reglab/statecodes huggingface dataset:
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:01 - Manufacturing practices

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis product manufacturing facility shall follow
				  standard operating procedures to ensure workplace, environmental, and product
				  safety:
(1) Ensuring that all
				equipment and surfaces that come into contact with cannabis or other
				ingredients are food grade and nonreactive;
(2) Maintaining all counters and surface
				areas in a manner that reduces the potential for development of microbials,
				molds, mildew, fungi, and other contaminants;
(3) Providing adequate refrigeration for
				ingredients and products during manufacture, storage, or transport;
(4) Ensuring that all electrical equipment is
				listed by a nationally recognized testing laboratory or inspected annually by
				an engineer licensed pursuant to SDCL chapter 36-18 A; and
(5) Storing all chemicals in a safe
				manner.
General Authority:
SDCL
					 34-20G-72(5)(d)(e)(h).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:02 - Work environment

Current through Register Vol. 51, page 10, July 15, 2024
As applicable, all agents of a cannabis product manufacturing
				  facility shall:
(1) Work in an
				environment with proper ventilation, controlling all sources of ignition where
				a flammable atmosphere is or may be present;
(2) Use proper eye protection, respiratory
				protection, and gloves;
(3) Use
				only water that is potable and ice that is made from potable water;
				and
(4) Undergo safety training on
				fire prevention and safe operation of equipment used for
				manufacturing.
General Authority:
SDCL
					 34-20G-72(5)(d)(e)(h).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:03 - Cannabis product nonusable

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis product is nonusable if it contains:
(1) For an inhalable cannabis product:
(a) A level of any contaminant listed in
				§
										44:90:05:10 at or in excess of the
				corresponding action level specified in that section; or
(b) Residual solvents other than glycerin,
				propylene glycol, or cooking fats at or in excess of the following action
				level:
Residual Solvents
Action Level ug/g (parts per
								million)
Acetone
750
Butanes
800
Heptanes
500
Pentanes
750
Propane
2100
Ethanol
1000
Benzene
1
Toluene
150
Hexane
50
Total Xylenes
150
Isopropyl alcohol
500
Methanol
250
Ethyl acetate
400
Any other prohibited solvent
50
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:04 - Prohibited manufacturing activities

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis product manufacturing facility may not:
(1) Manufacture a product in the distinct
				shape of human, animal, creature, vehicle, fruit, cartoon character, toy,
				emoji, or other artwork likely or intended to appeal to anyone under twenty-one
				years of age;
(2) Manufacture a
				cannabis product by adding or infusing cannabis into a commercially available,
				noncannabis end product;
(3)
				Manufacture any edible cannabis product, except a tincture, oil, or capsule
				that has more than fifty milligrams of THC per serving;
(4) Package in a marketing layer an edible
				cannabis product, except a tincture or oil, or capsule containing oil with more
				than five hundred milligrams of total THC;
(5) Manufacture any cannabis product except:
(a) Vaporizer pens or cartridges;
(b) Concentrated cannabis;
(c) Cannabis tinctures, oils, and capsules
				containing oil;
(d) Cannabis
				beverages;
(e) Other edible
				cannabis products; and
(f) Topical
				cannabis products for external use;
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:05 - Extraction - Approved operating procedures

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis product manufacturing facility shall conform with
				  the standard operating procedures for extraction methods described in its
				  operating procedures and may not extract cannabis using any other methods
				  without prior written approval by the department.
A cannabis product manufacturing facility performing
				  extraction may be subject to inspection by the state fire marshal, local fire
				  department, building inspector, or code enforcement officer to confirm that no
				  health or safety concerns are present, and that the facility complies with all
				  applicable safety standards contained in local ordinance, SDCL chapter 11-10,
				  article 61:15, and chapter 20:44:22.
General Authority:
SDCL
					 34-20G-72(5)(e)(h).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:06 - Generally safe concentration methods

Current through Register Vol. 51, page 10, July 15, 2024
The following methods of preparing concentrated cannabis are
				  permissible if listed in the establishment's operating procedures on file with
				  the department:
(1) Mechanical
				concentration using:
(a) Potable water and ice
				made from potable water;
(b) Dry
				screening or sieving;
(c) Cryogenic
				or subzero processing not involving a solvent; and
(d) Pressure and temperature.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:07 - Potentially hazardous extraction methods

