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

contact@klsecurity.com

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

Electronic Records Management for Illinois Marijuana Dispensaries

 

 

 

 

Illinois legislature requires dispensaries in Illinois to maintain security measures to protect both people and product.  One of the requirements for dispensary security is 24/7 video surveillance. Cameras must be rolling at all times and record footage of all entries & exits, parking lots, exterior of building, all vaults, safes, storage areas , and anywhere cannabis is handled in any fashion (sales, disposal, preparation, retail areas, storage, etc.) These cameras must be of substantial quality with the ability for law enforcement to identify vehicle license plates and use facial recognition. These records must be maintained for a minimum of 90 days, and available for review at any time.

All security system equipment and recordings shall be maintained in good working order, in a secure location so as to prevent theft, loss, destruction, or alterations.
Cannabis Regulation and Tax Act., 2019 Bill Text IL H.B. 1438

As if this wasn’t an already massive amount of data to store, dispensaries must also electronically maintain records of the following items for a minimum of three years (even in the event the dispensary closes):

(1)  Operating procedures;

(2)  Inventory records, policies, and procedures;

(3)  Security records;

(4)  Audit records;

(5)  Staff training plans and completion documentation;

(6)  Staffing plan; and

(7)  Business records, including but not limited to:

  • (i)  Assets and liabilities;
  • (ii)  Monetary transactions;
  • (iii)  Written or electronic accounts, including bank statements, journals, ledgers, and supporting documents, agreements, checks, invoices, receipts, and vouchers; and
  • (iv)  Any other financial accounts reasonably related to the dispensary operations.
Offering solutions for Business Continuity & Disaster Recovery planning of records management as part of your cannabis security plan and design.

Cannabis Regulation and Tax Act., 2019 Bill Text IL H.B. 1438 

These are all just the requirements set in place by the state of Illinois. It is important to also check the local ordinances to review any additional local guidelines, “…it is crucial to understand compliance within the state or states where an organization operates.” Smallwood, Robert F. Managing Electronic Records: Methods, Best Practices, and Technologies, John Wiley & Sons, Incorporated, 2013.

 

Effective electronic record management is vital to the efficient operation of any modern business; “An investment in ERM (Electronic Record Management) is an

ioSafe data storage products are the best brand manufacturer of virtual cloud data to physical endpoint files and complete systems that process, store and archive data and electronic records for Illinois Dispensary and retail marijuana shops.

investment in business process automation and yields document control, document integrity, and security benefits.” Smallwood, Robert F. Managing Electronic Records: Methods, Best Practices, and Technologies, John Wiley & Sons, Incorporated, 2013.

When you’re ready to begin the process of securing your business (cannabis or otherwise), 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.  With sufficient cannabis security planning and programming your facility will be ready for license and compliance

TOLL FREE 1-866-867-0306

contact@klsecurity.com

DEA Rules, security requirements and regulations per the Code of Federal Regulations 21CFR1301.72https://www.klsecurity.com/products/medical-marijuana-dea-storage.html

 

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 legislation: Cannabis Regulation and Tax Act., 2019 Bill Text IL H.B. 1438

 

 

Secure your Stash: Licensing and Security in Michigan’s Medical Cannabis & Recreational Marijuana Market

Due to the legalization of marijuana on a medical and recreational level, Michigan is ripe with financial opportunities. There are many different levels of operation an entrepreneur may engage. To cultivate, sell, or transfer marijuana to establishments, one would need a Michigan Grower’s license. There are three classes of license for growers: Class A – 500 marijuana plants; Class B – 1,000 plants; Class C – 1,500 plants. Remember, cannabis still may be subject to DEA Rules, security requirements and regulations per the Code of Federal Regulations 21CFR1301.72

THC360’s approach to integrated security plans, compliance with state laws and maximize business revenues is part of the leading cannabis companies success and growth plans. As a premier partner of Total Harvest Coverage, we believe in designing best in class plans for your cannabis facility or transportation fleet.

Within the pot hierarchy, there is a step directly below growers: microbusiness. Michigan Microbusiness license holders may cultivate up to 150 marijuana plants, process/package marijuana, and may sell/transfer to those 21 & over but cannot sell to other marijuana businesses. (Think: start up with little capital.)

Next in the cannabis chain, we will find the processor and the retailer. These are separate licenses and have different limitations/functions. The processor may purchase marijuana from a grower, extract resin, or create a marijuana infused product for sale (edibles, etc.), and/or transfer said product to another processor or provisioning center. The retailer may acquire marijuana from establishments and sell to other establishments or individuals.

