20 comments
I. 18VAC110-60-285. Registration of products and 18VAC110-60-290. Labeling of batch of cannabidiol oil or THC-A oil products.
Support the deletion of naming of the "products" or "batches", however there is still concern with naming by "Brand" name if same brand also manufactures or sells cannabis for recreational use.
II. 18VAC110-60-110 through 130.
For safety and security of employees, the public and adjacent neighbors, the Emergency Regulations should require Permittees be be housed in free-standing buildings, not multi-tenanted buildings with shared demising walls and parking areas. Fire safety, noxious odors, personnel safety, facility security, are all compromised with shared tenancy.
To discourage promotion of recreational use, the Emergency Regulations should require that applicants should be isolated from residential development, much like the stipulated minimum distances from schools (1000'). Average families may not care to distinguish between medical and recreational use and may not wish to be exposed to traffic generated by medical cannabis users, security risks, etc…
III. 18VAC110-60-330. Disposal of cannabidiol oil or THC-A oil.
The Regulations are not specific enough regarding acceptable methods of disposal (incineration, mulching/composting/disposal). Rather than run afoul of a subjective standard, Processors would appreciate further detail as to which methods of disposal are acceptable to the Board. Further, in the event disposal where time is of the essence, e.g., contamination of plant material, please stipulate availability of Agent of the Board.
IV. Preference to Virginia Applicants. The Emergency Regulations should stipulate a preference for applicants owned of 51% or greater Virginia residents. This should be an industry by Virginians for Virginians.
VI. Avoidance of Monopoly. Permittees should not have interest in more than one Processing Permitee, creates a monopoly and inhibits fair trade.
VII. Regulations should stipulate that Permits should be renewable automatically upon compliance with Regulations and payment of Fees. Permits should be renewable automatically upon the payment of fees if inspections are obtained and in absence of infractions to Regulations. Significant investment in infrastructure requires objective renewal standard (vs. discretionary renewal.)
"Temperature and Humidity”
The proposed regulations state that the temperature for growing cannabis when the growing lights are on should be between 77-85 degrees. This is an appropriate temperature range for when the growing lights are on and the plants are growing. However, the proposed regulations do not mention the temperature for when the lights are off. For optimal plant health, the temperature for when the lights are off and the plants are sleeping is 10 degrees under what the set temperature was for when the plants are growing and lights are on. So if the daytime lights on growing phase is set at 81 degrees then the lights off night temperature should be at 71 degrees.
Regulations regarding Pharmacist-in-charge (18VAC110-60-170) must be retained as they are essential to safe therapeutic use of medical cannabinoid products.
In 18VAC110-60-C, clarify that continuing inservice training may be conducted by an external organization accredited by the American Council for Pharmaceutical Education.
Section 18VAC110-60-220. A.2 "Sell, deliver, transport or distribute Cannabis, including cannabidiol oil or THC-A oil, to any other facility;" and A.4 "Provide cannabidiol oil or THC-A oil samples" should be revised to allow delivery and/or samples to qualified external laboratories for testing.
Sections relating to pharmacist-on-duty and pharmacist-in-charge should be revised to allow a pharmacy student intern to work in the facility under the direction of the pharmacist.
In order to ensure that all patients benefit from comprehensive medication management provided by a pharmacist who is part of a health care team, Pharmacist-in-charge must be part of Section 18VAC110-60-170.
To encourage research and discovery that enhances patient care, Section 18VAC110-60-220. A.2 and A.4 should support delivery to laboratories for use in research.
Currently, pharmacy students are allowed to perform all the duties of a pharmacist as long as they are under a pharmacist's supervision. We suggest you revise sections regarding pharmacist-on-duty and pharmacist-in-charge to allow pharmacy students to work under the supervision of a pharmacist at all facilities that have received a pharmaceutical processor permit.
In Accordance to section B, "Immediately prior to producing any cannabidiol oil or THC-A oil product, a pharmaceutical processor shall segregate all harvested Cannabis into homogenized batches. A pharmaceutical processor shall make a sample available from each batch for a laboratory to test for microbiological contaminants, mycotoxins, heavy metals, and pesticide chemical residue, and for purposes of conducting an active ingredient analysis."
I suggest that "samples" (i.e., more than one sample) be made available due to the need most likely for more than one laboratory to perform all tests. Secondly, the storage of a small sample size may require additional requirements beyond a secure, cool, dry place (i.e., humidity and temperature controlled environment) to ensure stability.
