Chapter 4729:5-7 | Charitable Pharmacies

Rule 4729:5-7-01 | Definitions - Charitable pharmacies.

• Effective: July 1, 2019
• Promulgated Under: 119.03

As used in Chapter 4729:5-7 of the Administrative Code:

(A) "Charitable pharmacy" means a pharmacy that meets all of the following requirements:

(1) Holds a terminal distributor of dangerous drug license issued under section 4729.54 of the Revised Code;

(2) Is exempt from federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) (5/28/2015); and

(3) Is not a hospital as defined in section 3727.01 of the Revised Code.

(B) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(C) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(D) "Sample drug" has the same meaning as in section 2925.01 of the Revised Code.

Supplemental Information

Authorized By: 3719.28, 4729.26, 3719.811
Amplifies: 3719.81, 3719.811, 3719.812, 3719.813
Five Year Review Date: 7/1/2024
Prior Effective Dates: 1/1/2006

Rule 4729:5-7-02 | Licensure, compliance, and support personnel.

• Effective: July 1, 2019
• Promulgated Under: 119.03

(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.

Supplemental Information

Authorized By: 3719.28, 4729.26, 3719.811
Amplifies: 3719.81, 3719.811, 3719.812, 3719.813
Five Year Review Date: 7/1/2024
Prior Effective Dates: 1/1/2006, 1/15/2016

Rule 4729:5-7-03 | Persons eligible to transfer sample drugs to a charitable pharmacy.

• Effective: July 1, 2019
• Promulgated Under: 119.03

(A) An eligible sample drug shall only be transferred directly to a charitable pharmacy by any of the following:

(1) A manufacturer licensed in accordance with section 4729.52 of the Revised Code, including a representative of the manufacturer;

(2) A person licensed in accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer; or

(3) A prescriber practicing at a location that is licensed as a terminal distributor of dangerous drugs, unless exempt from licensure pursuant to section 4729.541 of the Revised Code.

(B) If a sample drug is transferred by a prescriber:

(1) A record must be created by the prescriber documenting the transfer. The record shall contain the:

(a) Name and address of the supplying prescriber;

(b) Name, strength, and quantity of the sample drug being transferred;

(c) Date of the sample drug transfer; and

(d) Name and address of the charitable pharmacy receiving the sample drug.

(2) A copy of all required records documenting the transfer of a sample drug shall be kept by the prescriber and the charitable pharmacy for a minimum of three years and shall be stored in a readily retrievable manner.

(3) The prescriber shall not transfer a sample drug to a charitable pharmacy unless the sample drug was received directly from a manufacturer, a manufacturer's representative, or by a person licensed in accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer.

(4) The sample drug complies with the requirements of rule 4729:5-7-04 of the Administrative Code.

(5) The sample drug must not have any physical signs of tampering.

(6) The sample drug packaging must not have any physical signs of tampering.

Supplemental Information

Authorized By: 3719.28, 4729.26, 3719.811
Amplifies: 3719.81, 3719.811, 3719.812, 3719.813
Five Year Review Date: 7/1/2024
Prior Effective Dates: 10/19/2007

Rule 4729:5-7-04 | Eligibility requirements for sample drugs received by a charitable pharmacy.

• Effective: July 1, 2019
• Promulgated Under: 119.03

An eligible sample drug received by a charitable pharmacy shall meet all the following requirements:

(A) The sample drug is in the original manufacturer's container and the container is clearly marked as a sample.

(B) Prior to being transferred, the sample drug has been stored under the proper conditions to prevent deterioration or adulteration.

(C) The sample drug is clearly marked with an expiration date and lot number.

(D) The sample drug is not expired.

(E) The sample drug is not a controlled substance.

Supplemental Information

Authorized By: 3719.28, 4729.26, 3719.811
Amplifies: 3719.81, 3719.811, 3719.812, 3719.813
Five Year Review Date: 7/1/2024
Prior Effective Dates: 1/1/2006

Rule 4729:5-7-05 | Dispensing a sample drug by a charitable pharmacy.

• Effective: July 1, 2019
• Promulgated Under: 119.03

(A) A pharmacist in a charitable pharmacy must have a valid prescription prior to dispensing a sample drug to a patient.

(B) The pharmacy shall comply with all requirements for the dispensing of drugs pursuant to Chapter 4729:5-5 of the Administrative Code.

(C) The charitable pharmacy shall determine the eligibility requirements for a patient to receive a sample drug.

(D) The sample drug shall be dispensed to the patient free of charge.

(E) The sample drug may be dispensed:

(1) In the manufacturer's original container where the container is clearly marked as a sample; or

(2) By removing the sample drug from the original container only if the prescription label on the appropriate container, pursuant to all state and federal requirements, clearly states that the drug dispensed is a sample drug.

Supplemental Information

Authorized By: 3719.28, 4729.26, 3719.811
Amplifies: 3719.81, 3719.811, 3719.812, 3719.813
Five Year Review Date: 7/1/2024