2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.87 | Drug Repository Program for Donated Prescription Drugs - Definitions.

Effective:
April 6, 2023
Latest Legislation:
House Bill 558 - 134th General Assembly
(A) As used in this section and in sections 3715.871, 3715.872, and 3715.873 of the Revised Code:
(1) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.
(2) "Charitable pharmacy" has the same meaning as in section 3719.811 of the Revised Code.
(3) "Health care facility" has the same meaning as in section 1337.11 of the Revised Code.
(4) "Hospital" has the same meaning as in section 3727.01 of the Revised Code.
(5) "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, or to underinsured persons, as defined in rules adopted under section 3715.873 of the Revised Code. "Nonprofit clinic" does not include a hospital, a facility licensed under Chapter 3721. of the Revised Code, or a facility that is operated for profit.
(6) "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 prescription drugs donated or given for the purpose of being distributed to individuals who are residents of this state and meet eligibility standards established in rules adopted under section 3715.873 of the Revised Code.
(C) All of the following conditions shall apply to the drugs that are accepted and distributed under the program:
(1) Except as provided in division (D) of this section:
(a) Only drugs in their original sealed and tamper-evident unit dose packaging may be accepted and distributed.
(b) The packaging must be unopened, except that drugs packaged in single unit doses may be accepted and distributed when the outside packaging is opened if the single unit dose packaging is undisturbed.
(2) A drug shall not be accepted or distributed if either of the following is the case:
(a) There is reason to believe that the drug is adulterated, as described in section 3715.63 of the Revised Code.
(b) The drug, as determined in accordance with rules adopted under section 3715.873 of the Revised Code, is a drug for which the United States food and drug administration requires, as a risk evaluation and mitigation strategy, that the patient be registered with the drug's manufacturer.
(D) Drugs that are not in their original sealed and tamper-evident unit dose packaging may be accepted and distributed under the program, subject to rules adopted under section 3715.873 of the Revised Code, if the drugs are included in either of the following categories and are not controlled substances:
(1) Orally administered cancer drugs that do not require refrigeration, freezing, or storage at a special temperature;
(2) Drugs that are accepted and distributed under the program by a charitable pharmacy, hospital, or nonprofit clinic, including any such drugs that are orally administered cancer drugs or that may require storage at a special temperature.
(E) Subject to the limitations specified in divisions (B) to (D) of this section, unused drugs for which the cost was covered by the medicaid program may be accepted and distributed under the drug repository program.
Last updated March 15, 2023 at 12:46 PM