3719.811 Sample drug furnished to or by charitable pharmacy - exceptions.

(A) As used in this section:

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

(a) Holds a terminal distributor of dangerous drugs license under section 4729.54 of the Revised Code.

(b) Is exempt from federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) .

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

(2) "Prescription" has the same meaning as in section 4729.01 of the Revised Code.

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

(B) A manufacturer of dangerous drugs or wholesale distributor of dangerous drugs may furnish a sample drug to a charitable pharmacy if all of the following apply:

(1) The sample drug is in the original container in which it was placed by its manufacturer and the container is plainly marked as a sample.

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

(3) If the sample drug is of a type that deteriorates with time, the container in which the sample drug is stored is plainly marked with the date beyond which the sample drug is unsafe to use, and the date has not expired on the sample drug furnished. Compliance with the labeling requirements of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C. 301 , as amended, constitutes compliance with division (B)(3) of this section.

(4) The sample drug is distributed, stored, or discarded in such a way that the sample drug may not be acquired or used by any unauthorized person, or by any person, including a child, for whom it may present a health or safety hazard.

(5) The sample drug is furnished free of charge.

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

(C) A representative of a manufacturer of dangerous drugs or a licensed health professional authorized to prescribe drugs may furnish a sample drug to a charitable pharmacy if all of the following apply:

(1) The state board of pharmacy has adopted rules under division (F) of this section to permit such a representative or health professional to furnish a sample drug to a charitable pharmacy.

(2) The representative or health professional complies with standards and procedures established in rules adopted under division (F) of this section.

(3) The requirements in divisions (B)(1) to (6) of this section are satisfied.

(D) A pharmacist working, whether or not for compensation, in a charitable pharmacy may dispense a sample drug to a person if all of the following apply:

(1) The person to whom the sample drug is dispensed is eligible for the sample drug under standards established by the body responsible for the charitable pharmacy's general management.

(2) The person to whom the sample is dispensed presents to the pharmacist a valid prescription for the sample drug.

(3) The sample drug is dispensed free of charge.

(4) The requirements in divisions (B)(1) to (4) and (6) of this section are satisfied.

(E) Divisions (B), (C), and (D) of this section do not do either of the following:

(1) Apply to or restrict the furnishing of any sample of a nonnarcotic substance if the substance may, under the "Federal Food, Drug, and Cosmetic Act" and under the law of this state, otherwise be lawfully sold over the counter without a prescription.

(2) Authorize a pharmacist working, whether or not for compensation, in a charitable pharmacy to dispense a sample drug that the charitable pharmacy is unauthorized to possess, have custody or control of, or distribute.

(F) The state board of pharmacy shall, in accordance with Chapter 119. of the Revised Code, adopt rules as necessary to give effect to this section. The rules may permit representatives of manufacturers of dangerous drugs or licensed health professionals authorized to prescribe drugs to furnish sample drugs to charitable pharmacies under this section. If they do so, the rules shall establish standards and procedures for the representatives or health professionals to furnish the sample drugs.

Effective Date: 04-15-2005