Current through Register Vol. 51, page 10, July 15, 2024
he department shall permit extraction using the following
				  substances, if 99 percent or greater in purity and if the department deems
				  storage, preparation, electrical, gas monitoring, fire suppression, and exhaust
				  systems methods to be adequate:
(1)
				Carbon dioxide;
(2) Another liquid
				chemical, compressed gas, or commercial product that has a flashpoint above 100
				degrees Fahrenheit; or
(3) Ethanol
				or solutions of ethanol and water.
General Authority:
SDCL
					 34-20G-72(5)(e)(h).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:08 - Extraction using inherently hazardous substances

Current through Register Vol. 51, page 10, July 15, 2024
Before performing extraction using an inherently hazardous
				  substance, the establishment must have prior physical inspection and written
				  approval by an engineer licensed pursuant to SDCL chapter 36-18 A that the
				  establishment's storage, preparation, electrical, gas monitoring, fire
				  suppression, and exhaust systems are adequate for the extraction methods and
				  substances used.
Any extraction method using inherently hazardous substances
				  must be listed in the operating procedures on file with the department and use
				  a substance of 99 percent or greater purity. The resulting extract must not
				  exceed residual limits for the substance established by the department as part
				  of testing requirements.
The following solvents may be used in approved inherently
				  hazardous extraction:
(1)
				Butane;
(2) Propane;
(3) Acetone;
(4) Heptane; or
(5) Pentane.
The use of any inherently hazardous substance other than
				  butane, propane, acetone, heptane, or pentane requires written approval of the
				  department, upon documentation of the safety and efficacy of the selected
				  method. All flammable gas must be stored and handled in accordance with all
				  applicable safety standards contained in local ordinance, SDCL chapter 11-10.
				  article 61:15, and chapter 20:44:22.
General Authority:
SDCL
					 34-20G-72(5)(e)(h).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:07 - Cannabis product manufacturing facilities › Section 44:90:07:09 - Edible cannabis products

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis product manufacturing facility that has declared
				  edible cannabis products as part of its approved operating procedures
				  shall:
(1) Obtain a South Dakota food
				service establishment license, pursuant to SDCL chapter 34-18, covering ongoing
				activities at the location identified in the operating procedures;
(2) Employ a Certified Food Service Manager
				meeting the requirements of §
									44:02:07:03;
(3) Comply with all applicable standards of
				chapter 44:02:07, and the city or county in which the establishment is
				located.
General Authority:
SDCL
					 34-20G-72(5)(e)(h).
Law Implemented:
SDCL
					 34-20G-72(5).
Person in charge,
					 44:02:07:03.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:08 - Cannabis dispensaries › Section 44:90:08:01 - Preventing unauthorized access - Age verification

Current through Register Vol. 51, page 10, July 15, 2024
No dispensary may allow entry into areas containing cannabis
				  without first identifying an individual as a cardholder or other person
				  authorized pursuant to §
									44:90:04:14. No dispensary may
				  allow entry to an age-restricted cardholder. Acceptable methods of controlling
				  access include:
(1) Verification at
				an external cashier window or ticket window, followed by unlocking an exterior
				door to admit the individual into the building;
(2) Verification at a cashier window or
				ticket window located in an entryway with a locked interior door that prevents
				access to any area containing cannabis, followed by unlocking the interior
				door; and
(3) Verification by an
				agent outside a locked exterior or interior door, followed by unlocking the
				door.
Verification may not take place in any area in which a person
				  may access cannabis without passing through a lockable door.
General Authority:
SDCL
					 34-20G-72(5)(c),
					 34-20G-75.
Law Implemented:
SDCL
					 34-20G-64,
					 34-20G-72(5),
					 34-20G-95.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:08 - Cannabis dispensaries › Section 44:90:08:02 - Preventing unauthorized access - Age verification - Website or mobile application

Current through Register Vol. 51, page 10, July 15, 2024
Any website or mobile application developed or hosted by an
				  establishment must:
(1) Include
				verification that the visitor is a cardholder or nonresident cardholder, except
				an age-restricted cardholder, or is 21 years of age or older;
(2) Require the cardholder's or nonresident
				cardholder's registry identification number for verification of any online
				purchases; and
(3) Limit online
				sales to cardholders and nonresident cardholders who previously have made a
				purchase of cannabis or cannabis products at the establishment.
General Authority:
SDCL
					 34-20G-72(5)(c).
Law Implemented:
SDCL
					 34-20G-64,
					 34-20G-72(5),
					 34-20G-95.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:08 - Cannabis dispensaries › Section 44:90:08:03 - Preventing unauthorized sales - Training requirements

