2013 Maryland Code
HEALTH OCCUPATIONS
§ 12-6C-09 - Distribution of prescription drugs; returns or exchanges.

(a) Returns or exchanges. --

(1) A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse according to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or pharmacy warehouse.

(2) Returns of expired, damaged, recalled, or otherwise nonsaleable prescription drugs shall be distributed by the receiving wholesale distributor only to either the original manufacturer or a third party returns processor.

(3) Returns or exchanges of prescription drugs, saleable or otherwise, including any redistribution by a receiving wholesaler, are not subject to the pedigree requirements of § 12-6C-10 of this subtitle if they are exempt from the pedigree requirement of the U.S. Food and Drug Administration's currently applicable Prescription Drug Marketing Act guidelines.

(4) Wholesale distributors and pharmacies shall be accountable for:

(i) Administering their returns process; and

(ii) Ensuring that the returns process is secure and does not permit the entry of adulterated and counterfeit product.

(b) Wholesale distributor to supply prescription drugs only to authorized persons. -- A wholesale distributor may supply prescription drugs only to a person authorized by law to dispense or receive prescription drugs.

(c) Delivery. --

(1) Except as provided in paragraph (2) of this subsection, a wholesale distributor may deliver prescription drugs only to:

(i) The premises listed on the recipient's license or permit; or

(ii) An authorized person or an agent of an authorized person at the premises of the wholesale distributor if:

1. The identity and authorization of the person or agent is properly established; and

2. This method of delivery is employed only to meet the immediate needs of a particular patient of the authorized person.

(2) (i) Prescription drugs may be supplied to a hospital pharmacy receiving area if a pharmacist or authorized receiving personnel of the hospital pharmacy signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received.

(ii) Any discrepancy between the type and quantity of the prescription drug indicated on the receipt and the type and quantity of the prescription drug received:

1. Shall be reported to the delivering wholesale distributor by the next business day after the delivery to the hospital pharmacy receiving area; and

2. May be reported to the Board for investigation.

(d) Payment. --

(1) A wholesale distributor may not accept payment or allow the use of a person's credit to establish an account for the purchase of prescription drugs from any person other than the owner of record, the chief executive officer, or the chief financial officer listed on the license or permit of a person legally authorized to receive prescription drugs.

(2) Any account established for the purchase of prescription drugs shall bear the name of the license or permit holder.

(e) Operating out of residence prohibited. -- A wholesale distributor may not operate out of a residence.