N.Y. Comp. Codes R. & Regs. Tit. 9 § 123.6 - Processor License Facility Operations
(a)
Good manufacturing practices.
(1) All
cannabis and cannabis product processing shall be in accordance with good
manufacturing practice (GMP) standards, pursuant to either Part 111 or Part 117
of Title 21 of the Code of Federal Regulations, as applicable for the type of
cannabis or cannabis product being processed or as otherwise determined by the
Office.
(2) A licensee who is
authorized to conduct certain processing activities as determined by the Office
shall establish compliance with GMP standards by submitting to the Office proof
of a qualified third-party GMP audit, of the licensee's extraction and/or
manufacturing processes as applicable, to the satisfaction of the Office,
within one (1) year of commencing licensed operations. The Office shall
determine which third-party GMP auditors are authorize and qualified.
(3) A licensee who is processing in
accordance with requirements by the Office, shall maintain proof of current GMP
certification for the duration of the license and make such certification
readily available to the Office upon request.
(b) General requirements. A processor shall:
(1) maintain all designated processing areas
in accordance with general sanitary practices as set forth in section
125.7 of this Title;
(2) assign a lot unique identifier on all
cannabis and cannabis products, which allows for complete traceability of all
cannabis and cannabis products processed during a specific period of time and
under similar conditions;
(3)
comply with all packaging and labeling standards in Part 128 of this
Title;
(4) maintain, and make
available to the Office upon request, processing, packaging, labeling and batch
production records, including records of all ingredients and materials used in
the processing of each lot of cannabis or cannabis product, and any other
applicable records required by Part 125 of this Title;
(5) develop and maintain written standard
operating procedures for all processing activities to ensure homogeneity and
consistency of cannabis products, including, but not limited to, development of
a master manufacturing record containing standards for product purity,
strength, and composition for each type of cannabis product produced. Common
plan types include a GMP Plan, Quality Assurance Plan, or Hazard Analysis and
Critical Control Points (HACCP) Plan.
(c) Requirements for extraction. Unless
otherwise approved in writing by the Office, a processor authorized to perform
extraction may only use the methods, equipment, solvents, gases, and mediums
set forth in this section and approved on the processor's application and shall
be conducted only in a manner exhibiting minimal risks to worker safety and
public health.
(1) All extraction processes
and activities shall:
(i) be conducted by
employees trained in the operation of the extraction equipment to be utilized,
as well as the emergency plan for incidents and any hazards associated with
chemicals, ingredients, solvents, or processes used;
(ii) demonstrate control of all sources of
ignition, and occur in a spark-free environment where appropriate for the type
of extraction method used;
(iii)
ensure proper ventilation;
(iv)
have ongoing equipment monitoring and maintain a record of regular maintenance
of equipment based on equipment specifications;
(v) follow all applicable state and local
fire, safety and building codes, regulations, laws and guidance related to the
use and storage of solvents, including, but not limited to, maximum quantities
to be held onsite; and
(vi) have
evidence of the purity of any chemical solvents used and make any certificate
of analysis for the solvents or other documentation evidencing such purity
readily available to employees and to the Office upon request.
(2) Unless a processor obtains
prior written approval from the Office, extraction shall only be conducted
using the following methods:
(i) mechanical
extraction methods;
(ii) a
professional grade, closed-loop CO2 extraction system that is of a supply
equivalent to food or beverage grade of at least 99.5% purity;
(iii) ethanol or alcohol based, provided that
all ethanol or alcohol used shall be of a grade that meets or exceeds
specifications of official compendiums as defined in
section
321 of Title 21 of the United States Code
(USC);
(iv) a volatile solvent or
hydrocarbon extraction method, provided that the method:
(a) utilizes a commercial, professional grade
closed-loop system designed to recover the solvent; and
(b) utilizes the following permissible
volatile solvent-based or hydrocarbon extraction substances, which shall be
accompanied by a certificate of analysis which establishes that said substances
have a minimum purity level of 99%:
(1)
butane;
(2) propane; or
(3) any other volatile solvent or hydrocarbon
with prior written approval by the Office prior to
use.
