Mo. Code Regs. tit. 19 § 30-1.064

Current through Register Vol. 49, No. 17, September 3, 2024
Section 19 CSR 30-1.064 - Partial Filling of Controlled Substance Prescriptions

PURPOSE: This amendment updates Missouri's partial filling of controlled substances prescriptions regulation to be consistent with federal law and recently promulgated federal regulations regarding the partial filling of controlled substances listed in Schedule II.

PURPOSE: This rule sets requirements for the partial filling of controlled substance prescriptions.

(1) The partial filling of a controlled substance listed in Schedule II is permitted as provided in this rule and federal regulations.
(A) Insufficient supply on hand. The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription, and s/he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription), or in the electronic record. The remaining portion of the prescription may be filled within seventy-two (72) hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the seventy-two- (72-) hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond seventy-two (72) hours without a new prescription.
(B) Long-term care or terminally ill patient. A prescription for a Schedule II controlled substance written for a patient in a long-term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of Chapter 195, RSMo. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed sixty (60) days from the issue date unless sooner terminated by the discontinuance of medication.
(C) Patient or prescriber request. For a patient who is not terminally ill or a patient in a long-term care facility, the partial filling of a prescription for a controlled substance listed in Schedule II may occur at the request of a patient or it may be directed by the prescriber in the manner established by applicable federal regulations. The dispensing of a partial filling under this subsection shall not occur beyond thirty (30) days from the date of the issuance of the prescription.
(2) The partial filling of a prescription for controlled substances listed in Schedules II, III, IV, or V is permissible, provided that-
(A) Each partial dispensing is recorded in the same manner as a refilling would be;
(B) With each partial dispensing, the pharmacy must document the date and quantity dispensed on the original prescription record or their electronic computer applications, provided that the electronic system meets all of the federal requirements for handling of electronic prescriptions for controlled substances, including the ability to retrieve the information pertaining to partially filled controlled substances;
(C) The total quantity dispensed in all partial fillings cannot exceed the total quantity prescribed;
(D) No dispensing occurs-
1. For controlled substances listed in Schedule II written for a patient in a long term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness, sixty (60) days after the date on which the original prescription was issued;
2. For a partial filling of a prescription of a controlled substance listed in Schedule II at the request of a prescribing practitioner or patient, thirty (30) days after which the original prescription was issued;
3. For emergency oral prescriptions for controlled substances listed in Schedule II, seventy-two (72) hours after which the original emergency oral prescription was issued; and
4. For controlled substances listed in Schedules III and IV, six (6) months after the date on which the original prescription was issued;
(E) A partial dispensing is not considered a "refill" if the patient does not receive the full authorized amount at one time; and
(F) The prescription was written and filled in accordance with all other applicable laws and regulations.

19 CSR 30-1.064

AUTHORITY: section 195.195, RSMo 1994.* Original rule filed April 14, 2000, effective Nov. 30, 2000.
Amended by Missouri Register June 15, 2015/Volume 40, Number 12, effective 7/31/2015
Amended by Missouri Register February 15, 2019/Volume 44, Number 4, effective 4/1/2019
Amended by Missouri Register March 15, 2021/Volume 46, Number 06, effective 4/30/2021
Amended by Missouri Register July 15, 2024/volume 49, Number 14, effective 8/31/2024.

*Original authority: 195.195, RSMo 1957, amended 1971, 1989, 1993.