Current through Register Vol. 51, page 10, July 15, 2024
Before interacting with any cardholder, any employee of a
				  dispensary shall be trained to:
(1)
				Determine the authenticity of registry identification cards;
(2) Ensure that the person presenting a
				registry identification card is the authorized cardholder with a valid
				photographic identification document;
(3) Use the verification system by phone,
				point-of-sale software, and mobile application;
(4) Track the amount of cannabis dispensed
				for a patient's use and consolidate the amounts in sales to the patient and the
				patient's designated caregiver; and
(5) Verify that the dispensary has been
				designated to make sales to the patient or the patient's designated
				caregiver.
General Authority:
SDCL
					 34-20G-72(5)(g).
Law Implemented:
SDCL
					 34-20G-70,
					 34-20G-71,
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:08 - Cannabis dispensaries › Section 44:90:08:04 - Sales of cannabis and cannabis products

Current through Register Vol. 51, page 10, July 15, 2024
No cannabis or cannabis product sale may take place at any
				  location other than at a certified medical cannabis dispensary. All sales must
				  take place at a certified medical cannabis dispensary in clear view of security
				  cameras.
General Authority:
SDCL
					 34-20G-72(4)(j).
Law Implemented:
SDCL
					 34-20G-72.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:01 - Mandatory testing prior to transfer for retail sale

Current through Register Vol. 51, page 10, July 15, 2024
A medical cannabis establishment must test every batch of
				  cannabis or cannabis product intended for consumption prior to transfer for
				  retail sale in final form prior to transfer. Any alterations made by a medical
				  cannabis establishment after receipt of cannabis or cannabis product results in
				  the creation of a new final form.
The following tests are required for cannabis and cannabis
				  products:
(1) Potency testing for THC
				content and, if so labeled, CBD content. The allowed variance for THC content
				may not exceed plus or minus ten percent; and
(2) Microbials listed in §
									44:90:05:10(3);
(3) Mycotoxins listed in §
									44:90:05:10(2);
(4) Metals listed in §
									44:90:05:10(4)
				and 44:90:07:03;
(5) Pesticides listed in §
									44:90:05:10(1);
				and
(6) Solvents listed in §
									44:90:07:03.
General Authority:
SDCL
					 34-20G-72(5)(d)(e)(l).
Law Implemented:
SDCL
					 34-20G-72.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:02 - Absence of mandatory testing

Current through Register Vol. 51, page 10, July 15, 2024
The absence of mandatory testing may not be interpreted to
				  allow:
(1) The use of prohibited
				solvents or pesticides;
(2)
				Agricultural or manufacturing practices that promote the growth of mold, yeast,
				or bacteria; or
(3) Soil or growing
				media containing unsafe levels of lead, arsenic, cadmium, or mercury.
General Authority:
SDCL
					 34-20G-72(5)(d)(e).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:03 - Prohibited transfer of cannabis or cannabis product - Exceptions

Current through Register Vol. 51, page 10, July 15, 2024
Except as allowed by §
									44:90:09:11, no cannabis or
				  cannabis products may be transferred by a cannabis cultivation facility or
				  cannabis product manufacturing facility to a cannabis dispensary unless:
(1) A cannabis testing facility has performed
				all mandatory tests on the cannabis or cannabis products and determined it
				complies with this article; and
(2)
				The cannabis or cannabis products are accompanied by a certificate of analysis
				issued by the cannabis testing facility that covers all mandatory tests.
Except samples for testing, any cannabis or cannabis products
				  transferred from a cannabis cultivation facility or a cannabis product
				  manufacturing facility without a certificate of analysis is nonusable and may
				  not be remediated.
General Authority:
SDCL
					 34-20G-72(5)(d)(e)(l).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:04 - Retention of certificate of analysis

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis product manufacturing facility or cannabis
				  dispensary shall maintain the certificate of analysis for any cannabis or
				  cannabis products for 180 days or until all of the cannabis or cannabis
				  products have been transferred or destroyed, whichever is
				  later.
General Authority:
SDCL
					 34-20G-72(5)(d)(e)(l).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:05 - Payment of fees associated with testing

Current through Register Vol. 51, page 10, July 15, 2024
The establishment submitting the cannabis or cannabis
				  products for testing shall pay all fees associated with
				  testing.
General Authority:
SDCL
					 34-20G-72(5)(d)(e)(l).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:06 - Creation of batches

