Bill Text: OR HB2705 | 2013 | Regular Session | Introduced

Oregon House Bill 2705 (Prior Session Legislation)

Bill Title: Relating to biological products; declaring an emergency.

Spectrum: Bipartisan Bill

Status: (Failed) 2013-07-08 - In committee upon adjournment. [HB2705 Detail]

Download: Oregon-2013-HB2705-Introduced.html



     77th OREGON LEGISLATIVE ASSEMBLY--2013 Regular Session

NOTE:  Matter within  { +  braces and plus signs + } in an
amended section is new. Matter within  { -  braces and minus
signs - } is existing law to be omitted. New sections are within
 { +  braces and plus signs + } .

LC 2898

                         House Bill 2705

Sponsored by Representatives KOTEK, THOMPSON, Senators MONNES
  ANDERSON, WINTERS

                             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.

  Restricts substitution of biosimilar product for prescribed
biological product.
  Becomes operative on January 1, 2014.
  Declares emergency, effective on passage.

                        A BILL FOR 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 biological
products as biosimilar products or for determination that
biosimilar products are 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 biological product for the use for which the prescribing
practitioner prescribed the 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 prescribing practitioner, and the pharmacy or
pharmacist, retain 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 with a reference biological
product. + }
  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.  { + 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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