Does Virginia Require Testing for Marijuana and Marijuana Products?
The Administrative Code of the Commonwealth of Virginia necessitates the testing of all cannabis produced and dispensed in the state. Post-processing and prior to the dispensing of any cannabis products, a sample must be made available from each batch of products for laboratory testing. An employee of the laboratory shall be allowed to select samples for testing. The samples made available must represent the entire batch and be enough to carry out all required laboratory tests. The laboratory will;
- Test for microbiological contaminants, mycotoxins, heavy metals, residue solvents, pesticide residue, water activity, and moisture content.
- Conduct an analysis on the active ingredients for each batch and terpenes profile.
A retail dispensary cannot sell any cannabis product until a licensed laboratory in the state has completed testing and issued a certificate of analysis.
Virginia adult-use cannabis laws establish a marijuana testing facility license that enables the license holder to test marijuana and marijuana products. Testing facilities are also able to research and develop marijuana products. The Cannabis Control Authority (CCA) will not adopt any regulations for the procedures regarding cannabis business licenses until July 1, 2022.
Does Virginia License Independent Marijuana Testing Facilities?
The Cannabis Control Authority (CCA) has not yet adopted any recommendations on processes regarding the testing of marijuana or marijuana products. However, the Administrative Code of Virginia mandates that any laboratory or facility that tests controlled substances must possess a controlled substances registration certificate. The Department of Health Professions is mandated to give licenses to laboratories in Virginia for specific purposes. The Board will give a controlled substances registration certificate to any state-run or private laboratories that meet the eligibility requirements specified by the Code.
For a laboratory to be eligible to test marijuana and marijuana products in Virginia, the laboratory must:
- Be independent of persons involved in the cannabis industry in Virginia. Any persons associated with the laboratory can have no direct or indirect interests in cannabis businesses in Virginia.
- Employ at least one individual who will be responsible for the testing processes. The individual must possess a college/university degree that is at least:
- Advanced degree in any chemical or biological sciences with a minimum of two years post-degree experience.
- Bachelor’s level degree in chemical or biological sciences with a minimum of four years post-degree experience.
- Provide proof of accreditation in accordance with the most current version of the ISO/IEC 17025 standards for testing and calibration.
- Possess a controlled substances registration certificate from the Department of Health Professions.
What Type of Accreditations Do Marijuana Testing Facilities Need in Virginia?
Testing facilities in Virginia that need to handle controlled substances must obtain a controlled substances registration certificate from the Board of Pharmacy. Facilities applying for this certificate must provide proof of accreditation for testing and calibration in the most current version of ISO/IEC 17025. This accreditation is a company-level standard established by the International Standards Organization (ISO). It is known as “General Requirements for the Competence of Testing and Calibration Laboratories.” Laboratories in Virginia must possess this accreditation to certify that they have met the management and technical standards of ISO 17025. As such, the laboratories are certified competent to operate and generate valid results. The International Electrotechnical Commission (IEC) also regulates this standard with the ISO.
ISO/IEC 17025:2017 is the most current version of this standard and was published in 2017. A laboratory facility must comply with a defined set of requirements to meet the ISO/IEC 17025:2017 standards for accreditation. These requirements are:
General Requirements - This defines the requirements on:
- Impartiality - The laboratory can have no conflicts of interest. Risks to impartiality must be identified continuously, and corrective measures must be implemented (and documented) to eliminate these risks.
- Confidentiality - All data created or derived in the laboratory is proprietary and confidential unless required by law. The laboratory is responsible for the management of the data, and customers must be given prior notice before their information is shared with third parties.
Structural Requirements - The laboratory facility must document all procedures and processes involved in their activities. All equipment to be utilized in the laboratory must be included in the scope of the accreditation. The laboratory facility must also define and document the following processes to comply with the requirements;
- Organizational structures
- Management and their responsibilities
- Personnel responsibilities
- Laboratory activities
Resource Requirements - These requirements involve:
- General resources - These concern the standards for personnel, facilities, equipment, systems, and support services. All internal and external personnel must be competent and impartial.
- Personnel - All personnel in the facility must function within the laboratory organizational system structure, and job functions must be adequately documented. Duties, responsibilities, and authorities must be communicated by management to personnel on a regular basis via meetings and performance reviews.
- Facilities and environmental conditions - Laboratory conditions must be controlled, monitored, recorded, and documented always. The facility must be capable of performing all laboratory activities without compromising the accuracy and validity of the test results.
- Equipment - Proper equipment must be readily available and easily accessible for the performance of laboratory activities.
- Metrological traceability - Metrological traceability of all test results must be established and maintained by the laboratory.