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis cultivation facility or cannabis product
				  manufacturing facility shall:
(1)
				Divide cannabis into batches not to exceed 50 pounds, and as directed by a
				registered cannabis testing facility;
(2) Divide cannabis products into homogenous
				batches as directed by a registered cannabis testing facility and in accordance
				with the following size limitations:
(a)
				Cannabis product batches containing concentrated cannabis may not exceed 50
				pounds (22.7kg);
(b) Cannabis
				product batches containing extract or products that are infused with cannabis
				or cannabis extract may not exceed 70,000 unpackaged retail servings;
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:07 - Collection of samples

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis testing facility or a designee of a cannabis
				  testing facility shall collect representative samples for laboratory testing
				  from each batch of 36 cannabis or cannabis products created pursuant to §
									44:90:09:06.
A designee of a cannabis testing facility may only collect
				  samples on behalf of a cannabis testing facility upon completing the following
				  requirements:
(1) Obtain a valid agent
				identification card issued by the testing facility;
(2) Confirm physical ability to perform
				sample collection procedures and activities;
(3) Complete no less than 10 hours of initial
				training on sample collection procedures provided by the cannabis testing
				facility and in accordance with this Chapter; and
(4) Demonstrate competency in sample
				collection in compliance with the cannabis testing facility's sample collection
				procedures and this Chapter.
A designee of a cannabis testing facility is required to
				  attend no less than 10 hours of continuous training throughout each year in
				  addition to the initial training requirements.
Prior to performing sample collection for mandatory tests,
				  the designee of a cannabis testing facility shall contact the testing facility
				  to obtain instructions for each sampling event, including the instruments to be
				  used, the containers required to store samples, storage and transportation
				  requirements, receipt and recordkeeping of the samples.
The collection of samples must comply in all manner with
				  §§ 44:90:09:07 and
				  44:90:09:09, the testing
				  facility's standard operating procedures and sample collection procedures, and
				  requirements for ISO/IEC 17025 accreditation.
General Authority:
SDCL
					 34-20G-72(5)(d)(k)(l).
Law Implemented:
SDCL
					 34-20G-72(5).
International Organization for Standardization &
					 International Electrotechnical Commission. (2018). ISO/IEC 17025:2017: General
					 Requirements for the Competence of Testing and Calibration Laboratories.
https://www.iso.org/standard/66912.html
.
					 Cost : $138.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:07.02 - Procedures to ensure representative sampling

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis testing facility or a designee of the cannabis
				  testing facility must sample in accordance with cannabis testing facility
				  sample collection procedures and the following procedures to ensure
				  representative sampling:
(1) Check the
				cannabis or cannabis product batch in its entirety for any signs or indications
				of non-uniformity and differences from content appearing on the batch
				label;
(2) Homogenize the cannabis
				and cannabis product batch
(3)
				Confirm the cannabis or cannabis product batch size matches the information in
				the inventory tracking system
(4)
				Randomly select sample increments throughout each cannabis or cannabis product
				batch following sample collection procedures representing no less than the
				total minimum sample requirements in accordance with §
									44:90:09:07
(5) Take equal portions for each sample
				increment
(6) Record all
				observations and procedures used for the collection of each sample increment
				and maintain records pursuant to §
									44:90:11:02.
General Authority:
SDCL
					 34-20G-72(5)(l).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:08 - Packaging of samples for testing

Current through Register Vol. 51, page 10, July 15, 2024
All samples of cannabis or cannabis products must be
				  transferred to a testing facility in sealed and tamper-evident containers that
				  are supplied by a testing facility or that meet criteria specified by a testing
				  facility.
General Authority:
SDCL
					 34-20G-72(5)(f)(k)(l).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:09 - Storage while awaiting test results

Current through Register Vol. 51, page 10, July 15, 2024
A cultivation facility or cannabis product manufacturing
				  facility awaiting testing results shall:
(1) Enter the identification number of the
				batch and the identification number of the samples associated with the batch
				into the establishment's inventory records;
(2) Store the batch in one or more sealed
				containers enclosed on all sides; and
(3) Affix to the container a label including
				the following information:
(a) The
				establishment's identification number;
(b) The batch number entered into inventory
				records;
(c) Name and
				identification number of the testing facility that will perform the
				tests;
(d) The sample's unique
				identification number;
(e) The date
				the samples were taken; and
(f) In
				bold, capital letters, no smaller than 12-point font, PRODUCT NOT
				TESTED.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:10 - Receipt of results - Remediation

