Grow Class Tonight – Wed. 12/28

Looks like we will have some open seats in the Grow Class tonight at 7PM in Providence.  It’s an important class on seed germination, transplanting seedlings, cloning, and transplanting clones. Class is taught by one of Rhode Island’s most knowledgeable and respected growers. If you are interested, please email joanne@ripatients.org for last minute registration. Licensed patients and caregivers only. Fee for this 2 hour class (7-9pm) is only 25 dollars.

Health Dept. Finalizes Regulations

The Health Dept adopted regulations that:

Require caregivers to live in RI.  The regulations take effect January 1.  We are in the process of finding out if out of state caregivers are required to turn in their cards and take down their gardens by January 1 or whether they can keep their cards until the expiration date.

Require doctors who sign applications to see their MMj patients at least every 6 months and:

(a) The certifying practitioner shall obtain three (3) hours or equivalent of Category 1 CME regarding medical marijuana every two (2) years as part of usual CME/CE requirement.

(b) The certifying practitioner shall document in the medical record the basis for issuance of a written certification regarding use of medical marijuana, specifically identifying the debilitating condition(s) being met.

(c) Patient Education: The certifying practitioner shall document in the medical record and provide in written or verbal format, that patient was educated regarding maximum daily dose of active ingredient, minimum interval between doses, possible drug interactions – including risk of co-ingesting alcohol.

(d) The certifying practitioner must document after examination, the patient’s response to conventional medical therapies and explain the risks and benefits of the use of marijuana to the qualifying patient.

(e) The certifying practitioner must be committed to the continual assessment of the patient and the patient’s response to the use of marijuana. This must be demonstrated through follow-up appointments, semi-annually at minimum, before the card is renewed. The practitioner will send updates to the primary care provider (if not the PCP), at intervals 5 not to exceed twelve (12) months, documenting patients progress or experience using medical marijuana.

(f) The certifying practitioner must have a current license to practice medicine, as specified in § 1.21 of these regulations, and current DEA registration and appropriate state controlled substance registration.

(g) Before issuing a written certification, a certifying physician must review the Rhode Island Prescription Drug Monitoring Program, review the patients’ prescription history and make a judgement about the potential for drug interaction, adverse events or untoward clinical outcome from adding medical marijuana.

(h) Document in the medical record a full assessment as defined in § 1.13 of these Regulations Addition of Debilitating Medical Conditions

Defines Role of “Authorized Purchaser”as a person who purchases MMj for a patient at a compassion center. Must pass same national crime record check (fingerprints and 35 dollar fee) as caregivers. Same fee as caregivers (100 dollars per year). May reside out of state.

The regulations do not state that patients who are eligible for hospice (and their caregiver, if any)should have their fees waived.  This was included in the PTSD bill that became law last July.

RIPAC, the ACLU, and many patients and caregivers submitted testimony suggesting changes that the Health Dept. chose not to incorporate. To read the new regs  go to the Health Dept.’s website:  http://sos.ri.gov/documents/archives/regdocs/released/pdf/DOH/8435.pdf

Reminder:  As of January 1, licenses will be on a one year cycle instead of two. If you renew your license after Jan 1, you will receive one year license instead of two.If you are currently paying 100 dollars for a two year registration, you will pay 50 dollars for a one year license. Caregivers will pay 100 dollars per year. However, if you currently pay the reduced fee of 25 dollars, you will pay 25 dollars every year instead of every 2 years. So, in effect, the patients with the lowest incomes are receiving a increase in fees. We were told that the conversion to a one year cycle would NOT result in fee increases. To see the fees: http://sos.ri.gov/documents/archives/regdocs/released/pdf/DOH/8436.pdf

 

 

 

 

 

DBR Issues Final Regulations

The Dept of Business Regulation (DBR) has issued final regulations . These are the regulations that were recently the subject of a public hearing and DBR was accepting comments on them until Dec. 7. RIPAC has not yet analyzed the difference between the proposed regulations and the final regulations. When we do, we will post on the  RIPAC website.  In the meanwhile, the final regulations can be viewed on the DBR website at: http://www.dbr.state.ri.us/documents/rules/medical_marijuana/DBR_Medical_Marijuana_Regulations_Final.pdf

Rep. Corvese of North Providence Intends to File Bill That Will Make Caregiver Grows Public

The Medical Marijuana Act protects the privacy of the identity of patients, caregivers, and their grow locations.   According to  Go Local.Prov,  Rep. Corvese of North Providence, wants the public to know the location of caregiver grows.