The chart below demonstrates which cannabis license holder can engage with another:

The state of Michigan will begin accepting applications for select licenses beginning December 6, 2019. If an individual is thinking of applying for any licensure, it would be in his/her best interest to start assembling documents now. The forms and applications are not yet available, but It’s safe to assume the document checklist will resemble those for medicinal facilities. The MMFL prequalification requires over 40 documents alone.  This information can be found on the state of Michigan’s website: https://www.michigan.gov/lara/0,4601,7-154-89334_79571_87302—,00.html

In Michigan, security requirements vary by municipality.  It is imperative one checks the local code for a potential business to correctly implement the adequate standard. It is of the utmost importance that recreational businesses/operators are complying with regulations as these establishments are available for inspection at any time. Performing a realistic evaluation of the expected size of business (as well as future growth) should be done at the introductory phase. For example: a microbusiness may suffice with several small TL-15 Rated safes bolted to the floor or a dispensary may require a modular vault and vault door to house the quantity of inventory.

In summation, asset protection should always be at the forefront of a business owner’s mind. Replacing valuable product or having to cease business to meet government regulations is costly, inconvenient, and stressful.  The cannabis and marijuana industry is sure to be highly competitive and a highly sought-after revenue stream. KL Security has experienced consultants ready to help, and offers security solutions for dispensaries, growers and retails that meet compliance for security.

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

Full line of cash management safes for retail point of sale

Cannabis Inventory Management

Growers, Greenhouses, or Cultivations Farms and Land

  • Safe and Vault Systems
Modular Vaults systems that meet DEA 21CFR1301.72 for Dispensaries are designed for DEA Approved Storage at Growers, Retail and Cultivation Farms

For the latest updates, the Michigan Marijuana Regulatory Agency (MRA) is in the process of implementing the security and regulatory framework for the entire state, Michigan County and Townships. 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 legislation: Michigan Regulation and Taxation of Marihuana Act. “REGULATION AND TAXATION OF MARIHUANA ACT”. , 2017 Bill Text MI S.B. 1243 SEC. 501

 

LINKS TO FORMS & LEGISLATION:

MICHIGAN MARIJUANA REGULATORY AGENCY

https://www.michigan.gov/lara/0,4601,7-154-89334_79571_90056—,00.html

MICHIGAN REGULATION AND TAXATION OF MARIHUANA ACT

https://www.legislature.mi.gov/(S(wwmtk0j1m4jeg10at2zbsucs))/mileg.aspx?page=getObject&objectName=mcl-Initiated-Law-1-of-2018

 

 

 

 

 

Contact Information for DEA Offices in the United States

Contact Information for DEA Offices in the United States

 

Atlanta Division (Georgia, North Carolina, South Carolina and Tennessee)

Georgia

Atlanta (Head office): (404) 893-7000

Augusta: (706) 724-9021

Columbus: (706) 649-7850

Macon: (478) 330-7750

Rome: (706) 232-5104

Savannah: (912) 447-1035

 

North Carolina

Asheville: (828) 350-3440

Charlotte: (704) 770-2050

Greensboro: (336) 547-4210

Raleigh: (919) 790-3004

Wilmington: (910) 815-4513

 

South Carolina

Charleston: (843) 308-6660

Columbia: (803) 765-5251

Florence: (843) 661-2171

Greenville: (864) 234-0237

 

Tennessee

Chattanooga: (423) 855-6600

Jackson: (731) 422-2696

Johnson City: (423) 854-9100

Knoxville: (865) 584-9364

Memphis: (901) 969-3500

Nashville: (615) 736-5988

 

Chicago Division (Illinois, Indiana, Minnesota, North Dakota and Wisconsin)

 

Illinois

Chicago (Head office): (312) 353-7875

Rockford: (815) 987-4494

Springfield: (217) 585-2750

 

Indiana

Evansville: (812) 465-6457

Ft. Wayne: (260) 420-4018

Indianapolis: (317) 226-7977

Merrillville: (219) 681-7000

 

Minnesota

Minneapolis: (612) 344-4100

 

North Dakota

Bismarck: (701) 250-4550

Fargo: (701) 476-5500

 

Wisconsin

Green Bay: (920) 492-4907

Madison: (608) 210-4300

Milwaukee: (414) 336-7300

 

Dallas Division (Texas and Oklahoma)

Texas

Dallas (Head office): (214) 366-6900

Fort Worth: (817) 639-2000

Lubbock: (806) 798-7189

Tyler: (903) 579-2400

 

