November 20, 2017 - Introduced by Senators Vukmir, Carpenter, Craig, Olsen,
Vinehout, Bewley and Marklein, cosponsored by Representatives
Rohrkaste, Kolste, Spiros, Anderson, Berceau, R. Brooks, Considine,
Crowley, Felzkowski, Fields, Horlacher, Jacque, Kooyenga, Kremer,
Krug, Kuglitsch, Ohnstad, Sargent, Sinicki, Skowronski, Spreitzer,
Thiesfeldt, Tusler, Subeck and Edming. Referred to Committee on Health
and Human Services.
SB575,1,5 1An Act to renumber and amend 450.13 (1); to amend 102.425 (1) (c), 450.11
2(4g) (title), 450.11 (4g) (a) 2., 450.13 (2), 450.13 (3) and 450.13 (5) (intro.); and
3to create 450.01 (1z), 450.11 (4g) (c), 450.11 (4i), 450.12 (4), 450.122, 450.13 (6)
4and 450.135 of the statutes; relating to: the treatment of biological products
5for various purposes under the pharmacy practice law.
Analysis by the Legislative Reference Bureau
This bill makes a number of changes to the pharmacy practice laws regarding
the prescribing and dispensing of biological products, including changes to address
the dispensing of interchangeable biological products.
Current state law contains a number of provisions that address the dispensing
of drug product equivalents in lieu of the specific drug product described.
Specifically, current law allows a pharmacist to dispense the “drug product
equivalent” of a drug prescribed if the drug product equivalent is lower in price to the
consumer than the drug product prescribed, unless the prescribing practitioner
specifically indicates on the prescription order that no substitution of the drug
product prescribed may be made. Current law defines “drug product equivalent” as
a drug product that the federal Food and Drug Administration, which regulates
drugs pursuant to the Federal Food, Drug, and Cosmetic Act, has determined is
therapeutically equivalent to the drug product prescribed. Current law also provides
that if a pharmacist, pursuant to a prescription order that specifies a drug product
by its brand name, dispenses the drug product equivalent of the drug product

specified in the prescription order, the label required for the drug may include both
the generic name of the drug product equivalent and the brand name specified in the
prescription order, unless the prescribing practitioner requests that the brand name
be omitted from the label.
This bill creates provisions similar to those described above that apply with
respect to biological products, which are regulated somewhat differently from other
drugs by the FDA under the federal Public Health Service Act. Specifically, the bill
allows a pharmacist to dispense an interchangeable biological product in lieu of the
biological product prescribed if the interchangeable biological product is lower in
price to the consumer than the biological product prescribed, unless the prescribing
practitioner specifically indicates on the prescription order that no substitution of
the biological product prescribed may be made. The bill defines “interchangeable
biological product” as a biological product that the FDA has determined is
therapeutically equivalent to the biological product prescribed or that the FDA has
licensed and determined meets standards for interchangeability pursuant to
provisions in federal law. The bill further establishes requirements for pharmacists
who dispense biological products to make an entry into an electronic records system
or to otherwise communicate to the prescribing practitioner regarding the biological
product dispensed, subject to certain exceptions. The bill provides that if a
pharmacist, pursuant to a prescription order that specifies a biological product by its
brand name, dispenses the interchangeable biological product of the biological
product specified in the prescription order, the label required for the drug may
include both the proper name of the interchangeable biological product and the
brand name specified in the prescription order.
Current law also contains provisions regarding the labeling of prescription
drugs, including requirements that certain information be contained on the
commercial container of a prescription drug. The bill creates a similar provision that
applies only to biological products, which includes a requirement that certain
information to be contained on the commercial container of the biological product,
including the brand name, if any, of the biological product, and the proper name of
the biological product.
The provisions newly created in the bill apply only to biological products. The
bill modifies the provisions under current law that apply to drugs generally so that
they apply only to drugs that are not biological products.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
SB575,1 1Section 1. 102.425 (1) (c) of the statutes is amended to read:
SB575,2,32 102.425 (1) (c) “Drug product equivalent" has the meaning given in s. 450.13
3(1) (1e).
SB575,2 4Section 2. 450.01 (1z) of the statutes is created to read:
SB575,3,1
1450.01 (1z) “Biological product” has the meaning given in 42 USC 262 (i).
SB575,3 2Section 3. 450.11 (4g) (title) of the statutes is amended to read:
SB575,3,33 450.11 (4g) (title) Brand name permitted on label; drugs and drug products.
