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Sub. H. B. No. 221As Reported by the Senate Health, Human Services and Aging CommitteeAs Reported by the Senate Health, Human Services and Aging Committee
124th General Assembly | Regular Session | 2001-2002 |
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REPRESENTATIVES Schuring, Jolivette, Hollister, Hagan, Cates, D. Miller, Calvert, Hartnett, Patton, Seitz, Britton, Willamowski, Otterman, Ogg, Perry, Allen, Collier, DePiero, Webster, Jones, Boccieri, Schaffer, Redfern, Damschroder, Metelsky, Coates, Aslanides, Lendrum, Kearns, Raga, Kilbane, Mason, Cirelli, Beatty, Williams, Schneider, Flowers, Buehrer, Metzger, Niehaus, Carey, Rhine, Flannery, Barrett, Sulzer, Krupinski, Carano, Key, Latta, Carmichael, Strahorn, Hoops, Stapleton, Fedor, DeBose, Clancy, Driehaus, Manning, Peterson, Core, G. Smith, Reidelbach, Faber, Widowfield, Hughes, McGregor, Young, Olman, Brown, Oakar, Sykes, Wolpert, Salerno, Setzer, Womer Benjamin, Roman, Woodard
SENATORS Prentiss, Wachtmann, Randy Gardner
A BILL
To enact sections 3715.87, 3715.871, 3715.872, and
3715.873 of the Revised Code to
establish under
the
direction of the State Board of Pharmacy a drug
repository program to accept and
dispense donated
prescription drugs.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 3715.87, 3715.871, 3715.872, and
3715.873 of the Revised Code be enacted to read as
follows:
Sec. 3715.87. (A) As used in this section and in sections
3715.871, 3715.872, and 3715.873 of the Revised Code: (1) "Hospital" has the same meaning as in section 3727.01 of
the Revised Code. (2) "Nonprofit clinic" means a charitable nonprofit
corporation organized and operated pursuant to Chapter 1702. of
the Revised Code, or any charitable organization not organized and
not operated for profit, that provides health care services to
indigent and uninsured persons as defined in section 2305.234 of
the Revised Code. "Nonprofit clinic" does not include a hospital
as defined in section 3727.01 of the Revised Code, a facility
licensed under Chapter 3721. of the Revised Code, or a facility
that is operated for profit. (3) "Prescription drug" means any drug to which the following
applies: (a) Under the "Food, Drug, and Cosmetic Act," 52 Stat. 1040
(1938), 21 U.S.C.A. 301, as amended, the drug is required to bear
a label containing the legend, "Caution: Federal law prohibits
dispensing without prescription" or "Caution: Federal law
restricts this drug to use by or on the order of a licensed
veterinarian" or any similar restrictive statement, or the drug
may be dispensed only upon a prescription. (b) Under Chapter 3715. or 3719. of the Revised Code, the
drug may be dispensed only upon a prescription. (B) The state board of pharmacy shall establish a drug
repository
program to accept and dispense prescription drugs
donated for the
purpose of being dispensed to individuals who are
residents of this state and meet
eligibility
standards established
in rules adopted by the board
under section 3715.873 of the
Revised Code. Only drugs
in their
original sealed and
tamper-evident unit dose packaging
may be
accepted and dispensed.
The packaging
must be unopened,
except
that drugs packaged in
single unit doses
may be accepted
and
dispensed when the outside
packaging is opened
if the single
unit
dose packaging is
undisturbed. Drugs donated by individuals
bearing an expiration
date that is less than six months from the
date the drug is
donated shall not be accepted or dispensed. A
drug shall
not be
accepted or dispensed if there is reason to
believe that it is
adulterated as described in section 3715.63 of
the Revised Code.
Subject to the limitation specified in this
division, unused drugs
dispensed for purposes of the medicaid
program may be accepted and
dispensed under the drug repository
program.
Sec. 3715.871. (A) Any person, including a drug manufacturer
or any health care
facility as defined in section 1337.11 of the
Revised Code, may
donate prescription drugs to the drug repository
program. The
drugs must be donated at a pharmacy, hospital, or
nonprofit
clinic that
elects to participate in the drug repository
program and meets criteria for participation in the program
established in rules adopted by the state board of pharmacy under
section 3715.873 of the Revised Code.
Participation in the program
by pharmacies, hospitals, and nonprofit clinics
is voluntary.
