Elizabeth Whalley Buono, a Director at Hancock, Daniel & Johnson, P.C. (Hancock Daniel), has been serving as an expert panel member at a series of FDA public workshops regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of opioids.[1] Based on the work done by this and several other FDA working groups, as well as on input from other key federal and state agencies, the Congressional Health Committee recently passed The Opioid Crisis Response Act of 2018.[2] This bipartisan legislation provides a comprehensive blueprint for tackling the opioid crisis to be implemented by the National Institutes of Health, the Food and Drug Administration, the Substance Abuse and Mental Health Services Administration, the Center for Disease Control, the Drug Enforcement Agency, and individual state agencies. Given the gravity of the crisis itself, pundits are optimistic that this bill will be passed by both the House and Senate in identical form and then be signed by the President to become law.

The legislation includes forty different proposals designed to focus resources most effectively on critical challenges, many of which will directly impact health systems, pharmacies, hospitals and providers. As the bill progresses, Hancock Daniel will be sending ongoing updates on potential opportunities and compliance implications of the law to you, our clients. Please find below a list of provisions most likely to have a direct bearing on your day-to-day operations.


Substance Abuse and Mental Health Services Administration:

  • Cures Grant Changes – Focuses federal funds on geographic areas hit hardest by the opioid crisis. Allows Health and Human Services (HHS) to fund states with the highest age-adjusted mortality rate associated with opioid use disorders.
  • Comprehensive Opioid Recovery Centers – Authorizes a grant program for entities to establish or operate comprehensive opioid recovery centers to serve areas hit hardest by the opioid crisis.
  • Opioid Prescription Limits – Requires the Secretary of HHS to issue a report on federal and state laws regulating the length, quantity, or dosage of opioid prescriptions.
  • First Responder Training – Expands a grant program from the Comprehensive Addiction and Recovery Act designed to allow first responders to administer a drug or device, like naloxone, to treat an opioid overdose.
  • Youth Prevention and Recovery Initiative – Requires the Secretary of HHS, in consultation with the Department of Education, to disseminate best practices and issue grants for prevention of and recovery from substance use disorder in children, adolescents, and young adults.
  • Coordination and Continuation of Care for Drug Overdose Patients – Requires the Secretary of HHS to identify best practices and establish a grant program for the provision of care, overdose reversal medication, and follow up services to an individual after an overdose.
  • Alternatives to Opioids – Requires the Secretary of HHS to provide technical assistance to hospitals and other acute care settings seeking to manage pain without using opioids related to the use of alternatives to opioids.

Centers for Disease Control and Prevention:

  • Grants and Other Support – Advancing a broad array of state and federal efforts to collect data on

Drug Enforcement Administration (DEA):

  • Telemedicine – Clarifies DEA’s ability to develop a regulation to allow qualified providers to prescribe controlled substances in limited circumstances via telemedicine.
  • Disposal of Controlled Substances by Hospice Care Providers – Gives certain employees of qualified hospice programs the legal authority to dispose of controlled substances after a patient’s death.
  • Medication-Assisted Treatment (MAT) – Codifies the ability for qualified physicians to prescribe MAT for up to 275 patients.
  • Delivery of Controlled Substances by a Pharmacy to an Administering Practitioner – Permits implantable or injectable buprenorphine products, and intrathecal pumps, to be delivered by a pharmacy to an administering provider.


  • Jessie’s Law – Requires HHS to develop best practices for prominently displaying a history of substance abuse information in each patient’s electronic health record (when requested by the patient).
  • Confidentiality of Substance Use Disorder Records – Identifies model training programs on how to protect and appropriately disclose confidential substance use disorder medical records for health care providers, patients, and their families.
  • Supporting State Prescription Drug Monitoring Programs (PDMP) –Streamlines federal requirements for PDMPs so doctors and pharmacies can know if patients have a history of substance use.
  • Access to Behavioral and Mental Health Services in Schools – Permits mental and behavioral health providers participating in the National Health Services Corps to provide services in schools and other community-based settings.
  • Substance Use Provider Workforce in Shortage Areas – Provides loan repayment to substance use disorder treatment providers, including masters level, licensed substance use disorder counselors, for practicing in substance use disorder treatment facilities and other health care settings in underserved areas through the National Health Service Corps.
  • Education and Training for Providers – Updates and improves resources for pain care providers to assess, diagnose, prevent, treat, and manage acute or chronic pain, as well as to detect the early warning signs of opioid use disorders. This provision also updates mental and behavioral health training programs to include trauma-informed care.

If you have any questions about the bill or its provisions, please contact a member of Hancock Daniel’s Life Sciences team.


The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C. is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.



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