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Am. Sub. H. B. No. 221As Passed by the HouseAs Passed by the House
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
A BILL
To enact sections 3701.79, 3701.791, 3701.792, and
3701.793 of the Revised Code to
establish under the
direction of the Director of
Health 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 3701.79, 3701.791, 3701.792, and
3701.793 of the Revised Code be enacted to read as
follows:
Sec. 3701.79. (A) As used in this section and in sections
3701.791, 3701.792, and 3701.793 of the Revised Code: (1) "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. (2) "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 director of health shall establish a drug repository
program to accept and dispense prescription drugs donated for the
purpose of being dispensed to individuals who meet eligibility
standards established in rules adopted by the state board of
pharmacy under section 3701.793 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. 3701.791. (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 or nonprofit
clinic that
elects to participate in the drug repository program.
Participation in the program by pharmacies and nonprofit clinics
is voluntary. Nothing in this or any other section of the Revised
Code requires a pharmacy or nonprofit clinic to participate in the
program. (B) A pharmacy or nonprofit clinic shall dispense drugs
donated under
this section to individuals who meet the eligibility
standards
established in rules adopted by the state board of
pharmacy under
section 3701.793 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 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 or nonprofit clinic may charge individuals receiving
donated drugs a handling fee established in accordance with rules
adopted by the state board of pharmacy under section 3701.793 of
the Revised Code. Drugs donated to the repository may not be
resold.
Sec. 3701.792. (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 director of health; any person, including a drug
manufacturer, or government
entity
that donates drugs to the
repository program; any
pharmacy,
nonprofit clinic, or health care
professional that
accepts or
dispenses drugs under the program;
and any pharmacy 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.
Sec. 3701.793. 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) Standards and procedures for accepting, safely storing,
and dispensing donated drugs;
(B) 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;
(C) Eligibility standards based on economic need for
individuals to receive drugs;
(D) A means, such as an identification card, by which an
individual who is eligible to receive donated drugs may
demonstrate eligibility to the pharmacy or nonprofit clinic
dispensing the drugs;
(E) 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; (F) A formula to determine the amount of a handling fee that
pharmacies and nonprofit clinics may charge to drug recipients to
cover restocking and dispensing costs;
(G) 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. (H) 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. (I) 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 3701.79, 3701.791, and 3701.792 of the
Revised Code as enacted by this act shall take effect one year
after the effective date of this act.
Section 3. The State Board of Pharmacy shall adopt the rules
required by section 3701.793 of the Revised Code not later than
nine months after the effective date of this act.
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