“It’s often apparent to the neighbors when someone is selling drugs illegally. Allowing the public to know who is a legitimate caregiver and who is not can be helpful in getting people to report those who are just street-level illegal drug dealers as well as caregivers who are abusing the program and fueling drug abuse in their neighborhoods. There’s no legitimate reason this information should be kept secret from the public when providers of other drugs are disclosed,” said Corvese.

The legislature comes back in January and Rep.Corvese  has announced his intention to introduce a bill that will change the MMj Act to delete caregiver privacy protections and make their grow sites a matter of public record.

 

 

Reminder: written comments on proposed regs due by tomorrow, 12/7/16 at 5pm

Both the Health Dept. and the Department of Business Regulation (DBR) have recently proposed  substantial regulations for the RI MMj Program.  The DBR regulations are 80 pages long.  Written comments can be submitted to DBR and the Health Dept. until Wednesday December 7 at 5pm. Written comments on the DBR proposed regulations should be sent to:   Norman Birenbaum  by email: DBR.MMPCompliance@dbr.ri.gov .  Written comments on the Health Dept. proposed regulations should be submitted to: James McDonald  by e-mail: James.McDonald@health.ri.gov.

A public hearing to consider both sets of regulations was held on Nov. 22, 2016.

DEPT. OF HEALTH PROPOSED REGULATIONS – SUMMARY OF KEY PROVISIONS   You can read the actual text of the proposed regs but please note that the changes are not indicated. If the link does not work, please cut and paste into your browser:  http://sos.ri.gov/documents/archives/regdocs/holding/DOH/MMP_PublicHearingDraft_7Nov2016.pdf

Here is a summary of the proposed Health Dept. changes followed by a summary of the DBR proposed regulations:

New limit and definition of “Wet marijuana” the harvested leaves and flowers of the marijuana plant before they have reached a dry usable state. Marijuana that has been dried to a usable state shall be assumed to have yielded twenty percent (20%) of the weight of the wet marijuana.

Wet flower weight  Dry Flower Weight (20% of wet)
12.5 oz. wet 2.5 oz. dry
25 oz. wet 5 oz.  dry
37.5 oz. wet  7.5 oz. dry
50 oz wet  10 oz.  dry

 

Conversion Tables to calculate edibles and concentrate equivalency.  The law says that a patient may possess 2.5 ounces of Usable marijuanameans the dried leaves and flowers of the marijuana plant, and any mixture or preparation thereof, (but does not include the seeds, stalks, and roots of the plant). These tables provide equivalencies that will count toward limit.

 

FLOWER WEIGHT  Equivalent number of 10mg edible units
   1 oz flower         83
 0.25 oz. of flower         21
    1 gram of flower           3

 

FLOWER WEIGHT   Equivalent grams of concentrate
  1 oz. flower         7.7
   0.25 oz. of flower          1.9
   1 gram of flower          0.3

 

 Expedited applications for chemo and hospice patients. Patients receiving chemotherapy or have been admitted to hospice will be expedited and their applications will be approved within seventy-two (72) hours.

 Patients and caregivers who grow must register grow locations with Health Dept and be subject to DBR regulations .

Authorized purchaser –   new category. Someone who is registered with the health dept. for the purpose of assisting a qualifying patient in purchasing marijuana from a compassion center. An authorized purchaser may assist no more than one patient, and is prohibited from consuming marijuana obtained for the use of the qualifying patient. Must be 21 years old, satisfy National Criminal Records Check, pay 100 registration fee for one year, but cannot cultivate. Can live out of state.

Caregivers can no longer reside out of state. Must be RI resident

 New requirements for physicians who sign applications:  The physician must obtain three (3) hours or equivalent of Category 1 continuing medical education (CME) regarding medical marijuana every two (2) years as part of usual CME requirement.

