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Rule 4729:5-3-16 | Returned drugs.

 

(A) No drug that has been dispensed pursuant to a prescription or personally furnished by a prescriber and has left the physical premises of the terminal distributor of dangerous drugs shall be returned to the terminal distributor or dispensed or personally furnished again, except as follows:

(1) Drugs dispensed for inpatients, as defined in agency 4729 of the Administrative Code, or personally furnished to inpatients provided that:

(a) The drugs are packaged in unopened, single-dose or tamper-evident containers; and

(b) The drugs have not been in the possession of the ultimate user.

(2) Drugs dispensed for inpatients, as defined in agency 4729 of the Administrative Code, in accordance with rule 4729:5-9-02.11 of the Administrative Code.

(3) Drugs dispensed for outpatients in accordance with rules 4729:5-5-22 and 4729:5-5-18 of the Administrative Code.

(4) Drugs dispensed for patients, which have not been dispensed or personally furnished directly to the ultimate user, that require further manipulation prior to administration.

(5) Drugs donated to a drug repository program in accordance with Chapter 4729:5-10 of the Administrative Code.

(6) Drugs returned for destruction or disposal in accordance with division 4729:10 of the Administrative Code and rule 4729:5-5-14 of the Administrative Code.

(7) Hazardous drugs for destruction or disposal in accordance with all applicable federal, state, and local laws, rules, and regulations.

(B) As used in this rule, "hazardous drug" means any drug listed on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code.

(C) Except as provided in section 4729.43 of the Revised Code, nothing in this rule prohibits a terminal distributor of dangerous drugs from administering a dangerous drug that was dispensed or personally furnished directly to a patient or patient's caregiver.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 3715.63, 3719.05
Five Year Review Date: 3/9/2025
Prior Effective Dates: