Why is regulation in the U.S Medical Cannabis industry so important?
A new proposal for Medical Cannabis regulation in California has recently been published under the Medical Cannabis Regulation and Safety Act (MCRSA).
The purpose of this proposal is to regulate and license the commercial and Medical Cannabis market in California, which will surely be expanded to other U.S states in the future.
The majority of the new regulations deal with improved controls for the Cannabis market. The new regulations vision is focused on the protection of Californian residents using Cannabis for medical purposes. These regulations are intended to minimize risks associated with an unregulated, uncontrolled and insecure Cannabis market while closing gaps used by the illegal cannabis market. This is done by enabling better law enforcement to investigate crimes in a more effective manner, relying on solid data and documented evidence.
The new regulatory requirements are focused on improving the safety and efficacy of Cannabis products on the market. The new regulations also cover areas related to the Cannabis industry employee’s safety, health, quality of life and job security.
One of the most effective tools emphasized in the regulatory requirements several times relates to security, quality, distribution, transportation and dispensaries with a Track & Trace computerized system.
Quality Assurance implementation, via an effective Quality System, Good Security, Distribution, Manufacturing and Laboratory Practices (GSP, GDP, GMP and GLP) together with Cannabis products analysis and Quality Control testing will provide a high degree of assurance that Cannabis products reaching consumers will contain Cannabinoid concentrations as declared on product labels and that the final product is safe and pure. Controlled and well-defined packaging, storage, distribution, selling, and shipping processes will prevent harmful Cannabis products from reaching the market.
General regulatory requirements for Medical Cannabis
The general regulatory requirements related to the Medical Cannabis life cycle as a whole should include the following:
- Clear definitions of key statutory terms related to the new Medical Cannabis licensing program, including growers, manufacturers, distributors, dispensaries, laboratories, and transportation as a minimum.
- Clear checklist of terms, documentation, and information required for each application submission and license type.
- Clarification regarding specific prohibitions, pre-requisites and general conditions in order to comply with MCRSA
- Documented information on Cannabis products’ processing, manufacturing and packaging technologies.
- Documented proof of property ownership and approval for commercial activity in the Cannabis industry, local authority’s premises diagram, proof of bond, etc.
- Valid insurance policies for Medical Cannabis manufacturing, selling, distribution, transportation etc.
- Labor peace contracts, job description and employee’s and managers qualifications
- Fingerprint submission documentation.
- Documentation center and recordkeeping methodology, procedures and archives.
- Validated Track &Trace system.
- Security, protection systems and procedures.
- Rejected, adulterated and returning Cannabis products destruction procedures in order to avoid non-safe and defective Medical Cannabis products reaching an illegal or unregulated market or the public.
Regulatory requirements for Medical Cannabis Distributors
- Medical cannabis products should be distributed in a safe and secure manner throughout all relevant stages such as storage, handling, testing, analysis, and packaging.
- Medical Cannabis distributors should keep and maintain records that conform with data generated from the Track & Trace system, to prevent untested or rejected Medical Cannabis products reaching patients and illegal or unregulated bodies.
- Information about the licensee from whom Medical Cannabis products were supplied including quantities, data and batch numbers.
- Information about the internal and external Quality Control (QC) testing lab certifications, license number, lab analysts, accuracy and validity of test methods, the weight of samples were taken for each analysis, etc.
- Information about Medical Cannabis product such as transaction date, product type, quantity, distributor info from manufacturer to dispensaries, transporter info, license number, vehicle information and other relevant information entering into the Track & Trace system.
- Destruction of Medical Cannabis products by the distributor should be defined separately in destruction procedures and assurance for execution for his own goods as well as for other licensee’s goods.
- The distributor is responsible that Medical Cannabis products are stored and handled properly and in controlled conditions such as temperature, relative humidity, light intensity, etc.
- The distributor is not allowed to receive unpackaged Medical Cannabis products and to package or label these products in-house or via a third party. Medical Cannabis products packaging should be performed in a controlled manner by the manufacturer only.