- Externally provided products and services - The laboratory can only utilize externally provided products and services that are compliant with the standards. The laboratory must have a process for establishing this compliance and maintaining the records.
Process Requirements - These include the requirements for different laboratory processes:
- Review of requests, tenders, and contracts - The laboratory must have defined processes for the review of proposals, tenders, and contracts.
- Selection, verification, and validation of methods - The laboratory must use the appropriate techniques and procedures for these processes.
- Sampling - The laboratory must have a defined sampling plan and method.
- Handling - The laboratory must have defined procedures for transporting, receipt, handling, storage, retention, and disposal or return of test items.
- Technical records - All technical records in the laboratory must contain results, a report, and information to facilitate the retention of results and repetition of lab activities.
- Evaluation of measurement uncertainty - The laboratory facility must evaluate measurement and testing uncertainties and identify the contributions to these uncertainties.
- Ensuring the validity of results - The laboratory facility must have established procedures for monitoring the validity of results, which is a top priority of ISO/IEC 17025:2017 accredited laboratories.
- Reporting of Results - This covers the presentation of the different types of reports of the results of laboratory activities. It defines the following:
- Common requirements
- Specific requirements for test reports
- Specific requirements for calibration certificates
- Requirements for report sampling
- Requirements for reporting statements of conformity
- Requirements for reporting opinions and interpretations
- Requirements for amending reports
- Complaints - The laboratory must have a documented process for managing customer complaints. This process must encompass the receipt, evaluation, and complaints resolution.
- Non-conforming Work - The laboratory must have procedures in place that must be implemented if activities and results do not conform to normal procedures or agreed customer requirements.
- Control of Data and Information Management - The laboratory must ensure adequate access to data and information required for its activities. The information management system must be validated for functionality, and personnel must have access to manuals, instructions, and reference data relevant to the management system.
Management System Options - Facilities must implement a management system capable of supporting all the requirements. The system must also demonstrate a commitment to the established standards. The management system can follow either Option A or Option B;
- Option A - Management systems that follow this option must address the following:
- Management system documentation
- Control of management system documents
- Control of records
- Actions to address risks and opportunities
- Corrective actions
- Internal audits
- Management reviews
- Option B - This option states that a laboratory facility’s management system is compliant if:
- It has established and maintained a management system compliant with the requirements of ISO 9001:2015
- The laboratory facility is capable of supporting and demonstrating the fulfillment of the requirements of ISO 17025:2017
- The laboratory facility has fulfilled the requirements for the management system documentation and management reviews.
How to Get a Marijuana Testing Laboratory License in Virginia
The Cannabis Control Authority (CCA) has not yet adopted any recommendations on the procedures for obtaining licenses for any cannabis-affiliated businesses, including marijuana testing facilities. Rules and procedures governing cannabis business operations can not be adopted until the laws are re-enacted in 2022.
However, to obtain approval to test marijuana products in Virginia, the laboratory must possess a controlled substance registration certificate from the Board of Pharmacy. This will be in addition to whatever procedures the CCA will adopt for obtaining a marijuana testing facility license. Marijuana is still a controlled substance in Virginia, and any facility that possesses controlled substances must be duly inspected and certified by the Board.
To obtain a controlled substance registration certificate, complete and submit the Application for a Controlled Substances Registration Certificate form to:
Department of Health Professions
Board of Pharmacy
9960 Mayland Drive,
Henrico, VA 23233
The applicant will need to provide certain information in the application, including;
- The type of activity to be conducted in the facility
- Information about the facility’s responsible person
- Information about the facility’s supervisory practitioner
- Inspection information
- Ownership details, including names and contact addresses
There is a $120 application fee that must accompany the form submission, payable to the Treasurer of Virginia. The facility must also undergo an on-site inspection by the Board on an agreed-upon date before they can receive their registration certificate. This is to verify the actual state of the laboratory corresponds with the information provided on the application form. Applications for controlled substances registration certificates are valid for one year.
How Much Does a Marijuana Testing Laboratory License Cost in Virginia?
No costs have been instituted for the different marijuana facility licenses available in the Commonwealth of Virginia from the Cannabis Control Authority (CCA). As such, there is no established fee for the procurement of a marijuana testing facility license presently.
Are there Local Regulations for Cannabis Testing Facilities in Virginia?
Laboratories in Virginia that are eligible to apply for a cannabis testing facility license must possess a controlled substances registration certificate from the Board of Pharmacy. To obtain this certification, the lab must have complied with all state and local regulations on air quality, odor control, chemical exposure, and ventilation requirements. It should be noted that no recommendations regarding the regulation of cannabis facilities in Virginia have been adopted by the Cannabis Control Authority (CCA).