PURPOSE: This rule provides effective controls for the prescribing, dispensing and administering of controlled substances to prevent diversion from lawful usage.

PUBLISHER’S NOTE: The publication of the full text of the material that the adopting agency has incorporated by reference in this rule would be unduly cumbersome or expensive. Therefore, the full text of that material will be made available to any interested person at both the Office of the Secretary of State and the office of the adopting agency, pursuant to section 536.031.4, RSMo. Such material will be provided at the cost established by state law.

1. (1) As used in this rule, the following terms shall have the meanings specified:

   1. (A) Home infusion pharmacy means a pharmacy which compounds solutions for direct administration to a patient in a private residence, long-term care facility or hospice setting by means of parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;
   2. (B) Long-term care facility means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients; and
   3. (C) Prescription means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. (For example, an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)
2. (2) When determining if controlled substances are being lawfully prescribed, dispensed and administered by practitioners, the Department of Health shall enforce Chapter 195, RSMo, the Department of Health rules in 19 CSR 30 pertaining to controlled substances, and the federal Controlled Substances Act 21 U.S.C. 801–966, and its regulations, 21 CFR 1300–1399. In determining lawful prescribing, dispensing and administering of controlled substances, the Department of Health also shall consider the provisions of Chapters 330, 332, 334, 336, 338 and 340, RSMo, the rules in 4 CSR 110, 4 CSR 150, 4 CSR 210, 4 CSR 220, 4 CSR 230 and 4 CSR 270, and protocols relating to the respective practitioners established and on file at the respective licensing boards.

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

   1. (A) Provide direct supervision to employees or agents who assist in the 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 when a registered professional nurse is dispensing under a collaborative practice agreement;
   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; and
   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.

4. (4) Controlled substances may be administered to a hospital emergency room patient under a verbal order of a registered practitioner who is not physically present if—

   1. (A) The order is for a legitimate medical purpose and the practitioner who orders the administration of a controlled substance is acting in the usual course of his/her medical practice, after sufficient examination and establishment of a practitioner/patient relationship;
   2. (B) The practitioner who orders the administration of a controlled substance is a medical staff member of the hospital;
   3. (C) The administration of a controlled substance is documented in a formal medical record for the patient;
   4. (D) The patient is assessed in the hospital by a practitioner, when available, or a registered nurse. If the patient is not assessed by a practitioner in the hospital, a registered nurse shall assess the patient and confirm and document in the patient’s medical record the existence of a preestablished practitioner/patient relationship with the practitioner who ordered administration of a controlled substance; and
   5. (E) The order is written in the patient’s medical record and within seventy-two (72) hours, is authenticated by the ordering practitioner.
5. (5) A pharmacist may dispense directly a controlled substance in Schedule III, IV or V only under a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or his/her authorized agent or under an oral prescription made by an individual practitioner whether communicated by the practictioner or his/her authorized agent a prescription transmitted by electronic computer transmission by the authorizing practitioner or the practitioner’s agent to the pharmacy. All oral prescriptions and prescriptions transmitted by electronic computer transmission shall be promptly reduced to writing by the pharmacist containing all information required in section 195.060, RSMo, except for the signature of the practitioner.

6. (6) A pharmacist may dispense a controlled substance in Schedule II only under a written prescription signed by the practitioner, except as provided in section 195.060.3, RSMo. A prescription for a Schedule II controlled substance may be transmitted from the prescribing practitioner to a pharmacy by facsimile equipment or electronic computer transmission, provided the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except that—

   1. (A) A prescription written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner’s agent to the home infusion pharmacy by facsimile. The facsimile shall serve as and shall be maintained in the same manner as an original written prescription.
   2. (B) A prescription written for a Schedule II substance for a resident of a long-term care facility may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile. The facsimile shall serve as and shall be maintained in the same manner as an original written prescription.
7. (7) All written controlled substance prescriptions shall be signed by the prescribing practitioner on the date prescribed. No controlled substance prescription shall be signed prior to the actual date it is issued.

AUTHORITY: sections 195.040.3(2), 195.050.6 and 195.195, RSMo 1994.* Original rule filed Nov. 14, 1988, effective Feb. 24, 1989. Amended: Filed Aug. 26, 1992, effective April 8, 1993. Amended: Filed Nov. 1, 1994, effective June 30, 1995. *Original authority: 195.040.3(2), RSMo 1939, amended 1971, 1978, 1987, 1989, 1994; 195.050.6, RSMo 1939, amended 1971, 1989; and 195.195, RSMo 1957, amended 1971, 1989, 1993.