Make no mistake, pharmacies can still deliver controlled substances to patients

10/10/2024|5 minute read

Under the federal Controlled Substances Act (CSA) and the Drug Enforcement Administration's (DEA) implementing regulations, pharmacies must deliver controlled substances to the ultimate user. Common sense, as well as DEA's regulations, tells us that pharmacies act through their employees. Thus an employee of a DEA-registered pharmacy may deliver controlled substances to the ultimate users. Now that we've set the record straight, we will further deconstruct DEA's policy on actual transfer compared with constructive transfer, which is often a source of confusion.[1] For decades, the DEA's legal position on activities allowed or prohibited by the CSA regarding a pharmacy delivering a patient-specific controlled substance prescription to the patient's prescribing physician has been a source of confusion for practitioners. Many practitioners conflate "constructive transfer" with "delivery" and do not appreciate the nuances leading to potential legal trouble and patient access issues.

A full understanding requires an examination of several terms defined under the CSA:

• "The term 'dispense' means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery."[2]
• "The term 'dispenser' means a practitioner who so delivers a controlled substance to an ultimate user or research subject."[3]
• "The terms 'deliver' or 'delivery' mean the actual, constructive, or attempted transfer of a controlled substance or a listed chemical, whether or not there exists an agency relationship."[4]
• "The term '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."[5]
• The term "practitioner" means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis a controlled substance in the course of professional practice or research.[6]

Notably, pharmacies are typically registered with DEA as practitioners. In comparison, pharmacists are typically not considered "dispensers" or "practitioners" under the CSA. This distinction is critical, as many in the pharmacy industry view pharmacists as dispensers. Viewing pharmacists, instead of pharmacies, as dispensers is a critical oversight when examining DEA's enforcement of the CSA because pharmacies, not pharmacists, are DEA-registered practitioners.

"Delivery" is another term for which it is critical to examine the definition provided by the CSA. Delivery involves a transfer of controlled substances. Actual transfer is when a pharmacy (through its employees) transfers a controlled substance to an ultimate end user. Constructive transfer, on the other hand, appears to be the delivery of a controlled substance by someone other than the pharmacy.[7] For example, DEA counsel has argued that under CSA's constructive transfer language, "the patient or even the ultimate user does not have to be the person that actually picks up the prescription, but the transfer requires that the pharmacy identify who that patient is."[8]

With that said, under the CSA's current framework, pharmacies may utilize other employees, in addition to pharmacists, in parts of the dispensing process that involve delivery of a prescription, or order, to an ultimate user under the CSA. In other words, a pharmacy that offers home delivery could utilize other employees or contactors - such as a pharmacy clerk, technician, nurse, courier (such as FedEx or UPS) or delivery driver - to make the actual transfer of a controlled substance to the ultimate user.[9] In fact, DEA has regulations that expressly discuss requirements associated with shipping or delivering controlled substances through contract carriers and agents.[10]

While DEA's own regulations recognize that a pharmacy may utilize common carriers and employees for delivery, importantly, neither the CSA nor DEA regulations defines constructive transfer. Constructive transfer is often discussed in situations where a prescription is delivered to a practitioner's office. On one hand, DEA has taken a position that such deliveries (from a pharmacy to a patient's prescriber in response to a valid prescription) are prohibited by the CSA. On the other, DEA acknowledged in 2016 that its then-current view was that "neither the CSA nor DEA regulations specifically address [patient-specific prescription delivery to the patient's prescriber],"[11] and that "DEA would consider it permissible under the CSA and DEA regulations for the pharmacy to deliver the controlled substance to the practitioner"[12] subject to certain conditions. In 2018, DEA reiterated this position in a letter to Janssen Pharmaceuticals inquiring about its network of specialty pharmacies dispensing the Janssen product esketamine nasal spray (which requires administration under the supervision of a healthcare provider)[13] directly to prescribing practitioners. Again, DEA stated its then-current view that "neither the CSA nor DEA regulations specifically address [patient-specific prescription delivery to the patient's prescriber],"[14] but "DEA would consider it permissible under the CSA and DEA regulations for the pharmacy to deliver the controlled substance to the practitioner."[15]

However, it appears that DEA's view of constructive transfer has started to change. On December 12, 2023, according to the pharmacy's court filings, DEA ordered Bond Pharmacy Inc. dba AIS Healthcare to cease and desist any further shipments directly to the practitioner when a DEA inspection revealed that the pharmacy shipped patient-specific controlled substances directly to more than 4,000 practitioners.[16] DEA cited to 21 CFR § 1306.07, which limits delivery of controlled substances from pharmacies to prescribers when the controlled substance is to be administered for the purpose of opioid maintenance or detoxification treatment.[17] Whether this regulatory language governs delivery of controlled substances only for opioid maintenance or detoxification or limits controlled substance delivery to a patient's prescriber more broadly is not clear. However, a pharmacy may potentially avoid DEA scrutiny if it either 1) delivers to practitioners after a power of attorney was in place to authorize the constructive transfer or 2) performs the actual transfer of the controlled substances to the ultimate user through its own employees, thus delivering controlled substances to the ultimate user as required under the CSA.

Under DEA regulations such as 21 CFR 1301.74, DEA has made clear that its implementing regulations allow for "agents" and common carriers to ship or deliver controlled substances if certain requirements are met. In other words, pharmacies should take care to review their dispensing procedures to ensure their prescriptions are delivered to the ultimate user via their employees, agents or common carriers.

[1]Seehttps://www.thefdalawblog.com/2024/06/deas-expected-guidance-it-should-reduce-current-pain-at-the-intrathecal-pain-pump-dispensing-process-and-improve-therapeutic-outcomes/; see alsoBond Pharmacy v. Garland, U.S. District Court for the Southern District of Mississippi, Civil Action No. 3:23-cv-3158-CWR-LGI.

[2] 21 USC 802(10).

[3] Id.

[4] 21 USC 802(8).

[5] 21 USC 802(27).

[6] 21 USC 802(21).

[7]See Wedgewood Vill. Pharmacy v. D.E.A., 509 F.3d 541, 551 (D.C. Cir. 2007).

[8] Id., Recording of 9/10/07 Oral Argument at 30:50.

[9] 21 CFR § 1306.26 provides a framework for dispensing controlled substances that are not prescription drugs. DEA recognizes that pharmacists have unique professional and legal responsibilities but contemplates a function for nonpharmacist employees to include actual cash or credit transactions as well as delivery.

[10] DEA regulations discuss agency and common carriers. See 21 CFR 1301.74.

[11] 2016 letter from DEA to D. Linden Barber in response to "you[r] inquir[y] about a pharmacy delivering controlled substances to the prescribing practitioner, rather than directly to the patient…."

[12] Id.

[13] Spravato Prescribing Information, Dosage and Administration. Revised 10/2023. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf.

[14] 2018 letter from DEA to Janssen Pharmaceuticals wherein Janssen "requested DEA's permission for specialty pharmacies…to deliver patient-specific esketamine nasal spray directly to prescribing practitioners...."

[15] Id.

[16]Bond Pharmacy v. Garland, U.S. District Court for the Southern District of Mississippi, Civil Action No. 3:23-cv-3158-CWR-LGI, Exhibit B.

[17] Id.

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