Legalizing Marijuana for Medicinal Use in Kentucky

UPDATE:

February 13, 2020–In August 2019, State Representative Jason Nemes was optimistic about the potential success of a bill he co-sponsored. This bill, House Bill 136, would legalize marijuana for medicinal use in Kentucky.

 

Yesterday (Wednesday, February 12, 2020), HB 136 passed the House Judiciary Committee 17-1. The bill now moves on to the House of Representatives, where Nemes expects it to pass.

 

“We won the battle in the House committee,” Nemes said. “It’s almost, pretty much over in the House of Representatives. Now we’ve got to let our senators understand where you are and educate them on the bill.”  – Jason Nemes1

 

Sources & Helpful Links

  1. Desroches, Daniel. February 12, 2020. Medical Marijuana bill clears KY House panel, gains momentum heading into House vote. Lexington Heard Leader. Retrieved from: https://www.kentucky.com/news/politics-government/article240232736.html

Kentucky House Bill 136

https://apps.legislature.ky.gov/record/20rs/hb136.html

___________________________________

August 16, 2019 –Kentucky politicians are and have been optimistic about the legal status of marijuana within their state. “State Rep. Jason Nemes of Louisville predicts medical marijuana will be legal in Kentucky within the next year. The Louisville Republican has co-sponsored a bill that he believes addresses most of the past concerns about medical marijuana…’ Fundamentally, we’re going to have, I believe, medical marijuana in Kentucky within the next year,’ said Nemes. ‘I strongly believe that.’”  [1]

as a premier partner of Total Harvest Coverage, we help businesses with security plans, architectural planning and programming and design of compliant solutions for cannabis facilities.

Mr. Nemes was a little off on his prediction. We are fast approaching the one-year mark from when Mr. Nemes made this prediction. Kentucky has moved closer, and many are sure the legislation will pass in the upcoming session. The community of Louisville has agreed that possession of small quantities of marijuana shouldn’t be a priority for law enforcement. [2]

Jason Nemes is co-sponsor of House Bill 136, legislation to legalize and regulate marijuana for medicinal use in Kentucky. In March of 2019, the House Judiciary Committee approved this bill almost unanimously [3].

This bill proposes that a new organization be formed within the powers of state government to regulate the medicinal marijuana industry, ‘The Department for Alcoholic Beverage and Cannabis Control’. While there is no legislation to review as of yet, it would appear that their requirements and guidelines for facilities will mirror those of Michigan and Illinois. Why not mirror your midwestern neighbors if their system is working efficiently?

A recent story posted by High Times, indicates that even though cannabis remains illegal in Kentucky, the state has the highest per capita rate of plants destroyed by the DEA. Approximately 80 percent of voters in the State of Kentucky favor reform or legalization of cannabis and marijuana plants and products. Kentucky house bill HB 136 would provide for improved access for medicinal marijuana. Security plans and requirements have yet to be released or published as of this article.

In other news, Hempwood and hemp processing facilities are up and running in Murray, Kentucky

 

KL Security is able to help at all levels of the supply chain:

Deter Diversion & Theft with Security Planning and Cannabis Facility Design Standards

Reinforced Vault Rooms & Custom Vaults of All Sizes

Smart Cash Management Safes & CashControl Software

  • Ideal for Retail Dispensaries in Kentucky, Growers & Cash Businesses

Bulletproof Glass, Doors and Retail Dispensary Design & Build

Security Cameras, Recorders and Software for Surveillance and Cash in Transit

 

[1] Lawmaker says medical marijuana will be legal in Ky. ‘within the next year’. (2018, August 24). Retrieved from: https://www.wdrb.com/news/lawmaker-says-medical-marijuana-will-be-legal-in-ky-within/article_62e82cd3-ef4a-5491-a7de-f5dd13a6ac82.html

[2] Costello, Darcy. (2019, June 19) “Louisville is moving closer to telling police not to prioritize marijuana possession”. Louisville Courier Journal. Retrieved from: https://www.courier-journal.com/story/news/politics/metro-government/2019/06/19/louisville-moves-closer-effectively-decriminalizing-pot/1499214001/

[3] Cheves, John. (2019, March 6) Medical marijuana approved by Kentucky House panel. More legislative hurdles remain. Lexington Herald Leader. Retrieved from: https://www.kentucky.com/news/politics-government/article227177759.html

 

Helpful Links:
Code of Federal Regulations: Title 21

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=205.50

 

Kentucky House Bill 136

https://apps.legislature.ky.gov/record/19rs/hb136.html

 

When you’re ready to begin the process of securing your facility, the consultants at KL Security are available to assist. Well versed in government regulations and recent legal mandates, we are prepared to ensure your business will pass requirements.