E. The processor shall require the laboratory to immediately return or properly dispose of any Cannabis upon the completion of any testing, use, or research.
Suggest that Cannabis be specifically defined or add in "all cannabis products or materials".
Under section A, suggest adding the following requirements:
1) Laboratory must have at Schedule I Analytical Laboratory licensure throught the VA Board of Pharmacy and registration with the Drug Enforcement Agency.
2) Laboratory must utilize validated methods such as ICH guidelines for method validation, USP, or equivalent.
Under section A or B, all cannibis products (or materials) should have established stability and storage requirements prior to and under packaging conditions. Testing for microbiological and active ingredients should be considered.
Suggest that "practitioner" include DVM.
Current methods, or standardized methods do not yet exist however all extractors should be; a) professionally designed, b) peer reviewed, and c) closed loop hydrocarbon extractors, or other extractor deemed safe and acceptable in chapter 38 of NFPA 1.
Substance Abuse Free Environment, Inc. (SAFE), is a non-profit substance abuse prevention coalition serving Chesterfield County since 1999. Our mission is to engage key community stakeholders in working together to prevent and reduce substance abuse. www.chesterfieldsafe.org
SAFE provides this public comment in response to permanent adoption of Virginia Board of Pharmacy New regulations Chapter 60, Regulations Governing Pharmaceutical Processors and states:
If the Virginia Board of Pharmacy does pass these new regulations, the following changes should be made:
Contact Information:
Regina Whitsett, SAFE Executive Director, 804-694-7794, whitsett@chesterfieldsafe.org
Community Coalitions of Virginia (CCoVA) is a non-profit organization that consists of representation from substance abuse prevention coalitions across the state. CCoVA works collaboratively to prevent and reduce substance abuse and related risk factors in Virginia communities in ways that are measurable and improve quality of life. www.communitycoalitionsofva.com
Community Coalitions of Virginia provides this public comment in response to permanent adoption of Virginia Board of Pharmacy New regulations Chapter 60, Regulations Governing Pharmaceutical Processors and states:
Marijuana and its extracts are dangerous and addictive illegal Schedule 1 drugs according to federal law and the DEA.
The Virginia Board of Pharmacy is violating federal law by setting up marijuana growers and dispensaries.Virginia law nor the board’s regulations preempt federal law.
CBD-THC-A-THC oils are not FDA approved medicines.
There are already FDA approved drugs (dronabinol and nabilone) available that contain THC and parallel the effects of marijuana.
Epidolex is now an FDA approved medication that is available to treat intractable epilepsy patients. Treatment options already exist for other illnesses covered in these regulations.
FDA approved drugs are the only way to ensure proper recommended dosage and patient safety through side effect and drug interaction warning labels.
It is medical malpractice for physicians to provide written certification for the promotion and use of marijuana as a medicine in the form of CBD-THC-A-THC oils without FDA approval because there is not sufficient scientific evidence of the benefits and effects on patient safety are unknown.
It is ethically inappropriate for pharmacists to grow and dispense CBD-THC-A-THC oil without sufficient research on dosage and interactions.
Attorney General Jeff Session has reversed the Cole Memo, now instructing federal law enforcement to enforce federal law with regard to marijuana manufacturing and possession.
Increased access to marijuana oils may contribute to increased usage in 12-17 year olds. (The National Survey on Drug Use and Health reports, SAMHSA 2016)
Marijuana usage, including oils, is linked to mental illness and opioid use.
If the Virginia Board of Pharmacy adopts these new permanent regulations, it will further open the door to marijuana legalization in Virginia.All states that have legalized marijuana began with medical marijuana.
Revenues collected from marijuana do not outweigh the negative impacts on public safety, public health, the workplace, academics, health, black market and natural resources.
If the Virginia Board of Pharmacy does pass these new regulations, the following changes should be made:
On page 2, Registered Patient definition should be “to receive” not “for dispensing of”.
On page 3, Registration fees for practitioners should be higher than patients’ fees.
On page 11, B.2, should also include within 1,000 feet of a church.
On page 24, 1., 12 plants per patients is too high.Other states that have medicinal marijuana laws or marijuana legalization have a limitation of 6 plants per patients.