Patient Education: The certifying practitioner must document in the medical record and provide in written or verbal format, that patient was educated regarding maximum daily dose of active ingredient, minimum interval between doses, possible drug interactions – including risk of co-ingesting alcohol. The certifying practitioner must document after examination, the patient’s response to conventional medical therapies and explain the risks and benefits of the use of marijuana to the qualifying patient.  The certifying practitioner must be committed to the continual assessment of the patient and the patient’s response to the use of marijuana. This must be demonstrated through follow-up appointments, semi-annually at minimum, before the card is renewed. The practitioner will send updates to the primary care provider (if not the PCP), at intervals not to exceed twelve (12) months, documenting patients progress or experience using medical marijuana.

Before issuing a written certification, a certifying physician must review the Rhode Island Prescription Drug Monitoring Program, review the patients’ prescription history and make a judgement about the potential for drug interaction, adverse events or untoward clinical outcome from adding medical marijuana. Physician must document in the medical record a full assessment which means: history of present illness, social history, past medical and surgical history, alcohol and substance use history, physical exam and documentation of therapies with inadequate response.

Written comments on the above Health Dept. proposed regulations should be submitted to: James McDonald  by e-mail: James.McDonald@health.ri.gov.

DBR PROPOSED REGULATIONS The following is a summary of the key provisions of the new proposed DBR Regulations.  The proposed regulations are 80 pages long and you can read them at: http://www.dbr.ri.gov/documents/divisions/medicalmarijuana/Notice_MedicalMarijuana_Proposed_Rulemaking.pdf If the link does not work, please cut and paste into your browser. There are four sections: compassion centers, cultivators license and plant tags for patients and caregivers.

I. COMPASSION CENTERS (pages 1-31 of DBR proposed regulations) The new law requires that the responsibility for regulating the compassion centers be transferred from the Health Dept to DBR. It also authorizes DBR (with Health Dept) to regulate labeling and testing of MMj products. The proposed regulations provide the following specifics. Labels would have product weight, amounts of THC and CBD, all ingredients (for edibles), pesticides, type of extracts used including solvents or chemicals used in production, applicable instructions for use and storage.  Several warning labels would also be required. Containers must be child resistant.

Pesticides – only “minimal risk pesticides” are be permitted. Must qualify for “food use” by EPA standards. No pesticides for flowering plants.  Application of pesticides must be recorded on video. Must use best cultivation practices to limit mold, mildew, pests, pesticides, fungus, etc.

Mandated Outreach Activities to Educate Patients –  Centers would be required to provide Frequently Asked Question information sheets including option for how to use products, potential side effects, etc.  Centers may also be required to inform patients about changes in the MMj Program.

Purchasing from Cultivators – No purchasing from patients and caregivers after Jan.1, 2017.  Can purchase from licensed cultivators only, with whom they have formal agreements. Must pay cultivators within 60 days.

One year license/renewal – All licenses, including patient, caregiver, co-ops and cultivators will have one year cycle. DBR will conduct annual review of compassion centers and consider whether they are adequately providing patients at “reasonable rates”.

Financial interests- A compassion center and “key persons” could not have any “material  financial interest or control” in another compassion center, a cultivator, or a  licensed cooperative cultivation or vice versa. a compassion center may not have any material financial interest or control in a Rhode Island DOH-approved third party testing entity.

Note: specific requirements on testing are not included in this set of proposed regulations.

II. LICENSED CULTIVATOR (pages 32-60 of proposed regulations)

Can sell only to compassion center. Cannot be a caregiver.

Only Class A and Class B licenses will be available for the first years. Application fee is 5,000 dollars

Class A is a grow facility of 5000 sq ft or less. Annual licensing fee is 20,000 dollars. When seed to sale program is implemented, there will be no plant limit.  Until then it is 250 mature and 250 seedlings. Can have up to 5lbs of uncommitted dried usable.  Otherwise, all inventory must be under formal agreement with a compassion center.

Class B is a grow facility of 5001-10,000 sq. ft. with 35,000 dollar annual licensing fee. Until seed to sale program is implemented, the plane limit is 500 mature and 500 seedlings. Can have up to 10 lbs of uncommitted dried usable. Otherwise, all inventory must be under formal agreement with a compassion center.

