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"
In case you missed this important bulletin Click Here to read more.
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.
|
|
|
Third Party Audits
ICS Consulting Service is ready to go with our Third Party Auditing Services. All of our Audits are updated to reflect all new January 1, 2019 regulation changes.
How Your Business Will Benefit
Having a third-party audit shows the State that you take complying seriously and are willing to put in the extra effort to strive for excellence on the scale of compliance. An audit creates an on-going culture of compliance in your facility, this culture then spreads into the environment in which your employees work in every day. Audits minimize violation infractions from the State, which could cost you money in the end if you get a fine that could have been caught by doing an audit. We recommend quarterly or yearly third party audits for all licensed facilities.
We can audit the following Medical and/or Retail facilities: (Nationally)
- MIPS (Manufacturers)
- Cultivation
- Dispensary
- Transporter
Also included in our on-site assessments, Labeling and Packaging Audit, Health and Sanitation, Product Handling and Safety, OSHA Compliance.
|
|
|
Upcoming PPE Cultivation Training
We highly recommend this training, if your facility is utilizing any chemicals in your facility that requires PPE.
Personal Protective Equipment for Cannabis Cultivators
Tuesday, February 19, 2019
9:00am–3:30pm
CU Anschutz Medical Campus, Fulginiti Pavilion
13080 E. 19th Ave., Aurora, CO 80045
Join the Center for Health, Work & Environment, the 3M Personal Safety Division, and the Colorado Department of Public Health and Environment for a training on personal protective equipment (PPE) for cannabis cultivation workers. This training will cover PPE regulations and feature demonstrations by experts in audiology, respiratory protection, dermal protection, and more. Anyone working in the cannabis cultivation industry is encouraged to attend.
Breakfast and lunch are included. Early Bird Tickets $25 Before Feb. 1rst
|
|
|
ICS Webinar Series
We hope everyone had a Happy New Year! We felt like welcoming in 2019 with rolling our sleeves up and jumping into employee retention.
This is an common industry issue and felt it was important to start a conversation about it.
Join us January 30th, 2019 @ 11AM MST for our FREE Webinar
"How to Prevent the Employee Talent Drain"
* Assessing your compliance & overall workforce culture
* Identifying the issues
* How to change the culture for the better
* Tips on how to make internal improvements (even on a small budget)
* How losing employees can cost you more money then it does to retain them
|
|
|
Speaking Opportunities
ICS Consulting CEO was invited to be a guest speaker this past December in Boston, at the International Cannabinoid Derived Pharmaceuticals Summit. We were extremely honored to be asked and had the amazing opportunity to meet a diverse range of people from around the globe, including Doctors, Pharmacists, Bio-Chemist, CBD enthusiast, Hemp and Cannabis Growers and Cannabis Experts. It is truly amazing to see all the different ways the Cannabis plant can be utilized and hearing everyone's unique connection to it.
If you are looking for a speaker at your upcoming event or conference, reach out to request a booking.
|
|
Have a Topic You Would Like To Hear On Our Next Webinar?
Let us know! Reach out, send an email or message us. If there is a topic you wish to be covered in one of our upcoming FREE webinars - Feel free make a suggestion.
|
|
|
|
Jenny Germano, the CEO of ICS Consulting, is a long time industry vet. Seeing the industry in Colorado go from an unregulated wild, wild, west in 2009 to the strictly regulated market of 2019, has taught her the importance of understanding regulation and protocol.
|
|
|
|
|
