(A) A pharmacy seeking authorization to be a charitable pharmacy shall maintain a terminal distributor of dangerous drug license. An application for licensure shall include the following:
(1) A completed terminal distributor application requesting licensure as a charitable pharmacy;
(2) Documentation to support the exemption from federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) (5/28/2015);
(3) The fee for the appropriate category of licensure; and
(4) Any other requirements set forth in division 4729:5 of the Administrative Code.
(B) A charitable pharmacy is considered to be a pharmacy pursuant to section 4729.01 of the Revised Code and shall comply with all federal and state laws, rules, and regulations that pertain to outpatient pharmacies and the practice of pharmacy, including chapter 4729:5-5 of the Administrative Code.
(C) A charitable pharmacy may designate employees and volunteers as support personnel, as defined in rule 4729:3-1-01 of the Administrative Code, for the purposes of sorting donations of non-controlled substance dangerous drugs.
(1) Drug sorting shall be conducted under the personal supervision of a licensed pharmacist.
(2) Support personnel are not permitted to label, package, repackage or dispense dangerous drugs.
(3) The charitable pharmacy shall have written policies and procedures for drug sorting by support personnel. Such policies and procedures shall require documentation of all activities related to drug sorting, including participation logs, support personal information (name, address, contact phone, etc.), and a daily activity log to be signed by the licensed pharmacist or pharmacists providing supervision. All documents and records must be readily retrievable and shall be maintained on-site for a period of three years.
Replaces: 4729-36-02, 4729-36-03
Five Year Review (FYR) Dates: 07/01/2024
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26, 3719.811
Rule Amplifies: 3719.81 , 3719.811 , 3719.812, 3719.813
Prior Effective Dates: 01/01/2006, 01/15/2016