4729-16-10 In-state pharmacy compounding for drug shortages.

(A) In the event of a drug shortage as defined in rule 4729-16-01 of the Administrative Code, an in-state pharmacy may request an exemption from rule 4729-16-07 of the Administrative Code from the state board of pharmacy.

(B) Upon provision of an exemption, a pharmacist working at an in-state pharmacy, as defined in rule 4729-16-01 of the Administrative Code, licensed as a terminal distributor of dangerous drugs may compound and provide without a prescription a non-patient specific drug pursuant to a request made by a medical director of an in-state health care facility, as defined in rule 4729-16-01 of the Administrative Code, for a drug that is to be used by the facility for the purpose of direct administration to patients.

(C) In order to obtain an exemption, the responsible pharmacist for the in-state pharmacy and the medical director of an in-state health care facility or Ohio licensed pharmacist who is authorized by the in-state health care facility to act on behalf of the medical director must notify the executive director of the state board of pharmacy in a manner prescribed by the board.

(D) The executive director may, on behalf of the board, place restrictions on the exemption including, but not limited to, the following:

(1) A limit on the quantity of the drug(s) compounded without a patient specific prescription by the in-state pharmacy;

(2) A limit on the time the exemption shall be in effect;

(E) The board shall review each exemption notification provided to the executive director and may place restrictions on the exemption including, but not limited to, the following:

(1) A limit on the quantity of the drug(s) compounded without a patient specific prescription by the in-state pharmacy; and

(2) A limit on the time the exemption shall be in effect.

Effective: 5/1/2015
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 3719.28
Rule Amplifies: 4729.01