Key Takeaways
- DEA permits a DEA-registered pharmacy to deliver certain prescribed controlled substances to a practitioner for direct administration to the patient, provided the patient executes a power of attorney (POA), consistent with state law, designating the practitioner as the patient’s agent to accept delivery.
- The pathway is limited to controlled substances that must (pursuant to FDA requirements) or should (for quality control or other reasons) be delivered directly to the administering practitioner for administration in a healthcare setting and does not affect deliveries already authorized under 21 U.S.C. § 829a.
On Oct. 28, 2026, the Drug Enforcement Administration’s (DEA’s) Diversion Control Division added a new question and answer to its Administering and Dispensing Q&A addressing whether a DEA-registered pharmacy may deliver certain prescribed controlled substances to a practitioner for direct administration to the patient.[1] DEA answered yes, so long as the patient executes a power of attorney (POA) designating the administering practitioner as the patient’s agent for the limited purpose of accepting delivery from the dispensing pharmacy.
Notably, the guidance is “limited to those controlled substances that either must (pursuant to FDA requirements) or should (for quality control or other reasons) be delivered directly to the administering practitioner for administration in a healthcare setting.” It does not apply to two classes of controlled substances already authorized for such delivery under 21 U.S.C. §§ 829a(a)(2)(A) and (B).[2]
The guidance offers a practical and much-needed solution for products that, for safety or quality reasons, are often better kept within the clinical setting where they will be administered. Pharmacies, health systems, and specialty practices should take note of the new guidance and its conditions.
The POA Pathway and What This Means for Industry Participants
The guidance gives specialty pharmacies, health systems, infusion centers, and physician practices a welcome, DEA-sanctioned route to keep certain sensitive products within a controlled clinical setting. The pathway comes with conditions, however.
First, and as stated above, the POA pathway is “limited to controlled substances that either must (pursuant to FDA requirements) or should (for quality control or other reasons) be delivered directly to the administering practitioner for administration in a healthcare setting.” It does not apply to two classes of controlled substances already authorized for such delivery under 21 U.S.C. §§ 829a(a)(2)(A) and (B).
Next, the practitioner holds the medication on the patient’s behalf as the patient’s agent rather than as a registrant or as part of the practitioner’s own registered inventory. Because of this, the pathway requires key controls, including segregated storage, patient-level recordkeeping, and patient-specific tracking.
Once dispensed to a patient, a controlled substance has left the closed system of distribution under the Controlled Substances Act (CSA) and generally may not re-enter it. The practitioner therefore receives the medication as the patient’s agent, not as a DEA registrant, and may not take any action that the patient could not take or any action not specifically authorized in the POA. As these are patient-specific medications, the practitioner also may not place such medications, even those that become unwanted or waste, into the practitioner’s own registered inventory as office stock.
Finally, if the dispensed controlled substance subsequently becomes unwanted or waste, DEA has made clear that it cannot be returned to a DEA registrant. Instead, it must be disposed of by the ultimate user through an authorized mail-back package or collection receptacle consistent with applicable regulations.
Obligations for Prescribers and Administering Practitioners
DEA emphasized that a valid POA does not alter prescribers’ and pharmacies’ continuing responsibilities under applicable law. When a prescription will be delivered to an administering practitioner under a POA:
- The dose should be for a named patient only (not a take-home supply or office stock), and the practitioner should administer the dose only to the named patient;
- The practitioner should store the medication separately from the practitioner’s registered stock;
- The practitioner should maintain controls against theft and diversion; and
- The practitioner should consider keeping any POAs for at least two years after the last delivery or administration.
Obligations for Pharmacies
Further, pharmacies filling prescriptions under the POA option and delivering the medication to the practitioners must comply with all CSA and DEA dispensing requirements. In particular, pharmacies should:
- Record delivery to the practitioner, including the practitioner’s name and delivery address;
- Deliver only to the practitioner at the address in the POA;
- Verify both the POA and the prescription before dispensing; and
- Consider keeping any POAs for at least two years after the last delivery or administration.
Structuring a Compliant POA
DEA does not impose requirements on the content or structure of the POA, other than that the POA should comply with state law. The POA pathway is an additional option, and it does not change, limit, or add POA requirements for direct-to-end-user deliveries already authorized under 21 U.S.C. § 829a.
Because the guidance defers to state law on POA formalities, relevant entities should also review applicable state POA requirements before implementing a POA system. That review should inform how the POA itself is drafted: pharmacies and practitioners relying on a POA to support delivery of a prescribed controlled substance to an administering practitioner under the guidance should ensure the instrument is both narrowly tailored and compliant with those state requirements.
At a minimum, the POA should identify the patient and the designated administering practitioner, including the practice location or registered address. It should also limit the practitioner’s authority to accepting delivery of the patient’s medication from the dispensing pharmacy, along with any closely related logistical steps, since broader grants of authority may be read to permit the practitioner to take actions the patient could not lawfully take. Finally, consistent with the guidance’s deference to state law, the parties should observe all state-specific execution formalities, such as witnessing or notarization.
For questions about this alert, the new DEA guidance, or controlled substances compliance generally, contact the authors or a member of the firm’s Healthcare Compliance, Regulatory & Policy Practice Group, FDA & Life Sciences Practice Group, or Government Investigations & White Collar Litigation Practice Group.
[1] U.S. Drug Enf’t Admin., Diversion Control Div., Administering and Dispensing Q&A, EO-DEA315 (Oct. 14, 2026), https://www.deadiversion.usdoj.gov/faq/administering-faq.html. See also U.S. Drug Enf’t Admin., Diversion Control Div., EO-DEA315, DEA-DC-88, Delivery of a Prescribed Controlled Substance by a Drug Enforcement Administration (DEA)-Registered Pharmacy to a Practitioner for Direct Administration to the Patient Under Power of Attorney (POA) (Oct. 14, 2026), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-88)(EO-DEA315)_QA_Delivering_Dispensed_CSs_to_Administering_Pracitioner.pdf.
[2] Those include Schedule III, IV, or V drugs to be administered by injection or implantation for the purpose of maintenance or detoxification treatment or Schedule III–V medications that are subject to a risk evaluation and mitigation strategy (REMS) and require the patient to be subject to certain monitoring to ensure safe use (including post-administration monitoring).