Chapter 4729-36 Charitable Pharmacy

4729-36-01 Definitions.

As used in Chapter 4729-36 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) ; 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) "Manufacturer" means the drug company that manufactures a sample drug.

(D) "Pharmacist" has the same meaning as in rule 4729-5-01 of the Administrative Code.

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

(F) "Terminal Distributor" has the same meaning as in section 4729.01 of the Revised Code.

(G) "Wholesale Distributor" has the same meaning as in section 4729.01 of the Revised Code.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
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: 1/1/06

4729-36-02 Licensure of a charitable pharmacy.

A pharmacy that desires to be a charitable pharmacy shall maintain a terminal distributor of dangerous drug license. An application for licensure must include the following:

(A) A completed application designating the desire to become a charitable pharmacy;

(B) Documents to support the exemption from federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) ; and

(C) The fee for the appropriate category of licensure.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
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: 1/1/06

4729-36-03 Requirements of a charitable pharmacy.

A charitable pharmacy is considered to be a pharmacy pursuant to section 4729.01 of the Revised Code and must follow all federal and state laws, rules, and regulations that pertain to pharmacies and the practice of pharmacy, including, but not limited to, the following:

(A) Minimum standards for a pharmacy pursuant to rule 4729-9-02 of the Administrative Code;

(B) Security requirements pursuant to 4729-9-05 of the Administrative Code;

(C) Security and control of the sample drugs pursuant to rule 4729-9-11 of the Administrative Code;

(D) Record keeping pursuant to rules 4729-5-27 and 4729-9-22 of the Administrative Code;

(E) Serial numbering of prescriptions pursuant to rule 4729-5-19 of the Administrative Code;

(F) Prescription filing pursuant to rule 4729-5-09 of the Administrative Code;

(G) Confidentiality of patient records pursuant to 4729-5-29 of the Administrative Code;

(H) Labeling pursuant to 4729-5-16 of the Administrative Code;

(I) Patient profiles pursuant to rule 4729-5-18 of the Administrative Code;

(J) Prospective drug utilization review pursuant to 4729-5-20 of the Administrative Code;

(K) Patient counseling pursuant to rule 4729-5-22 of the Administrative Code;

(L) Reporting of theft or loss of dangerous drugs pursuant to 4729-9-15 of the Administrative Code; and

(M) Storage of adulterated drugs pursuant to rule 4729-9-17 of the Administrative Code.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
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: 1/1/06

4729-36-04 Sample drug distribution to a charitable pharmacy.

(A) An eligible sample drug shall only be distributed directly to a charitable pharmacy by a:

(1) Manufacturer;

(2) Manufacturer's representative;

(3) Wholesale distributor of dangerous drugs acting on behalf of a manufacturer; or

(4) Prescriber practicing in a location that is licensed as a terminal distributor of dangerous drugs unless exempt from licensure pursuant to sections 4729.51 and 4729.541 of the Revised Code.

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

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

(a) Name and address of the supplying prescriber;

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

(c) Date of the sample drug transfer;

(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 must be kept by the prescriber and the charitable pharmacy for a minimum of three years and 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 wholesaler acting on behalf of a manufacturer and meets the eligibility requirements pursuant to rule 4729-36-05 of the Administrative Code.

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

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

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
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: 1/1/06, 10/19/07

4729-36-05 Eligibility requirements for sample drugs received by a charitable pharmacy.

(A) The sample drug is in the original container in which it was placed by its manufacturer and the container is clearly marked sample;

(B) Prior to being furnished, the sample drug has been stored under the proper conditions to prevent deterioration or contamination;

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

(D) The sample drug is not expired; and

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

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
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: 1/1/06

4729-36-06 Dispensing a sample drug by a charitable pharmacy.

(A) A pharmacist in a charitable pharmacy must have a valid prescription prior to dispensing a sample drug to a patient pursuant to rules 4729-5-21 and 4729-5-30 of the Administrative Code.

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

(C) The sample drug is dispensed to the patient free of charge.

(D) The sample drug may be dispensed:

(1) In the original container in which it was placed by its manufacturer where the container is clearly marked as sample; or

(2) By removing the sample drug from the original container only if the prescription label on the appropriate container, pursuant to rule 4729-9-02 of the Administrative Code, clearly states that the drug dispensed is a sample drug.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
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: 1/1/06