Nothing in this or any other section of the Revised
Code requires
a pharmacy, hospital, or nonprofit clinic to participate in the
program. (B) A pharmacy, hospital, or nonprofit clinic eligible to
participate in the program shall dispense drugs
donated under
this
section to individuals who are residents of this state and meet
the eligibility
standards
established in rules adopted by the
board under
section 3715.873
of the Revised Code or to other
government
entities and nonprofit
private entities to be dispensed
to
individuals who meet the
eligibility standards. A drug may be
dispensed only pursuant to a
prescription issued by a licensed
health professional authorized
to prescribe drugs, as defined in
section 4729.01 of the Revised
Code. A pharmacy, hospital, or
nonprofit
clinic
that accepts
donated drugs shall comply with all
applicable
federal laws and
laws of this state dealing with
storage and
distribution of
dangerous drugs and shall inspect all
drugs prior
to dispensing
them to determine that they are not
adulterated. The
pharmacy,
hospital, or nonprofit clinic may
charge individuals receiving
donated drugs a handling fee
established in accordance with rules
adopted by the board under
section 3715.873 of
the Revised Code. Drugs donated to the
repository may not be
resold.
Sec. 3715.872. (A) As used in this section, "health care
professional" means any of the following who provide medical,
dental, or other health-related diagnosis, care, or treatment: (1) Individuals authorized under Chapter 4731. of the
Revised Code to practice medicine and surgery, osteopathic
medicine and surgery, or podiatric medicine and surgery; (2) Registered nurses and licensed practical nurses licensed
under Chapter 4723. of the Revised Code; (3) Physician assistants authorized to practice under Chapter
4730. of the Revised Code; (4) Dentists and dental hygienists licensed under Chapter
4715. of the Revised Code; (5) Optometrists licensed under Chapter 4725. of the Revised
Code; (6) Pharmacists licensed under Chapter 4729. of the Revised
Code. (B) The state board of pharmacy; the director of health;
any
person, including a drug
manufacturer, or government
entity
that
donates drugs to the
repository program; any
pharmacy,
hospital,
nonprofit clinic, or health care
professional that
accepts or
dispenses drugs under the program;
and any pharmacy,
hospital, or
nonprofit
clinic that employs a health care
professional who
accepts or
dispenses drugs under the program
shall not, in the
absence of bad
faith, be subject to any of the
following for
matters related to
donating, accepting, or
dispensing drugs under
the program:
criminal prosecution;
liability in tort or other
civil action for
injury, death, or loss
to person or property; or
professional
disciplinary action. A drug manufacturer shall not, in the absence of bad faith, be subject to criminal prosecution or liability in tort or other civil action for injury, death, or loss to person or property for matters related to the donation, acceptance, or dispensing of a drug manufactured by the drug manufacturer that is donated by any person under the program, including but not limited to liability for failure to transfer or communicate product or consumer information or the expiration date of the donated drug.
Sec. 3715.873. In consultation with the director of health,
the state board of pharmacy shall adopt rules governing the drug
repository program that establish all of the following:
(A) Eligibility criteria for pharmacies, hospitals, and
nonprofit clinics to receive and dispense donated drugs under the
program; (B) Standards and procedures for accepting, safely storing,
and dispensing donated drugs;
(C) Standards and procedures for inspecting donated drugs
to determine that the original unit dose packaging is sealed and
tamper-evident and that the drugs are unadulterated, safe, and
suitable for dispensing;
(D) Eligibility standards based on economic need for
individuals to receive drugs;
(E) A means, such as an identification card, by which an
individual who is eligible to receive donated drugs may
demonstrate eligibility to the pharmacy, hospital, or nonprofit
clinic
dispensing the drugs;
(F) A form that an individual receiving a drug from the
repository must sign before receiving the drug to confirm that the
individual understands the immunity provisions of the program; (G) A formula to determine the amount of a handling fee that
pharmacies, hospitals, and nonprofit clinics may charge to drug
recipients to
cover restocking and dispensing costs;
(H) In addition, for drugs donated to the repository by
individuals:
(1) A list of drugs, arranged either by category or by
individual drug, that the repository will accept from individuals;
(2) A list of drugs, arranged either by category or by
individual drug, that the repository will not accept from
individuals. The list must include a statement as to why the drug
is ineligible for donation.
(3) A form each donor must sign stating that the donor is
the owner of the drugs and intends to voluntarily donate them to
the repository. (I) In addition, for drugs donated to the repository by
health care facilities:
(1) A list of drugs, arranged either by category or by
individual drug, that the repository will accept from health care
facilities;
(2) A list of drugs, arranged either by category or by
individual drug, that the repository will not accept from health
care facilities. The list must include a statement as to why the
drug is ineligible for donation. (J) Any other standards and procedures the board considers
appropriate.
The rules shall be adopted in accordance with Chapter 119.
of the Revised Code.
Section 2. Sections 3715.87, 3715.871, and 3715.872 of the
Revised Code as enacted by this act shall take effect one year
after the effective date of this section.
Section 3. The State Board of Pharmacy shall adopt the rules
required by section 3715.873 of the Revised Code not later than
nine months after the effective date of this section.
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