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On July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) of 2016 became law. One section of the CARA amended the Controlled Substances Act to allow a pharmacist, if certain conditions are met, to partially fill a prescription for a schedule II controlled substance when requested by the prescribing practitioner or the patient. The Drug Enforcement Administration is proposing to amend its regulations to implement this statutory change.

Statement of Need:

This rule is needed to implement the partial fill provisions of the CARA. The CARA amended the CSA to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions. Specifically, the CARA amended 21 U.S.C. 829 by adding new subsection (f), which allows a pharmacist to partially fill a prescription for a schedule II controlled substance where requested by the prescribing practitioner or the patient. However, the CARA does not state how the prescribing practitioner should indicate that a prescription for a schedule II controlled substance be partially filled, nor how a pharmacist should record the partial filling of such a prescription. This rule proposes prescribing and recordkeeping requirements to provide clear direction to practitioners and patients.

The changes in this rule are also important in helping address the ongoing opioid epidemic, by allowing practitioners and patients to limit the amount of schedule II opioids left unused after a course of treatment.

Summary of the Legal Basis:

While the CARA laid out the framework for partial filling of prescriptions for schedule II controlled substances, there were a number of issues left unresolved. Congress granted the DEA authority to fill in any gaps in the regulatory scheme not addressed by the statute itself; the CARA provides that partial filling of schedule II prescriptions is permitted if the prescription is written and filled in accordance with, among other things, regulations issued by DEA.

Additionally, under 21 U.S.C. 871(b), the Attorney General may promulgate and enforce any rules, regulations, and procedures deemed necessary for the efficient execution of the Attorney General’s functions, including general enforcement of the CSA. Consistent with 21 U.S.C. 871(a), the Attorney General has delegated that authority to the DEA.

Alternatives:

This rule would only amend the DEA’s regulations to the extent necessary to fully implement the partial fill provisions of the CARA, and would be in addition to the existing regulations of 21 CFR 1306.13. Consistent with 21 U.S.C. 829(f)(3), any circumstances allowing a lawful partial fill prior to the implementation of the statute would still be allowed under the new rules.

The proposed rule will include provisions aimed at giving patients and practitioners a simple and low-cost way to request and record partial fills that also ensures accountability and prevents diversion of controlled substances. The DEA will request comment on the proposed rule and will consider all alternatives. Special consideration will be given to flexible approaches that reduce burdens and maintain freedom of choice for the public.

Some of the provisions in this proposed rule merely restate the general requirements of the CARA for partial filling of prescriptions for schedule II controlled substances. Since these provisions are mandated by Congress, the DEA is obligated to incorporate them into its regulations, and has no discretion to consider alternatives.

Anticipated Costs and Benefits:

In order to ensure accountability and maintain the closed system of distribution, the proposed rule will likely impose certain costs on DEA registrants. Current projections indicate the primary cost would be the additional time needed to be spent by pharmacies to fill the remaining portions of partially filled prescriptions. Whereas before the CARA, a pharmacy would fill all of a schedule II prescription during a single visit by a patient, if the practitioner or the patient requests a partial fill, the pharmacy will only fill part of the prescription on the patient’s first visit, and will need to fill the remainder of the prescription if the patient returns for a second visit. The DEA currently estimates the total cost of the proposed rule to be approximately $12 million annually.

The provisions of this rule may also require prescribers to take additional time writing prescriptions, since they would need to include partial fill instructions on the prescriptions, and pharmacists to take additional time tracking the status of partially filled prescriptions, in order to ensure that the proper amount of medication is dispensed if a patient returns to fill the remainder of a prescription, but the DEA believes this additional time required would be minimal, and that the cost of such additional time would be minimal.

There is also the potential for benefits to patients and society as a result of this proposed rule. Patients could request a partial fill of a prescription if they are unlikely to use the full amount, and save money by not paying for pills they would not use. Furthermore, reducing the quantity of leftover schedule II controlled substances would reduce the risk of diversion and the risk of improper disposal and associated environmental impact. This is an enabling rule because it allows for partial fills of prescriptions for schedule II controlled substances, which was previously prohibited.

Risks:

If the DEA did not promulgate this rule, patients and practitioners would face uncertainty in complying with the requirements for partial fills of prescriptions for schedule II controlled substances. While the statute does directly address many aspects of the partial fill process, there are a number of details left out, which must be supplied by regulation. Without such clarifying regulations, few practitioners would take advantage of the partial fill provisions for fear of violating federal law, thus frustrating the original purposes of the CARA.