PURPOSE: This rule sets requirements for individual practitioners who dispense controlled substances.

1. (1) An individual practitioner who dispenses controlled substances shall—

   1. (A) Provide direct supervision to employees or agents who assist in the administering or dispensing of controlled substances. Controlled substances shall not be dispensed from an individual practitioner’s inventory unless a practitioner is physically in the registered location except pursuant to the provisions of section (2) of this rule;
   2. (B) Package all controlled substances dispensed from an individual practitioner’s inventory in compliance with the Poison Prevention Packaging Act of 1970, 15 U.S.C. 1471–1476;
   3. (C) Permanently affix a label to the exterior of the drug container which includes: the date, the name and address of the dispensing practitioner, the name of the patient, directions for use, and the exact name and strength of the drug dispensed for all controlled substances dispensed;
   4. (D) Dispense only to individuals with whom the practitioner has established and documented a practitioner/patient relationship. An individual practitioner shall not dispense under the order of another practitioner not practicing at that location.

2. (2) Controlled substances may be administered or dispensed from an individual practitioner’s inventory by an authorized employee or agent when the practitioner is not present at the registered location when—

   1. (A) The administration or dispensing is authorized by the individual practitioner under a written agreement pursuant to an arrangement established and implemented in accordance with Missouri statutes;
   2. (B) The person who administers or dispenses the controlled substance is authorized by statute to administer or dispense controlled substances;
   3. (C) The person who administers or dispenses the controlled substance is registered with the Department of Health to administer or dispense controlled substances;
   4. (D) The person who administers or dispenses the controlled substance does so in compliance with all provisions of Chapter 195, RSMo and subsections (1)(B), (C) and
3. (D) of this rule. AUTHORITY: section 195.195, RSMo 1994.* Original rule filed April 14, 2000, effective Nov. 30, 2000. *Original authority: 195.195, RSMo 1957, amended 1971, 1989, 1993.