A licensed cultivator and “key persons” thereof, may not have any “material financial interest or control” in another licensed cultivator, a compassion center, or a licensed cooperative cultivation or vice versa    Licensed cultivator may not have any material financial interest or control in a Rhode Island DOH-approved third party testing provider and vice versa.

Concentrates and edibles – may only receive medical marijuana and marijuana products from a Rhode Island registered compassion center if the receipt is pursuant to a written contract or purchase order for the cultivator to process the medical marijuana into a product to be furnished back to the compassion center.

Need zoning approval from local city or town for location and building.

May acquire clones from co-ops.

III. CO-OPS (pages 60-70 of proposed regulations)

The proposed regulations do not change the current rules regarding co-ops. They add to them as DBR implements new oversight and licensing requirements. If you currently have a co-op, we suggest you read the proposed regs from pages 60-70 in their entirety.

 Application fee for all co-ops is 25 dollars

Annual licensing fee for residential co-ops is 250 dollars

Annual licensing fee for non-residential co-ops is 500 dollars

These fees are in addition to the existing patient and caregiver registration fees and upcoming plant tag fees.

All documentation currently required (zoning approval or electrician affidavit, fire dept approval) must be submitted to DBR with list of members, d.o.b.s, MMP registration numbers, mailing addresses, email or phone numbers, evidence of ownership or landlord permission.

Non-residential co-ops must submit security plan and draft diagram of premises.

Must submit tax affidavit filled out by the “primary applicant” or legal entity who will hold the license stating compliance with RI tax obligations.

Must still register with state police or can have DBR register  with state police for you.

Co-ops and their key people cannot have a financial interest or control in another co-op, licensed cultivator, compassion center or vice versa.

Methods of extraction must be approved by DBR and fire dept. or fire marshal.

Residential Co-op possession limits stay at 24 mature plants and 24 seedlings, 10 ounces of dried usable and 50 ounces of wet.   Possession limits for marijuana possessed in mixed forms shall be calculated as a total equivalent to the maximum limit of dried usable marijuana in pounds in accordance with the equivalency conversion factors delineated in DOH Regulations.

Non-residential Co-op limit stay at 48 mature plants and 48 seedlings and 10 ounces of dried usable and 50 ounces of wet.   Possession limits for marijuana possessed in mixed forms shall be calculated as a total equivalent to the maximum limit of dried usable marijuana in pounds in accordance with the equivalency conversion factors delineated in DOH Regulations.

Licensed cultivators may acquire 12 clones per month from a co-op (no more than 8 inches long). Co-op may supply a maximum of two licensed cultivators with clones per month.

Co-ops are subject to reasonable inspections by DBR which could include local zoning officials.

DBR could assess fines or revocation of license for non-compliance.

 IV. PLANT TAGS FOR PATIENTS AND CAREGIVERS

All plants being grown by patients and caregivers must have tags by April 1, 2017.

A set of tags will cost 25 dollars. A set is for one mature plant and for one seedling.

Qualifying low income patients will be eligible for 12 sets of free tags.

Caregivers growing for a qualifying low income patient will be eligible for 12 sets of free tags.

The specific qualifications to determine who is eligible for free tags are not in regulations.

A caregiver must have at least one set of tags for each patient they are registered for.

Co-ops must have tags on all plants.

Tags must be renewed and paid for annually, unless income eligible for free tags.

Plants must be is secure indoor location with four walls and a roof.

Reasonable efforts must be made to control odors.

Tags will have patient or caregiver numbers on them with location of grow and expiration date of tags.

DBR and Health Dept will have access to tag data.

DBR will not inspect patient or caregiver grows unless DBR has reasonable basis to believe that a cardholder is not in compliance. In which case, DBR shall first send a letter stating concern. If no response after 10 days, DBR shall send another letter. If no response after 10 days, DBR may attempt an alternative way to contact such as telephone. If that is unsuccessful then DBR will make an effort to schedule an inspection in advance.  Non compliance could result in administrative fines or revocation of tags.

Written comments on the DBR proposed regulations should be sent to:   Norman Birenbaum  by email: DBR.MMPCompliance@dbr.ri.gov