Oklahoma

McAlester: (918) 426-5020

Oklahoma City: (405) 475-7500

Tulsa: (918) 459-9600

 

Denver Division (Colorado, Montana, Utah and Wyoming)

Colorado

Centennial (Head office): (720) 895-4040

Colorado Springs: (719) 262-3000

Durango: (970) 385-5147

Glenwood Springs: (970) 945-0744

Grand Junction: (970) 683-322

 

Montana

Billings: (406) 655-2900

Missoula: (406) 552-6703

 

Utah

Salt Lake City: (801) 524-4156

St. George: (435) 673-6255

 

Wyoming

Casper: (307) 261-6200

Cheyenne: (307) 778-1500

 

Detroit Division (Michigan, Kentucky and Ohio)

 

Michigan

Detroit (Head office): (313) 234-4000

East Lansing: (517) 337-6604

Grand Rapids: (616) 458-0616

Flint: (810) 768-7600

 

Kentucky

Lexington: (859) 977-6100

London: (606) 862-4500

Louisville: (502) 582-5908

Madisonville: (270) 821-6899

 

Ohio

Cincinnati: (513) 684-3671

Cleveland: (216) 274-3600

Columbus: (614) 255 4200

Dayton: (937) 291-1988

Toledo: (419) 259-6490

Youngstown: (330) 740-7000

 

El Paso Division (New Mexico and Texas)

New Mexico

Albuquerque: (505) 452-4500

Las Cruces: (575) 526-0700

 

Texas

Alpine: (432) 837-6000

El Paso (Head office): (915) 832-6000

Midland: (432) 686-4085

 

Houston Division (Texas)

Texas

Austin: (512) 344-4900

Beaumont: (409) 981-7400

Brownsville: (956) 504-7000

Corpus Christi: (361) 887-1200

Del Rio: (830) 778-7886

Eagle Pass: (830) 752-4000

Galveston: (281) 335-2900

Houston (Head office): (713) 693-3000

Laredo: (956) 523-6000

McAllen: (956) 992-8400

San Antonio:  (210) 442-5600

Waco: (254) 297-0300

 

Los Angeles Division (California, Hawaii and Nevada)

California

Los Angeles (Head office): (213) 621-6700

Riverside: (951) 328-6000

Santa Ana: (714) 647-4900

Ventura: (805) 383-6454

 

Hawaii

Honolulu: (808) 541-1930

Maui: (808) 244-1136

 

Nevada

Las Vegas: (702) 759-8000

Reno: (775) 327-8900

 

Louisville Division (Kentucky, Tennessee and West Virginia)

West Virginia

Charleston: (304) 347-5209

Clarksburg: (304) 623-3700

Wheeling: (304) 234-6092

 

Tennessee

Chattanooga: (423) 855-6600

Jackson: (731) 422-2696

Johnson City: (423) 854-9100

Knoxville: (865) 584-9364

Memphis: (901) 969-3500

Nashville: (615) 736-5988

 

Kentucky

Lexington: (859) 977-6100

London: (606) 862-4500

Louisville (Head office): (502) 582-5908

Madisonville:  (270) 821-6899

 

 

Miami Division (Florida)

Florida

Fort Myers: (239) 275-3662

Gainesville: (352) 371-2077

Homestead: (305) 224-9850

Jacksonville: (904) 348-5225

Key West: (305) 295-8603

Orlando: (407) 333-7000

Panama City: (850) 913-2700

Pensacola: (850) 469-9060

Port St. Lucie: (772) 873-3600

Tallahassee: (850) 350-7300

Tampa: (813) 287-5160

Titusville: (321) 633-1216

Weston (Head office): (954) 660-4500

West Palm Beach: (561) 684-8000

 

 

New England Division (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont)

 

Connecticut

Bridgeport: (203) 579-5591

Hartford: (860) 240-3233

New Haven: (203) 497-5200

Maine

Bangor: (207) 262-4666

Portland: (207) 780-3331

 

Massachusetts

Boston (Head office): (617) 557-2100

Cape Cod: (508) 790-3713

New Bedford: (508) 996-4804

Springfield: (413) 306-6920

Worcester: (508) 793-0110

 

 

Manchester: (603) 628-7411

Portsmouth: (603) 433-0650

 

Rhode Island

Providence: (401) 732-2550

 

Vermont

Burlington: (802) 951-2900

 

New Jersey Division

New Jersey

Atlantic City: (609) 383-3322

Camden: (856) 321-2420

Paterson: (973) 357-4037

Newark (Head office): (973) 776-1100

 

