Nonpharmacy Dispensing

PURPOSE: This rule provides information concerning the general responsibilities of a physician who elects to dispense medications from his/her office or clinic. (1) Physicians must provide patients the freedom of choice concerning the source of drugs and devices prescribed during the course of the physician/patient relationship. This means that no physician may require, as a condition of the physician/patient relationship, that the patient only receive drugs dispensed directly from the physician’s office. By the same token, a physician cannot require any patient to use the services of any particular pharmacy. (2) Physicians must provide appropriate supervision to personnel employed to assist in the dispensing of drugs and devices from the physician’s office. (A) When the dispensing personnel is either a licensed physician assistant acting within the scope of a supervision agreement or licensed nurse acting within the scope of a collaborative practice arrangement, the physician is not required to be present. (B) In all other instances, it shall be a violation of this rule for any physician to permit the dispensing of medication from his/her clinic or office when that physician is not present unless another physician duly licensed under the provisions of Chapter 334, RSMo, is present. (3) Physicians who elect to dispense medication must comply with the regulations governing the types of container that may be used to repackage prescription drugs as specified by federal law or rule unless the individual to whom the drug is dispensed gives written authorization for the container to be otherwise. (4) All drugs dispensed by a physician shall bear a label permanently affixed to the exterior of the drug container which sets forth the following information: (A) The date; (B) The patient’s name; (C) Complete directions for usage; (D) The physician’s name and address; and (E) The exact name and strength of the drug dispensed and, in the case of a generic drug, the name of the manufacturer or repackager of the drug. It shall be a violation of this rule for a physician to dispense a generic drug and affix to the label any trade name or other identification that would serve to misrepresent the source of the drug. (5) Physicians may dispense only to individuals with whom they have established a physician/patient relationship. It shall be a violation of this rule for a physician to dispense medication at the order of any other physician not registered to practice at that same location. (6) It is not the intention of this rule to interfere with any recognized system for physician education operated by any accredited medical school located within the borders of Missouri nor is it the intention of this rule to interfere with the individual physician’s appropriate use of professional samples nor is it the intention of this rule to interfere in any way with the physician’s right to directly administer drugs or medicines to any patient. (7) Whenever dispensing takes place, appropriate records shall be maintained. These records must be adequate to show the name of the patient, the name and strength of the drug dispensed, the quantity, the dose, etc. A separate log must be maintained for controlled substance dispensing. AUTHORITY: section 334.125, RSMo 2000.* This rule originally filed as 4 CSR 150-5.020. Original rule filed May 11, 1984, effective Sept. 14, 1984. Moved to 20 CSR 2150-5.020, effective Aug. 28, 2006. Amended: Filed Aug. 14, 2009, effective Jan. 30, 2010. *Original authority: 334.125, RSMo 1959, amended 1993, 1995.