Current through Register Vol. 51, page 10, July 15, 2024
Upon receipt of a certificate of analysis indicating that
				  cannabis or cannabis products comply with SDCL chapter 34-20 G and this article
				  and after the cannabis testing facility updates the inventory tracking system,
				  the cannabis cultivation facility or cannabis product manufacturing facility
				  may transfer the cannabis or cannabis products to another establishment,
				  subject to the inventory tracking requirements of this article.
Upon receipt of a certificate of analysis indicating that
				  cannabis or cannabis products are nonusable, the cannabis or cannabis products
				  shall remain, until remediated or destroyed in accordance with this article, in
				  the same storage container with a new label depicting:
(1) The establishment's identification
				number;
(2) The batch number
				entered into inventory records;
(3)
				Name and identification number of the testing facility that will perform the
				tests;
(4) The sample's unique
				identification number;
(5) The date
				the samples were taken;
(6) The
				reason for failed analytical testing; and
(7) In bold, capital letters, no smaller than
				12-point font, PRODUCT FAILED TESTING.
General Authority:
SDCL
					 34-20G-72(5)(d)(e)(f)(l).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:11 - Remediation of nonusable batches

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis cultivation facility or cannabis product
				  manufacturing facility may elect to remediate a batch of cannabis or cannabis
				  products that failed testing, provided that:
(1) Cannabis and cannabis products that fail
				tests for metals or pesticides may not be remediated;
(2) Cannabis and cannabis products that fail
				tests for prohibited solvents may not be remediated;
(3) An establishment shall outline its
				processes for remediating cannabis and cannabis products in its operating
				procedures;
(4) An establishment
				shall obtain department permission before remediating a batch of cannabis or
				cannabis products; and
(5) Any
				cannabis or cannabis products must be retested and must pass all required tests
				after remediation.
General Authority:
SDCL
					 34-20G-72(5)(d)(e)(l).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:09 - Sampling and testing › Section 44:90:09:12 - Destruction of nonusable batches

Current through Register Vol. 51, page 10, July 15, 2024
If a cultivation facility or product manufacturing facility
				  is unable or unwilling to remediate a nonusable batch of cannabis or cannabis
				  products, the establishment shall:
(1)
				Note in the inventory tracking system, or if unavailable, provide notice within
				one business day in writing to the department, that the establishment will
				destroy the cannabis or cannabis products;
(2) Follow the procedures for destroying
				cannabis waste in the establishment's approved operating procedures;
				and
(3) Ensure that destruction of
				the nonusable batch is captured by functioning security cameras and stored
				according to this article.
If a cultivation facility or product manufacturing facility
				  fails to follow the procedures under this section, the department shall:
(1) Submit a notice to all medical cannabis
				dispensaries that the inventory tracking system batch number associated with
				the unusable batch has not passed the required tests pursuant
				44:90:09:01.
(2) Provide procedures
				for recall pursuant to §
										44:90:12:02 if the unusable
				cannabis or cannabis product has been made available for retail sale.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:01 - Packaging for retail sale - General requirements

Current through Register Vol. 51, page 10, July 15, 2024
A dispensary shall transfer any cannabis or cannabis products
				  to the patient or designated caregiver in packaging that is:
(1) Child-resistant in compliance with 16
				C.F.R. part 1700.15 (July 21, 1995);
(2) Tamper-evident, using a sealing method
				that provides clear, lasting evidence that the package has previously been
				opened;
(3) Resealable, except for
				single-serving cannabis products; and
(4) Opaque and does not allow the product to
				be seen without opening the packaging material.
Unless otherwise specified by this article, each packaging
				  requirement may be met by the container provided by either the cultivation
				  facility or cannabis product manufacturing facility or by exit packaging
				  supplied by the dispensary at the time of sale.
General Authority:
SDCL
					 34-20G-72(5)(j).
Law Implemented:
SDCL
					 34-20G-72.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:01.01

Current through Register Vol. 51, page 10, July 15, 2024
The adopted version of this section by
				  48
				  SDR 54, effective
				  11/15/2021 is not
				  yet available.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:02 - Packaging of cannabis flower or trim or inhalable cannabis products for retail sale