SB575,4 4Section 4. 450.11 (4g) (a) 2. of the statutes is amended to read:
SB575,3,65 450.11 (4g) (a) 2. “Drug product equivalent" has the meaning given in s. 450.13
6(1) (1e).
SB575,5 7Section 5. 450.11 (4g) (c) of the statutes is created to read:
SB575,3,98 450.11 (4g) (c) This subsection does not apply to a prescription order for a
9biological product.
SB575,6 10Section 6. 450.11 (4i) of the statutes is created to read:
SB575,3,1211 450.11 (4i) Brand name permitted on label; biological products. (a) In this
12section:
SB575,3,1313 1. “Brand name" has the meaning given in s. 450.122 (1) (a).
SB575,3,1414 2. “Interchangeable biological product” has the meaning given in s. 450.135 (1).
SB575,3,1515 3. “Proper name” has the meaning given in s. 450.122 (1) (b).
SB575,3,2016 (b) If a pharmacist, pursuant to a prescription order that specifies a biological
17product by its brand name, dispenses the interchangeable biological product of the
18biological product specified in the prescription order, the label required under sub.
19(4) (a) may include both the proper name of the interchangeable biological product
20and the brand name specified in the prescription order.
SB575,7 21Section 7. 450.12 (4) of the statutes is created to read:
SB575,3,2222 450.12 (4) This section does not apply with respect to biological products.
SB575,8 23Section 8. 450.122 of the statutes is created to read:
SB575,3,24 24450.122 Labeling of biological products. (1) In this section:
SB575,4,2
1(a) “Brand name" means the name, other than the proper name, that the labeler
2of a biological product places on its commercial container at the time of packaging.
SB575,4,53 (b) “Proper name” means the nonproprietary name for a biological product
4designated by the federal food and drug administration licensure for use upon each
5package of the product.
SB575,4,11 6(2) The manufacturer's or distributor's commercial container of every
7biological product delivered to any pharmacist, practitioner, hospital, or nursing
8home shall bear a label containing the proper name of the biological product, the
9brand name of the biological product, if any, the name and address of the
10manufacturer of the biological product and, if different from the manufacturer, the
11name and address of the distributor of the biological product.
SB575,4,14 12(3) Every prescription order or medication profile record for a biological
13product shall include the brand name, if any, and the name of the manufacturer of
14the biological product.
SB575,9 15Section 9. 450.13 (1) of the statutes is renumbered 450.13 (1s) and amended
16to read:
SB575,4,2117 450.13 (1s) Drug product or equivalent to be used. Except as provided in sub.
18(2), a pharmacist shall dispense every prescription using either the drug product
19prescribed or its drug product equivalent, if its drug product equivalent is lower in
20price to the consumer than the drug product prescribed, and shall inform the
21consumer of the options available in dispensing the prescription.
SB575,5,2 22(1e) Definition. In this section, “drug product equivalent" means a drug
23product that is designated the therapeutic equivalent of another drug product by the
24federal food and drug administration as set forth in the latest edition of or

1supplement to the federal food and drug administration's Approved Drug Products
2with Therapeutic Equivalence Evaluations
.
SB575,10 3Section 10. 450.13 (2) of the statutes is amended to read:
SB575,5,114 450.13 (2) Exception. A prescriber prescribing practitioner may indicate, by
5writing on the face of the prescription order or, with respect to a prescription order
6transmitted electronically, by designating in electronic format the phrase “No
7substitutions" or words of similar meaning or the initials “N.S.", that no substitution
8of the drug product prescribed may be made under sub. (1) (1s). If such indication
9is made, the pharmacist shall dispense the prescription with the specific drug
10product prescribed. No preprinted statement regarding drug product substitution
11may appear on the face of the prescription order.
SB575,11 12Section 11. 450.13 (3) of the statutes is amended to read:
SB575,5,1513 450.13 (3) Renewed Refilled prescriptions. Prescriptions dispensed with a
14drug product equivalent may be renewed refilled with a different drug product
15equivalent only if the pharmacist informs the consumer of the change.
SB575,12 16Section 12. 450.13 (5) (intro.) of the statutes is amended to read:
SB575,5,2417 450.13 (5) Use of drug product equivalent in hospitals. (intro.) Subsections
18(1) (1s) to (4) do not apply to a pharmacist who dispenses a drug product equivalent
19that is prescribed for a patient in a hospital if the pharmacist dispenses the drug
20product equivalent in accordance with written guidelines or procedures previously
21established by a pharmacy and therapeutics committee of the hospital and approved
22by the hospital's medical staff and use of the drug product equivalent has been
23approved for a patient during the period of the patient's stay within the hospital by
24any of the following:
SB575,13 25Section 13. 450.13 (6) of the statutes is created to read:
SB575,6,2
1450.13 (6) Applicability. This section does not apply with respect to a
2prescription for a biological product.
