Major Legislative Update: Congress Has Fixed the Persistent Pharmacy-to-Clinic Delivery Confusion for DEA-Regulated REMS Drugs.

By: Hunter DeKoninck (with credit to Scott Brinks)

In August 2025, I authored a post highlighting the persisting confusion pharmacies were experiencing with DEA's regulation of pharmacies’ delivery of patient-specific controlled substances to physicians’ offices in instances where in-office administration was either medically necessary or required by the FDA under a REMS program (e.g. Spravato® was the REMS drug most commonly caught in the crosshairs of this issue). In that post, I provided a detailed history the issue and its origins in the 2018 SUPPORT Act, so please re-read that post for a refresher.

Since publishing that post, Congress has acted (in a rather subtle way) to permanently resolve the issue by amending § 829a of the CSA to expand the delivery allowance to include REMS drugs.

...Yes, you heard me correctly: the U.S. Congress demonstrated it is still capable of working together to fix important issues facing the nation! The legislation passed in the Senate with unanimous consent and it passed the House with significant bipartisanship: 366 yeas to 57 nays. Let's be encouraged by this!

On December 1, 2025, President Trump signed into law the "SUPPORT for Patients and Communities Reauthorization Act of 2025" (the "2025 SUPPORT Act") which amended § 829a of the CSA to expand the types of patient-specific controlled substances a pharmacy may deliver to a practitioner for administration to a patient. Historically, following the 2018 SUPPORT Act, pharmacies were only expressly authorized to deliver to practitioners patient-specific Schedule III-V MOUD medication that were to be administered by injection or implantation. Under the 2025 SUPPORT Act, § 829a now expressly permits pharmacies to also deliver controlled substances that are subject to a REMS program, which includes Spravato®.

Now, 21 U.S.C § 829a(2) states (red font is new language added by the 2025 SUPPORT Act):

“[A] pharmacy may deliver a controlled substance to a practitioner … for the purpose of administering the controlled substance by the practitioner if...(2) the controlled substance is a drug in schedule III, IV, or V to be administered:

(A) by injection or implantation for the purpose of maintenance or detoxification treatment; or

(B) subject to a risk evaluation and mitigation strategy pursuant to section 355–1 of this title that includes elements to assure safe use of the drug described in subsection (f)(3)(E) of such section, including a requirement for post-administration monitoring by a health care provider..."

To emphasize, Congress only extended the delivery allowance to include Schedule III-V controlled substances (not Schedule II drugs) that are subject to a REMS program. Thus, going forward, pharmacies may only deliver patient-specific drugs that are: (1) injectable or implantable Schedule III-V drugs intended to treat OUD and (2) Schedule III-V drugs subject to a REMS program that require in-office administration to ensure safe use.

If you are a pharmacy or a practitioner and you have legal questions and compliance needs regarding the 2025 SUPPORT Act and how to comply with it, please contact me.