Ohio Medical Marijuana Control Program Mandatory Product Recall October 1, 2020

Ohio Medical Marijuana Control Program
Mandatory Product Recall – 10/1/2020
UPDATE
Yesterday, the Ohio Medical Marijuana Control Program (MMCP) issued a mandatory product recall on edible products sold by Mother Grows Best, LLC dba Verano Brands. This recall was initiated by the MMCP because the product did not pass the full battery of required testing and was sold at specific dispensaries (see complete recall notice for product and dispensary information).
The MMCP identified the brand product, Encore Edibles (Dark Chocolate), as exceeding the regulatory thresholds for cadmium. Cadmium is a heavy metal found in soil and water that can be absorbed by and accumulated in plants (including cocoa beans) that are used to make food products. For non-smokers, food is the main source of cadmium intake for the general population. Increased daily exposure to cadmium can pose a health risk to patients.
Ohio Admin. Code 3796:4-2-04(H) states a heavy metal contamination analysis passes for cadmium if “the detected amount of cadmium, if any, is less than 0.09 micrograms per kilogram.” When establishing the thresholds, the MMCP utilized the average body weight assumption for a 10-year-old child. Utilizing this assumption creates a higher standard for MMCP products, with the goal of reducing the maximum daily exposure to heavy metals for patients.
For questions regarding cadmium, please review the following resources:
The MMCP continues to investigate this matter and will provide a comprehensive executive summary once complete. As a reminder, no reports of adverse reactions for this product have been reported to the MMCP at this time.
Anyone who thinks that they may be experiencing serious or life-threatening issues should seek immediate medical attention. Patients are reminded that any adverse reactions should be reported to the MMCP toll-free helpline (1-833-464-6627).

OHIO:  The Ohio Medical Marijuana Control Program (MMCP) is issuing a mandatory product recall on edible products sold by Mother Grows Best. This recall is being initiated by the MMCP because the product did not pass the full battery of required testing and was sold at specific dispensaries (see Product ID information below). Additional details on the specifics of the recall will be provided in the coming days. The MMCP has initiated an investigation into the noncompliance and identified product samples to be tested. These results will be communicated publicly.

AFFECTED PRODUCT:

Product Name: Encore Edibles (Dark Chocolate)

Purchase Dates: 8/17/2020 – 10/1/2020

Processor Name: Mother Grows Best

Product ID:
Sold at Zen Leaf (Canton)
M00000078821: Edb Oral Admin – 10 – 0.4 – 10 – Dark Chocolate Indica
Batch Number: 1A40701000020D1000001083

Sold at Greenleaf Apothecaries (Akron)
M00000078821: Edb Oral Admin – 10 – 0.4 – 10 – Dark Chocolate Indica
Batch Number: 1A40701000020D1000001105

Sold at Greenleaf Apothecaries (Canton)
M00000078821: Edb Oral Admin – 10 – 0.4 – 10 – Dark Chocolate Indica
Batch Number: 1A40701000020D1000001111

Sold at Ohio Cannabis Company (Coshocton)
M00000078821: Edb Oral Admin – 10 – 0.4 – 10 – Dark Chocolate Indica
Batch Number: 1A40701000020D1000001124

Sold at Greenleaf Apothecaries (Cleveland)
M00000078821: Edb Oral Admin – 10 – 0.4 – 10 – Dark Chocolate Indica
Batch Number: 1A40701000020D1000001137

Sold at Greenleaf Apothecaries (Columbus)
M00000078821: Edb Oral Admin – 10 – 0.4 – 10 – Dark Chocolate Indica
Batch Number: 1A40701000020D1000001191

Sold at Pure Ohio Wellness (Dayton)
M00000078821: Edb Oral Admin – 10 – 0.4 – 10 – Dark Chocolate Indica
Batch Number: 1A40701000020D1000001219

Sold at Have a Heart Cincy (Cincinnati)
M00000078821: Edb Oral Admin – 10 – 0.4 – 10 – Dark Chocolate Indica
Batch Number: 1A40701000020D1000001310

No reports of adverse reactions for this product have been reported to the MMCP at this time.

Patients who have purchased the recalled product should stop using it.

All unused product should be returned to the dispensary where purchased. Returned products will not count toward a patient’s 45-day possession limit. For more information on returns, please contact the dispensary where the product was purchased.