Current through Register Vol. 51, page 10, July 15, 2024
Cannabis flower or trim or an inhalable cannabis product
				  shall be transferred by a dispensary in a container that is fully enclosed on
				  all sides, as follows:
(1) If the
				container is soft-sided, it must be four mil or greater in thickness;
				or
(2) If the container has rigid
				sides, it must have a lid or enclosure that can be placed tightly and securely
				on the container.
General Authority:
SDCL
					 34-20G-72(5)(j).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:03 - Packaging of edible cannabis products for retail sale - Tinctures, oils, and beverages excluded

Current through Register Vol. 51, page 10, July 15, 2024
Edible cannabis products shall be packaged as follows:
(1) Single-serving edible cannabis
				products, other than tinctures, oils, and beverages:
(a) Shall be placed into a child-resistant
				container that may or may not be resealable; and
(b) May be bundled into a larger marketing
				layer so long as the total amount of active THC per marketing layer does not
				exceed 100 milligrams.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:04 - Packaging of cannabis tinctures and oils for retail sale

Current through Register Vol. 51, page 10, July 15, 2024
Cannabis tinctures or oils shall be packaged:
(1) In a glass or plastic vial or dosage
				syringe, either:
(a) With a resealable
				child-resistant cap; or
(b) With a
				resealable cap and enclosed in a child-resistant, soft-sided container made of
				plastic that is four mil or greater in thickness and heat-sealed; and
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:05 - Packaging of cannabis beverages for retail sale

Current through Register Vol. 51, page 10, July 15, 2024
Cannabis beverages shall be packaged as follows:
(1) Single-serving cannabis beverages that do
				not contain more than ten milligrams of THC must be packaged in:
(a) A child-resistant container;
(b) A metal can with a stay tab mechanism
				opening; or
(c) A glass bottle with
				a cork or metal crown style bottle cap;
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:06 - Packaging of topical cannabis products for retail sale

Current through Register Vol. 51, page 10, July 15, 2024
Ointments, creams, and lotions must be packaged in a
				  child-resistant container that has a resealing cap or closure compliant with 16
				  C.F.R. part 1700.15 (July 21, 1995). Dry bath soaks and transdermal patches
				  must be packaged in a plastic that is four mil or greater in thickness to
				  prevent unintended access to and ingestion by children or pets and is
				  heat-sealed with no easy-open tab, dimple, corner, or flap.
General Authority:
SDCL
					 34-20G-72(5)(j).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:07 - Labeling required

Current through Register Vol. 51, page 10, July 15, 2024
All cannabis and cannabis products must be labeled in
				  accordance with this chapter before sale or transfer to the patient or
				  designated caregiver.
Prior to transferring cannabis to a dispensary, a cultivation
				  facility shall label the marketing layer of each container. Prior to
				  transferring cannabis products to a dispensary, a cannabis product
				  manufacturing facility shall label each the marketing layer of each
				  container.
Unless otherwise specified, all required information shall be
				  printed directly on the marketing layer of the cannabis or cannabis product or
				  printed on a sticker attached to the marketing layer of the cannabis or
				  cannabis product.
General Authority:
SDCL
					 34-20G-72(5)(j),(7).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:08 - Format of labeling - Font size - Multiple labels

Current through Register Vol. 51, page 10, July 15, 2024
All required information must be printed clearly in English
				  on the label in type no smaller than six-point font (1/12 inch). An
				  establishment may affix an extendable, accordion-style label, layered label, or
				  multiple labels to the marketing layer if none of the required information is
				  obstructed and the label can be easily identified by a patient or designated
				  caregiver as containing important information.
General Authority:
SDCL
					 34-20G-72(7).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:09 - Labeling claims - Results of testing

Current through Register Vol. 51, page 10, July 15, 2024
The results of any testing mandated by the department must be
				  included on the label of any cannabis or cannabis product. The label must state
				  the THC content in milligrams of total THC and as a percentage of the product's
				  weight. No label may contain claims regarding cannabidiol content or the
				  absence of microbials, metals, solvents, or pesticides except to list the
				  results of analytical tests performed by a registered cannabis testing
				  facility.
General Authority:
SDCL
					 34-20G-72(7).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:10 - Expected effects - Time to take effect - Duration of effect