TOLL FREE 1-866-867-0306

[email protected]

Information has been gathered from sources deemed reliable but not guaranteed and is subject to change without notice. All license information and security measures taken directly from the Code of Federal Regulations: 21CFR205.50

Image source: http://thesource.com/2018/10/30/weed-marijuana-2018-midterm-elections/

The EPA ‘Final Rule’: Amendment to P075 Safes and Cabinets for Regulated Materials

The ‘Final Rule’, by its title, sounds rather ominous. When the government institutes regulatory changes, it is often to the lament of affected agencies. This time: not so much. The Final Rule regarding Management Standards for Hazardous Waste Pharmaceuticals is actually overall beneficial to facilities as well as the environment. One of the key focuses of the amendment is how facilities handle expired or unused pharmaceuticals and the compliant storage of hazardous waste pharmaceuticals.

Hazmat Storage Lockers & Buildings Specifically designed for hazardous material storage and dispensing from 55-gallon drums containing flammable or combustible liquids.

 

Historically, the most common way of disposing pharmaceuticals has been flushing (pouring down the drain), “Until this final rule, drain disposal has been an allowable disposal method for hazardous waste pharmaceuticals under RCRA…” 84 FR 5816. It was previously thought that this had no impact on our water sources, but the opposite has been scientifically proven. There have been multiple studies performed on the effect of flushing on wildlife, “A study by Karen Kidd et al., in the 22 May 2007 issue of Proceedings of the National Academy of Sciences, showed the collapse of a population of fish in an isolated lake spiked with relatively high levels of the synthetic estrogen 17α-ethinylestradiol.” Lubick, Naomi. “Drugs in the environment: do pharmaceutical take-back programs make a difference?.” Environmental health perspectives vol. 118,5 (2010): A210-4. doi:10.1289/ehp.118-a210 

 

List of Potentially Affected Facilities:
Drug Wholesalers
Supermarkets and Other Grocery (except convenience) Stores.
Pharmacies and Drug Stores.
Warehouse Clubs and Supercenters.
Veterinary Services.
Physicians’ Offices.
Dentists’ Offices.
Other Health Practitioners (e.g., chiropractors).
Outpatient Care Centers.
Other Ambulatory Health Care Services.
Hospitals.
Nursing Care Facilities (e.g., assisted living facilities, nursing homes).
Continuing Care Retirement Communities (e.g., assisted living facilities with on-site nursing facilities).
Reverse Distributors.

 

The scientific community has not yet definitively linked the flushing of pharmaceuticals to adverse effects on humans. If these chemicals are being introduced into our drinking water and having profound effects on the wildlife within the drinking water, it is only logical to assume that humans would incur negative consequences as well. Now that an issue has been identified, we must address it: “One way to prevent additional impact to our waters is the cessation or reduction of pharmaceutical drugs disposed of via sewers,” C.G. Daughton, I.S. Ruhoy, Environmental footprint of pharmaceuticals: The significance of factors beyond direct excretion to sewers, Environ. Toxicol. Chem., 28 (2009), pp. 2495-2521, 10.1897/08-382.1.

Another beneficial facet of this amendment is the new guideline on how Nicotine products will be handled. Traditionally, smoking cessation products containing Nicotine qualified as hazardous waste and had to be disposed of as such. Not anymore; from now on, these products are categorized as nonhazardous pharmaceutical waste.

