4730-2-09 Standards for personally furnishing samples of drugs and therapeutic devices.

(A) The following general provisions apply for purposes of this rule:

(1) The term "certificate to prescribe" includes the provisional certificate to prescribe and the full certificate to prescribe issued by the board pursuant to section 4730.44 of the Revised Code.

(2) The physician assistant may personally furnish a sample of a drug or therapeutic device only in accordance with this rule and any other applicable state or federal laws or rules relative to personally furnishing drugs and therapeutic devices, including, but not limited to, rules adopted by the Ohio board of pharmacy.

(B) A physician assistant who holds a certificate to prescribe and who has been granted physician-delegated prescriptive authority by a supervising physician may personally furnish to a patient a sample of drugs and therapeutic devices included within the physician-delegated prescriptive authority, in accordance with all of the following conditions:

(1) The physician assistant shall personally furnish the samples in accordance with the requirements of section 3719.81 of the Revised Code;

(2) The physician assistant shall not personally furnish samples of controlled substances or any drug or device used to perform or induce an abortion;

(3) The samples are of drugs and devices included among the drugs and devices set forth in the formulary established in rule 4730-2-06 of the Administrative Code;

(4) The samples are of drugs and devices included among the drugs and devices for which the supervising physician has granted prescriptive authority to the physician assistant;

(5) The amount of the sample furnished shall not exceed a seventy-two hour supply, except when the minimum available quantity of the sample is packaged in an amount that is greater than a seventy-two hour supply, in which case the physician assistant must furnish the sample in the packaged amount;

(6) The physician assistant shall not sell, impose a charge, or accept a fee for the sample or for furnishing it;

(7) Where the directions for use by a particular patient are different from the directions on or in the sample container, the physician assistant shall provide, in written format, the following:

(a) The name of the prescribing physician assistant and the name of the physician under whose supervision the physician assistant is authorized to write the prescription;

(b) The name of the patient; and

(c) Directions for use of the drug or therapeutic device.

(8) The physician assistant shall maintain a written record of all samples of drugs and devices personally furnished by the physician assistant.

R.C. 119.032 review dates: 03/19/2014 and 03/19/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.43
Prior Effective Dates: 10/31/2007