Current through Register Vol. 51, page 10, July 15, 2024
The label of any cannabis or cannabis product must
				  indicate:
(1) The length of time, in
				hours or minutes, that it may take the patient to feel effects; and
(2) The length of time the patient should
				expect the effects to last.
The estimated time to take effect and duration of effect
				  shall be based on the best estimate of the establishment printing the label.
				  The label on any edible product, except an ethanol-based tincture, must
				  additionally contain the following warning: Effects of this product may not be
				  felt for up to four hours.
General Authority:
SDCL
					 34-20G-72(7)(a).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:11 - Ingredients - Allergen warnings

Current through Register Vol. 51, page 10, July 15, 2024
The label of any cannabis or cannabis product must identify
				  any pesticides used in cultivation. The label of any cannabis product must list
				  all ingredients and, if applicable, gases, solvents, or other chemicals used in
				  extraction. The label of any edible cannabis product must identify any major
				  allergens contained in the product in accordance with
				  21 U.S.C. §
										321(qq) (April 23, 2021),
				  including milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat,
				  and soybeans.
General Authority:
SDCL
					 34-20G-72(7)(b).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:12 - Contents - Net weight or volume - Nutritional information

Current through Register Vol. 51, page 10, July 15, 2024
The label of any cannabis or cannabis product must:
(1) Include a statement of net contents
				identifying the net weight or volume of the cannabis or cannabis product,
				expressed:
(a) If a solid, in both ounces and
				grams or milligrams; or
(b) If a
				liquid or colloid, in both fluid ounces and milliliters;
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:12.01

Current through Register Vol. 51, page 10, July 15, 2024
The adopted version of this section by
				  48
				  SDR 54, effective
				  11/15/2021 is not
				  yet available.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:13 - Identifying information - Establishment identification number - Batch - Dates

Current through Register Vol. 51, page 10, July 15, 2024
The container or exit packaging for any cannabis or cannabis
				  product sold by a dispensary must identify:
(1) The registration number of any
				cultivation facility, cannabis product manufacturing facility, or dispensary
				involved in the cultivation, processing, or sale of the item;
(2) Batch numbers;
(3) Cultivation date of cannabis flower or
				trim; and
(4) Production date of
				cannabis products.
General Authority:
SDCL
					 34-20G-72(5)(j),(7).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:14 - Labeling prohibitions

Current through Register Vol. 51, page 10, July 15, 2024
No label may:
(1)
				Include representations as to cannabinoid content or to the absence of
				pesticides, mold, or other contaminants, other than to provide the results of
				analysis performed -Rby a cannabis testing facility
				certified in accordance with this article;
(2) Make claims regarding health or physical
				benefits to the consumer;
(3)
				Include any false or misleading statements;
(4) Obscure identifying information or
				warning statements;
(5) Use any
				trademark without authorization;
(6) Depict a human, animal, creature,
				vehicle, fruit, cartoon character, toy, emoji, or other artwork likely or
				intended to appeal to anyone under 21 years of age;
(7) Include the word "Scandy" or "Scandies";
				or
(8) Refer to any item typically
				marketed to persons under 21 years of age.
General Authority:
SDCL
					 34-20G-72(7).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:14.01

Current through Register Vol. 51, page 10, July 15, 2024
The adopted version of this section by
				  48
				  SDR 54, effective
				  11/15/2021 is not
				  yet available.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:15 - Target audience - Establishments and adult cardholders only - Prohibition on advertising to practitioners

Current through Register Vol. 51, page 10, July 15, 2024
Advertisements must be targeted as directly as possible to
				  other establishments, cardholders who are 21 years of age or older, and readers
				  of medical publications. Advertisements may not target:
(1) Non-cardholders, including:
(a) Suggesting a medical evaluation;
				or
(b) Interacting with the public
				at events sponsored by the establishment;
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:16 - Advertising on websites, social media, and mobile applications

Current through Register Vol. 51, page 10, July 15, 2024
Any advertising on websites, social media, or mobile
				  applications must include:
(1) A
				verification that the recipient is not an age-restricted cardholder;
				and
(2) A permanent opt-out
				feature.
General Authority:
SDCL
					 34-20G-72(5)(i).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:17 - Prohibited content - Advertisements

