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Final Bill Analysis

Legislative Service Commission



Effective Date from the Status Report of Legislation: 04/07/03 Effective
Because of Ohio Supreme Court interpretations, effective dates published in the Status Report of Legislation are not authoritative, and users of the Status Report of Legislation rely upon them at their own risk. The effective dates have been unofficially and undefinitively determined by the LSC Division of Legal Review and Technical Services solely for the convenience of users.

Signed by Governor: 01/06/03
Subject: Health


Sub. H.B. 221
124th General Assembly
(As Passed by the General Assembly)

ACT SUMMARY CONTENT AND OPERATION
Creation of the drug repository program
(secs. 3715.87 and 3715.873)
The act requires the State Board of Pharmacy to establish a drug repository program for the collection and redistribution of unadulterated prescription drugs that are in their original sealed and tamper-evident unit dose packaging.  The Board, in consultation with the Director of Health, is required to adopt rules pursuant to the Administrative Procedure Act (Revised Code Chapter 119.) that govern the program and establish all of the following: Donation and distribution of drugs
(secs. 3715.87 and 3715.871)
The act permits the drug repository program to accept drugs from any person, including a drug manufacturer, or any health care facility, provided that the donation takes place at a pharmacy, hospital, or nonprofit clinic that has elected to participate in the repository program and meets eligibility requirements established in rules adopted by the Pharmacy Board.[2]  The act specifies that participation in the repository program by pharmacies, hospitals, and nonprofit clinics is voluntary.  The act permits unused drugs dispensed for purposes of the Medicaid program to be accepted and dispensed by the repository program.  Individuals who donate drugs to the repository program must sign a form established by the Board in rules that states that the individual is the owner of the drugs and intends to donate them to the program.
To be accepted by the repository, the drugs must be in their original sealed and tamper-evident unit dose packaging.  The packaging must be unopened, except that drugs packaged in single unit doses may be accepted and dispensed when the outside packaging is opened, provided that the single unit dose packaging is undisturbed.  A drug cannot be accepted or dispensed by the program if there is reason to believe that it is adulterated.  Drugs donated by individuals bearing an expiration date that is less than six months from the date the drug is donated cannot be accepted or dispensed by the repository program.
The act requires that the participating pharmacies, hospitals, and nonprofit clinics distribute donated drugs to individuals who are Ohio residents and meet eligibility standards established by the Pharmacy Board in rules.  Drugs may be dispensed from the repository program only pursuant to a prescription issued by a health care professional authorized to prescribe drugs.[3]  The act also requires that the dispensing of donated drugs comply with all applicable federal and state laws dealing with storage and distribution of prescription drugs.
Drugs donated to the repository program may not be resold, but pharmacies, hospitals, and nonprofit clinics may charge recipients a handling fee to cover restocking and dispensing costs in accordance with a formula established by the Board.  Before receiving a drug from the repository program, the recipient must sign a form established by the Board in rules to confirm that the recipient understands the program's immunity provisions.
Liability
(sec. 3715.872)
The act provides that, in the absence of bad faith, the following are not subject to criminal prosecution, civil liability, or professional discipline for matters related to the acceptance or dispensing of donated drugs:  the Pharmacy Board; Director of Health; any person, including the manufacturer of a donated drug regardless of who donated the drug, government entity, pharmacy, nonprofit clinic, or health care professional, that accepts or dispenses drugs under the repository program; and any pharmacy, hospital, or nonprofit clinic that employs a health care professional who accepts or dispenses drugs under the program.
Effective date
(Sections 2 and 3)
The act requires the Pharmacy Board to adopt the rules to govern the repository program no later than nine months after the act's effective date.  The other provisions are to take effect one year after the act's effective date.
HISTORY

ACTIONDATEJOURNAL ENTRY
    Introduced
04-18-01p.         305
    Reported, H. Health &
    Family Services

03-20-02

pp.       1595-1596
    Passed House (94-0)
04-24-02pp.       1706-1711
    Reported, S. Health, Human
    Services, & Aging

11-14-02

p.         2125
    Passed Senate (32-0)
11-14-02p.         2130
    House concurred in Senate
    amendments (91-0)

11-20-02

pp.       2069-2070




* The Legislative Service Commission had not received formal notification of the effective date at the time this analysis was prepared.  Additionally, the analysis may not reflect action taken by the Governor.
[1] As used in the Revised Code, unless otherwise specified, "person" includes an individual, corporation, business trust, estate, partnership, and association (Revised Code § 1.59).
[2] For the purposes of the act, "hospital" has the same meaning as in Revised Code provisions providing for hospital classification (R.C. 3727.01, not in the act).  "Hospital" means an institution classified as a hospital under Ohio law in which are provided to inpatients diagnostic, medical, surgical, obstetrical, psychiatric, or rehabilitation care for a continuous period longer than 24 hours or a hospital operated by a health maintenance organization.  Certain facilities, such as nursing homes and outpatient clinics, are specifically excluded from this definition of "hospital."  "Nonprofit clinic" means a charitable nonprofit corporation organized and operated in accordance with Ohio law, or any charitable organization not organized and not operated for profit, that provides health care services to indigent and uninsured persons.  "Nonprofit clinic" does not include a hospital, a facility licensed as a nursing home or residential care facility, or a facility that is operated for profit (R.C. 3715.87).
[3] The following health care professionals licensed under Ohio law are authorized to prescribe drugs:  dentists; nurses who hold a certificate to prescribe; optometrists licensed to practice optometry under a therapeutic pharmaceutical agents certificate; physicians authorized to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery; and veterinarians (R.C. 4729.01(I)).

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