A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills

President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016.  CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).  With the amendment by CARA, the CSA allows for partial dispensing of schedule II prescriptions if not prohibited by state law, is requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed.  21 U.S.C. § 829(f)(1).

Over a year later in a December 22, 2017, Congress in a bipartisan letter noting that “[l]arge amounts of unused medications are a key contributor” to the nationwide opioid crisis and that between 67% and 92% of surgery patients “reported they had unused opioids remaining after the procedures,” urged the Drug Enforcement Administration (“DEA”) to quickly update its regulations on the partial filling of schedule II prescriptions.  Letter from Congress of the United States, to Robert Patterson, Acting Administrator, DEA (Dec. 21, 2017).  Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020.  Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. Reg. 78,282 (Dec. 4, 2020).

Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances.  Partial Filling of Prescriptions for Schedule II Controlled Substances, 88 Fed. Reg. 46,983 (July 21, 2023).

Partial Filling of Schedule II Prescriptions Historically

Pharmacists generally have been able to partially fill prescriptions for most schedule III-V controlled substances and non-controlled substances but have been permitted to partially fill prescriptions for II substances only in very limited circumstances.  Pharmacists could partially fill a schedule II prescription if the pharmacy is unable to supply the full quantity of a written or emergency oral prescription.  21 C.F.R. § 1306.13(a).  In addition, a pharmacist could partially fill a schedule II prescription issued to patients in a Long Term Care Facility or who have a terminal medical illness diagnosis.  21 C.F.R. § 1306.13(b).

The Final Rule

a.  General Requirements

DEA’s final rule allows the partial filling of a prescription for a schedule II substance at the request of either the prescribing practitioner or a patient.  Consistent with CARA, a pharmacist may partially fill a prescription for a schedule II controlled substance if:

(1) Not prohibited by state law;

(2) The prescription is written and filled in accordance with the CSA, DEA regulations, and state law;

(3) Partial filling is requested by the patient, by a person acting on behalf of the patient (a caregiver of an adult patient authorized in a medical power of attorney or a parent or legal guardian of a minor patient), or by the practitioner who wrote the prescription; and

(4) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.  Id. at 47,001-02 (codified at 21 C.F.R. § 1306.13(b)(1)).

b.  Time Limits

If all of these conditions are met, remaining portions of a partially filled schedule II prescription, if filled, must be filled not later than 30 days after the date the prescription is written.  However, the remaining portions of a partially filled emergency oral prescription for a schedule II controlled substance, if filled, must be filled not later than 72 hours after the prescription is issued.  Id. at 47,002 (codified at 21 C.F.R. § 1306.13(b)(2)).

c.  Practitioner’s Partial Fill Request

A practitioner issuing a schedule II prescription who wants it to be partially filled must specify the quantity to be dispensed in each partial filling on the face of a written prescription, in the written record of an emergency oral prescription, or in the record of an electronic prescription.  After consulting with a pharmacist, a practitioner may also authorize a partial fill after the date the prescription was initially issued but the prescription cannot be filled later than 30 days after it was written.  The pharmacist must note the subsequent request.  All required information, except authorization for partial filling at a later date, must be included on the prescription with all other required elements at the time the practitioner signs the prescription.  For an emergency oral prescription, the prescribing practitioner must communicate the information to the pharmacist during the oral communication.  Id. (codified at 21 C.F.R. § 1306.13(b)(3)).

d.  Patient Request

A patient may also request that their prescription for a schedule II substance be partially filled.  A caregiver named in an adult patient’s medical power of attorney or a parent/legal guardian of a patient who is a minor under age 18, may also request that a prescription be partially filled.  If a practitioner has requested partial filling of a prescription, neither the patient nor one acting on behalf of a patient may request partial filling in an amount greater than what has been requested by the practitioner.  A request by or on behalf of a patient may be made in person; in writing if signed by the patient, caregiver, or parent/legal guardian; or by a phone call to the pharmacist from the patient, caregiver, or the parent/legal guardian.  Id. (codified at 21 C.F.R. § 1306.13(b)(4)).

e.  Recording Required Information

(1)  At the Request of a Prescriber

The pharmacist, upon partially filling a prescription at the request of the prescribing practitioner when the prescriber issued the prescription, must note the quantity dispensed on the face of the written prescription or in the pharmacy’s electronic records, in the written record or the pharmacy’s electronic records of the emergency oral prescription, or in the record of the electronic prescription.  When the pharmacist partially fills a prescription, after the prescriber has conveyed the request during consultation with a pharmacist, the pharmacist must note: “Authorized by Practitioner to Partial Fill,” practitioner’s name, discussion date and time, with the pharmacist’s initials.

In addition, for each partial filling whether requested by the prescriber on the prescription or during consultation with the pharmacist, the pharmacy must maintain a dispensing record of each dispensing date, name or initials of the individual dispensing, controlled substance name and dosage form, date filled, and quantity dispensed.  For electronic prescriptions, the quantity dispensed, date dispensed, and the dispenser must be linked to each electronic prescription record.  Id. (codified at 21 C.F.R. § 1306.13(b)(5)(i)).

(2)  Record at the Request of a Patient

For partially filling a prescription at the request of a patient or by a caregiver or parent/legal guardian, the pharmacist must note on the face of the written prescription or in the pharmacy’s electronic records, in the written record or the pharmacy’s electronic records of the emergency oral prescription, or in the record of the electronic prescription: “The [patient, parent or legal guardian of a minor patient, or caregiver of an adult patient named in a medical power of attorney] requested partial fill on [date such request was made]” and the quantity dispensed.

In addition, for each partial filling, the pharmacy must maintain a record that includes the date of each dispensing, the name or initials of the individual who dispensed the substance, controlled substance name and dosage form and date filled.  For electronic prescriptions, the quantity dispensed, date dispensed, and the dispenser must be linked to each electronic prescription record.  Id. (codified at 21 C.F.R. § 1306.13(b)(5)(ii)).

Effective Date

The final rule is effective on August 21, 2023, over seven years after CARA became law, five and a half years after the congressional letter urging DEA to quickly update its regulations and more than two and a half years after the proposed rule.