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Seven years ago, President Barack Obama signed into the law the Comprehensive Addiction and Recovery Act (CARA) of 2016 (88 Fed. Reg. 46983). One of the important restrictions on prescribing and dispensing of Schedule II (CII) controlled substances included in this law was that no refills are permitted.

In August 2023, the DEA finalized regulations for partial fills under CARA, which provided long sought clarification for pharmacists, health care providers and politicians. The clarification now allows for three different situations when pharmacists could dispense partial fills of CII medications. Each of these situations is described further below.

1. Partial Fills for 30 days under CARA 2016
2. 72-Hour Partial Fill when Pharmacy is Unable to Supply
3. 60-Day LTCF or Terminally Ill Patients

Each of these situations is described further below.

Partial Fills for 30 Days Under CARA 2016

CARA 2016 included comprehensive strategies to address the opioid epidemic, with one strategy amending the federal Controlled Substances Act (CSA) to allow pharmacies to dispense partial fills of a CII medication up to 30 days from the date of the prescription. For pharmacists to partially fill a CII prescription under CARA, it must be requested by the patient or the pre­scriber, and the total quantity dispensed in all par­tial fills cannot exceed the total quantity prescribed.

The DEA regulations add requirements for documentation of the partial fill on the prescription record, and pharmacists should carefully review DEA rules for compliance with the various scenarios under CARA (21 CFR§ 1306.13(b)). In general, when a par­tial fill is requested by a prescriber at the time the prescription is ordered, he or she must specify the quantity to be dispensed in the partial filling on the face of the written prescription, in the record of the electronic prescription, or in the written record of the emergency oral prescription. When a partial fill is requested by the patient, the pharmacist must indicate on the prescription that the patient requested partial fill, the date the request was made, and the quantity dispensed. The prescriber may also request a partial fill after an oral consultation with a pharmacist, after the prescription was issued. In these instances, the pharmacist must properly document the subsequent partial fill request and all the required information on the prescription.

The DEA has also clarified that the patient request does not have to be made in person. For example, a patient could make the request verbally over the phone to the pharmacist, or send a signed note to the pharmacy with a family member. The DEA has also stated it will authorize as a valid patient request one from the parent or legal guardian for minor children or the caregiver named in the medical power of attorney for an adult patient.

Keep in mind, if state law prohibits or places stricter limits on partial fills, the pharmacist must follow state law. Partial fills of CII controlled substances may also be provided under CARA when a pharmacist receives a verbal prescription in an emergency sit­uation. However, the remainder of the prescription must be provided to the patient within 72 hours in these situations. After 72 hours, no further dispensing of the emergency prescription is allowed.

72-Hour Partial Fill When Pharmacy is Unable to Supply

In the DEA Pharmacist’s Manual: An Outline of the Controlled Substances Act published in 2022, the DEA stated “DEA views CARA’s partial fill excep­tion to be in addition to the exceptions currently listed under 21 CFR 1306.13.” Therefore, the long-standing DEA rule (21 CFR 1306.13(a)) allowing for the partial filling of a schedule II-controlled substance when a pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription is still permitted.

Under this cir­cumstance, the pharmacist is required to note the quantity supplied on the face of the prescription, in the electronic prescription record, or in the written record of the oral emergency prescription. Further­more, the pharmacist may fill the remaining portion of the prescription within 72 hours of the first par­tial filling. If the pharmacist is unable to supply the remaining quantity within 72 hours, the pharmacist must notify the prescriber and no further quantity is to be supplied beyond 72 hours without a new prescription.

In practice, there has been confusion over whether the patient had to obtain the remain­ing balance within 72 hours. The DEA clarified this concern in the 2022 Pharmacist’s Manual, stating, “[I]t is the position of DEA that the pharmacy must have the balance of the prescription ready for dis­pensing prior to the 72-hour limit, but the patient is not required to pick up the balance of the prescrip­tion within that 72-hour limit.”

Historically, “unable to supply” under the DEA rule meant the pharmacy did not have enough of the medication in stock to supply at the time of dispens­ing. Subsequently, however, the DEA decided that other situations would also be appropriate, including when the drug was in stock, but the pharmacy was waiting for verification of the legitimacy of the pre­scription and when the patient could not afford to pay for the entire amount.

60-Day Long Term Care Facility (LTCF) or Terminally Ill Patients

The last situation where a pharmacist may par­tially fill CII controlled substances is for patients in LTCFs or for patients with a medical diagnosis documenting a terminal illness. For these patients, schedule II prescriptions may be partially filled to allow for the dispensing of individual dosage units but for no longer than 60 days from the date of issuance (21 C.F.R. § 1306.13(c)). The total quan­tity of drug dispensed in all partial fillings must not exceed the quantity prescribed. If there is any ques­tion regarding whether a patient may be classified as having a terminal illness, the pharmacist must con­tact the prescriber before partially filling the prescrip­tion.

Both the pharmacist and the prescriber have a corresponding responsibility to ensure 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” is deemed to have been filled in violation of the CSA.

For each partial filling, the pharmacist must record:

• The date,
• The quantity dispensed,
• The remaining quantity authorized to be dispensed,
• The identification of the dispensing pharmacist.

This record may be kept on the back of the prescrip­tion or on any other appropriate record, including a computerized system. If a computerized system is used, it must have the capability to permit the following:

• Output of the original prescription number,
• Date of issue,
• Identification of the prescribing individual practitioner, the patient, the LTCF (if applicable), and the medication authorized, including the dosage form strength and quantity and a listing of partial fillings that have been dis­pensed under each prescription,
• Immediate (real-time) updating of the prescrip­tion record each time that the prescription is partially filled.

About the Author:

Kimberly A. Burns, RPh, JD is a Professor at the Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy, located in Erie, PA. She received her B.S. in Pharmacy from the University of Pittsburgh School of Pharmacy (cum laude) and her Juris Doctor degree from Duquesne University Law School (cum laude). She is both a licensed pharmacist and attorney in Pennsylvania. Kim has been a professor at the LECOM School of Pharmacy since 2002. Her teaching responsibilities include Pharmacy Law and Ethics and an elective advanced practice rotation site at the Erie County Department of Health, where she primarily contributes to local prescription drug abuse efforts. In addition to her academic career, she practiced community pharmacy for over 15 years and has consulted on various legal cases regarding pharmacy law issues. She has also written a number of papers and commentaries, and has made presentations at the local, state, and national level on a variety of pharmacy law topics. Professor Burns has been active in several state and national pharmacy organizations, including the American Society of Pharmacy Law where she served as board member and president. Professor Burns has also been recognized with various awards for her leadership and contributions to community service, research, and teaching.