Anyone who thinks that they may be experiencing serious or life-threatening issues should seek immediate medical attention. Patients are reminded that any adverse reactions should be reported to the MMCP toll-free helpline (1-833-464-6627).

Ohio Board Of Pharmacy Awards Dispensary Certificate Of Operation In London

OHIO: The State of Ohio Board of Pharmacy today awarded a Dispensary Certificate of Operation to Pure Ohio Wellness, located at 920 U.S. 42 West, London.

The Board has now issued 52 Dispensary Certificates of Operation.

The interactive map of Dispensaries with Certificates of Operation will be updated within two business days.

OLCC Compliance Education Bulletin: Medical Sales To A Designated Caregiver

OREGON: The OLCC has added a “Bulletins” section to its Recreational Marijuana Program website with important information for licensees and marijuana worker permit holders.

The Oregon Liquor Control Commission is providing the following information to: recreational marijuana licensees.

The bulletin is part of OLCC’s compliance education. It is important that you read it, and understand it.If you don’t understand it please contact the OLCC for help.

Failure to understand and follow the information contained in this bulletin could result in an OLCC rules compliance violation affecting your ability to work or operate your business.

A bulletin previously issued by Metrc inadvertently provided the incorrect date for when the CTS functionality change takes place.  The change in Metrc is effective starting September 14, 2020.

Bulletin CE2020-04 covers the following issues:

  • Medical Sales to a Caregiver
  • Sales Limits to Caregivers and Patients
  • New Metrc Functionality – Designating Caregiver Sales

Compliance Education Bulletin CE2020-04 provides updated guidance on medical sales to a Designated Caregiver, sales limits caregivers and patients, and changes in Metrc functionality for caregiver sales.

Medical Sales to a Designated Caregiver

The Oregon Medical Marijuana Program (OMMP) provides for patients to designate a caregiver who can purchase and possess marijuana items for the patient. The caregiver’s card references both the caregiver’s and patient’s registration number.

Effective September 14, 2020 new functionality in the Cannabis Tracking System (CTS), Metrc, now allows retailers to designate sales as “caregiver” sales, in addition to consumer and patient. When a caregiver sales is recorded, either manually in Metrc or through API or CSV upload, the retailer must input both the patient and caregiver numbers.

Rules allow for a patient and their caregiver to jointly possess up to 24 ounces of usable marijuana. This is to say, a retailer may sell up to the daily limit under both the patient’s and caregiver’s cards under the caregiver sales. This will go into effect when the daily sales limit returns to 8 ounces on September 18, 2020.

The bulletin describes the new functionality in Metrc and provides a step by step guide to entering a caregiver sales manually in the system. Metrc has previously provided API partners with details on this addition, so they should be ready to use this functionality in their systems.

Questions regarding the contents of this bulletin may be sent to marijuana.cts@oregon.gov.

FDA Approves New Indication For Drug Containing An Active Ingredient Derived From Cannabis To Treat Seizures In Rare Genetic Disease

DISTRICT OF COLUMBIA: Last month, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

CBD is a chemical component of the Cannabis sativa plant. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

TSC is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. TSC affects about 1 in 6,000 people.

Epidiolex’s effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. Additional side effects for patients with LGS, DS, or TSC include: liver injury, decreased weight, anemia, and increased creatinine.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior, or thoughts of self-harm. Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression, suicidal thoughts or behavior. Patients, caregivers, and families should report behaviors of concern immediately to healthcare providers. Epidiolex also caused liver injury in some patients. Most cases were generally mild, but a risk of rare, but more severe liver injury exists. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

The FDA granted Priority Review designation for this application. The approval of Epidiolex was granted to Greenwich Biosciences Inc., of Carlsbad, California.

ILLINOIS: IDFPR Announces Approval Of Permanent Rules For Conditional Adult-Use Cannabis Dispensary Licenses Tie-breaking Process

Illinois Joint Committee on Administrative Rules Approves Tiebreaker Rules; Dispensary Licenses to be Issued in Coming Weeks

ILLINOIS: The Illinois Department of Financial and Professional Regulation (IDFPR) announced today that permanent rules have been adopted for adult use cannabis dispensary licensees to be selected when there are two or more applicants in the same Bureau of Labor Statistics Regions with tied high scores. The rules, which were filed in June, may be found here.

