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Legislative Update: Quarter 2, 2024
By Eric Roath, Pharm.D., MPA director of government affairs
Department of Justice Proposes Rule to Move Marijuana to Schedule III
On May 21, the Department of Justice (DOJ) published a notice of proposed rulemaking in the Federal Register to reclassify marijuana as a Schedule III controlled substance. According to the posting’s summary:
(“DOJ”) proposes to transfer marijuana from Schedule I of the Controlled Substances Act (“CSA”) to schedule III of the CSA, consistent with the view of the Department of Health and Human Services (“HHS”) that marijuana has a currently accepted medical use as well as HHS's views about marijuana's abuse potential and level of physical or psychological dependence. The CSA requires that such actions be made through formal rulemaking on the record after opportunity for a hearing. If the transfer to Schedule III is finalized, the regulatory controls applicable to Schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations. If marijuana is transferred into Schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA's definition of “marijuana” would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act (“FDCA”). DOJ is soliciting comments on this proposal.
Comments will be taken on the proposed rule until July 22, 2024.
Hormonal Contraception Bill Package Voted Out of Committee
On April 18, House Bills 5013, 5435 and 5436 were voted out of the House Health Policy Committee. The votes in the committee were as follows:
Yeas:
- Rep. Julie Rogers, D-District 41
- Rep. Karen Whitsett, D-District 4
- Rep. Brenda Carter, D-District 53
- Rep. Jim Haadsma, D-District 44
- Rep. Cynthia Neeley, D-District 70
- Rep. Carol Glanville, D-District 84
- Rep. Betsy Coffia, D-District 103
- Rep. Jennifer Conlin, D-District 48
- Rep. Alabas Farhat, D-District 3
- Rep. John Fitzgerald, D-District 83
- Rep. Reggie Miller, D-District 31
- Rep. Carrie Rheingans, D-District 47
Nays:
- Rep. Curtis VanderWall, R-District 102
- Rep. Jamie Thompson, R-District 28
Abstaining:
- Rep. Graham Filler, R-District 93
- Rep. Mike Mueller R-District 72
- Rep. Greg VanWoerkom, R-District 88
- Rep. John R. Roth, R-District 104
- Rep. Kathy Schmaltz, R-District 46
HB 5013 requires insurance coverage of a 12-month supply of hormonal contraception furnished in a single dispensing. HBs 5435 and 5436 allow pharmacists to prescribe hormonal contraception and requires reimbursement for the prescription and associated screening services rendered under a pharmacist NPI.
The bills now move on for a vote in the full House of Representatives. It’s vitally important that pharmacy professionals take the time to reach out to their representatives and encourage them to support this bill package. Click here to go to the MPA Advocacy Action Center and send an email to your state representative telling them to support this initiative.
Naloxone Bill Package Clears House, Referred to the Senate
House Bills 5077 (Rep. Curtis VanderWall) and 5078 (Rep. Carrie Rheingans) passed out of the House of Representatives April 24 by a vote of 96-11. The bill package amends the Administration of Opioid Antagonists Act and the Public Health Code to allow an agency (or a trained employee of that agency) that purchases an opioid antagonist to directly or indirectly distribute that opioid antagonist to any individual. A distribution described in the bills would be added to provisions that now provide immunity from civil liability for injury, death, or damages arising from the administration or failure to administer an opioid antagonist, as long as the person’s conduct does not amount to willful or wanton misconduct. Similarly, the agency, employee, or agent would be exempt from criminal prosecution for the distribution. The bills would also allow an agency to obtain an opioid antagonist by means other than purchasing it.
Pharmacy General Rule Revisions Now in Effect
The revised Pharmacy – General Ruleset was filed with the Secretary of State and became effective Feb. 29, 2024. As previously reported by MPA and the Bureau of Licensing and Regulatory Affairs (LARA), the revised rules contained several notable changes, including:
- MPJE requirement eliminated
- New USP 795 and 797 chapters adopted (2023 revisions)
- PIC must be changed if unable to fulfill duties for 120 consecutive days
- Implementation of the emergency supply of insulin provision:
- Only one emergency dispensing per qualified prescription
- Limit of three emergency dispensings per year
- Smallest package size available to provide up to a 30-day supply
Within the ruleset now being official, the path for the Board of Pharmacy to reopen the rules to incorporate legislative changes required by Senate Bill 219 is now open. This would include, at a minimum, the establishment of approved training programs for immunization and point-of-care testing services.
Make Your Voices Heard: Call Out PBM Abuses
The rollout of enforcement for the PBM Licensure and Regulation Act has been slow. This means that it is more important than ever to make your concerns to the Department of Insurance and Financial Services (DIFS).
The Department of Insurance and Financial Services (DIFS) has updated their website to include the mechanism for filing a report against pharmacy benefit managers (PBMs) who are suspected of having violated the PBM Licensure and Regulation Act. Complaints can be submitted:
If you are unable to file a complaint online, you may obtain a copy of the complaint form and mail, email, or fax it to DIFS. MPA encourages you to retain a copy of any complaint you submit and share the outcome with Eric Roath at eroath@michiganpharmacists.org.
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