prescriber prescribes, in
32writing, electronically, by facsimile, or orally, a drug
33by its brand or trade name, the pharmacist may exercise
34professional judgment in the economic interest of the patient
35by selecting a drug product with the same generic name
-1-1and demonstrated bioavailability as the one drug product
2 prescribed for dispensing and sale to the patient. If the
3cost of the prescription or any part of it will be paid by
4expenditure of public funds authorized under chapter 249A, the
5pharmacist shall exercise professional judgment by selecting
6a drug product with the same generic name and demonstrated
7bioavailability as the one drug product prescribed for
8dispensing and sale. If the pharmacist exercises drug product
9selection, the pharmacist shall inform the patient of the
10savings which the patient will obtain as a result of the drug
11product selection and pass on to the patient no less than fifty
12percent of the difference in actual acquisition costs between
13the drug prescribed and the drug substituted.
14b. If an authorized prescriber prescribes a biological
15product, the pharmacist may exercise professional judgment in
16the economic interest of the patient by selecting a biological
17product that is an interchangeable biological product for the
18biological product prescribed for dispensing and sale to the
19patient. If the cost of the prescription or any part of it will
20be paid by expenditure of public funds authorized under chapter
21249A, the pharmacist shall exercise professional judgment by
22selecting a biological product that is an interchangeable
23biological product for the biological product prescribed for
24dispensing and sale. If the pharmacist exercises biological
25product selection, the pharmacist shall inform the patient of
26the savings which the patient will obtain as a result of the
27biological product selection and pass on to the patient no less
28than fifty percent of the difference in actual acquisition
29costs between the biological product prescribed and the
30interchangeable biological product substituted.
312. The pharmacist shall not exercise the drug or biological
32 product selection described in this section if either any of
33the following is true:
34a. The prescriber specifically indicates that no drug or
35biological product selection shall be made.
-2- 1b. The person presenting the prescription indicates that
2only the specific drug product prescribed should be dispensed.
3However Except for biological products, this paragraph does not
4apply if the cost of the prescription or any part of it will be
5paid by expenditure of public funds authorized under chapter
6249A.
73. If selection of a generically equivalent drug product
8or an interchangeable biological product is made under this
9section, the pharmacist making the selection shall note that
10fact and the name of the manufacturer of the selected drug on
11the prescription presented by the patient or the patient’s
12adult representative or transmitted by the prescriber or the
13prescriber’s authorized agent.
144. a. Within five business days following the dispensing
15of a biological product, the dispensing pharmacist or the
16pharmacist’s designee shall make an entry of the specific
17biological product provided to the patient, including the name
18of the biological product and the manufacturer. The entry
19shall be electronically accessible to the prescriber through
20one of the following means:
21(1) An interoperable electronic medical records system.
22(2) An electronic prescribing technology.
23(3) A pharmacy benefit management system.
24(4) A pharmacy record.
25b. An entry into an electronic records system as described
26in this subsection is presumed to provide notice to the
27prescriber. If the entry is not made electronically, the
28pharmacist shall communicate the name and manufacturer of the
29biological product dispensed to the prescriber using facsimile,
30telephone, electronic transmission, or other prevailing means.
31c. Communication under this subsection shall not be required
32in either of the following circumstances:
33(1) There is no federal food and drug
34administration-approved interchangeable biological product for
35the product prescribed.
-3- 1(2) A refill prescription is not changed from the product
2dispensed on the prior filling of the prescription.
3EXPLANATION
4The inclusion of this explanation does not constitute agreement with
5the explanation’s substance by the members of the general assembly.
6This bill adopts by reference to federal law a definition of
7“biological product” and defines “interchangeable biological
8product”. As described by the United States food and drug
9administration, a “biological product” is a medical product,
10often made from a variety of natural sources, used for a broad
11range of diseases or conditions, particularly chronic, serious,
12or life-threatening conditions such as cancer and rheumatoid
13arthritis.
14The bill provides that pharmacists may use professional
15judgment to distribute an interchangeable biological product
16when an authorized prescriber prescribes a biological product.
