Intended Uses
These are the four rules (2 M, 2 R) governing intended uses, audited products, and alternative products.
What are rules M 607, M 1003-1, R 607, and R 1003-1?
July 1, 2019
When do all vertical integration requirements for medical marijuana businesses end?
(Currently, the VI minimum has been raised from 30% to 50%, excluding trim)
With this in hand, a marijuana cultivation may temporarily store marijuana concentrate and products received from a MIP for the sole purpose of Transfer to a commonly owned Center/Store.
What is a Centralized Distribution Permit?
Any roots, stalks, and stems of a marijuana plant (called _____ _______) may be trasnferred to an ________ ________ ________ ________.
What are Fibrous Waste and Industrial Fiber Products Producer?
Lists permissible levels of contaminants, which sometimes vary based upon the intended use.
What is Rule 712(E)?
(Rule 1501(C) lists which contaminant tests are required. The required tests now include requierd metals testing.)
(Also per 1503(C.1), Kief, which is now defined, must undergo potency testing as often as concentrate (every Harvest Batch).)
These are the intended uses for audited products. (They are not the traditional intended uses: smoking/vaping; oral consumption; skin and body products.)
What are metered dose nasal sprays; pressurized metered dose inhalers; vaginal administration; or rectal administration?
Authorization to grow between 500 and 1500 medical marijuana plants.
What is a Class 2 Production Management Class?
(for comparison a Tier 2 Production Management Tier is authorized to grow between 1801 and 3600 retail marijuana plants)
Allows a medical or retail marijuana manufacturer or cultivation to share a single Licensed Premises with a Marijuana Research and Development Licensee.
What is an R&D Co-Location Permit?
An Associated Key Licensee or a Key Licensee may be designated by a cultivation or MIP for this privilege.
What is a Sampling Manager authorized to receive Sampling Units?
SLA may order this to verify that marijuana (or concentrate or product) does not pose a threat to public health and safety, after the MED, in consultation with CDPHE, finds that the marijuana contains one or more substances known to cause harm or that could be toxic as consumed under the intended use.
What is an independent third-party review? (note: under Rule M/R 712)
The MIP must have products liability insurance, must follow packaging and labeling requirements in accordance with the Rule 1000-1 series, and must comply with adverse event reporting requirements.
What are the conditions to allow MIPs to transfer an Audited Product between January 1, 2019 and June 30, 2019 without fully complying with the new rules (Rules M and R 607)?
(Note the MIP also must certify it will be in full compliance with all parts of Rules M/R 607 by July 1, 2019)
The Licensee cultivated an average of 90% of its average authorized plant count and Transferred at least 90% of its inventory produced during the prior 180 days.
What are the minimum requirements to APPLY for a 2-tier increase for indoor grows/grows with more than one harvest season?
(and then must meet other requirements)
(different percentages are required for a one tier increase)
Any entity and all individuals within the entity responsible for taking possession of, operating, managing, or controlling a Medical Marijuana Business or Retail marijuana Establishment.
Who must have a Temporary Appointee Registration?
(The registration is deemed effective as of the date of court appointment. Then appointeee must timely notify MED & apply for a finding of suitability. By contrast Operators need only notify of appointment and notify the court of SLA action.)
1. May not in one month exceed one ounce of marijuana or 8 g of retail marijuana or 15 g of medical marijuana concentrate or 14 servings of marijuana product;
2. May not be used as compensation;
3. May not be consumed on-premises.
What are some restrictions that apply to Sampling Units provided to Sampling Managers?
Two enforcement tools that do not constitute disciplinary action, but that may be used as evidence of the fact that the enforcement tool was utilized.
What are written warnings and AVCs?
(1200 Series - not 1300 Series)
The process for gaining approval to manufacture a marijuana product that is intended to be used by intravenous drip.
What is an application for an Alternative Use Designation?
(The State Licensing Authority grants the Alternative Use Designation in consultation with the Colorado Department of Public Health and Environment)
These two scenarios are exceptions to THIS RULE:
1. Collapse of two medical or retail cultivations through an approved change of location application, or
2. Continued operation of medical cultivations that do not have Identifical DBIO Percentages.
What is the rule that only one medical OPC and only one retail cultivation facility may be permitted at each location?
The suspended DBIO may not participate in control of the marijuana business.
What happens when one DBIO is summarily suspended but the business has other DBIOs who were not subject to the summary suspension?
See Rules M/R 204
A provisional certification or temporary exemption from this accreditation requirement may be granted for up to 12 months.
What is ISO/IEC (International Organization for Standardization/International Electrotechincal Commission 17025:2005 Standard) for testing facilities?
Certification for mycotoxin testing is required beginning July 1, 2019 for any marijuana testing facility wishing to obtain this type of certification.
What is certification for Pesticide testing?
(1) before the first Transfer of Audited Product to a Store/Center; (2) prior to Transfer of any Audited Product following a Material Change to any SOP or master formulation record; and (3) with renewal.
When must a written audit report be submitted?
(It must come from an independent third-party auditor, it must be completed within the last 24 months, and it must be submitted to the Division and, if applicable, the local licensing authority.)
May possess the number of ounces of medical marijuana (excluding concentrate/product) that equals the greater of 2x the aggregate ounces allowed to its patients or the total ounces transferred to patients over the prior 30 days.
What are the new possession limits of a Medical Marijuana Center?
(Beginning July 1, 2019)
This person must update its curriculum within 30 days of a change to the Medical Code, Retail Code, or rules.
An Immature Plant that has not been exposed to a chemical prohibited by Rule M 504(F) and (H).
What may a Licensed Research Business Transfer to another Medical Marijuana Business?
1. Arrest(s) or charge(s) of a criminal offense that is not actively pending;
2. Conviction of a criminal offense for which a pardon, sealing, or expungement occurred;
3. Conviction of a criminal offense in which a court issued an order of collateral relief specific to the application for state licensure.
What may not be considered when MED evaluates whether an individual is of good moral character?