Lastly, this new rule affects how expired medicines are returned. An outdated drug may be returned to a reverse distributor. This is common practice; after August 21, 2019, a drug becomes eligible for return the day it expires or ‘outdates’ (assuming it meets other mitigating factors: “original manufacturer packaging; undispensed; and unexpired or less than a year past expiration” SMITH, CHARLOTTE A. “Countdown to New Drug Waste Rule: EPA’s New Disposal Regulations to Require Operational Changes.” Health Facilities Management, vol. 32, no. 6, July 2019, p. 52. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&db=f5h&AN=137427558&site=eds-live.

The exact dates for when regulations roll out may be affected by state guidelines, so a facility must always be sure to cross-check federal regulations with state level regulations. These changes will take some time for facilities to adjust, but are anticipated to be overall cost-saving. Less training will be needed for staff with the list of hazardous products lessened by the release of Nicotine products for hazardous disposal. Distribution centers may qualify for different (less expensive) licensing options with the removal of Nicotine products from the list. Waste management practices will be more streamlined by the removal of flushing as an option for disposal.

After expiration and before disposal, facilities must still adhere to government regulations of containment.

Schedules I and II

May suffice with safe or steel cabinet:

Safe or cabinet must have following specifications: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques.  These includes TL-15 Rated EPA Safes and some agencies may be approved for GSA Approved Class 5 rated containers.

Or if quantities require a vault:

Walls, floors, and ceiling are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with ½ inch steel rods tied 6inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings. Modular vault structures of a UL Class 1 rating are equivalent to 12″ inch poured concrete w/ 4 layers of re-bar per ASTM specifications.

Vault includes Choice of Class 1 Door or ArmorStor ™ Class 5 Equivalency Rated Door.

Following specifications: 30 man minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques

One of the following: Electrical lacing of the walls, floor, and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by administration

Schedules III, IV and V

Subject to the same storage security regulations as schedules I and II

May utilize a building used specifically for storage of controlled substances providing the building:

Has an electrical alarm system

Perimeter security during working and non-working hours

Etc.

May store drugs in a cage within a building on the premises

Cage must have walls of no less than No. 10 gauge steel fabric mounted on steel posts

Posts are at least one inch in diameter, set in concrete or installed with lag bolts that are pinned or brazed, and placed no more than ten feet apart with 1 and 1 ½ inch reinforcements every sixty inches

Etc.

Helpful Links:
Code of Federal Regulations: Title 21

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=205.50

EPA: Final Rule

https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075

Federal Register

https://www.federalregister.gov/documents/2019/02/22/2019-01298/management-standards-for-hazardous-waste-pharmaceuticals-and-amendment-to-the-p075-listing-for

When you’re ready to begin the process of securing your facility, the consultants at KL Security are available to assist. Well versed in government regulations and recent legal mandates, we are prepared to ensure your business will pass requirements.

TOLL FREE 1-866-867-0306

[email protected]

Information has been gathered from sources deemed reliable but not guaranteed and is subject to change without notice. All license information and security measures taken directly from the Code of Federal Regulations: 21CFR205.50 and 84 FR 5816.

 

503A & 503B Facility Security Requirements

Outsourcing Facilities and Security

An outsourcing facility combines pharmaceutical drugs to tailor meet the needs of an individual; a person may be allergic to a component of a medication or may need a solid drug transformed to liquid form for consumption. This compounding of drugs must be done by a pharmacist, physician, or under supervision of a pharmacist. The individual drugs are FDA approved, but the new combination of two drugs is not. There are two categories of facilities: 503A and 503B.

Facilities that fall under the 503A category are pharmacies licensed for operation under Federal and State Codes. Facilities that fall under the 503B category are pharmacies, or often manufacturers, that have applied for 503B licensing through the FDA.  The 503B status gives a facility the license to compound drugs on a larger scale, save money by producing compounded drugs in bulk, and the ability to relay these savings on to a consumer.

Applying for status as a 503B facility is voluntary, but affords benefits. The facility may be able to qualify certain compounded drugs for FDA approval exemptions, but must still conform to current good manufacturing practice requirements and FDA regulations.

