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 Emergency/NOIRA
Comment Period Ended on 11/28/2018
spacer
Back to List of Comments
11/27/18  2:39 pm
Commenter: Regina Whitsett, Substance Abuse Free Environment, Inc. (SAFE)

SAFE's Public Comment in Response to adoption of VA BOP Emergency Regulations Pharmaceutical Process
 

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 Emergency Regulation Title of Regulation: 18VAC110-60. Regulations Governing Pharmaceutical Processors (amending 18VAC110-60-10 through 18VAC110-60-40, 18VAC110-60-90, 18VAC110- 60-110, 18VAC110-60-220, 18VAC110-60-240, 18VAC110-60-290, 18VAC110-60-310; adding 18VAC110-60-285, 18VAC110-60-295). Statutory Authority: §§ 54.1-2400 and 54.1-3442.6 of the Code of Virginia 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 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.  
  8. It is ethically inappropriate for pharmacists to grow and dispense CBD-THC-A-THC oil without sufficient research on dosage and interactions.     
  9. Former United States Attorney General Jeff Session 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 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, 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. 

If the Virginia Board of Pharmacy does pass these emergency regulations, the following changes should be made:

  • Registered Patient definition should be “to receive” not “for dispensing of”. 
  • 12 plants per patient is too high.  Other states that have medicinal marijuana laws or marijuana legalization have a limitation of 6 plants per patients. 

Contact Information:

Regina Whitsett

SAFE Executive Director

804-694-7794

whitsett@chesterfieldsafe.org

 

 

CommentID: 68789