Controlled Prescribing and Dispensing Criterias

What must a controlled prescription include?

• Patient full name and address

• Prescriber full name, business address, and DEA number

• Drug name, strength, dosage form, and quantity prescribed

• Number of refills authorized

What credentials are permitted for DEA-sanctioned validation?

• Something you know (Password)

• Something you have (Hard token)

• Something you are (Biometric)

What items can not be changed on a controlled substance prescription?

• Patient name

• Prescribed Drug (Except for generic substitution)

• Prescriber signature

When can a faxed prescription serve as the original copy for a CII?

• A drug compounded for administration for a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal route

• The prescription is for a resident at a long-term care facility

• The prescription is for a patient enrolled in a hospice program

What circumstances can a CII prescription be partially filled and how long do patients have to fill the remaining balance?

• The pharmacy does not have sufficient stock of the drug

  • Within 72 hours after first partial fill

• Requested by the patient or the prescriber

  • Within 30 days after the issue date

• Terminally ill patients or LTCF residents

  • Within 60 days after the issue date

What must be documented for each partial fill for LTCF or terminally ill patients?

• Date of partial fill

• Amount dispensed

• Amount remaining

• Name of Dispensing Pharmacists

What electronic records must be kept for partial fills for LTCF or terminally ill patients?

• Original prescription number

• Date of issue

• Drug name, dose, form, strength, and quantity

• Quantity authorized

• Patient name

• Prescriber name

• Address of LTCF, hospital or patient’s home

• List of partial refills

What is the criteria to dispense an Emergency fill of CII medication?

• Dispense minimum necessary amount

• Prescriber must provide the original prescription within 7 days of

• Pharmacist must attach the written prescription to the emergency oral prescription

• Pharmacist must report breach to local DEA office if original prescription is not received in 7 days