New Orleans Division (Alabama, Arkansas, Louisiana and Mississippi)

Alabama

Birmingham: (205) 321-1300

Huntsville: (256) 519-6722

Mobile: (251) 441-5831

Montgomery: (334) 273-7300

 

Arkansas

Fayetteville: (479) 442-2618

Fort Smith: (479) 783-6300

Little Rock: (501) 217-6500

 

Louisiana

Baton Rouge: (225) 389-0254

Lafayette: (337) 706-3940

Metaire (Head office): (504) 840-1100

Monroe: (318) 651-7117

Shreveport: (318) 676-4080

 

Mississippi

Gulfport: (228) 863-2992

Jackson: (601) 965-4400

Oxford: (662) 234-8542

 

New York Division

 

New York

Albany: (518) 782-2000

Buffalo: (716) 846-6000

Long Island: (631) 420-4500

New York (Head office): (212) 337-3900

Plattsburgh: (518) 562-6900

Rochester: (585) 263-3180

Syracuse: (315) 426-5300

Westchester: (914) 682-6256

 

Philadelphia Division (Delaware and Pennsylvania)

 

Delaware

Dover: (302) 672-6383

Wilmington: (302) 395-4600

 

Pennsylvania

Allentown: (610) 770-0940

Harrisburg: (717) 221-2270

Philadelphia (Head office): (215) 861-3474

Pittsburgh: (412) 777-6940

Scranton: (570) 496-1020

 

Phoenix Division

Arizona DEA Offices

Flagstaff: (928) 226-1659

Lake Havasu: (928) 955-9496

Nogales: (520) 281-1727

Phoenix (Head office): (602) 664-5600

Sierra Vista: (520) 458-3691

Tucson: (520) 573-5500

Yuma: (928) 344-9550

 

San Diego Division

California

Carlsbad: (760) 268-5700

Imperial County: (760) 355-0857

San Diego (Head office): (858) 616-4100

San Ysidro: (619) 671-4500

 

San Francisco Division

California

Bakersfield: (661) 396-3736

Fresno: (559) 487-5402

Modesto: (209) 558-6300

Oakland: (510) 637-5600

Redding: (530) 722-2056

Sacramento: (916) 480-7100

San Francisco (Head office): (415) 436-7900

San Jose: (408) 282-3400

Santa Rosa: (707) 837-2324

Seattle Division (Alaska, Idaho, Oregon and Washington)

Alaska

Anchorage: (907) 271-5033

Fairbanks: (907) 455-1818

 

Idaho

Boise: (208) 386-2100

 

Oregon

Bend: (541) 385-8798

Eugene: (541) 465-6861

Medford: (541) 776-4260

Portland: (503) 721-6600

Salem: (503) 399-5902

 

Washington

Bellingham: (360) 676-3100

Seattle (Head office): (206) 553-5443

Spokane: (509) 353-2964

Tacoma: (253) 383-7901

Tri-Cities, Kennewick: (509) 374-3444

Yakima: (509) 454-4407

 

St. Louis Division (Illinois, Iowa, Kansas, Missouri, Nebraska and South Dakota)

Illinois

Carbondale: (618) 457-3605

Fairview Heights: (618) 628-0025

Quad Cities: (309) 793-5708

 

Iowa

Cedar Rapids: (319) 393-6085

Des Moines: (515) 284-4700

Sioux City: (712) 255-9128

 

Kansas

Garden City: (620) 275-7798

Kansas City: (913) 951-4000

Topeka: (785) 232-4065

Wichita: (316) 838-2500

 

Missouri

Cape Girardeau: (573) 334-1534

Jefferson City: (573) 635-1331

St. Louis (Head office): (314) 538-4600

Springfield: (417) 888-9800

 

Nebraska

Omaha: (402) 965-3600

 

South Dakota

Rapid City: (605) 343-4947

Sioux Falls: (605) 330-4421

 

Washington, DC Division (Maryland, Virginia and West Virginia)

 

Maryland

Baltimore: (410) 244-3500

Hagerstown: (301) 223-1997

Salisbury: (410) 860-4800

 

Virginia

Bristol: (276) 466-4057

Hampton: (757) 825-5799

Norfolk: (757) 314-2200

Richmond: (804) 627-6300

Roanoke: (540) 857-2555

Springfield (DEA Headquarters): (202) 307-1000

Winchester: (540) 662-5879

 

Washington, DC

Head office: (202) 305-8500

 

West Virginia

Charleston: (304) 347-5209

Clarksburg: (304) 623-3700

Wheeling: (304) 234-6092