In Hesse, medicinal cannabis flowers must be dried and cut where the plants are harvested, the Hessian State Office for Health and Care says in a June 8 guidance letter, unless a grower can prove beyond doubt that skipping or splitting the drying does not result in a loss of quality.

The document treats drying under controlled conditions as a critical manufacturing step that affects product quality, which places its parameters within GMP standards rather than the more lenient GACP standard that governs cultivation (source: HLfGP brochure). Annex 7 of the GMP guideline allows coarse cutting and possibly a primary drying step under GACP conditions, but only when the work actually falls within these limits and the quality of the drug is not compromised. The authority says it does not have a process that has allowed flowers that can be classified as GACP material to be transported over long distances, stored, imported and further processed without loss of quality. Either the requirements for GACP flower are not met because the handling goes beyond the initial drying and coarse cutting, or the flower cannot be shown to survive longer storage and transport without degrading before subsequent steps.

© Philiprowe | Dreamstime

What a third country allows does not change that. According to the authority, if the cannabis flower is partially manufactured in a country where the GMP guideline does not apply, the guidelines must still be met for material released and sold as medicine in Germany. The responsibility lies with the Qualified Person under the German Medicinal Products Act who releases the flower for sale, and is responsible, even if partial manufacturing takes place in sites operating under different regulations in other EU states or third countries.

This is the mechanism behind EU GMP clearance, the practice of converting imported flowers through a European facility to obtain certification that the original material would not otherwise carry. The Hesse letter does not use that term. What it does is to close the interpretation loophole that allows a partial dry abroad to be finished and certified in Europe, by calling the dry finish a GMP step that cannot be cleared through a GACP origin.

The policy also restricts reprocessing. According to Chapter 5 of the EU GMP guideline, reprocessing is only possible in exceptional cases, under strictly defined conditions and a full risk assessment, which includes drying or reducing the microbial load. Batches undergoing such steps cannot be sold without proof of suitability and stability, and when rework is applied to most batches, it should become a validated part of the standard process.

A producer active in the supply chain, who asked not to be named, says the Hesse letter is one of two recent moves, covering the second-issued Darmstadt district, in line with the regions already taking a stand against EU GMP clearance in Cologne. In the accounts of this grower, the regions have closed the loophole that allowed partial drought in a country like Colombia to end in Germany, Darmstadt has refused to allow this conversion in its territory.

The most difficult case, according to this producer, is the multi-country chain. The flower partially processed in Colombia, sent to Portugal and converted there according to the EU GMP is still something that Germany completely rejects, although it should be caught by a qualified person who does the job properly, and a chain that goes to a third country, according to the producer’s estimates, approximately ninety percent is not allowed. Qualified people have more responsibility than before, and when they check the supply line and find the chain invalid, the Darmstadt regional authority would look into it.

Lawyers for opponents of marijuana reform who are participating in the Drug Enforcement Administration (DEA) lawsuit. The Trump administration’s cannabis rescheduling proposal On the second day of the proceedings, he focused significantly on pressing a government witness about changes approved in an analysis used to determine whether drugs have approved medical value.

A separate government witness who began his testimony Tuesday focused on cannabis’ role in treating pain patients and its relative safety compared to opioids.

Under federal law, drugs with currently accepted medical use (CAMU) cannot be classified in Schedule I, the narrowest category. For years, officials used a five-part test to determine a substance’s medical usefulness, including whether its chemistry is known and reproducible, safety studies, research demonstrating efficacy, approval by qualified experts, and available scientific evidence.

But to evaluate marijuana in 2023, they switched to a new two-part analysis that examines whether current licensed health care providers operating under state law have extensive experience with the medical use of the substance and, if so, whether there is credible scientific support for at least one of the medical conditions for which it is being used.

Opponents of the reform, however, say that the change was inappropriate. Their attorneys cross-examined Dominic Chiapperino, director of the controlled substances staff at the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research and one of two DEA witnesses.

A lawyer in the states of Idaho, Indiana and Nebraska, for example, described how a 2015 review of the older marijuana study concluded that it should not be rescheduled because it had no currently accepted medical use.

When questioned, the FDA’s Chiapperino testified that the new two-part test did not exist when he and his agency colleagues began the final analysis of marijuana that led to his scheduling recommendation and that in July 2023, two months before the work was completed, officials were notified of the new approach in a letter from the assistant secretary of health.

Chiapperino also conceded that marijuana would not pass the previous five-part test. DEA attorneys objected to the line of questioning that led to that testimony, but the judge overseeing the proceedings overruled it.

