Latest News

Prepared by: Simone Armour and James McGovern, Esq.

Overview

Congress is advancing H.R. 27, the HALT Fentanyl Act, to permanently classify fentanyl-related substances (FRS) as Schedule I drugs under the Controlled Substances Act. This marks a major shift in federal drug policy, with significant compliance and enforcement implications for licensees handling controlled substances.

Regulatory Compliance and Enforcement

The DEA will implement stricter regulations, increasing compliance requirements for businesses, researchers, and healthcare providers. Licensees must prepare for updated DEA registrations, heightened scrutiny, and enforcement risks.

The Act may also expand federal enforcement actions, leading to more administrative hearings, license sanctions, and regulatory disputes. Legal representation will be crucial in navigating these challenges.

Impact on Research and Healthcare

A key concern is the potential restriction of medical research. Some researchers argue that broad FRS scheduling could limit studies on opioid use disorder (OUD) treatments. While accommodations have been added, hurdles remain.

Dr. Timothy Westlake testified that research safeguards are included and noted support from NIH and the FDA. However, legal guidance will be needed to ensure compliance while advancing critical research.

Graff & McGovern is positioned to help clients challenge restrictive provisions and navigate licensing and approval processes for new pharmaceutical treatments.

Workplace, Pharmacy, and Public Health Impacts

If the HALT Fentanyl Act becomes law, healthcare and pharmaceutical employers will need to revise policies on handling Schedule I substances, update employee training, and ensure DEA and OSHA compliance.

In addition, pharmacies will need to align procedures with stricter DEA regulations on dispensing and reporting. Responsible persons will bear greater accountability, making proactive legal guidance essential.

Dr. Westlake highlighted that class-wide FRS scheduling has deterred illicit fentanyl development. This reinforces the need for strict pharmacy compliance to prevent regulatory violations.

The Act would also influence public health and addiction treatment policies, potentially increasing regulatory disputes and funding challenges.

Next Steps

If passed, the Act will undergo public comment, DEA rulemaking, and possible legal challenges before full implementation.

Graff & McGovern will monitor developments, provide compliance guidance, and support clients through regulatory transitions. Staying ahead of these shifts is essential for businesses, researchers, and healthcare providers.

For legal counsel on compliance, enforcement risks, or regulatory strategies, contact our team today.

---

This document is intended to provide general information regarding potential regulatory changes under the HALT Fentanyl Act. It does not constitute legal advice. For specific guidance, please consult a Graff & McGovern attorney at 614-228-5800.