SB575,14 3Section 14. 450.135 of the statutes is created to read:
SB575,6,10 4450.135 Using interchangeable biological product in dispensing
5prescriptions.
(1) Definition. In this section, “interchangeable biological product”
6means a biological product that the federal food and drug administration has
7licensed and has determined meets the standards for interchangeability pursuant
8to 42 USC 262 (k) (4) or has determined is therapeutically equivalent as set forth in
9the latest edition of or supplement to the federal food and drug administration's
10Approved Drug Products with Therapeutic Equivalence Evaluations.
SB575,6,16 11(2) Biological product or interchangeable biological product to be used.
12Except as provided in sub. (3), a pharmacist shall dispense every prescription using
13either the biological product prescribed or an interchangeable biological product, if
14the interchangeable biological product is lower in price to the consumer than the
15biological product prescribed, and shall inform the consumer of the options available
16in dispensing the prescription.
SB575,6,24 17(3) Exception. A prescribing practitioner may indicate, by writing on the face
18of the prescription order or, with respect to a prescription order transmitted
19electronically, by designating in electronic format the phrase “No substitutions” or
20words of similar meaning or the initials “N.S.,” that no substitution of the biological
21product prescribed may be made under sub. (2). If such indication is made, the
22pharmacist shall dispense the prescription with the specific biological product
23prescribed. No preprinted statement regarding biological product substitution may
24appear on the face of the prescription order.
SB575,7,3
1(4) Refilled prescriptions. Prescriptions dispensed with an interchangeable
2biological product may be refilled with a different interchangeable biological product
3only if the pharmacist informs the consumer of the change.
SB575,7,6 4(5) Communication of biological product dispensed. Within 5 business days
5after the dispensing of a biological product, the dispensing pharmacist or the
6pharmacist's designee shall do one of the following:
SB575,7,117 (a) Make an entry of the specific product provided to the patient, including the
8name of the product and the manufacturer. Entry into an electronic records system
9as described in this paragraph is presumed to provide notice to the prescribing
10practitioner. The communication shall be conveyed by making an entry that is
11electronically accessible to the prescribing practitioner through one of the following:
SB575,7,1212 1. An interoperable electronic medical records system.
SB575,7,1313 2. An electronic prescribing technology.
SB575,7,1414 3. A pharmacist benefit management system.
SB575,7,1515 4. A pharmacy record.
SB575,7,2016 (b) If a pharmacist is unable to make an entry as provided in par. (a),
17communicate the biological product dispensed to the prescribing practitioner using
18facsimile, telephone, electronic transmission, or another prevailing means, except
19that communication under this paragraph is not required if any of the following
20applies:
SB575,7,2121 1. There is no interchangeable biological product for the product prescribed.
SB575,7,2322 2. A refill of the biological product is not changed from the product dispensed
23on the prior filling of the prescription.
SB575,8,2 24(6) Limitation of liability. A pharmacist who dispenses a prescription with an
25interchangeable biological product under this section assumes no greater liability

1than would be incurred had the pharmacist dispensed the prescription with the
2biological product prescribed.
SB575,8,10 3(7) Use of interchangeable biological product in hospitals. Subsections (2)
4to (6) do not apply to a pharmacist who dispenses an interchangeable biological
5product that is prescribed for a patient in a hospital if the pharmacist dispenses the
6interchangeable biological product in accordance with written guidelines or
7procedures previously established by a pharmacy and therapeutics committee of the
8hospital and approved by the hospital's medical staff and use of the interchangeable
9biological product has been approved for a patient during the period of the patient's
10stay within the hospital by any of the following:
SB575,8,1111 (a) The patient's individual physician.
SB575,8,1412 (b) The patient's advanced practice nurse prescriber, if the advanced practice
13nurse prescriber has entered into a written agreement to collaborate with a
14physician.
SB575,8,1515 (c) The patient's physician assistant.
SB575,8,17 16(8) Applicability. This section applies only with respect to prescriptions for
17biological products.
SB575,8,20 18(9) Links to be maintained by board. The board shall maintain links on the
19department's Internet site to the federal food and drug administration's lists of all
20currently approved interchangeable biological products.
SB575,8,2121 (End)
Loading...
Loading...