In February 2024, the Drug Enforcement Administration (DEA) issued crucial guidance answering a pertinent question: must practitioners receiving controlled medications from pharmacies be registered with the DEA at each location of receipt? This guidance, EO-DEA285, DEA-DC82, stemming from 21 U.S.C. 829a(a), carries significant implications for practitioners, pharmacies, and regulatory compliance.
Understanding the Guidance:
The DEA’s guidance provides a clear and unequivocal answer to the question posed: yes, practitioners receiving controlled medications from pharmacies must be registered with the DEA at every location where they receive such medications.
Key Points from the Guidance:
- Statutory Basis: The guidance references 21 U.S.C. 829a(a)(1), which mandates that controlled medications for maintenance or detoxification treatment of an opioid use disorder must be delivered to the location listed on the practitioner’s certificate of registration. This requirement underscores the importance of registration for the lawful receipt of controlled medications.
- Dispensing Requirements: Additionally, the guidance highlights the broader statutory framework governing the dispensing of controlled substances. Under 21 U.S.C. 822(e)(1) and 21 CFR 1301.12(a), practitioners are required to maintain separate registrations at each principal place of business or professional practice where they dispense controlled substances. Unless the practitioner is registered to that location, there is no authorization for the delivery of controlled medication there.
- Definition of Dispensing: The guidance clarifies that the term “dispense,” as defined in 21 U.S.C. 802(10), encompasses the delivery of controlled substances to ultimate users or research subjects by practitioners. This expansive definition underscores the regulatory imperative for practitioners to be registered at every location where such dispensing occurs.
Implications for Stakeholders:
The issuance of this guidance carries profound implications for various stakeholders within the healthcare and pharmaceutical sectors:
- Practitioners: Practitioners must ensure compliance with DEA registration requirements at each location where they receive controlled medications from pharmacies. Failure to register appropriately could jeopardize their ability to lawfully receive and dispense controlled substances, potentially impeding patient care and treatment, and subject them to criminal liability.
- Pharmacies: Pharmacies play a pivotal role in ensuring compliance with DEA regulations by verifying the registration status of practitioners prior to dispensing controlled medications. Collaboration between pharmacies and practitioners is essential to uphold regulatory compliance and patient safety.
- Regulatory Oversight: Regulatory authorities, including the DEA, are tasked with enforcing registration requirements and safeguarding against illicit diversion and misuse of controlled substances. The issuance of clear guidance enhances regulatory oversight and promotes accountability within the controlled substances ecosystem.
The DEA’s recent guidance on registration requirements for practitioners receiving controlled medications underscores the imperative of compliance with regulatory obligations under 21 U.S.C. 829a(a). If you are a practitioner of other stakeholder seeking information on this regulation or have concerns regarding compliance, GreenClark PLLC is here to help. Contact us for more information or a free consultation.
Disclaimer: This blog post is for informational purposes only and does not constitute legal advice. Each case is unique, and readers should consult a qualified attorney for advice regarding their specific situation.
