More than four years ago, the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) was signed into law. CARA, among other things, includes provisions allowing for the partial filling of prescriptions for Schedule II controlled substances. On December 4, 2020, the Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) implementing the partial fill provisions of CARA. While DEA does include additional provisions in the NPRM “to address certain regulatory requirements not addressed by the CARA[,]” the agency appears to have neglected to fully address circumstances when a prescription for a Schedule II is partially filled.
As you will recall, certain provisions in CARA allow for the partial filling of prescriptions for Schedule II controlled substances if all the following requirements were met:
- it is not prohibited by State law;
- the prescription is written and filled in accordance with [the Controlled Substances Act], regulations prescribed by [DEA], and State law;
- the partial fill is requested by the patient or the practitioner that wrote the prescription; and
- the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
In addition to including the statutorily required provisions in the NPRM, DEA also proposes to add requirements to ensure proper documentation of the partial fill on the prescription record – a reasonable requirement to maintain accountability of the drugs and to prevent over-dispensing.
Specifically, DEA proposes that when a partial fill is requested by a practitioner “the practitioner must specify the quantity to be dispensed in the partial filling on the face of the written prescription, in the written record of the emergency oral prescription, or in the electronic prescription record.” When the partial fill is requested by the patient, in addition to the information that a practitioner is required to include on a prescription, the pharmacist must indicate on the prescription “patient requested partial fill on [date such request was made]” and the quantity dispensed.
The scenario not contemplated by DEA in the NPRM is when a practitioner requests a partial fill after consultation with a pharmacist. In my experience, this is more common than a practitioner proactively writing partial fill instructions on a prescription in the first instance.
Will DEA require a new prescription in this scenario? Will DEA require the pharmacist to document the partial fill in the same manner when a patient requests the partial fill? My guess is the latter, but we cannot know for sure unless DEA specifically addresses this scenario.
One final takeaway. CARA is clear that the request for partial fill must come from the patient or the prescriber. Congress did not use the term “ultimate user” here (which includes the patient or a member of his/her household). Thus, DEA reminds us that CARA “did not authorize members of the patient’s household to request the partial filling of a prescription on behalf of the patient.”
Comments are due 60 days from publication in the Federal Register.