The approval of these rules allows IDFPR to move forward in awarding the 75 conditional adult use cannabis dispensary licenses that were authorized by the 2019 Cannabis Regulation and Tax Act. Consistent with the new rules, IDFPR will provide a public notice announcing the applicants with tied high scores who, if they meet the requirements in the rules, may participate in the selection process for a conditional license.

“We are pleased that these rules have been adopted, and we remain unwavering in our commitment to ensuring these licenses are issued in a fair and objective way that implements Illinois’ equity-centric law,” said Toi Hutchinson, Senior Advisor for Cannabis Control to Gov. Pritzker. “Additional licenses will be made available in the coming years and these rules will help ensure a strong foundation is established for the licensing process in the future.”

Once IDFPR awards a conditional license, the licensee will have 180 days to find a location within its BLS Region to operate. A license to operate cannot be issued if the location is within 1,500 feet of an existing licensed dispensing organization. More about the awarding of the conditional adult use dispensing organization licenses may be found under 410 ILCS 705/15-25 and 15-30 of the Cannabis Regulation and Tax Act.

In addition, application scoring for craft grower, infuser and transporter licenses is being finalized, and the Illinois Department of Agriculture will announce award dates in the near future.

Oklahoma Medical Marijuana Authority Names New Director

OKLAHOMA:  The deputy director of the Oklahoma Medical Marijuana Authority will serve as interim director of the authority, officials announced Friday.

Kelly Williams replaces Travis Kirkpatrick, who was recently named deputy commissioner of prevention and preparedness at the Oklahoma State Department of Health.

Kirkpatrick, who will oversee the OMMA from his new position, chose Williams for the interim post. Kirkpatrick had been named director of the authority in January after serving as interim director for about three months.

“This is a young agency and we have seen massive growth over the past two years,” Williams said in a statement. “I look forward to the challenges and the rewards of growing the Oklahoma Medical Marijuana Authority into an agency that will make Oklahomans proud.”

Ohio Medical Marijuana Control Program Releases Testing Laboratory Provisional License Application Materials

OHIO:The Ohio Medical Marijuana Control Program (MMCP) is scheduled to accept new testing laboratory license applications beginning the week of August 3, 2020. On its testing laboratories webpage, the MMCP has posted two documents for potential applicants to assist in understanding the key substantive attributes of the application.

Potential applicants may submit questions regarding the application materials using instructions listed on the testing laboratories webpage. All questions must be submitted by July 31, 2020. The MMCP will then provide the frequently asked questions and MMCP answers to potential applicants.

For more information, visit the MMCP’s testing laboratories webpage.

Maine: 17 New Adult Use Conditional Licenses Issued

MAINE: How big is Maine’s new adult-use cannabis industry? According to the Maine Office of Marijuana Policy, there are 17 new adult use conditional licenses. The breakdown includes seven marijuana stores, five cultivation facilities, four products manufacturing facilities, and one testing facility.

Ohio Board Of Pharmacy Publishes Updated Patient & Caregiver Numbers For June 2020

OHIO: The State of Ohio Board of Pharmacy today published updated patient & caregiver numbers for June 2020. These numbers include:

  • 147,245 Recommendations
  • 116,497 Registered patients
    • 8,349 Patients with Veteran Status
    • 8,713 Patients with Indigent Status
    • 644 Patients with a Terminal Diagnosis
  • 91,330 Unique patients who purchased medical marijuana (as reported to OARRS by licensed dispensaries)
  • 13,140 Registered Caregivers

For the full list of program numbers, please visit the Program Update page.

Ohio Board Of Pharmacy Releases MMJ Patient & Caregiver Numbers For March 2020

OHIO: The State of Ohio Board of Pharmacy today published updated patient & caregiver numbers for March 2020. These numbers include:

  • 113,359 Recommendations
  • 94,356 Registered patients
    • 7,031 Patients with Veteran Status
    • 6,990 Patients with Indigent Status
    • 544 Patients with a Terminal Diagnosis
  • 69,585 Unique patients who purchased medical marijuana (as reported to OARRS by licensed dispensaries)
  • 10,790 Registered Caregivers

For the full list of program numbers, please visit the Program Update page.