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ENGROSSED SENATE
BILL NO. 4 By: Garvin of the Senate
and
Marti of the House
An Act relating to pharmacy; providing definitions;
allowing a pharmacist to substitute interchangeable
product for certain prescribed product under
specified conditions; requiring a pharmacist or
designee to make entry of provided products into an
electronic records system; specifying method of
certain communication; prov iding for notice to
prescriber; providing exemption for certain
communication; excluding dispensing pharmacist or
prescriber from certain requirement and certain
penalties; directing the State Board of Pharmac y to
maintain certain link on its website; providing
certain construction; 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 355.4 of Title 59, unless there
is created a duplication in numbering, reads as follows:
A. For the purposes of this section:
1. “Biological product” has the same meaning given to that term
in 42 U.S.C., Section 262; and
2. “Interchangeable biological produ ct” means a biological
product that the U.S. Food and Drug Administration (FDA):
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a. has licensed, and determined to meet the standards for
interchangeability pursuant to 42 U.S.C. , Section
262(k)(4), or
b. has determined is therapeu tically equivalent as se t
forth in the latest edit ion of or supplement to the
United States Food and Drug Administration’s (FDA)
Approved Drug Products with Therapeutic Equivalence
Evaluations.
B. A pharmacist may sub stitute an interchangeable biological
product for a prescribed biological product if:
1. The substituted product has been determined by FDA to be
interchangeable, as defined in subsection A o f this section, with
the prescribed biological product;
2. The prescribing health care provider does not express a
preference against substitution in w riting, verbally or
electronically; and
3. The pharmacy informs the patient of the substitut ion.
C. The dispensing pharmacist or the p harmacist’s designee shall
make an entry into an electronic records system of the specific
product provided to the patient including the name of the product
and the manufacturer. The communication shall be conveyed by making
an entry through:
1. An interoperable electronic medical record s system;
2. An electronic prescribing technology;
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3. A pharmacy benefit mana gement system; or
4. A pharmacy record.
D. Entry into an electronic records system as described in
subsection C of this s ection is presumed to provide notice to the
prescriber. If no electronic records system is in use by the
pharmacy, the pharmacist shall communicate the biological product
dispensed to the prescriber using facsimile, telephone, electronic
transmission or other preva iling means, except that communication
shall not be required where:
1. There is no FDA-approved interchangeable biological product
for the product prescribed; or
2. A refill prescription is not changed from the product
dispensed on the prior filling of t he prescription.
E. The dispensing pharmacist or a prescriber shall not be:
1. Required to show proof that the prescriber has access to the
record in any type of payment aud it conducted by a payer or pharmacy
benefit manager; or
2. Subject to disciplina ry action or civil penalties for
failure to ensure that the record is accessible or for failure to
access the record.
F. The State Board of Pharmacy shall maintain a link on its
Internet website to the current list of all biological products
determined by the FDA to be interchangeable with a specific
biological product.
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G. Nothing in this section shall pre clude existing approved
brand and generic substitutions.
SECTION 2. This act shall become effective November 1, 2021.
Passed the Senate the 10th day of March, 2021.
Presiding Officer of the Senate
Passed the House of Representatives the ____ day of __________,
2021.
Presiding Officer of the House
of Representatives