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83rd OREGON LEGISLATIVE ASSEMBLY--2025 Regular Session
Senate Bill 441
Sponsored by Senator PATTERSON (Presession filed.)
SUMMARY
The following summary is not prepared by the sponsors of the measure and is not a part of the body thereof subject
to consideration by the Legislative Assembly. It is an editor’s brief statement of the essential features of the
measure as introduced. The statement includes a measure digest written in compliance with applicable readability
standards.
Digest: The Act takes away two steps a pharmacist has to do when substituting some drugs.
(Flesch Readability Score: 73.1).
Removes the requirements for notification of substitution and records retention for prescribed
biological products.
A BILL FOR AN ACT
Relating to biological products; amending ORS 689.522.
Be It Enacted by the People of the State of Oregon:
SECTION 1.
ORS 689.522 is amended to read:
689.522. (1) A pharmacy or pharmacist filling a prescription order for a biological product may
not substitute a biological product for the prescribed biological product unless:
(a) The substitute biological product has been determined by the United States Food and Drug
Administration to be interchangeable with the prescribed biological product; and
(b) The prescribing practitioner has not designated on the prescription that substitution is
prohibited[ ;]
[(c) The patient for whom the biological product is prescribed is informed of the substitution in a
manner reasonable under the circumstances; and ]
[(d) The pharmacy or pharmacist retains a record of the substitution for a period of not less than
three years ].
(2) Not later than five business days after the dispensing of a biological product, the pharmacy
or pharmacist, or the pharmacist’s designee, shall communicate the specific biological product dis-
pensed to the patient, including the name and manufacturer of the biological product, by making an
entry into an electronic system that the prescribing practitioner can access electronically and that
is:
(a) An interoperable electronic medical records system;
(b) An electronic prescribing technology;
(c) A pharmacy benefit management system; or
(d) A pharmacy record.
(3) If the pharmacy or pharmacist, or the pharmacist’s designee, does not have access to an
electronic system described in subsection (2) of this section, the pharmacy or pharmacist, or the
pharmacist’s designee, shall communicate not later than five business days to the prescribing prac-
titioner the specific biological product dispensed to the patient, including the name and manufac-
turer of the biological product. The communication may be by facsimile, electronic mail, telephone
or another method.
(4) If the biological product is dispensed to a patient in a clinic, community-based care facility,
NOTE: Matter in boldfaced type in an amended section is new; matter [ italic and bracketed] is existing law to be omitted.
New sections are in boldfaced type.
LC 3009
SB 441
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hospital or long term care facility, an entry made to the patient’s medical record of the specific bi-
ological product dispensed to the patient, including the name and manufacturer of the biological
product, satisfies the communication requirements of subsection (2) of this section.
(5) Notwithstanding subsections (2) and (3) of this section, the pharmacy or pharmacist, or the
pharmacist’s designee, is not required to communicate to the prescribing practitioner the specific
biological product dispensed to the patient if:
(a) The United States Food and Drug Administration has not approved an interchangeable bi-
ological product for the prescribed biological product;
(b) The pharmacy or pharmacist is refilling a prescription and the pharmacy or pharmacist is
dispensing the same biological product that was dispensed the last time the pharmacy or pharmacist
filled or refilled the patient’s prescription; or
(c) The pharmacy or pharmacist is filling a prescription for a vaccine.
(6) The entries described in subsections (2) and (4) of this section or the communication de-
scribed in subsection (3) of this section provides notice to the prescribing provider of the dispensa-
tion of a biological product to a patient.
(7) The State Board of Pharmacy shall, on a website maintained by the board, maintain a link
to the current list, if available, of biological products determined by the United States Food and
Drug Administration to be interchangeable.
(8)(a) For purposes of this section, the board shall adopt by rule definitions for the terms “bi-
ological product” and “interchangeable.”
(b) The rule defining the term “biological product” must be consistent with 42 U.S.C. 262(i)(1).
(c) The rule defining the term “interchangeable” must:
(A) For biological products licensed under the Public Health Service Act, define the biological
products that may be substituted for other biological products as having been determined by the
United States Food and Drug Administration as meeting the standards in 42 U.S.C. 262(k)(4); and
(B) For biological products approved by the United States Food and Drug Administration under
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., define the biological products that
may be substituted for other biological products as having been determined by the United States
Food and Drug Administration as therapeutically equivalent as set forth in the latest edition or
supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations.
SECTION 2.
ORS 689.522, as amended by section 6, chapter 45, Oregon Laws 2022, is amended
to read:
689.522. (1) A pharmacy or pharmacist filling a prescription order for a biological product may
not substitute a biological product for the prescribed biological product unless:
(a) The substitute biological product has been determined by the United States Food and Drug
Administration to be interchangeable with the prescribed biological product; and
(b) The prescribing practitioner has not designated on the prescription that substitution is
prohibited[ ;]
[(c) The patient for whom the biological product is prescribed is informed of the substitution in a
manner reasonable under the circumstances; and ]
[(d) The pharmacy or pharmacist retains a record of the substitution for a period of not less than
three years ].
(2) The State Board of Pharmacy shall, on a website maintained by the board, maintain a link
to the current list, if available, of biological products determined by the United States Food and
Drug Administration to be interchangeable.
[2]
SB 441
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(3)(a) For purposes of this section, the board shall adopt by rule definitions for the terms “bi-
ological product” and “interchangeable.”
(b) The rule defining the term “biological product” must be consistent with 42 U.S.C. 262(i)(1).
(c) The rule defining the term “interchangeable” must:
(A) For biological products licensed under the Public Health Service Act, define the biological
products that may be substituted for other biological products as having been determined by the
United States Food and Drug Administration as meeting the standards in 42 U.S.C. 262(k)(4); and
(B) For biological products approved by the United States Food and Drug Administration under
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., define the biological products that
may be substituted for other biological products as having been determined by the United States
Food and Drug Administration as therapeutically equivalent as set forth in the latest edition or
supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations.
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