Oklahoma 2022 Regular Session

Oklahoma House Bill HB2549 Compare Versions

Only one version of the bill is available at this time.

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28	28	STATE OF OKLAHOMA
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30	30	1st Session of the 58th Legislature (2021)
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32	32	HOUSE BILL 2549 By: Virgin
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38	38	AS INTRODUCED
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40	40	An Act relating to pharmacy; defining terms;
41	41	providing for the substitution of an interchangeable
42	42	biological product for a prescribed bio logical
43	43	product under certain conditions; requiring
44	44	electronic notice of substitution; providing
45	45	exceptions; directing State Board of Pharmacy to
46	46	maintain link of all interchangeable biological
47	47	products; providing for codification; and providing
48	48	an effective date.
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54	54	BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
55	55	SECTION 1. NEW LAW A new section of law to be codified
56	56	in the Oklahoma Statutes as Section 353.18B of Title 59, unless
57	57	there is created a duplication in numb ering, reads as follows:
58	58	A. As used in this section:
59	59	1. "Biological product" has the same meaning g iven to that term
60	60	in 42 U.S.C., Section 262; and
61	61	2. "Interchangeable biological product " means a biological
62	62	product that the United States Food and Drug Administration (FDA):
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89	89	a. has licensed and determined it to meet the standards
90	90	for interchangeability pursuant to 42 U.S.C., Section
91	91	262(k)(4), or
92	92	b. has determined is therapeutically equivalent as set
93	93	forth in the latest edition of or supplement to the
94	94	FDA's Approved Drug Products with Therapeutic
95	95	Equivalence Evaluations (Orange Book).
96	96	B. A pharmacist may substitute an interchangeable biological
97	97	product for a prescribed biological product only if:
98	98	1. The substituted product has been determined by the FDA t o be
99	99	interchangeable with the prescribed biological product;
100	100	2. The prescribing physician has permitted substitution; and
101	101	3. The pharmacy informs the patient of the substitution.
102	102	C. Within five (5) business days following the dispensing of a
103	103	biological product, the dispensing pharmacist or the pharmacist's
104	104	designee shall make an entry of the specific product provided to the
105	105	patient, including the name of the product and the manufacturer.
106	106	The entry shall be conveyed in a manner electronically accessible by
107	107	the prescriber through:
108	108	1. An interoperable electronic medical records system;
109	109	2. An electronic prescribing technology;
110	110	3. A pharmacy benefit management system; or
111	111	4. A pharmacy record.
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138	138	D. Entry into an electronic medical records system as describe d
139	139	in subsection C of this section is presumed to provide notice to the
140	140	prescriber. If the pharmacist is unable to comply with the
141	141	provisions of subsection C of this section, the pharmacist shall
142	142	communicate the biological product dispensed to the prescrib er using
143	143	facsimile, telephone, electronic transmission or other prevailing
144	144	means, except that communication shall not be required if:
145	145	1. There is no FDA-approved interchangeable biological product
146	146	for the product prescribed; or
147	147	2. A refill prescription i s not changed from the product
148	148	dispensed on the prior filling of the prescription.
149	149	E. The State Board of Pharmacy shall maintain a link on its
150	150	website to the current list of all biological products determined by
151	151	the FDA to be interchangeable with a specif ic biological product.
152	152	SECTION 2. This act shall become effective November 1, 2021 .
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154	154	58-1-6687 AB 12/18/20
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