71st OREGON LEGISLATIVE ASSEMBLY--2001 Regular Session
Enrolled
Senate Bill 568
Sponsored by Senator FISHER (at the request of Oregon State
Pharmacist Association)
CHAPTER ................
AN ACT
Relating to information provided by pharmacy about prescription
medications; amending ORS 689.515.
Be It Enacted by the People of the State of Oregon:
SECTION 1. ORS 689.515 is amended to read:
689.515. (1) As used in this section unless the context
requires otherwise:
(a) 'Brand name' means the proprietary or trade name selected
by the manufacturer and placed upon a drug, its container, label
or wrapping at the time of packaging.
(b) 'Dosage form' means the physical formulation or medium in
which the product is intended, manufactured and made available
for use, including but not limited to tablets, capsules, oral
solutions, aerosols, ointments, inhalers and suppositories, and
the particular form of which utilizes a specific technology or
mechanism to control, enhance or direct the release, targeting,
systemic absorption or other delivery of a dosage regimen in the
body.
(c) 'Generic name' means the official title of a drug or drug
ingredients published in the latest edition of the official
Pharmacopoeia, Homeopathic Pharmacopoeia or Formulary.
(d) 'Substitute' means to dispense without the prescriber's
express authorization a different drug product in place of the
drug ordered or prescribed.
(e) 'Therapeutically equivalent' means drugs that are approved
by the United States Food and Drug Administration for interstate
distribution and the Food and Drug Administration has determined
that the drugs will provide essentially the same efficacy and
toxicity when administered to an individual in the same dosage
regimen.
(2) Except as limited by subsections (3) and (5) of this
section, unless the purchaser instructs otherwise, the pharmacist
may substitute as follows:
(a) A drug product with the same generic name in the same
strength, quantity, dose and dosage form as the prescribed drug
which is, in the pharmacist's professional opinion,
therapeutically equivalent.
(b) When the prescriber is not reasonably available for
consultation and the prescribed drug does not utilize a unique
delivery system technology, an oral tablet, capsule or liquid
form of the prescribed drug so long as the form dispensed or
Enrolled Senate Bill 568 (SB 568-A) Page 1
administered has the same strength, dose and dose schedule and is
therapeutically equivalent to the drug prescribed.
(3) A practitioner may specify in writing or by a telephonic
communication that there shall be no substitution for the
specified brand name drug in any prescription. The phrase 'no
substitution' or the notation 'N.S.' must be in the
practitioner's handwriting or, if the prohibition was
communicated by telephonic communication, in the pharmacist's
handwriting and shall not be preprinted or stamped or initialed
on the prescription form.
(4) Every pharmacy shall post a sign in a location easily seen
by patrons at the counter where prescriptions are dispensed or
administered stating that, 'This pharmacy may be able to
substitute a less expensive drug which is therapeutically
equivalent to the one prescribed by your doctor unless you do not
approve.' The printing on the sign shall be in block letters not
less than one inch in height. If the pharmacist has reasonable
cause to believe that the purchaser cannot read the sign or
comprehend its content, the pharmacist shall endeavor to explain
the meaning of the sign.
(5) A pharmacist shall substitute a drug product under this
section only when there will be a savings in or no increase in
cost to the purchaser.
(6) If the practitioner prescribes a drug by its generic name,
the pharmacist shall, consistent with reasonable professional
judgment, dispense or administer the lowest retail cost,
effective brand which is in stock.
(7) Except as provided in subsection (8) of this section, when
a pharmacist dispenses a substituted drug as authorized by
subsection (2) of this section, the pharmacist must label the
prescription container with the name of the dispensed drug. If
the dispensed drug does not have a brand name, the prescription
label shall indicate the generic name of the drug dispensed along
with the name of the drug manufacturer.
(8) A prescription dispensed by a pharmacist shall bear upon
the label the name of the medication in the container
{ - except if the prescriber writes 'do not label,' or words of
similar import, on the prescription or so designates in an oral
transmission of the prescription - } { + or shall be labeled as
intended by the prescriber + }.
(9) The substitution of any drug by a licensed pharmacist or
the pharmacist's employer pursuant to this section does not
constitute the practice of medicine.
(10) No substitution of drugs made by a pharmacist or the
pharmacist's employer in accordance with this section and any
rules that the State Board of Pharmacy may adopt thereunder shall
constitute evidence of negligence if the substitution was made
within reasonable and prudent practice of pharmacy or if the
substituted drug was accepted in a generally recognized formulary
or government list.
(11) Failure of a practitioner to specify that no substitution
is authorized does not constitute evidence of negligence unless
the practitioner knows that the health condition of the patient
for whom the practitioner is prescribing warrants the use of the
brand name drug product and not the substituted drug.
----------
Enrolled Senate Bill 568 (SB 568-A) Page 2
Passed by Senate May 1, 2001
...........................................................
Secretary of Senate
...........................................................
President of Senate
Passed by House May 29, 2001
...........................................................
Speaker of House
Enrolled Senate Bill 568 (SB 568-A) Page 3
Received by Governor:
......M.,............., 2001
Approved:
......M.,............., 2001
...........................................................
Governor
Filed in Office of Secretary of State:
......M.,............., 2001
...........................................................
Secretary of State
Enrolled Senate Bill 568 (SB 568-A) Page 4