ESHB 2228 -
By Committee on Health & Long-Term Care
Strike everything after the enacting clause and insert the following:
"NEW SECTION. Sec. 1 The definitions in this section apply
throughout this chapter unless the context clearly requires otherwise.
(1) "Department" means the department of health.
(2) "Drug manufacturer" means a facility licensed by the board of
pharmacy under chapter 18.64 RCW that engages in the manufacture of
drugs or devices.
(3) "Drug wholesaler" means a facility licensed by the board of
pharmacy under chapter 18.64 RCW that buys drugs or devices for resale
and distribution to corporations, individuals, or entities other than
consumers.
(4) "Medical facility" means a hospital, pharmacy, nursing home,
boarding home, adult family home, or medical clinic where the
prescription drugs are under the control of a practitioner.
(5) "Person" means an individual, corporation, business trust,
estate, trust, partnership, association, joint venture, government,
governmental subdivision or agency, or any other legal or commercial
entity.
(6) "Pharmacist" means a person licensed by the board of pharmacy
under chapter 18.64 RCW to practice pharmacy.
(7) "Pharmacy" means a facility licensed by the board of pharmacy
under chapter 18.64 RCW in which the practice of pharmacy is conducted.
(8) "Practitioner" has the same meaning as in RCW 69.41.010.
(9) "Prescribing practitioner" means a person authorized to issue
orders or prescriptions for legend drugs as listed in RCW 69.41.030.
(10) "Prescription drugs" has the same meaning as "legend drugs" as
defined in RCW 69.41.010. The term includes cancer drugs and
antirejection drugs. The term does not include controlled substances.
(11) "Supplies" means the supplies necessary to administer
prescription drugs that are donated under the prescription drug
redistribution program.
NEW SECTION. Sec. 2 Any practitioner, pharmacist, medical
facility, drug manufacturer, or drug wholesaler may donate prescription
drugs and supplies to a pharmacy for redistribution without
compensation or the expectation of compensation to individuals who meet
the prioritization criteria established in section 3 of this act.
Donations of prescription drugs and supplies may be made on the
premises of a pharmacy that elects to participate in this chapter. A
pharmacy that receives prescription drugs or supplies may distribute
the prescription drugs or supplies to another pharmacy, pharmacist, or
prescribing practitioner for use pursuant to the program.
NEW SECTION. Sec. 3 Pharmacies, pharmacists, and prescribing
practitioners that elect to dispense donated prescription drugs and
supplies under this chapter shall give priority to individuals who are
uninsured and at or below two hundred percent of the federal poverty
level. If an uninsured and low-income individual has not been
identified as in need of available prescription drugs and supplies,
those prescription drugs and supplies may be dispensed to other
individuals expressing need.
NEW SECTION. Sec. 4 (1) The department must adopt rules
establishing forms and procedures to reasonably verify eligibility and
prioritize patients seeking to receive donated prescription drugs and
supplies. A patient's eligibility may be determined by a form signed
by the patient certifying that the patient is uninsured and at or below
two hundred percent of the federal poverty level.
(2) The department may establish any other rules necessary to
implement this chapter.
NEW SECTION. Sec. 5 (1) Prescription drugs or supplies may be
accepted and dispensed under this chapter if all of the following
conditions are met:
(a) The prescription drug is in:
(i) Its original sealed and tamper evident packaging; or
(ii) An opened package if it contains single unit doses that remain
intact;
(b) The prescription drug bears an expiration date that is more
than six months after the date the prescription drug was donated;
(c) The prescription drug or supplies are inspected before the
prescription drug or supplies are dispensed by a pharmacist employed by
or under contract with the pharmacy, and the pharmacist determines that
the prescription drug or supplies are not adulterated or misbranded;
(d) The prescription drug or supplies are prescribed by a
practitioner for use by an eligible individual and are dispensed by a
pharmacist; and
(e) Any other safety precautions established by the department have
been satisfied.
