Federal & State Cannabis Regulation 2024 PDF

Federal & State Cannabis Regulation March 4, 2024 Reminders Hospital/law skills lab Thursday Mississippi Regulations start Wednesday 3/6 No more slides… PDF Available on Blackboard under “MS Regulations” This will be your study copy for the MPJE next year You will want to take notes and highlight 2...

Federal & State Cannabis Regulation March 4, 2024 Reminders Hospital/law skills lab Thursday Mississippi Regulations start Wednesday 3/6 No more slides… PDF Available on Blackboard under “MS Regulations” This will be your study copy for the MPJE next year You will want to take notes and highlight 2 Learning Objectives Describe the purpose of prescription drug monitoring programs (PMPs) Describe the history of anabolic steroid regulation Describe the history of federal cannabis regulation Describe the regulatory elements of state medical cannabis laws Describe state medical marijuana program management Describe state requirements for qualifying conditions Describe the status of medical marijuana in Mississippi 3 Describe the purpose of prescription monitoring programs (PMPs) Nearly every state has enacted electronic prescription monitoring programs (PMPs). Although the details of the PMP may vary from state to state, typically the program requires pharmacists to electronically transmit to the state a record of each controlled substance prescription dispensed. PMPs allow investigators to obtain pharmacy data from multiple locations without actually having to visit each pharmacy. States review the data generated through a PMP to determine if diversion or abuse exists and can track patients, physicians, and pharmacies. 4 Describe the purpose of prescription monitoring programs (PMPs) Thus, PMPs can identify such situations as patients shopping multiple prescribers or multiple pharmacies. The DEA considered creating a national PMP, but was concerned about the cost and size of the database. So, instead, the federal government has passed a law to provide grant funding to states to help develop or enhance their PMPs. NABP’s PMP InterConnect facilitates the sharing of data between state PMPs. 5 https://nabp.pharmacy/members/programs-services/industry-information-networks/pmp-interconnect/ Describe the purpose of prescription monitoring programs (PMPs) 6 Describe the history of anabolic steroid regulation Anabolic Steroids Control Act of 1990 Made anabolic steroids for human use schedule III substances under the CSA Purpose was to stem abuse of anabolic steroids Anabolic Steroids Act of 2004 Re-defined anabolic steroid definition to include precursors and salts, etc. to give the DEA considerably more flexibility to immediately schedule steroid precursors, without having to play catch-up with every variation that enters the market. 7 State cannabis programs: 8 https://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx Describe the history of federal cannabis regulation DEA schedules adopted during Nixon administration come with a lot of controversy Marijuana is a schedule I, still (federally) Medical marijuana became legal in California in 1996, but also not without controversy What allowed states to make marijuana legal? Legal Illegal Legal 9 Describe the history of federal cannabis regulation In October of 2009, the Obama Administration sent a memo to federal prosecutors encouraging them not to prosecute people who distribute marijuana for medical purposes in accordance with state law. Referring to medical marijuana laws 10 https://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx Describe the history of federal cannabis regulation In late August 2013, the U.S. Department of Justice announced an update to their marijuana enforcement policy. The statement read that while marijuana remains illegal federally, the USDOJ expects states like Colorado and Washington to create "strong, state-based enforcement efforts.... and will defer the right to challenge their legalization laws at this time." The department also reserves the right to challenge the states at any time they feel it's necessary. Referring to recreational or adult use marijuana laws 11 https://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx Describe the history of federal cannabis regulation 12 https://www.justice.gov/opa/pr/justice-department-announces-update-marijuana-enforcement-policy Describe the history of federal cannabis regulation Eight Prioritization Areas: 1. 2. 3. 4. 5. 6. 7. 