Waiting for DEA's Next Move: Pharmacy-to-Clinic Deliveries of Patient-Specific Controlled Substances.

Confusion persists on how DEA intends to regulate and enforce pharmacies’ delivery of patient-specific medication to physicians’ offices in instances where in-office administration is either medically necessary or required by the FDA. Since it first began noticeably challenging the industry’s limited practice of pharmacy-to-clinic deliveries in mid-2019, DEA has failed to provide clarity on how it intends to regulate the delivery model or guidance on what it requires of those using the model. Rather than partnering with the industry to identify a practical solution, DEA has only teased its own wildly unpopular ideas for how to address the issue (e.g. a proposal to require patients to execute POAs with physicians in order to formally authorize the physician to accept deliveries on the patient’s behalf) but it still has not identified a solution that both adequately protects patients’ health and is operationally realistic for registrants. In the meantime, the industry sits in limbo as DEA’s field offices continue to adopt conflicting views on the legality of the delivery model and how to regulate it.

To clarify, DEA’s fundamental concern with pharmacy-to-clinic deliveries existed long before its 2019 uptick in scrutiny. Indeed, DEA has historically held a conviction that the Controlled Substances Act’s (“CSA”) definition of “dispense” impliedly restricts a pharmacy from physically delivering patient-specific controlled substances to anyone other than the patient or a member of his household, regardless of the circumstances. See 21 U.S.C. § 802(10) (“’dispense’ means to deliver a controlled substance to an ultimate user”); 21 U.S.C. § 802(27) (“’ultimate user’ means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of  a member of his household or for an animal owned by him or by a member of his household.”) Under this narrow interpretation of the two definitions, DEA has maintained that the CSA generally restricts pharmacies from delivering patient-specific controlled substances to clinics for the specific purpose of administering the medication to the patient. Thus, where in-office administration is necessary, DEA has expected that either (1) the physician administer medication dispensed from the clinic’s own general inventory or (2) the patient be physically present at the clinic to take possession of medication from the dispensing pharmacy at the time of delivery.

However, notwithstanding its concern with the two definitions, DEA historically understood and agreed that certain instances require use of the pharmacy-to-clinic delivery model and, to account for such instances, DEA came to believe there is adequate room within the CSA for registrants to use the delivery model in a limited capacity.  As a result, DEA issued letter guidance authorizing the practice for designated drugs when used in certain specific situations. One of those letters was issued to Janssen regarding its REMS drug, Spravato®.

Spravato® is a FDA-approved esketamine nasal spray intended for adults with treatment-resistant depression. The FDA subjected Spravato® to a strict REMS program that requires the drug only be administered in a healthcare setting in the presence of a practitioner. The REMS program expressly prohibits the drug from being delivered directly to the patient anywhere outside of that context. In 2018, DEA issued letter guidance to Janssen in which it approved the pharmacy-to-clinic delivery model for Spravato®, while also adding certain boundaries around the practice.

Soon after issuing the Janssen letter, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“the SUPPORT Act”). Among other things, the SUPPORT Act amended the CSA and added a provision expressly permitting the pharmacy-to-clinic delivery model when treating opioid use disorder (“OUD”). See 21 U.S.C. § 829(a)(2) (“a pharmacy may deliver a controlled substance to a practitioner…for the purpose of administering the controlled substance by the practitioner”). The new provision specifically authorized the delivery of injectable and implantable narcotics intended to treat OUD. Id. (pharmacies’ deliveries are permitted for “a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation”).

The SUPPORT Act’s amendment to the CSA was silent on pharmacies’ ability to use the delivery model for any other controlled substances outside of the OUD context. DEA convinced itself that, because it only addressed pharmacy-to-clinic deliveries for OUD-related treatment, Congress must have specifically intended to forbid the practice in all other contexts, including cases involving Spravato® and other drugs for which in-office administration is necessary. However, no such intent is reflected in the congressional record when the SUPPORT Act was being considered. Instead, Congress was strictly focused only on matters related to patients suffering from OUD while expressing no intent to affect non-OUD dispensing practices.

Nevertheless, convinced that Congress intended to restrict the delivery model to MOUD, DEA rescinded the Spravato® letter under Executive Order 13891, as well as any other letters like it. Since then, DEA has provided no coordination or communication with the industry regarding the implications for patients’ health, providers’ ethical obligations, supply chain challenges and REMS program requirements. Instead, registrants have each had to decide for themselves how to proceed, creating frustration and confusion among healthcare partners. Further compounding the confusion has been DEA’s inconsistent and unreliable handling of the issue across its field divisions and its diversion investigators.

Through it all, registrants have always assumed DEA would inevitably provide much needed guidance to bring clarity to the issue. But, at this point, it is appearing more and more likely that no such guidance is coming. DEA has had both ample time and opportunity to issue guidance, so the fact that it has declined to do so thus far may suggest DEA has already decided the best course of action is to remain silent and take no action. If that is true, I suspect it is because DEA simply cannot resolve for itself the unique tension between DEA’s strict interpretation of the SUPPORT Act and its recognition that there remains a legitimate need for pharmacy-to-clinic deliveries in certain instances. To the extent DEA found it could not reconcile these conflicting views in a way that would protect patients, then perhaps inaction really is the best course of action.

If you need any assistance regarding these challenges with dispensing, please contact me.