Pharmacy Policy, June 2024

DEA Moves to Reclassify Marijuana From Schedule I

The DEA is poised to reclassify marijuana as a Schedule III drug, according to reporting by the Associated Press. The proposal would mark a historic change, recognizing the medical uses of cannabis and acknowledging that it has a lower abuse potential than other Schedule I drugs.

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Importantly, the proposal must still be reviewed by the White House Office of Management and Budget before the US DEA publicly comments on the plan. If moved to Schedule III, cannabis would join ketamine and some anabolic steroids, which are still controlled substances but have accepted medical uses. After the public comment period and review by an administrative judge, the agency could eventually publish the final rule.

The Biden administration has signaled its support for this change, calling for a review of federal marijuana law in October 2022. President Joe Biden has also called on governors and local leaders to take similar steps.

Although the immediate impact of rescheduling would likely be muted, it could have significant long-term effects, including enabling easier clinical research. As a Schedule III drug, marijuana would still be regulated by the DEA, so cannabis dispensaries would have to register like regular pharmacies and fulfill strict reporting requirements. This could present challenges for both the dispensaries and the DEA.

New York Pharmacists Can Now Provide Hormonal Contraception Without Prescriptions

In March, New York Governor Kathy Hochul and New York State Commissioner of Health James McDonald, MD, MPH, signed a standing order authorizing pharmacists to dispense 3 types of hormonal contraception without a prescription. The goal of this order is to enable patients to access safe and effective contraception without requiring access to a primary care provider.

The 3 types of self-administered hormonal contraceptives included in the order are oral hormonal pills, hormonal vaginal rings, and hormonal contraceptive patches. Pharmacists who participate can dispense up to 12 months of a self-administered hormonal contraception based on the patient’s preference and insurance coverage.

“At a time when reproductive rights are under attack, New York will continue to fight for every individual’s right to access the health care they need,” Hochul said in a news release. “Starting a family is a deeply personal decision, and New York will always be a place where people can access safe and effective contraceptives.”

The announcement follows several other actions by Hochul to expand reproductive health access in the state, including investing $35 million to support abortion providers, purchasing a 5-year supply of misoprostol, and signing laws to strengthen access to abortion care via telehealth services.

On March 12, 2024, the New York State Board of Regents, which grants pharmacy licenses, voted to approve an emergency amendment that was necessary before the state health commissioner could issue the standing order.

HHS White Paper Highlights Steps Taken to Address Drug Shortages

The US Department of Health and Human Services (HHS) has taken several key steps to address drug shortages and proposed other steps to Congress, outlined in a recently released white paper. Notably, HHS has established a new supply chain resilience and shortage coordinator role that is designed to strengthen and better implement strategies to enhance supply chain resilience for pharmaceuticals and other medical products.

The white paper outlines several policy concepts for consideration, including collaborating with the private sector to develop and implement a Manufacturer Resiliency Assessment Program and a Hospital Resilient Supply Program. Combining these programs would bring transparency into the market, link purchasing and payment decisions to supply chain resiliency practices, and incentivize investments in supply chain resilience and diversification in the supply chain at scale.

“Across our department, we are working to ensure that millions of Americans will have access to medication, treatment, and services that save lives and improve health outcomes,” HHS Secretary Xavier Becerra, JD, said in a news release. “That’s why advancing and implementing solutions to the nation’s drug shortages are so important and why we want members of Congress and all actors in the supply chain to consider and act on the policy options presented in today’s white paper.”

Reference

HHS releases white paper focused on preventing drug shortages. News release. US Department of Health and Human Services; April 2, 2024. Accessed May 14, 2024. https://www.hhs.gov/about/news/2024/04/02/hhs-releases-white-paper-focused-preventing-drug-shortages.html