New Record Keeping Requirements for Colorado Facilities + Other Important Notices 2019
New Record Keeping Requirements for Colorado Facilities + Other Important Notices
On January 1, 2019 – New Regulations went into effect in Colorado. One of the new rules implemented is for two facility types: MIP Producers and Cultivation facilities. It is called a “Designated Sampling Manager”. This will allow managers – who are designated in METRC as the sampling manager to sample products from a licensed facility’s designated sampling units.
This is not a free for all by any means and it is tracked tightly in METRC for each facility type. This still means absolutely NO consumption on site at any facility in the State of Colorado.
Since we are covering regulations in this newsletter, we need to make a disclaimer, this is NOT legal advice nor are we lawyers. This is to educate and create awareness for licensed facilities in Colorado in order to engage in compliance.
At ICS Consulting, we perform third party compliance facility audits regularly, and the most common violation is Record Keeping and Standard Operating Procedures (SOPS) due to new rule changes that take place in January every year.
Sampling Managers, every facility type, MIPs and OPC’s have their own allotted amounts of product a sampling manager may sample each month from a sampling unit. Not only is it tracked in METRC, and every facility is now required to have Standard Operating Procedure for it, but also adhere to packaging and labeling requirements for the sampling unit, and record keeping requirements.
Here is a list of what is required for Record keeping requirements
(OPC & MIP – Medical & Retail Licenses)
- Shall maintain copies of any material documents created regarding the quality control and product development purpose(s) of each Sampling Unit.
- At a minimum, a Facility shall maintain records that show whether a Sampling Unit Transferred to a Sampling Manager is for the purpose of quality control or product development.
- Facility shall also maintain copies of the Facility’s standard operating procedures provided to Sampling Managers.
- You must have SOPs that establish protocol and procedures required in the regulations for the sampling manager to follow.
- Also noted in the new regulations – You are responsible for updating SOPS for your facility as necessary to reflect accurately any changes in the relevant statutes and rules.
- We recommend updating or adding this to your record keeping compliance binder or your SOP binder.
For additional information on where these new rules are located. See Rule References: M/R 901, M/R 503, M/R 507, M/R 603, M/R 607
Click Here to read new regulations that went into effect on January 1, 2019.
On December 3rd, 2018 a Statement of Position was released on the MED website on the “Definition of Kief” and the Marijuana Enforcement Division proposed a new definition of Kief and new requirements for potency testing of Kief.
To read Statement of Position Click Here.
If your Manufacturing facility falls under the definition of an “Audited Product”You need to follow specific procedures for this product in your licensed facility.
MED Definition of an “Audited Product” means a Medical/Retail Marijuana Product with an intended use of: (1) metered dose nasal spray, (2) pressurized metered dose inhaler, (3) vaginal administration, or (4) rectal administration. Audited Product types may raise public health concerns requiring additional safeguards and oversight. These product types may only be manufactured and Transferred by a Medical/Retail Marijuana Products Manufacturing Facility in strict compliance with Rule M/R 607. Prior to the first Transfer of an Audited Product to a Medical/Retail Marijuana Store or Medical/Retail Marijuana Cultivation Facility that has obtained a Centralized Distribution Permit, the Medical/Retail Marijuana Products Manufacturing Facility shall submit to the Division and, if applicable, to the local jurisdiction an independent third-party audit verifying compliance with Rule M/R 607. All rules regarding Medical/Retail Marijuana Product apply to Audited Product except where Rules M/R 607, 712, 1002-1, and 1003-1 apply different requirements.
Click Here for the Audited Product Attestation Form Necessary for Compliance with Rule 607.
Also, on December 3rd and MED Industry Wide Bulletin 18-11 was released.
“LABELING OF UNIVERSAL SYMBOL ON SEALED VAPORIZER CARTRIDGE, DISPOSABLE VAPORIZER PEN, OR SYRINGE‐TYPE DEVICE WITH AN INTENDED USE THAT IS LISTED IN MED RULE M & R 1003‐1”
We hope this helps support your facility in accessing and being made aware of information to further educate what is required in your licensed facility. We understand that regulations can pile up and overwhelm facility managers and owners – especially with new implementation requirements.