(2)(a) If a person who donates prescription drugs or supplies to a
pharmacy under this chapter receives a notice that the donated
prescription drugs or supplies have been recalled, the person shall
notify the pharmacy of the recall.
(b) If a pharmacy that receives and distributes donated
prescription drugs to another pharmacy, pharmacist, or prescribing
practitioner under this chapter receives notice that the donated
prescription drugs or supplies have been recalled, the pharmacy shall
notify the other pharmacy, pharmacist, or prescribing practitioner of
the recall.
(c) If a person collecting or distributing donated prescription
drugs or supplies under this chapter receives a recall notice from the
drug manufacturer or the federal food and drug administration for
donated prescription drugs or supplies, the person shall immediately
remove all recalled medications from stock and comply with the
instructions in the recall notice.
(3) A person receiving donated prescription drugs or supplies under
this chapter must be notified that the drug was donated.
(4) Prescription drugs and supplies donated under this chapter may
not be resold.
(5) Prescription drugs and supplies dispensed under this chapter
shall not be eligible for reimbursement under the medical assistance
program.
NEW SECTION. Sec. 6 (1) Any practitioner, pharmacist, or medical
facility who donates prescription drugs or supplies under this chapter
shall not, in the absence of a finding of gross negligence, be subject
to criminal prosecution, civil liability, or professional disciplinary
action, for injury, death, or loss to person or property relating to
the donation of the prescription drug or supply.
(2) Any drug manufacturer or drug wholesaler who donates
prescription drugs or supplies under this chapter shall not, in the
absence of a finding of gross negligence, be subject to criminal
prosecution or civil liability, for injury, death, or loss to person or
property relating to the donation of the prescription drug or supply,
failure to transfer or communicate product or consumer information, or
failure to communicate the expiration date of the donated prescription
drug or supply.
(3) Any pharmacist, pharmacy, or prescribing practitioner who
accepts or dispenses prescription drugs or supplies under this chapter
shall not, in the absence of a finding of gross negligence, be subject
to criminal prosecution, civil liability, or professional disciplinary
action, for injury, death, or loss to person or property relating to
accepting or dispensing the prescription drug or supply if the
pharmacist, pharmacy, or prescribing practitioner: Meets all the
requirements of section 5 of this act; maintains records of any
prescription drugs and supplies donated and dispensed under this
chapter; and identifies itself to the public as participating in this
chapter.
(4) The immunity provided under this section does not absolve a
drug manufacturer of a criminal or civil liability that would have
existed but for the donation, nor shall such donation, increase the
liability of the drug manufacturer in such an action.
NEW SECTION. Sec. 7 Access to prescription drugs and supplies
under this chapter is subject to availability. Nothing in this chapter
establishes an entitlement to receive prescription drugs or supplies
through the program.
NEW SECTION. Sec. 8 Nothing in this chapter restricts the use of
samples by a practitioner during the course of the practitioner's
duties at a medical facility or pharmacy.
NEW SECTION. Sec. 9 Nothing in this chapter authorizes the
resale of prescription drugs by any person.
NEW SECTION. Sec. 10 Sections 1 through 9 of this act constitute
a new chapter in Title
NEW SECTION. Sec. 11 This act takes effect July 1, 2013."
ESHB 2228 -
By Committee on Health & Long-Term Care
On page 1, line 1 of the title, after "uninsured;" strike the remainder of the title and insert "adding a new chapter to Title 69 RCW; and providing an effective date."
EFFECT: (1) Provides that donors and dispensers are provided with
immunity from criminal or civil actions, unless there is a finding of
gross negligence. (Rather than a "good faith" standard for drug
manufacturers and a "reasonable care" standard for other entities.)
This immunity applies to drug manufacturers for failure to transfer or
communicate product or consumer information or expiration dates. This
immunity does not apply to actions against a drug manufacturer that
would have existed but for the donation.
(2) Provides that a recipient of donated drugs must be informed
that the drug was donated.