Regulations for security requirements of outsourcing facilities can be found within the Code of Federal Regulations.  21CFR13.01.72 outlines the specific guidelines of storage for each schedule of drug. Listed are a few key notes of interest taken directly from legislature:

Schedules I and II

  • May suffice with safe or steel cabinet:
  • Safe or cabinet must have following specifications: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques.
Modular Reinforced Vaults of UL Class 1 Rating Equivalent to 12 Inches reinforced Concrete

Or if quantities require a vault:

Walls, floors, and ceiling are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with ½ inch steel rods tied 6inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings.

Following specifications: 30 man minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques

One of the following: Electrical lacing of the walls, floor, and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by administration

Schedules III, IV and V

  • Subject to the same storage security regulations as schedues I and II
  • May utilize a building used specifically for storage of controlled substances providing the building:
  • Has an electrical alarm system
  • Perimeter security during working and non-working hours
  • Etc.
  • May store drugs in a DEA approved cage within a building on the premises
  • Cage must have walls of no less than No. 10 gauge steel fabric mounted on steel posts
  • Posts are at least one inch in diameter, set in concrete or installed with lag bolts that are pinned or brazed, and placed no more than ten feet apart with 1 and 1 ½ inch reinforcements every sixty inches

Etc.

Helpful Links:

https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

https://www.fda.gov/drugs/human-drug-compounding/regulatory-policy-information

https://www.fda.gov/drugs/human-drug-compounding/regulatory-policy-information

https://www.klsecurity.com/index.php/products/vaults-and-doors/dea-approved.html

When you’re ready to begin the process of securing your facility, the consultants at KL Security are available to assist. Well versed in government regulations and recent legal mandates, we are prepared to ensure your business will pass requirements.

TOLL FREE 1-866-867-0306

[email protected]

Information has been gathered from sources deemed reliable but not guaranteed and is subject to change without notice. All license information and security measures taken directly from the Code of Federal Regulations: 21CFR13.01.72

Recycling Reefer: Proper Disposal of Cannabis Product in Massachusetts

There is no doubt that opening a marijuana business is complicated. Even taking out the trash has stringent requirements. Any marijuana refuse has to be secured, documented, and disposed of properly. Mass Ann Laws ch. 94G, § 4 (a ½) (xxviii) gives the Cannabis Control Commission power to regulate the disposal requirements for marijuana establishments. It also encourages the Commission to promote recycling within the industry. 

To properly recycle cannabis plant parts, they must be ground and mixed with other organic materials: food waste, soil, mulch, other plant waste. This will render the product unusable and ready for compost. If the facility does not have the physical space to compost the material on-site, the cannabis compost material may be sent to a facility approved to handle such materials, 935 CMR 502.105.

The department of Environmental Protection within the state of Massachusetts mandates that records be kept of any hazardous wastes created, stored, treated, disposed, or transferred for disposal, Mass Ann Laws ch. 21 C, § 6 and Mass Ann Laws ch. 111F, § 16. The Cannabis Control Commission of Massachusetts provides links to all disposal options and waste service providers on their website: https://mass-cannabis-control.com.

Secure Transport and In Transit Tracking of Plants and Product for the Cannabis Industry are also available

The marijuana industry is highly regulated at every level. It’s no surprise that waste management would be any different. It is also feasible that out of all processes to be overlooked within the planning of a Cannabis facility would be that of waste management, “…one of the top five cannabis cultivation violations for 2018 was cannabis waste management.” Commendatore, Cristina. “The Complicated World of Cannabis Waste Generation (Part One).” Waste 360, July 2019, https://www.waste360.com/legislation-regulation/complicated-world-cannabis-waste-generation-part-one

as a partner of the Total Harvest Coverage network, we assist cannabis facilities with designs, plans and deployment of compliant solutions to help them become more successful.

KL Security offers solutions to these rigorous regulations in the form of reinforced vault rooms, TL Rated DEA Approved safes, electronic data management storage and video surveillance solutions. Record keeping will undoubtedly be most efficiently be done electronically, and must be stored in a safe location to ensure access by local officials at a moment’s notice.

For more information on cannabis security plans and facility design, architectural programming and more, call 1-866-867-0306