17The bill requires the board of pharmacy to maintain a link
18on its internet site to the current list of all biological
19products that the United States food and drug administration
20has determined to be interchangeable biological products.
21The bill provides that a pharmacist may not dispense
22an interchangeable biological product if the prescriber
23specifically indicates that no product selection shall be made
24or the person presenting the prescription indicates that only
25the specific biological product prescribed should be dispensed.
26The bill requires that within five days of dispensing an
27interchangeable biological product, a pharmacist must make
28an entry into one of a specified type of electronic records
29systems noting the name and manufacturer of the biological
30product. According to the bill, such an entry is deemed to
31provide notice to the prescriber if done electronically. If
32it is not done electronically, the pharmacist must otherwise
33provide the name and manufacturer of the biological product to
34the prescriber. Such communication is not required if a refill
35prescription is not changed from the product dispensed on the
-4-1prior filling of the prescription.
2A person who violates these provisions with regard to
3a noncontrolled substance shall be guilty of a serious
4misdemeanor for a first violation, an aggravated misdemeanor
5for a second offense or if the person has been convicted with
6a violation of laws relating to prescription drugs or devices
7in other jurisdictions, or a class “D” felony for a third
8offense or a second offense with prior conviction in another
9jurisdiction. A person who violates these provisions with
10regard to a controlled substance shall be punished pursuant to
11Code section 124.401, subsection 1, and other provisions of
12Code chapter 124, division IV.
-5-tr/nh/rh
2making penalties applicable.
3BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. Section 155A.3, Code 2017, is amended by adding
2the following new subsections:
3 NEW SUBSECTION. 2A. “Biological product” means the same as
4defined in 42 U.S.C. §262.
5 NEW SUBSECTION. 19A. “Interchangeable biological product”
6means either of the following:
7a. A biological product that the United States food and
8drug administration has licensed and has determined meets
9the standards for interchangeability pursuant to 42 U.S.C.
10§262(k)(4).
11b. A biological product that the United States food and
12drug administration has determined to be therapeutically
13equivalent to another biological product as set forth in the
14latest edition or supplement of the United States food and
15drug administration approved drug products with therapeutic
16equivalence evaluations publication.
17 Sec. 2. Section 155A.28, Code 2017, is amended to read as
18follows:
19155A.28 Label of prescription drugs — interchangeable
20biological product list.
211. The label of any drug, biological product, or device sold
22and dispensed on the prescription of a practitioner shall be in
23compliance with rules adopted by the board.
242. The board shall maintain a link on its internet site to
25the current list of all biological products that the United
26States food and drug administration has determined to be
27interchangeable biological products.
28 Sec. 3. Section 155A.32, Code 2017, is amended to read as
29follows:
30155A.32 Drug product selection — restrictions.
311. a. If an authorized prescriber prescribes, in
32writing, electronically, by facsimile, or orally, a drug
33by its brand or trade name, the pharmacist may exercise
34professional judgment in the economic interest of the patient
35by selecting a drug product with the same generic name
-1-1and demonstrated bioavailability as the one drug product
2 prescribed for dispensing and sale to the patient. If the
3cost of the prescription or any part of it will be paid by
4expenditure of public funds authorized under chapter 249A, the
5pharmacist shall exercise professional judgment by selecting
6a drug product with the same generic name and demonstrated
7bioavailability as the one drug product prescribed for
8dispensing and sale. If the pharmacist exercises drug product
9selection, the pharmacist shall inform the patient of the
10savings which the patient will obtain as a result of the drug
11product selection and pass on to the patient no less than fifty
12percent of the difference in actual acquisition costs between
13the drug prescribed and the drug substituted.
14b. If an authorized prescriber prescribes a biological
15product, the pharmacist may exercise professional judgment in
16the economic interest of the patient by selecting a biological
17product that is an interchangeable biological product for the
18biological product prescribed for dispensing and sale to the
19patient. If the cost of the prescription or any part of it will
20be paid by expenditure of public funds authorized under chapter
21249A, the pharmacist shall exercise professional judgment by
22selecting a biological product that is an interchangeable
23biological product for the biological product prescribed for
24dispensing and sale. If the pharmacist exercises biological
25product selection, the pharmacist shall inform the patient of
26the savings which the patient will obtain as a result of the
27biological product selection and pass on to the patient no less
28than fifty percent of the difference in actual acquisition
29costs between the biological product prescribed and the
30interchangeable biological product substituted.