- The distributor should have sampling procedures in order to assure Medical Cannabis products sampling is being performed properly and in an arbitrary, statistical and representative manner. Sampling should be performed professionally and in clean areas in order to avoid contamination of the batch as a result of improper sampling activity. Sampling activities should be well documented, samples should be labeled and sampling should be supported by documented evidence such as a second employee as a witness or video recording.
- Each Medial Cannabis product type and strength should have formal release specifications that should be met in order to release the product to the market.
- Medical Cannabis distributors should establish and manage a controlled documentation and record system that will enable the effective traceability of the products, minimizing the risks of untested Medical Cannabis products reaching legal and illegal markets.
Regulatory requirements for Medical Cannabis Transporters
- Medical Cannabis products should be kept in a securely locked box placed in the interior of the vehicle during transportation.
- An alarm system should be installed in all Medical Cannabis transportation vehicles.
- Medical Cannabis transportation vehicles should not be driven outside residential neighborhoods.
- Recreational Cannabis products should not be transported together with Medical Cannabis products.
- Medical Cannabis dispensaries can deliver their own goods by themselves in cases where all requirements have been implemented properly.
- Transporters can store Medical Cannabis products for a limited duration in cases stored under the proper storage conditions.
- Licensed Medical Cannabis drivers and passengers should be older than 21.
- Documents and record keeping, management, control and full integration with the Track & Trace system should be demonstrated.
Regulatory requirements for Medical Cannabis Dispensaries
- Dispensaries have to receive Medical Cannabis products from licensed distributors only.
- Medical Cannabis products should be delivered from the manufacturer to the dispensary by licensed transporters only.
- Dispensaries should have a validated and functional Track & Trace system.
- Dispensaries have to assure all Medical Cannabis products sold are to legally certified patients only.
- Patients who go to the dispensary to purchase Medical Cannabis should arrive with I.D and with their physician’s recommendation or primary caregiver authorization.
- Dispensaries are authorized to sell only Medical Cannabis products that meet all these specifications.
- The maximum batch size of Medical Cannabis should be defined and limited.
- Security cameras should be installed in the dispensary. The recommended technical specification should be 1280 x 1024 resolution at 20 frames per second as a minimum in addition to video records keeping for at least 30 days.
- Dispensary delivery employees must not consume cannabis during deliveries.
- Medical Cannabis products should be stored in environmentally controlled conditions in order to prevent product adulteration, spoilage, contamination or degradation. Product storage conditions should be specified on product labels based on stability study data.
- Medical Cannabis products that have been returned from the market by a patient or primary caregiver must not be reprocessed or re-marketed.
- The dispensary should include an access control system and only authorized personnel will be allowed to enter the dispensary.
- Dispensaries should limit the quantity of Medical Cannabis items used for display and limit dispensary opening times in order to minimize the risk of robbery and theft.
- Dispensaries should manage their Medical Cannabis inventory carefully and conduct inventory reconciliation on a weekly basis.
- In cases of unexplained Medical Cannabis loses, dispensaries should report to law enforcement and the bureau.
- Dispensaries should prohibit free of charge samples to clients or patients.
- Reserved samples from every batch should be kept in order to enable investigation and analysis in the case of quality and safety issues or customer complaints were reported.
About Cannabis GxP consultancy
Cannabis GXP is proud to stand at the forefront of the Cannabis industry in Israel and worldwide thanks to many years of experience in these areas.
Our team is compelled to spread the message of the importance of cannabis science, regulation and standardization as the world enters a new era of cannabis legislation.
We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.
Our vast expertise allows us to assist companies in a wide range of services and needs: Anything from Cannabis R&D, growing and manufacturing, new products development, facility design, technology, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP/GCP), staff training, local and global regulations.
Cannabis GxP is a subsidiary company of Bio-Chem Ltd. (2007), a consultancy firm for the Pharmaceutical field, medical devices, Cosmetics and food supplements industry based in Israel.
Our cannabis consultancy services include:
- Product development, delivery system & clinical trials
- Growing, Manufacturing and Lab Facilities Design
- Quality Assurance and Good Practices (GxP)
- Cultivation & Product Manufacturing Technology
- New product Regulations and Submissions
- Qualification & Validation
- Risk Assessment
- Staff training
If you need one or several of our services, we will be more than happy to assist.
Please do not hesitate to contact us for further information.