Kevin Sabet, president and CEO of Smart Approaches to Marijuana, said in a video posted on social media that the approval is “truly extraordinary.”

“Let’s be clear about what that means,” he said. “It means that the government is asking for marijuana to be removed from schedule I, but it did it using a new standard instead of a standard that has been applied for years, that has been applied to all other drugs, and now in open court its witness has admitted that marijuana would not pass the standard test.”

In 2024, the Department of Justice (DOJ) Office of Legal Counsel (OLC) he said the previous five-part test was “unbelievably tight”. and said the two-part review “is sufficient to establish that a drug has CAMU, even though the drug has not been approved by the FDA and would not meet the DEA’s five-part test.”

The DEA has since took a new approach to evaluating cannabis for CAMU and then it has been used to evaluate other substances.

While the reconsideration proceedings are not broadcast live to the public, Marijuana Moment, at the request of one congressman and others, spoke with several people in the hearing room to find out how the testimony is going. Quotations from participants come from source notes and have not been verified, as official transcripts have not yet been made available.

On Monday, the first day of the hearing, DEA attorneys highlighted the testimony the medical benefits of marijuana and its relative safety compared to other substances such as alcohol and opioids.

Also Tuesday, the government’s second witness, Corey Burchman, a doctor from New Hampshire, began his testimony, focusing on how Medical marijuana provides relief to pain patients and can serve as an alternative to opioids.

When medical cannabis became available, he and his colleagues “would eagerly use that ability to limit opioids,” he said, adding that some patients were able to wean themselves off prescription painkillers entirely. It was “positive” and “beneficial to patients,” he said.

“It’s very helpful as a form of analgesia in chronic pain patients,” Burchman noted.

He also discussed the relative safety and effects of cannabis and opioids.

“Withdrawal from opioids is like a dumpster fire,” he said. “Withdrawal from marijuana is like extinguishing a bright campfire.”

Before Monday’s hearing, marijuana reform activists rallied They held a press conference outside DEA headquarters to highlight how they feel of the process – criticizing the fact that supporters of the reform were not invited to participate and that the proceedings are not reproduced live, despite the “transparency” oath of the officials.

DEA Administrator Terrance Cole only organizations and individuals opposed to marijuana reform have been invited to the hearing as a designated participant – telling followers that they do not meet the definition of “interested person” to participate because they are not “affected or prejudiced by any rule or proposed rule that may be issued.”

last week, Marihuana Moments sent petitions to DEA Chief Administrative Law Judge Derek Julius and DEA Administrator Cole asking for them reverse the decision to ban the public from tuning into the cannabis hearing via live stream. A Congressmen and other journalists later joined that request.

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The opponents who are participating in the hearing submitted statements last week anticipate the anti-marijuana arguments they intend to make during the procedure.

The hearing it will end before July 15.

Acting Attorney General Todd Blanche in April He issued an order that immediately reclassified the state’s licensed medical cannabisas well as marijuana products approved by the Food and Drug Administration (FDA) under Schedule I through Schedule III of the Controlled Substances Act (CSA).

According to a separate order signed by the acting attorney general, the upcoming hearing will include Class III marijuana.

Preliminary hearing process on the marijuana redistricting process initiated by the Biden administration It was halted last year amid allegations of improper communications and witness selection.

the current The marijuana redistricting process is being challenged in several ways which have been upheld by a federal Court of Appeals. those pieces of State attorneys general have filed lawsuits against cannabis reform, Opponents of marijuana legalization and a a cannabis-based biopharmaceutical corporation.

Meanwhile, the reorganization of state-licensed medical cannabis is already having a major impact.

The Congressional Research Service published a report on the current rescheduling of cannabis Certified patients with medical marijuana from state licensed dispensaries are now eligible for Class III. “The order appears to allow end users to use marijuana medically without a CSA prescription,” he says.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has published a Draft update to a gun purchase form to recognize the legal status of medical marijuana in the reprogramming. The revised section of the question states that only the “recreational use or possession of marijuana” is federally prohibited, omitting the prior form’s mention of medical cannabis.

The US Treasury and Internal Revenue Service (IRS) said they plan to issued new tax guidelines for the marijuana industry after reprogramming. The reform will benefit state-licensed marijuana businesses by allowing them to take federal tax deductions that are currently prohibited under IRS Code Section III, known as Section 280E.

