7.4 Emergency Schedule II Prescriptions & Partial Filling Rules (CARA Act)

Schedule II controlled substances are subject to the strictest statutory dispensing controls under federal law. As a general rule, Schedule II prescriptions require a written or compliant electronic prescription prior to dispensing and cannot contain refills. However, federal regulations establish narrow statutory exceptions for Emergency Oral Schedule II Prescriptions (21 CFR § 1306.11(d)) and specific frameworks for Partial Filling of Schedule II Prescriptions (21 CFR § 1306.13). Mastery of these specific timeframes, reporting duties, and partial fill rules is heavily tested on the MPJE.

Emergency Oral Schedule II Prescriptions: 21 CFR § 1306.11(d)

In an emergency situation, a pharmacist may dispense a Schedule II controlled substance upon receiving oral authorization from a prescribing individual practitioner, provided specific regulatory criteria are satisfied.

1. Definition of an Emergency Situation

Under federal law, an emergency situation exists ONLY if the prescribing practitioner determines that:

• Immediate administration of the Schedule II substance is necessary for proper treatment of the intended ultimate user.
• No appropriate alternative treatment is available (including non-controlled drugs or Schedule III–V medications).
• It is not reasonably possible for the prescribing practitioner to provide a written prescription or compliant EPCS order to the pharmacist prior to dispensing.

2. Statutory Emergency Requirements & Quantity Limits

• Quantity Restriction: The quantity prescribed and dispensed MUST be limited to the amount adequate to treat the patient during the emergency period ONLY. Prescribing a 30-day supply under emergency oral provisions is illegal if the emergency period is only 3 days.
• Immediate Transcription: The oral order must be immediately reduced to writing by the pharmacist and must contain all required 1306.05 prescription details except the practitioner's signature.
• Prescriber Verification: The pharmacist must make a good-faith effort to verify the prescriber's identity and authority if the prescriber is unknown to the pharmacist.

3. The 7-Day Cover Prescription & Mandatory DEA Reporting

Within 7 days after authorizing an emergency oral Schedule II prescription, the prescribing practitioner MUST deliver or postmark a written or EPCS cover prescription to the dispensing pharmacist.

• Annotation Requirement: The face of the cover prescription MUST bear the statement: 'Authorization for Emergency Dispensing' and the exact date of the oral order.
• Attachment: Upon receipt, the pharmacist attaches this written cover prescription to the oral order previously transcribed.
• MANDATORY DEA NOTIFICATION: If the prescribing practitioner fails to deliver or postmark a compliant cover prescription within the 7-day window, the pharmacist HAS A MANDATORY LEGAL DUTY to notify the local DEA Diversion Field Office. Failure of the pharmacist to report the prescriber voids the legal authority to dispense without a written prescription and exposes the pharmacist to federal enforcement action.

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Schedule II Partial Filling Frameworks: 21 CFR § 1306.13

Partial filling of Schedule II prescriptions is governed by three distinct regulatory pathways under federal law. Conflating these timeframes is one of the most common errors on the MPJE.

Framework 1: Insufficient Stock (21 CFR § 1306.13(a))

• Trigger: The pharmacy is unable to supply the full quantity prescribed due to inventory shortages.
• Rule: The pharmacist may dispense a partial quantity. The remaining balance MUST be filled within 72 hours of the first partial dispensing.
• Forfeiture Penalty: If the remaining balance is not supplied within 72 hours, the remaining quantity is forfeited. The pharmacist must notify the prescribing practitioner, and no further quantity can be dispensed without a brand new prescription.

Framework 2: Patient or Prescriber Request under the CARA Act of 2016 (21 CFR § 1306.13(b))

• Trigger: The Comprehensive Addiction and Recovery Act (CARA) permits partial fills of Schedule II prescriptions at the request of the patient or the prescribing practitioner to reduce excess opioid supply in households.
• Timeframe Limit: Partial fills may be requested and dispensed for up to 30 days from the date the prescription was ISSUED (written date).
• Important Distinction: The 30-day clock starts on the date of issuance, NOT the date of the first partial fill.
• Quantity Cap: The total quantity dispensed across all partial fills cannot exceed the total quantity prescribed.

Framework 3: Terminally Ill & Long-Term Care Facility (LTCF) Patients (21 CFR § 1306.13(c))

• Trigger: Schedule II prescriptions written for patients in a Long-Term Care Facility (LTCF) or patients certified as terminally ill.
• Timeframe Limit: Partial fills are permitted for up to 60 days from the date of issuance.
• Documentation Requirements: The pharmacist MUST record on the prescription whether the patient is 'terminally ill' or an 'LTCF patient'. For each partial fill, the dispensing record must log: date of partial fill, quantity dispensed, remaining authorized quantity, and identification of the dispensing pharmacist.

Comprehensive Schedule II Dispensing & Partial Fill Comparison

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Partial Filling of Schedules III, IV, and V: 21 CFR § 1306.23

Partial filling of Schedule III, IV, and V prescriptions is fully permissible under federal regulations, provided:

1. Each partial fill is recorded in the same manner as a refill.
2. The total quantity dispensed in all partial fills does not exceed the total quantity prescribed.
3. No dispensing occurs beyond 6 months from the date of issuance for Schedule III and IV medications.