Current through Register Vol. 49, No. 18, September 16, 2024
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.
*Original authority: 195.195, RSMo 1957, amended 1971,
1989, 1993.