Even the DEA, which has long opposed cannabis legalization and accused the Biden administration of stalling the initiative in the reorganization process, has done so. It launched a registration process for legal marijuana businesses in the state to take advantage of the federal benefits that come with the reform.

The Department of Transport, on the other hand, issued guidelines stating this use Legal medical cannabis in the state is still no excuse for truck drivers to test positive for drugspilots and other safety-sensitive personnel.

A congressional committee recently Federal officials voted to block further steps to reschedule cannabishowever lawmakers from both parties told Marihuana Moment they don’t think that provision will be enacted become law

user photo Carlos Gracia.

Entourage Health Corp. has entered creditor protection. The company and six related entities filed on June 17 under the Companies’ Creditors’ Arrangement Act owed approximately $240.1 million to the sole affiliate of the LiUNA Pension Fund, its owner, its secured creditor and the lender that is now funding the money (First Report pp. 3-6-9

That affiliate, 2437653 Ontario Inc. No. 1 company, Entourage, secured a 2024 deal that took the former WeedMD private and off the TSX Venture Exchange (December 2024 PR). Shareholders were paid half a Canadian cent per share, or C$0.005, and the board recommended a sale in December 2024 (December 2024 PR).

Jason Alexander, head of the special committee of independent directors, recommended to shareholders. “The transaction ensures that shareholders will receive immediate tangible value while positioning the Company for future growth and flexibility,” Alexander said (December 2024 PR). The company took on $167.6 million in debt in that sale, having already breached the covenant with the same guarantee (December 2024 PR). Eighteen months later that debt was $240.1 million when it was filed, and the growth promised by the sale is a settlement (First Report 6-18 p.

Adult use is off, medical is still running
The leisure business is closing, not saving. Entourage laid off about 53 workers in early June before the order, and 22 remain (First Report p. 6 Adult use inventory is being cleared, finished products are shipped to provincial distributors, and flowers are sold in bulk to the market to other licensed growers (First Report p. 12 Color Cannabis, Dime Bag and Saturday Cannabis are the brands going down with it (First Report p. 5

What remains open is the doctor’s arm as the exclusive supplier of cannabis under the Starseed brand to local residents of the Workers International Union of North America (First Report p. 5 The pension fund that funds the procedure is tied to the same union that the medical brand serves, and the part of Entourage that serves union members is the part that is kept alive while the rest is sold for parts.

At the end of July the money runs out with no new money (First Report p. 11 The money comes again from the pension fund affiliate, a $1.1 million debtor-in-possession facility at 5% per annum, no commitment fee, no exit fee (First Report pp. 10-11). The monitor, Ernst & Young, checked terms against other DIP loans in the cannabis sector from January 2024 and concluded that a third-party lender would not lend on better terms given the state of the business (First Report p. 11 The lender, which already owed $240 million, is the only one willing to advance another million to keep the lights on through the sale.

Health Canada is the largest unsecured creditor, owed $494,505, ahead of all suppliers and competitors on the company’s books (List of Creditors p. 1 Supreme Cannabis is owed $262,133, medical platform HelloMD is owed $169,564, the Town of Aylmer is owed $144,815, the Independent Retail Cannabis Board is owed $137,098 and High Tide is owed $124,583 (List of Creditors p. 1 Unsecured claims total $3,288,333 in more than 100 names, many of which have yet-to-be-determined amounts by medical clinics (List of Creditors 1-5 p. Against $240 million guaranteed, none of them will see much.

In the June 29 return, the lender asks the judge to extend the stay until August 28, approve the DIP facility, and double the Administrative and Directors fees to $500,000 each (First Report 4-8-12. p. The directorship is rising as directors face payroll, holiday pay and excise duties over a longer period of time, and the company’s directors and officers insurance expires at the start of July (First Report p. 12

The sales process starts on the same day, based on a marketing effort that started around May and was presented before the deal that sparked interest but no one could make a deal (First Report p. 13 Insiders and affiliates have until July 6th to say they intend to bid, the bid deadline is July 30th, the successful bid must be received by August 7th, and the outside deadline is August 28th (First Report p. 15 The affiliate of the pension fund has written to the Monitor that it will not make an offer (First Report p. 16), and any other affiliate that does so must be removed from the process (First Report p. 16 The settlement request for non-cannabis equipment and the sale of the Aylmer facility, a 26,000-square-foot extraction and processing facility that has been the company’s production base at 250 Elm St.

the source

For more information:
Neighborhood Health
1.844.933.3636
(email protected)
entouragehealthcorp.com