Bill Text: OR SB460 | 2013 | Regular Session | Enrolled
Bill Title: Relating to biological products; and declaring an emergency.
Spectrum: Slight Partisan Bill (Republican 4-2)
Status: (Passed) 2013-06-13 - Effective date, June 6, 2013. [SB460 Detail]
Download: Oregon-2013-SB460-Enrolled.html
77th OREGON LEGISLATIVE ASSEMBLY--2013 Regular Session
Enrolled
Senate Bill 460
Sponsored by Senators MONNES ANDERSON, WINTERS, Representatives
KOTEK, THOMPSON; Senators KNOPP, STARR
CHAPTER ................
AN ACT
Relating to biological products; and declaring an emergency.
Be It Enacted by the People of the State of Oregon:
SECTION 1. { + Section 2 of this 2013 Act is added to and made
a part of ORS chapter 689. + }
SECTION 2. { + (1) As used in this section:
(a) 'Biological product' means, with respect to the prevention,
treatment or cure of a disease or condition of human beings, a
virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component, blood derivative, allergenic product, protein other
than a chemically synthesized polypeptide, analogous products or
arsphenamine or any other trivalent organic arsenic compound.
(b) 'Biosimilar product' means a biological product licensed by
the United States Food and Drug Administration pursuant to 42
U.S.C. 262(k)(3)(A)(i).
(c) 'Interchangeable' means, in reference to a biological
product, that the United States Food and Drug Administration has
determined that a biosimilar product meets the safety standards
set forth in 42 U.S.C. 262(k)(4).
(d) 'Reference biological product' means the biological product
licensed pursuant to 42 U.S.C. 262(a) against which a biological
product is evaluated in an application submitted to the United
States Food and Drug Administration for licensure of a biological
product as a biosimilar product or for determination that a
biosimilar product is interchangeable.
(2) A pharmacy or pharmacist filling a prescription order for a
biological product may not substitute a biosimilar product for
the prescribed biological product unless:
(a) The biosimilar product has been determined by the United
States Food and Drug Administration to be interchangeable with
the prescribed biological product;
(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 prior to dispensing the
biosimilar product;
(d) The pharmacy or pharmacist provides written, electronic or
telephonic notification of the substitution to the prescribing
practitioner or the prescribing practitioner's staff within three
business days of dispensing the biosimilar product; and
(e) The pharmacy or pharmacist retains a record of the
substitution for a period of not less than three years.
Enrolled Senate Bill 460 (SB 460-A) Page 1
(3) The State Board of Pharmacy shall post and regularly update
on a website maintained by the board a list of biosimilar
products determined by the United States Food and Drug
Administration to be interchangeable. + }
SECTION 3. { + (1) Section 2 of this 2013 Act becomes
operative on January 1, 2014.
(2) The State Board of Pharmacy may take any action before the
operative date specified in subsection (1) of this section that
is necessary to enable the board to exercise, on and after the
operative date specified in subsection (1) of this section, all
the duties, functions and powers conferred on the board by
section 2 of this 2013 Act. + }
SECTION 4. Section 2 of this 2013 Act is amended to read:
{ + Sec. 2. + } (1) As used in this section:
(a) 'Biological product' means, with respect to the prevention,
treatment or cure of a disease or condition of human beings, a
virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component, blood derivative, allergenic product, protein other
than a chemically synthesized polypeptide, analogous products or
arsphenamine or any other trivalent organic arsenic compound.
(b) 'Biosimilar product' means a biological product licensed by
the United States Food and Drug Administration pursuant to 42
U.S.C. 262(k)(3)(A)(i).
(c) 'Interchangeable' means, in reference to a biological
product, that the United States Food and Drug Administration has
determined that a biosimilar product meets the safety standards
set forth in 42 U.S.C. 262(k)(4).
(d) 'Reference biological product' means the biological product
licensed pursuant to 42 U.S.C. 262(a) against which a biological
product is evaluated in an application submitted to the United
States Food and Drug Administration for licensure of a biological
product as a biosimilar product or for determination that a
biosimilar product is interchangeable.
(2) A pharmacy or pharmacist filling a prescription order for a
biological product may not substitute a biosimilar product for
the prescribed biological product unless:
(a) The biosimilar product has been determined by the United
States Food and Drug Administration to be interchangeable with
the prescribed biological product;
(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 prior to dispensing the
biosimilar product; { + and + }
{ - (d) The pharmacy or pharmacist provides written,
electronic or telephonic notification of the substitution to the
prescribing practitioner or the prescribing practitioner's staff
within three business days of dispensing the biosimilar product;
and - }
{ - (e) - } { + (d) + } The pharmacy or pharmacist retains
a record of the substitution for a period of not less than three
years.
(3) The State Board of Pharmacy shall post and regularly update
on a website maintained by the board a list of biosimilar
products determined by the United States Food and Drug
Administration to be interchangeable.
SECTION 5. { + The amendments to section 2 of this 2013 Act by
section 4 of this 2013 Act become operative on January 1,
2016. + }
Enrolled Senate Bill 460 (SB 460-A) Page 2
SECTION 6. { + This 2013 Act being necessary for the immediate
preservation of the public peace, health and safety, an emergency
is declared to exist, and this 2013 Act takes effect on its
passage. + }
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Passed by Senate April 24, 2013
.............................................................
Robert Taylor, Secretary of Senate
.............................................................
Peter Courtney, President of Senate
Passed by House May 30, 2013
.............................................................
Tina Kotek, Speaker of House
Enrolled Senate Bill 460 (SB 460-A) Page 3
Received by Governor:
......M.,............., 2013
Approved:
......M.,............., 2013
.............................................................
John Kitzhaber, Governor
Filed in Office of Secretary of State:
......M.,............., 2013
.............................................................
Kate Brown, Secretary of State
Enrolled Senate Bill 460 (SB 460-A) Page 4