312. The pharmacist shall not exercise the drug or biological
32 product selection described in this section if either any of
33the following is true:
34a. The prescriber specifically indicates that no drug or
35biological product selection shall be made.
-2- 1b. The person presenting the prescription indicates that
2only the specific drug product prescribed should be dispensed.
3However Except for biological products, this paragraph does not
4apply if the cost of the prescription or any part of it will be
5paid by expenditure of public funds authorized under chapter
6249A.
73. If selection of a generically equivalent drug product
8or an interchangeable biological product is made under this
9section, the pharmacist making the selection shall note that
10fact and the name of the manufacturer of the selected drug on
11the prescription presented by the patient or the patient’s
12adult representative or transmitted by the prescriber or the
13prescriber’s authorized agent.
144. a. Within five business days following the dispensing
15of a biological product, the dispensing pharmacist or the
16pharmacist’s designee shall make an entry of the specific
17biological product provided to the patient, including the name
18of the biological product and the manufacturer. The entry
19shall be electronically accessible to the prescriber through
20one of the following means:
21(1) An interoperable electronic medical records system.
22(2) An electronic prescribing technology.
23(3) A pharmacy benefit management system.
24(4) A pharmacy record.
25b. An entry into an electronic records system as described
26in this subsection is presumed to provide notice to the
27prescriber. If the entry is not made electronically, the
28pharmacist shall communicate the name and manufacturer of the
29biological product dispensed to the prescriber using facsimile,
30telephone, electronic transmission, or other prevailing means.
31c. Communication under this subsection shall not be required
32in either of the following circumstances:
33(1) There is no federal food and drug
34administration-approved interchangeable biological product for
35the product prescribed.
-3- 1(2) A refill prescription is not changed from the product
2dispensed on the prior filling of the prescription.
3EXPLANATION
4The inclusion of this explanation does not constitute agreement with
5the explanation’s substance by the members of the general assembly.
6This bill adopts by reference to federal law a definition of
7“biological product” and defines “interchangeable biological
8product”. As described by the United States food and drug
9administration, a “biological product” is a medical product,
10often made from a variety of natural sources, used for a broad
11range of diseases or conditions, particularly chronic, serious,
12or life-threatening conditions such as cancer and rheumatoid
13arthritis.
14The bill provides that pharmacists may use professional
15judgment to distribute an interchangeable biological product
16when an authorized prescriber prescribes a biological product.
17The bill requires the board of pharmacy to maintain a link
18on its internet site to the current list of all biological
19products that the United States food and drug administration
20has determined to be interchangeable biological products.
21The bill provides that a pharmacist may not dispense
22an interchangeable biological product if the prescriber
23specifically indicates that no product selection shall be made
24or the person presenting the prescription indicates that only
25the specific biological product prescribed should be dispensed.
26The bill requires that within five days of dispensing an
27interchangeable biological product, a pharmacist must make
28an entry into one of a specified type of electronic records
29systems noting the name and manufacturer of the biological
30product. According to the bill, such an entry is deemed to
31provide notice to the prescriber if done electronically. If
32it is not done electronically, the pharmacist must otherwise
33provide the name and manufacturer of the biological product to
34the prescriber. Such communication is not required if a refill
35prescription is not changed from the product dispensed on the
-4-1prior filling of the prescription.
2A person who violates these provisions with regard to
3a noncontrolled substance shall be guilty of a serious
4misdemeanor for a first violation, an aggravated misdemeanor
5for a second offense or if the person has been convicted with
6a violation of laws relating to prescription drugs or devices
7in other jurisdictions, or a class “D” felony for a third
8offense or a second offense with prior conviction in another
9jurisdiction. A person who violates these provisions with
10regard to a controlled substance shall be punished pursuant to
11Code section 124.401, subsection 1, and other provisions of
12Code chapter 124, division IV.
-5-tr/nh/rh