Introduction to the SUPPORT Act
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) was initially signed into law in 2018. It implemented so many things with regard to the nation’s healthcare, regulatory, and public health systems. Changes were made to Medicaid, Medicare, FDA regulations, Public Health programs, and DEA regulations.
SUPPORT Act provisions that affected the DEA included changing manufacturing quotas, requiring the DEA to consider public health data on overdose deaths and abuse, and mandating the expansion of telemedicine services, which required the DEA to create a special registration for telemedicine providers. (See our blog related to telemedicine for additional information.) It also changed the way pharmacies dispense certain medications to treat opioid use disorder (OUD).
The SUPPORT Act and dispensing controlled substances
The one change implemented with good intentions created some issues for DEA practitioners, pharmacies, and patients alike. The SUPPORT Act amended the Controlled Substances Act at 21 U.S.C. 829a(a), (and the implementing regulation found at 21 CFR 1306.07(f)), allowing pharmacies to dispense and deliver a controlled substance prescription used to treat OUD to the patient’s practitioner for administration to the patient.
Usually, a practitioner issues a prescription; the patient goes to a pharmacy to pick up their prescription medication, and a pharmacist dispenses the drug directly to the ultimate user (i.e., patient) or a member of their household. This is outlined at 21 U.S.C. 802(10).
The SUPPORT Act acknowledged that some medications used to treat OUD must be administered by injection or implantation. These are the types of drugs that a patient could not and should not self-administer. In fact, the FDA added a REMS requirement to the product information, prohibiting direct dispensing to a patient. Adding an exception of sorts that allows the delivery to the prescribing practitioner’s registered location or the administering practitioner’s registered location was a benefit for a patient who needed a medication to treat OUD, implanted or injected.
This change is beneficial to the practitioner. It allows them to administer a patient-specific prescription rather than requiring them to purchase and maintain stock, which could be costly. Practitioners were initially allowed to store the medication on behalf of the patient for up to 7 days. This timeframe was changed to 45 days.
Major Issues with the Statute
This statute is helpful, but prohibitive. The FDA has many other types of REMS drugs that require administration by a practitioner, as a patient could not and should not self-administer. Examples of these types of drugs include a ketamine nasal spray and Intrathecal pain pumps. These drugs are not prescribed to treat OUD and are excluded from the Act. Once prohibited, the DEA is not allowed to make an exception for pharmacies to deliver these REMS drugs to practitioners for administering to patients in need.
Another issue is the disposal of the drugs. Practitioners are not included in the list of registrants authorized to collect controlled substances from end-users. 21 CFR 1317.40(a). A practitioner in possession of a patient’s medication has no way to dispose of that medication should the patient not show up for their appointment and have the drug administered to them.
Action Needed
The SUPPORT Act was recently renewed, allowing funding for substance use disorder and mental health services to continue through fiscal year 2030. This is a good thing. I am hoping for additional changes.
Congress should consider amending 21 U.S.C. 829a(a) Delivery of a controlled substance by a pharmacy to an administering practitioner, to include other controlled substances that have a REMS requirement or require a practitioner to administer to the patient for patient safety. If I were drafting an amendment, I would change part 2 to include schedule II controlled substances, include additional medical conditions besides maintenance and detoxification treatment, and consider adding a disposal method for practitioners in possession of a patient’s prescription medication if the patient does not receive it.
Need Help?
If you need any advice on the CSA and its implementing regulations, email me at sarah.boblenz@sbrinksconsulting.com. I would be happy to help you.
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Disclaimer: Brinks DEA Consulting and its employees are not attorneys and do not provide legal advice. The guidance offered is based solely on their extensive experience in DEA compliance and investigations. If you need help finding a specialized attorney in DEA regulations, reach out to us—we’re happy to assist.