Req. No. 6687 Page 1 1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
STATE OF OKLAHOMA
1st Session of the 58th Legislature (2021)
HOUSE BILL 2549 By: Virgin
AS INTRODUCED
An Act relating to pharmacy; defining terms;
providing for the substitution of an interchangeable
biological product for a prescribed bio logical
product under certain conditions; requiring
electronic notice of substitution; providing
exceptions; directing State Board of Pharmacy to
maintain link of all interchangeable biological
products; providing for codification; and providing
an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 353.18B of Title 59, unless
there is created a duplication in numb ering, reads as follows:
A. As used in this section:
1. "Biological product" has the same meaning g iven to that term
in 42 U.S.C., Section 262; and
2. "Interchangeable biological product " means a biological
product that the United States Food and Drug Administration (FDA):
Req. No. 6687 Page 2 1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
a. has licensed and determined it to meet the standards
for interchangeability pursuant to 42 U.S.C., Section
262(k)(4), or
b. has determined is therapeutically equivalent as set
forth in the latest edition of or supplement to the
FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations (Orange Book).
B. A pharmacist may substitute an interchangeable biological
product for a prescribed biological product only if:
1. The substituted product has been determined by the FDA t o be
interchangeable with the prescribed biological product;
2. The prescribing physician has permitted substitution; and
3. The pharmacy informs the patient of the substitution.
C. Within five (5) business days following the dispensing of a
biological product, the dispensing pharmacist or the pharmacist's
designee shall make an entry of the specific product provided to the
patient, including the name of the product and the manufacturer.
The entry shall be conveyed in a manner electronically accessible by
the prescriber through:
1. An interoperable electronic medical records system;
2. An electronic prescribing technology;
3. A pharmacy benefit management system; or
4. A pharmacy record.
Req. No. 6687 Page 3 1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
D. Entry into an electronic medical records system as describe d
in subsection C of this section is presumed to provide notice to the
prescriber. If the pharmacist is unable to comply with the
provisions of subsection C of this section, the pharmacist shall
communicate the biological product dispensed to the prescrib er using
facsimile, telephone, electronic transmission or other prevailing
means, except that communication shall not be required if:
1. There is no FDA-approved interchangeable biological product
for the product prescribed; or
2. A refill prescription i s not changed from the product
dispensed on the prior filling of the prescription.
E. The State Board of Pharmacy shall maintain a link on its
website to the current list of all biological products determined by
the FDA to be interchangeable with a specif ic biological product.
SECTION 2. This act shall become effective November 1, 2021 .
58-1-6687 AB 12/18/20