Contact Information:
Mary Crozier, CCoVA Chair, 252-864-1478, mkcrozier@gmail.com
Keri Jones, CCoVA Legislative Chair, 540-332-3806, joneskd@ci.staunton.va.us
Keenan Caldwell, KC3 Consulting, LLC, 804-937-2673, kc3consulting@outlook.com
Regina Whitsett, SAFE Executive Director, 804-694-7794, whitsett@chesterfieldsafe.org
The Board of Pharmacy has received over a half million dollars in application fees from potential pharmacies/dispensaries. I propose substantial lowering of registry fees from patients and caregivers. The burden is specifically very high on guardians of disabled adults, with a $50 fee proposed for the patient, plus each of the guardians. The burden of paying for the medicine (currently not covered by insurance), paying for a doctor to certify the patient (not covered by insurance), in the setting of typically significant disease/disability is too burdensome for patients to additionally assume large costs associated with registration with Board of Pharmacy. I propose, for disabled adults, that parents or guardians should be exempt from any registration fees (as they are for parents of children, before age 18). I also propose waived fees for spouses or one or more family members of registered patients, as procurement/transport of this new class of medication is not without risk, and the logistics of obtaining this medication from just a few locations in the state, is already a large barrier to access, and need not be complicated by a fee for every registered caregiver.
I also propose a 2 year long time frame for patients and caregivers to remain certified with the state. Physician licensure with the state lasts 2 years. Asking a patient or caregiver to keep up with yearly registration is more burdensome than necessary.
1. The process is not clear as to how the BoP will assure that laboratories conduct appropriate analyses. Typically, laboratories must adhere to an accreditation expectation when responsible for analyses that impact public health and safety.
2. Paragraph 2: Qualifications for director level person. Suggest language change to be:
Has employed at least one person to oversee and be responsible for the laboratory testing who has earned, from a college or university accredited by a national or regional certifying authority, at least a master's level degree in chemical or biological sciences, or related discipline, and a minimum of five two years of post-degree laboratory management experience or a bachelor's degree in chemical or biological sciences, or related discipline, and a minimum of eight four years of post-degree laboratory management experience.
Justification for these edits: The instrumentation required for quality assurance testing for cannabinoid products is sophisticated, high complexity testing as defined by CLIAA, requiring intensive maintenance and calibration experience across various instrument platforms. Secondly, the director should have experience in developing instrument methods, laboratory procedures and safety and security, and be able to successfully implement and oversee quality control and quality assurance. This requires significant experience beyond the degree and bench level analyst work, as the proposed language would conceivably allow.
Would also highly recommend educational requirements for lab personnel such as bench scientists and instrument technicians.
3. Paragraph 3: Homogeneity of samples paragraph. Suggest the following change to the requirement:
Immediately prior to producing any cannabidiol oil or THC-A oil product, a pharmaceutical processor shall segregate all harvested Cannabis into homogenized batches. A pharmaceutical processor shall make, at minimum, 3 samples throughout a batch available from each batch to assure homogeneity within each batch, for a laboratory to test for microbiological contaminants, mycotoxins, heavy metals, and pesticide chemical residue, and for purposes of conducting an active ingredient analysis.
Justification for this comment: It is essential that quality throughout a batch is assured - requiring samples to be collected at the begining, middle, and end of a production. This would apply to both the plant batches and oil/resin product batches.
4. Once the plant product is deemed free of contaminants and a oil product is manufactured, quality assurance and safety of those oils also needs to be verified by the same analytical process. Therefore, a minimum of 3-5 samples in a product batch needs to be evaluated for the same contaminants. This is critical since the processing of the plant material to create the oils will concentrate any potential contaminants not detected above acceptable limits in the initial analysis, which may result in concentrations above acceptable safe limits. Additionally, even if the plant samples taken for the original testing are below the acceptable limits for contaminants, the storage and/or processing of those plant materials may lead to contaminants that would be concentrated during product processing.
5. 110-60-300 Lab Regulations does not define or specify requirements for identifying and quantitating the pharmacologically active ingredients (THC, THC-A, CBD, CBDA, and other cannabinoids that are naturally present in cannabis plant material) or identification the terpenes as are required in 110-60-285 Registration of Products. Recommend adding this requirement to this section of the regulations. This would require a clarification of the legislation defining acceptable limits of CBD, THC-A, and THC in plants and products.
