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Source: @norml @WeedConnection
Posted By: norml@weedconnection.com
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- Tue, 31 Mar 2020 04:20:21 PST

DEA Once Again Proposes Changes to Protocols Governing Bulk Production of Cannabis for Clinical Research

Washington, DC: For the second time in four years, the US Drug Enforcement Administration is proposing regulatory changes to procedures governing the federally licensed manufacture of cannabis for clinical research purposes.

In a Notice of Proposed Rulemaking, published in the Federal Register on Monday, the agency acknowledges its longstanding failure to act upon the 35 bulk cultivation applications before it. The DEA now estimates that, under the new rules, it may approve between three and 15 total applicants. Almost all of the applicants have been awaiting a response for two or three years.

Commenting on the proposed regulatory changes, NORML's Deputy Director Paul Armentano said: "These new rules are unduly onerous, expensive, and impractical. Even if they are ultimately implemented, it is unlikely that they would greatly facilitate clinical cannabis research in the United States."

He added, "Further, the DEA has an incredibly poor track record in this arena – having for years now promised to expedite and streamline this process, but failing to deliver. As the saying goes, 'Fool me once, shame on you; fool me twice, shame on me.'"

Under the proposed changes, the agency would purchase and warehouse all of the cannabis produced by federally licensed manufacturers. That is a change from the existing rules, which currently allow for only a single licensed manufacturer – the University of Mississippi – which maintains harvested cannabis on their premises.

The DEA states that, going forward, they will need to take possession of any marijuana grown by a federally licensed entity, including the University, in order to be compliant with the international Single Convention treaty.

The agency also estimates that it will require millions of dollars in additional funding in order to offset the financial costs involved in administering the updated procedures.

Investigators seeking to clinically study the therapeutic efficacy of cannabis have long complained that the existing regulations in place are unnecessarily burdensome and that the quality of cannabis cultivated by the University of Mississippi is of inferior quality. In 2016, the DEA publicly announced that it would, for the first time, begin accepting applications from private entities wishing to grow research-grade cannabis. However, since that time, neither the agency nor the Justice Department had taken any further action to move the application process forward. Last August, the agency announced that it would once again be reassessing and amending its policies.

The agency is accepting public comments on its proposed rule changes until May 22, 2020. Those entities who wish to either cultivate low-THC crops (those containing no more than 0.3 percent THC), or who wish to extract cannabinoids from plants that meet the federal definition of hemp, are not subject to the DEA's licensing requirements.

The full text of the DEA's Notice of Proposed Rulemaking is online.

Federal Agency Affirms That State-licensed Cannabis Entities Are Ineligible for Economic Relief

Washington, DC: Representatives with the United States Small Business Administration (SBA) reaffirmed publicly this week that state-licensed cannabis businesses remain ineligible for financial aid opportunities because marijuana remains classified as a schedule I controlled substance.

In an effort to help offset many businesses' recent economic losses because of the COVID-19 outbreak, the SBA announced that it would be infusing capital and liquidity to businesses adversely impacted by the pandemic.

Nevertheless, a representative from the Administration has acknowledged, "With the exception of businesses that produce or sell hemp and hemp-derived products (Agriculture Improvement Act of 2018, Public Law 115-334), marijuana-related businesses are not eligible for SBA-funded services."

It is estimated that the state-licensed cannabis industry employs more than 240,000 American workers, over four times the number of American workers as does the coal industry.

"With numerous states designating medical cannabis facilities as 'essential' to the health and welfare of the community during this time of crisis, it is critical that Congress authorize the Small Business Association to similarly recognize their importance and allow the agency to provide these small businesses with economic assistance to ensure patient access and continuity of care," said Justin Strekal, NORML's Political Director. "All that is needed by Congress is the passage of a one line legislative fix to protect tens-of-thousands of American jobs in a supply chain that serves over three million medical marijuana patients."

NORML has been working with its Congressional allies to move forward several pieces of legislation, such as HR 3540: The Ensuring Safe Capital Access for All Small Businesses Act, and HR 3884/S 2227: The Marijuana Opportunity, Reinvestment, and Expungement Act – which "prohibit the Small Business Administration from declining to provide certain small business loans to an eligible entity solely because it is a cannabis-related legitimate business or service provider."

Additional information regarding HR 3540 is available online.

Maryland: Lawmakers Approve Bill Permitting Medical Cannabis Access on School Grounds

Annapolis, MD: House and Senate lawmakers have advanced legislation to the Governor's desk to permit qualified patients access to certain medical cannabis products while on school grounds.

House Bill 617 permits either designated caregivers or designated school personnel to administer medical cannabis to students while they are either on school property, participating in school-sponsored activities, or on a school bus. More explicit guidelines regulating medical cannabis administration must be finalized by December 31, 2020.

Lawmakers in multiple states, including California, Delaware, Illinois, Virginia, and Washington, already regulate the administration and use of certain cannabis products to qualified student patients while on school campuses.

Maine: Over Regulators Issue Conditional Licenses to Over 30 Adult-Use Cannabis Enterprises

Augusta, ME: State officials have granted conditional approval to over 30 applicants seeking licensure to operate commercial, adult-use cannabis businesses.

Under the state's licensing regulations, facilities must be dually approved by both state and municipal officials before becoming operational.

Sixteen of the conditional licenses are for retail dispensing operations. Another ten licenses are for grow facilities.

Maine voters initially approved the legalization of cannabis sales in November 2016 by passing a statewide initiative, but lawmakers – led by former Republican Gov. Paul LePage – repeatedly took steps to delay the law's implementation. Rules governing adult-use cannabis production and sales were not ultimately finalized until 2019. Regulators now anticipate retail marijuana sales to begin either late this spring or early this summer.

Case Report: Chronic Pain Patient Weaned Off Opioids Following Cannabis Therapy

Philadelphia, PA: A patient with a multi-year history of chronic pain and opioid use was weaned off prescription opiates following the use of medical cannabis, according to a case study published in the journal Medical Case Reports.

A clinician with the Hospital of the University of Pennsylvania reported that a 43-year-old female patient with head trauma found relief from the inhalation of medical cannabis.

He reported that the patient's pain scores decreased from 8 out of 10 on the visual analog scale to 2 out of 10 following cannabis initiation. During this time, the patient also was able to "completely wean off her opioid narcotics and reported no side effects." The patient was confirmed by a drug test to still be opioid-free after six-months. The patient had previously been prescribed opioids for pain relief for a period of several years.

The author concluded: "Our patient was successfully weaned off her opioid medications with the help of medical cannabis and pain remained well controlled. More studies need to be done on using medical cannabis as an alternative to opioids."

The findings of the case report are consistent with those of numerous other studies reporting that the initiation of medical cannabis therapy influences patients' opioid consumption patterns.

Full text of the study, "Medical cannabis as an alternative for opioids for chronic pain: A case report," appears in Medical Case Reports.

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