Agencies | Governor
Virginia Regulatory Town Hall
Agency
Department of Health Professions
Board
Board of Pharmacy
chapter
Regulations Governing Pharmaceutical Processors [18 VAC 110 ‑ 60]
Action New Regulations Governing Pharmaceutical Processors
Stage Proposed
Comment Period Ends 5/17/2019
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3 comments

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5/17/19  2:38 pm
Commenter: Regina Whitsett, SAFE Executive Director

SAFE's Public Comment re Regulations Governing Pharmaceutical Processors
 

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 18VAC110-60. Regulations Governing Pharmaceutical Processors and states: 

  1. Marijuana and its extracts are dangerous and addictive illegal Schedule 1 drugs according to federal law and the DEA. 
  2. 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.
  3. CBD-THC-A-THC oils are not FDA approved medicines. 
  4. There are already FDA approved drugs (dronabinol and nabilone) available that contain THC and parallel the effects of marijuana. 
  5. 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. 
  6. FDA approved drugs are the only way to ensure proper recommended dosage and patient safety through side effect and drug interaction warning labels.
  7. It is medical malpractice for physicians, physicians’ assistants and nurses 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.  
  8. It is ethically inappropriate for pharmacists to grow and dispense CBD-THC-A-THC oil without sufficient research on dosage and interactions.  
  9. A registered agent model for pickup and delivery of CBD-THC-A-THC oils will increase the risk of diversion and access to non-registered patients.      
  10. 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 )
  11. Marijuana usage, including oils, is linked to mental illness and opioid use.
  12. If the Virginia Board of Pharmacy adopts these new emergency regulations as permanent regulations, it will further open the door to marijuana legalization in Virginia.  All states that have legalized marijuana began with medical marijuana.
  13. Revenues collected from marijuana do not outweigh the negative impacts on public safety, public health, the workplace, academics, health, black market and natural resources. 

Regina Whitsett, SAFE Executive Director, 804-694-7794, whitsett@chesterfieldsafe.org


5/17/19  4:31 pm
Commenter: Mary Crozier, Community Coaliltions of Virginia

restrict marijuana
 

Community Coalitions of Virginia (CCoVA) is a non-profit organization that consists of representation from substance abuse prevention coalitions (#41), organizations (#5) and individuals (#4) 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.  For more information please see our website, www.communitycoalitionsofva.com

Community Coalitions of Virginia provides this public comment in response to the Virginia Board of Pharmacy New Regulations Governing Pharmaceutical Processors; May 17, 2019. 

1.      Marijuana and its extracts are dangerous and addictive illegal Schedule 1 drugs according to federal law and the DEA. 

2.      The Virginia Board of Pharmacy is violating federal law by setting up marijuana grows and dispensaries.  Virginia law nor the board’s regulations preempt federal law.

3.      CBD-THC-A-THC oils are not FDA approved medicines. 

4.      There are already FDA approved drugs (dronabinol and nabilone) available that contain THC and parallel the effects of marijuana. 

5.      Epidolex is now an FDA approved medication that is available to treat intractable epilepsy patients. Treatment options already exist for other illness covered in these regulations. 

6.      FDA approved drugs are the only way to ensure proper recommended dosage and patient safety through side effect and drug interaction warning labels.

7.      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 oil without FDA approval because there is insufficient scientific evidence of the benefits and effects on patient safety are unknown.  

8.      It is ethically inappropriate for pharmacists to grow and dispense CBD-THC-A-THC oil without sufficient research on dosage and interactions.     

9.      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.

10.  Increased access to marijuana oils increases usage in 12-17 year olds. (The National Survey on Drug Use and Health reports, SAMHSA)

11.  Marijuana usage, including oils, is linked to mental illness and opioid use.

12.  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.

13.  Revenues collected from marijuana do not outweigh the negative impacts on public safety, public health, the workplace, academics, health, black market and natural resources. 

Contact Information:

Dr. 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

 


5/17/19  4:53 pm
Commenter: Cannabis Business Association of Virginia

Patient Access and Free Enterprise
 

Dear Mr. Chair and Members of the Board of Pharmacy,

The Cannabis Business Association of Virginia (CannaBizVA) is a non-profit, trade association formed to advance legislation, regulation and implementation to support and grow Virginia’s regulated cannabis industries. Accordingly, CannaBizVA offers the following comment, which prioritizes patient access to care and free enterprise.

CannaBizVA respectfully requests the Board of Pharmacy consider expanding, if not outright dissolving, the government-sanctioned oligopoly currently governing Virginia’s medical cannabis industry. Allowing for only one vertically integrated, seed-to-sale pharmaceutical processor in each of the Commonwealth’s five geographically bound Health Service Areas functions to the detriment of Virginia’s small business economy and, most importantly, patient access to care.

The regulatory framework currently in place, and again proposed through the present Notice of Proposed Rule Making, is outdated and not adequately scaled to meet anticipated patient demand. This framework and supply chain model was enacted during the 2017 General Assembly session when CBD and THC-A oil was approved only for patients with intractable epilepsy. It is estimated that around 25,000 Virginians are plagued with this ailment. CannaBizVA contends that one vertically integrated, seed-to-sale pharmaceutical processor in each of the Commonwealth’s five geographically bound Health Service Areas was likely sufficient to meet the demands of 25,000 potential patients.

However, in 2018, the General Assembly passed legislation providing practitioners latitude to treat with CBD or THC-A oil any diagnosed condition or disease determined by the practitioner to benefit from such use, which exponentially expanded the anticipated demand for CBD & THC-A oil treatments to potentially each of Virginia’s 8.5 million citizens without a coinciding expansion of supply channels. As such, the Commonwealth could very well be tasked with treating upwards of a few million patients through a system designed to serve less than 1% of that demand. The current proposal simply does not have the capacity to suit the demands soon to be placed on the system.

Further complicating patient access are the geographic limitations on the current and proposed regulatory framework. With only one pharmaceutical processor in each of the Commonwealth’s vast and sprawling Health Service Areas, a qualifying medical cannabis patient living in Danville would have to drive no less than two and a half hours to the closest pharmaceutical processor in order to receive his/her medicine. This is particularly troubling when you consider that these patients are dealing with any number of ailments, spanning from chronic pain, anxiety, autism, PTSD, or intractable epilepsy, which can cause multiple seizures an hour.

An easy fix to the patient access issues of supply chain capacity and geographic barriers would be to simply open up Virginia’s medical cannabis market. Allowing more growers, processors, and retailers to operate in Virginia would increase production capacity, decrease travel time, and stimulate small, local farms and businesses. CannaBizVA encourages the Board of Pharmacy to maintain current quality and security standards, but expand the number of CBD and THC-A oil suppliers, processors, and retailers operating in the Commonwealth.

Respectfully,

CannaBizVA