As defined in 110-60-285 Registration of Products, the analysis requires precise analytical work to ensure the 97%-103% range for product branding. Even for lab personnel experienced in analyzing and quantitating drugs, this precision and accuracy window is tight. This could lead to cost-prohibitive production and labelling of separate lots over conceivably insignificant analytical differences. The investment of personnel with experience and training and for material and methods to reduce error in the lab will also add exceptional cost. According to the U.S. Department of Health and Human Services FDA document entitled Guidance for Industry Q2B Validation of Analytical Procedures: Methodology, an assay for a drug substance or finished drug product is normally from 80-120% of the test concentration.
The financial burdens incurred by families with disabilities is extraordinary and the costs associated with obtaining this medicine are already extreme. I request that you limit the fees to $50 per patient total. I would also like to request that the registration be good for the same amount of time as the physician licensure. Thank you for your consideration.
Raising a child with speical needs causes already an undue burden on a family. According to the U.S. Department of Agriculture in 2015, it will take roughly $240,000 to raise a child from birth to age 18. For a special needs child, those expenses can QUADRUPLE! The families that will be acquiring this oil have already exhausted traditional pharmaceutical medications and will take on the burden of the cost of the oil with no assistance from insurance. For this operation to be successful in Virginia, you will need the individuals who fit this profile to purchase the oils. In Georgia, their registration is $25 for the patient or caregiver and their term is two years. I would hope Virginia would take into consideration what they have done. I believe that this would be much more affordable given the statistics cited by the US Dept. of Agriculture.
Greater Augusta Prevention Partners, (GAPP)
Serving City of Staunton, City of Waynesboro and Augusta County
GAPP’s mission is to create and implement intentional strategies to prevent youth from involvement in criminal gang activity, drug use, violence, and other risky behaviors to foster stronger and heathier community for our youth. http://www.valleyprevention.com/
Greater Augusta Prevention Partners provides this public comment in response to permanent adoption of Virginia Board of Pharmacy New regulations Chapter 60:
Marijuana and its extracts are dangerous and addictive illegal Schedule 1 drugs according to federal law and the DEA.
CBD-THC-A-THC oils are not FDA approved medicines.
There are already FDA approved drugs (dronabinol and nabilone) available that contain THC and parallel the effects of marijuana.
Epidolex is now an FDA approved medication that is available to treat intractable epilepsy patients. Treatment options already exist for other illnesses covered in these regulations.
FDA approved drugs are the only way to ensure proper recommended dosage and patient safety through side effect and drug interaction warning labels.
Attorney General Jeff Session has reversed the Cole Memo, now instructing federal law enforcement to enforce federal law with regard to marijuana manufacturing and possession.
Increased access to marijuana oils may contribute to increased usage in 12-17 year olds. (The National Survey on Drug Use and Health reports, SAMHSA 2016)
If the Virginia Board of Pharmacy adopts these new permanent regulations, it will further open the door to marijuana legalization in Virginia.All states that have legalized marijuana began with medical marijuana.
Revenues collected from marijuana do not outweigh the negative impacts on public safety, public health, the workplace, academics, black market and natural resources.
If the Virginia Board of Pharmacy does pass these new regulations, GAPP suggests the following changes should be made:
18VAC110-60-20. B. Parents of children with ongoing medical conditions under current treatment by a pediatrician should have their fee waived. (ie: cancer, epilepsy…..) Also applies to section 18VAC110-60-50
18VAC110-60-120. Conditional approval should also include within 1,000 feet of a church and within 1,000 feet of a residential dwelling.
Contact Information:
Keri Jones, GAPP Coalition Coordinator, 540-332-3806, joneskd@ci.staunton.va.u
When deciding to award the licenses, it should be to VA RESIDENTS ONLY, with the company controlled by members that are residents of VA, and not allow big known national companies from out of state, or partnering with VA Residents controlling 90% of partnership/company.
Commenter: Roanoke Prevention Alliance
RPA public comment
Roanoke Prevention Alliance, (RPA)
Serving City of Roanoke
RPA is devoted to preventing drug and alcohol abuse among teens and young adults in the City of Roanoke. www.roanokepreventionalliance.org
The Roanoke Prevention Alliance provides this public comment in response to permanent adoption of Virginia Board of Pharmacy New regulations Chapter 60:
Contact Information:
Melanie Morris RPA Director, 540-982-1427 ext 120, memorris@brbh.org