DEA Clarifies Direct Delivery of Prescribed Controlled Substances to Practitioners

On October 28th, DEA issued the guidance we anticipated and discussed over two years ago in our June 2024 blog post. The guidance explains when a DEA-registered pharmacy may deliver a prescribed controlled substance directly to a practitioner for administration to a patient, so long as the patient has executed a power of attorney (POA) permitting the practitioner to accept delivery of the substance on the patient’s behalf.

Importantly, this pathway is not limited to intrathecal pain pump medications or a particular class or schedule of controlled substances. It applies to prescribed controlled substances that must, pursuant to FDA requirements, or should, for quality-control or other reasons, be delivered directly to an administering practitioner for administration in a healthcare setting. Although still somewhat self-limiting, the guidance therefore has implications beyond the pain-treatment context highlighted in our earlier post.

The Patient’s Agent, Not Office Stock

DEA explains that, per 21 U.S.C. § 802(27), a pharmacy generally must dispense controlled substances directly to the “ultimate user,” meaning the patient or a member of the patient’s household. Under the guidance’s “new” pathway, a patient may execute a state-law-compliant POA designating the administering practitioner as the patient’s agent for the limited purpose of accepting delivery of the controlled substance from the dispensing pharmacy.

That distinction matters. The practitioner receives the medication as the patient’s agent, not as a DEA registrant. The practitioner cannot take actions beyond those authorized by the POA or actions the patient could not legally take. Medications must remain separate from controlled substances held under the practitioner’s DEA registration and may be administered only to the patient named on the prescription. Prescriptions subject to the POA should cover a dose for direct administration, not a take-home supply or office stock.

Practical Considerations

Pharmacies should verify the existence and validity of the POA before delivering the medication to the practitioner for administration to the patient. Delivery must be made to the address specified in the patient’s POA, and pharmacies must maintain records identifying the receiving practitioner and delivery address.

DEA recommends that pharmacies and practitioners consider retaining a copy of the POA for at least two years after the last delivery or administration of the controlled substance, or longer if applicable state law requires a longer retention period. Existing handling, prescribing, dispensing, security, and state-law obligations remain in place.

Disposal of controlled substances delivered to practitioners’ offices pursuant to a POA also requires attention. Dispensed medications generally cannot re-enter the closed distribution system. DEA states that unwanted medication or waste must be disposed of by the ultimate user through a mail-back package or collection receptacle. We assume this means that the ultimate user must take “leftovers” with him or her after in-office administration, or the office needs to provide mailers or have a collection receptacle on site.

Lastly, the guidance does not alter existing statutory delivery pathways for certain schedule III–V treatments and qualifying REMS medications. It is nonbinding and optional, but provides an additional delivery option for eligible prescriptions. Many DEA registrants will welcome this clarification and its potential to facilitate safer delivery of medications and more practical patient care.