Current through Register Vol. 51, page 10, July 15, 2024
No advertisement for a medical cannabis establishment
				  may:
(1) Make deceptive, false or
				misleading statements;
(2) Make
				claims related to potency beyond listing the cannabinoid content of the
				cannabis or cannabis product advertised, as verified by a testing
				facility;
(3) Depict consumption of
				cannabis or cannabis products;
(4)
				Depict pregnancy, breastfeeding, or operating a motorized vehicle, boat or
				machinery;
(5) Depict or refer to
				candy or a specific type of candy;
(6) Use a trademark associated with a
				non-cannabis product;
(7) Use a
				parody or other use that has similarity to the original;
(8) Encourage the transportation of cannabis
				across state lines or otherwise encourage illegal activity;
(9) Assert that cannabis is safe because it
				is regulated by the department, tested by a testing facility, or otherwise
				endorsed by any government agency;
(10) Make claims that cannabis has curative
				or therapeutic effects;
(11) Claim
				any health or physical benefits; or
(12) Encourage excessive or rapid
				consumption.
General Authority:
SDCL
					 34-20G-72(5)(i).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:18 - Required information - Advertisements

Current through Register Vol. 51, page 10, July 15, 2024
Any advertisement must contain the following information:
(1) A statement: For medical use by
				qualifying patients only.; and
(2)
				The medical cannabis establishment identification number of the establishment
				responsible for the advertisement.
General Authority:
SDCL
					 34-20G-72(5)(i).
Law Implemented:
SDCL
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:10 - Packaging, labeling, and advertising › Section 44:90:10:19 - Nonconforming advertising

Current through Register Vol. 51, page 10, July 15, 2024
Any nonconforming advertising is a violation of this article
				  and SDCL chapter 34-20 G.
(1) Upon
				notification by the department, the establishment shall cease the nonconforming
				advertisements and remove any nonconforming advertising from websites, social
				media, mobile applications, or signs.
(2) Failure to cease or remove the
				advertising within 48 hours is a serious and knowing violation of this article
				and SDCL chapter 34-20 G.
General Authority:
SDCL
					 34-20G-72(5)(i).
Law Implemented:
SDCL
					 34-20G-72(5),
					 34-20G-80.
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:11 - Recordkeeping › Section 44:90:11:02 - Retention of records - Electronic and paper - Amended records

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis establishment shall maintain, for a minimum of 18
				  months, the following records:
(1) All
				point of sale records, whether in electronic or paper form;
(2) Transport manifests; and
(3) Daily inventory records, transfer
				records, testing sample records, and transaction records.
No inventory record, transfer record, testing sample record,
				  or transaction record may be altered after the date on which it was created. If
				  necessary, an amended inventory record, transfer record, testing sample record,
				  or transaction record may be created, but the original record is subject to
				  record retention requirements.
General Authority:
SDCL
					 34-20G-72(5)(b)(j).
Law Implemented:
SDCL
					 34-20G-63,
					 34-20G-72(5).
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:11 - Recordkeeping › Section 44:90:11:03 - Daily inventory record

Current through Register Vol. 51, page 10, July 15, 2024
A medical cannabis establishment shall maintain and update by
				  midnight of each day of operation, an electronic record of the establishment's
				  inventory of cannabis and cannabis products that must:
(1) For prepackaged cannabis or cannabis
				products, the inventory record shall include the number of marketing layers of
				each item;
(2) Use the following
				units of measure:
(a) For seeds, seedlings,
				and plants, whole numbers;
(b) For
				cannabis flower, trim, pre-rolled cannabis cigarettes, and dry or powdered
				topical products, net weight in grams and ounces;
(c) For vaporizer cartridges, vaporizer pens,
				concentrated cannabis, tinctures, and other edible oils, net weight in
				grams;
(d) For edible cannabis
				products and transdermal patches, milligrams of THC; and
(e) For ointments, creams, or lotions, net
				volume in fluid ounces;
South Dakota Administrative Rules › Title 44 - Department of Health › Article 44:90 - MEDICAL CANNABIS › Chapter 44:90:11 - Recordkeeping › Section 44:90:11:04 - Daily transfer record

Current through Register Vol. 51, page 10, July 15, 2024
A cannabis establishment shall maintain and update by
				  midnight of each day of operation, an electronic record of all cannabis
				  obtained from a cardholder or another establishment, and all cannabis and
				  cannabis products transferred to another establishment that:
(1) Use the same units of measure as the
				inventory record;
(2) Reflect all
				transport manifests; and
(3) Be
				maintained securely and may not identify any cardholder except by the
				cardholder's identification number.
General Authority:
SDCL
					 34-20G-72(5)(b)(j).
Law Implemented:
SDCL
					 34-20G-63,
					 34-20G-72(5).