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SENATE FLOOR VERSION
February 3, 2021
SENATE BILL NO. 4 By: Garvin
An Act relating to pharmacy; providing def initions;
allowing a pharmacist to substi tute certain
interchangeable product for certain prescribed
product if certain conditions are met; requiring a
pharmacist or designee to make entry of certain
product provided within certain time frame; providing
for method of certain communication; provid ing for
notice to certain prescriber; providing exemption for
certain communication; excluding dispensing
pharmacist or prescriber from certain requirement and
certain penalties; directing the State Board of
Pharmacy to maintain certain link on its website ;
providing certain construction; providing for
codification; and pr oviding 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 edition of or supple ment 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 only if all of the
following conditions in this subsection are met:
1. The substituted p roduct 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 physician has permitted subs titution; and
3. The pharmacy informs the patient of the substitut ion.
C. Within five (5) business days following the dispensing of a
biological product, the dispensing pharmacist or the p harmacist’s
designee shall make an entry of the specific product p rovided to the
patient including the name of the product and the ma nufacturer. The
communication shall be conveyed by making an entry that can be
electronically accessed by the prescriber t hrough:
1. An interoperable electronic medical records 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. Otherwise , 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 audit conduct ed by a payer or pharmacy
benefit manager; or
2. Subject to disciplina ry action or civil penalties for
failure to ensure that the re cord 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.
COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES
February 3, 2021 - DO PASS