Recent DEA Rule Change – Partial Fills for Schedule II Controlled Substances

The DEA recently updated the rule regarding partial fills of Schedule II (C-II) prescriptions. Pursuant to the Comprehensive Addiction and Recovery Act (CARA) of 2016, pharmacies are allowed to partial fill any C-II (e.g., stimulants, opioids, etc.) at the request of the prescriber, or the patient, as long as all the following criteria are met:

  1. Partial filling is not prohibited by State law.
  2. The prescription is written and filled in accordance with the Controlled Substance Act.
  3. The cumulative quantity dispensed from all partial fills does not exceed the total quantity prescribed.
  4. If the remaining portion of the partial C-II is filled, it must be filled no later than 30 calendar days after the written date of the prescription; except if the prescription was an emergency oral prescription, then the remaining portion must be filled no later than 72 hours after it was issued and if it cannot be completed, the pharmacy must notify the prescribing practitioner (see Long Term Care Facility (LTCF)/terminally ill exception in PAAS Tips below).

The change to 21 CFR 1306.13 (effective August 21, 2023) addresses regulatory requirements not previously addressed in CARA, such as how the prescribing practitioner should indicate the C-II should be partially filled, and how the pharmacist should record the partial fillings.

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Prescriber Requested

The DEA rule clarifies that a prescriber “must specify the quantity to be dispensed in each partial filling on the face of the written prescription, in the written record of the emergency oral prescription, or in the record for an electronic prescription”. Additionally, a pharmacist may contact the prescriber after receiving a prescription without a partial fill annotation if the pharmacist believes a partial fill is appropriate, but they do not wish to seek approval from the patient. If the prescriber authorizes the partial fill, the pharmacist must note the following: “Authorized by Practitioner to Partial Fill,” the name of the practitioner, the date and time of the discussion, and the pharmacist’s initials.

Patient Requested

The rule also clarifies that the patient, a parent or legal guardian of a minor (under age 18), or an adult patient’s medical power of attorney may request a partial fill. Their request to partial fill may be received via phone or by sending a signed written note to the pharmacy with a family member. “DEA does not interpret the CARA to allow any ‘assumption’ for a justification of a more limited dispensing than originally requested,” therefore, if a partial fill is desired, the request must be made for each C-II prescription. For partial fills, the pharmacist must record “(1) “The [patient, parent or legal guardian of a minor patient, or caregiver of an adult patient named in a medical power of attorney, whichever is applicable] requested partial fill on [date such request was made],” and (2) the quantity dispensed.

When partial filling C-II prescriptions pursuant to CARA, the DEA clarified that the pharmacist must record the following elements:

  • Quantity Dispensed: On the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription -OR- the recordkeeping for a written prescription or an emergency oral prescription can be maintained in the pharmacy’s electronic recordkeeping system
    • Caution: if the partial fill is not pursuant to the prescriber or patient’s request, but instead pursuant to the pharmacy’s inability to supply the full amount, an LTCF patient, or a terminally ill patient, then documentation must occur on the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription
  • ALL Partial Fills: The pharmacy must have a record withthe date of each dispensing, the name or initials of the individual who dispensed the substance, and all other information required by 21 CFR 1306.22(c) for schedule III and IV prescriptionssuch as:
    • drug name
    • dosage form
    • date filled/refilled
    • quantity dispensed
    • initials of dispensing pharmacist for each refill
    • total number of refills for that prescription
    • Note: For an electronic prescription, the quantity dispensed, date dispensed, and the dispenser must be linked to the electronic prescription

PAAS Tips:

  • Download, print and reference the new PAAS Tool the Partial Fill Chart for C-II Controlled Substances to guide you through the different types of partial fills, the documentation requirements and the timeline for how long you have to dispense the remaining quantity on the prescription
  • Document all requests! If the prescribing practitioner requests a partial fill of a C-II, but the patient requests a smaller amount to be partial filled, the patient’s request to partial fill must be documented in addition to the prescriber’s request
  • A patient may not request a partial fill which is larger than the partial fill quantity authorized by the prescriber
  • If a partial fill is requested by the prescriber or the patient, but the pharmacy must dispense a smaller amount due to availability of stock, the pharmacy’s need to partial fill the quantity must also be documented
  • Remember the varying length of time the remaining portion is available on a partially filled prescription:
    • Partial fill due to limited quantity: If the prescription was partial filled due to the pharmacy being unable to supply the full quantity, then the remaining balance must be dispensed within 72 hours or the remaining balance is void
    • Long Term Care Facility (LTCF) patient or a terminally ill/hospice patient: If the prescription has “LTCF” or “terminally ill”, respectively, documented then the remaining portion is valid for 60 days from the written date of the prescription
    • CARA: If the partial fill was pursuant to CARA, the remaining portion must be filled within 30 days of the written date of the prescription (Be aware of laddered C-II prescriptions, as the subsequent prescriptions issued by the practitioner may fall outside the scope of CARA if they do not fall within the 30-day window of when the prescription was originally issued)
  • Do not partial fill simply to bypass plan limits; for example, OxyContin® 40 mg tablets, 1 tablet by mouth TID; #90
    • #90 should be billed for a 30 days’ supply
    • If the plan rejects the claim stating only two tablets are allowed per day, the pharmacy should not partial fill #60 for a 30 days’ supply to circumvent the rejection
    • Instead, the pharmacy should follow up with the prescriber for a prior authorization or a change in therapy
  • Follow all applicable State requirements for controlled substances (e.g., defacing C-II, alphanumeric quantities, etc.)

Sara Hathaway, PharmD