8. Distribution to minors Revenue to criminal enterprise-gangs, cartels, etc. Sale over state lines Drug trafficking Violence, firearms related to cultivation and sale of marijuana Drugged driving or other actions with public health consequences Growing of marijuana on public lands Possession or use on federal property 13 https://www.justice.gov/opa/pr/justice-department-announces-update-marijuana-enforcement-policy Describe the history of federal cannabis regulation The Rohrabacher-Farr Amendment is legislation first introduced by in 2001, prohibiting the Justice Department from spending funds to interfere with the implementation of state medical cannabis laws. It passed the House in May 2014 after six previously failed attempts, becoming law in December 2014 as part of an omnibus spending bill. The passage of the amendment was the first time either chamber of Congress had voted to protect medical cannabis patients, and is viewed as a historic victory for cannabis reform advocates at the federal level. The amendment does not change the legal status of cannabis however, and must be renewed each fiscal year in order to remain in effect. https://en.wikipedia.org/wiki/Rohrabacher%E2%80%93Farr_amendment 14 Describe the history of federal cannabis regulation The most significant legislation to date protecting the medical cannabis industry from the use of Department of Justice funds for enforcement of the Controlled Substance Act (CSA) was renewed on Friday, March 23, 2018. On that day, the $1.3 trillion omnibus spending bill was signed into law by President Trump. It included an updated version of the Rohrabacher-Farr Amendment which prohibits the use of DOJ funds for CSA enforcement in states with a medical cannabis program. Before the bill made it to the president’s desk, its fate hinged on a key vote in the U.S. House of Representatives and U.S. Senate. Both chambers voted to approve the bill on Thursday, March 22. https://en.wikipedia.org/wiki/Rohrabacher%E2%80%93Farr_amendment 15 Describe the history of federal cannabis regulation Are patients in state medical marijuana programs protected from federal prosecution? Technically, no. But… The U.S. Department of Justice (DOJ) has the authority to enforce civil and criminal federal laws relating to marijuana possession and use, regardless of state law. Growing, distributing, and/or possessing marijuana in any capacity, except through a federally-approved research program, is a violation of federal law, and no state or local law provides a legal defense to a violation of federal law. In light of current DOJ guidance, however, it may be unlikely that federal authorities would bring civil enforcement actions or criminal investigations and prosecutions against growers/ processors, dispensaries, physicians, seriously ill individuals or caregivers as long as they are acting pursuant to the Act. A memorandum from the DOJ (PDF), dated August 29, 2013, explains the priorities of federal authorities regarding marijuana possession and use, including state medical marijuana programs. States with medical marijuana laws generally have some form of patient registry, which may provide some protection against arrest for possession up to a certain amount of marijuana for personal medicinal use https://www.health.pa.gov/topics/programs/Medical%20Marijuana/Pages/Patients.aspx https://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx 16 Describe the regulatory elements of state medical cannabis laws Patient Requirements Qualifying conditions Dosage forms Possession limit (see https://medicalmarijuana.procon.org/legal-medical-marijuana-states-and-dc/) Home cultivation ID card Registration Physician certification Percent of adult population using Usage location Age $$$ (~$50) 17 Describe the regulatory elements of state medical cannabis laws Practitioner Requirements Registration Continuing education Dose determination 18 Describe the regulatory elements of state medical cannabis laws Dispenser Requirements Pharmacist staffing Storefronts Registration Permits Proof of capital $$$ (~35,000) 19 Describe the regulatory elements of state medical cannabis laws Producer Requirements Registration Training course Permits Proof of capital $$$ (>$200,000) 20 Describe state medical marijuana program management State Departments of Public Health 21 Describe state requirements for qualifying conditions Established by state law Some have more qualifying conditions than others Delaware Illinois Some have adult and pediatric indications Delaware 22 https://www.leafly.com/news/health/qualifying-conditions-for-medical-marijuana-by-state Describe state requirements for qualifying conditions Some leave it to the physician to make the call – no conditions indicated Ohio Maine Some indicate as an alternative to opioids (research) Missouri 23 https://www.leafly.com/news/health/qualifying-conditions-for-medical-marijuana-by-state Describe the status of medical marijuana in Mississippi Mississippi Medical Cannabis Program signed into law on 2/2/22 24 Describe the status of medical marijuana in Mississippi 25 Describe the status of medical marijuana in Mississippi 26 https://www.mmcp.ms.gov/