(3) For all proposed volatile solvent-based
or hydrocarbon extraction, a processor shall submit to the Office, prior to
receiving approval to commence extraction operations at a processing facility,
documentation which demonstrates, to the satisfaction of the Office, the
following additional requirements for all designated extraction equipment,
rooms, or other areas where volatile solvents used for extraction are handled
or stored:
(i) final certification letter
from a licensed professional engineer or registered architect which certifies
the completed installation of a professionally designed, commercially
manufactured extraction system, that is compliant with all applicable state or
local fire, safety or building codes;
(ii) a letter from the municipal
jurisdiction's fire marshal, or their designee, stating that a final inspection
of the facility has been conducted and that the processor has demonstrated
compliance with all applicable fire codes and/or regulations; and
(iii) a certificate of occupancy, or
equivalent document, from the local building official that all permits for
extraction related rooms or areas have been closed as
applicable.
(d)
Allowable cannabis and cannabis product types. A processor may produce the
following types of cannabis or cannabis products for sale:
(1) topicals;
(2) edibles, that are not in shapes
considered to be attractive to individuals under twenty-one as defined in Part
128 of this Title, including, but not limited to:
(i) capsules;
(ii) beverages;
(iii) tablets;
(iv) tinctures;
(v) baked goods;
(vi) gummies; or
(vii) chocolates;
(3) vaporization cartridges or single-use
pens;
(4) concentrates such as
shatters, waxes and resin;
(5)
cannabis flower products, including, but not limited to, whole flower, ground
flower, shake and pre-rolls;
(6)
cannabis extracts for intermediary sale; and
(7) any other cannabis product type or form,
except for the prohibitions in subdivision (e) of this section, with prior
written approval of the Office which, following written submission by the
processor and a review process by the Office of the proposal, including, but
not limited to, review of proposed manufacturing processes, methods of
administration and any other factors which assess risk to public health and
safety, is determined in writing by the Office to be suitable as a product for
retail sale.
(e)
Prohibitions and prohibited product types. A processor is prohibited from
processing any cannabis products which:
(1)
contain liquor, wine, beer, cider or meet the definition of an alcoholic
beverage as defined in section 3 of the Alcohol Beverage Control Law;
(2) contain tobacco or nicotine;
(3) exceed the maximum total THC per serving
and per package limits set forth in paragraph (1) of subdivision (f) of this
section;
(4) are attractive to
individuals under twenty-one pursuant to Part 128 and 129 of this
Title;
(5) contain synthetic
cannabinoids and/or cannabimimetic agents, as defined in subdivision (g) and
subdivision (h) of schedule I of section
3306 of the
Public Health Law;
(6) contain any
artificially derived phytocannabinoids;
(7) require manufacture under sterile
conditions;
(8) are considered a
potentially hazardous food as defined by 10 NYCRR section 14-1.31;
(9) contain any non-phytocannabinoid
ingredient that would increase potency, toxicity, or addictive potential, or
that would create an unsafe combination, known or unknown, with other
psychoactive substances. This prohibition shall not apply to products
containing naturally occurring caffeine, such as coffee, tea, or
chocolate;
(10) are manufactured by
application of phytocannabinoid concentrate or extract to commercially
available candy or snack food items without further processing of the product.
Commercially available candy or snack food items may be used as ingredients in
a cannabis product, provided that they are used in a way that renders them
unrecognizable as the commercially available items, and the label, including
the ingredient list, does not note that the final cannabis product contains the
commercially available item;
(11)
are in the shape of, or imprinted with the shape, either realistic or
caricature, of a human being, animal, insect, or fruit, or is otherwise
attractive to individuals under the age of twenty-one as defined in Part 128 of
this Title; or
(12) are in the form
of an injectable, inhaler, suppository, transdermal formulations, or any other
disallowed form, as determined by the Office, including a form allowed solely
for medical cannabis use, unless otherwise authorized by the
Office.
(f) Requirements
for all cannabis products. All cannabis products processed for distribution for
retail sale shall:
(1) if in the form of an
orally ingested product, conform to the product potency limit of 10 milligrams
(mg) total THC per serving, and 100 mg total THC per package, provided,
however, that tinctures shall conform to the product potency limit of 10 mg
total THC per serving, and 1,000 mg total THC per package.
(2) not contain less than 85% or more than
115% of the concentration of total THC, CBD, or any other phytocannabinoid and
terpene content as listed on the cannabis product label and reflected on the
cannabis product laboratory testing certificate of analysis. Any cannabis
product not meeting this requirement shall be relabeled with the accurate
phytocannabinoid and terpene content, provided that all other laboratory
testing results comply with Part 130 of this Title, and the maximum serving
requirements in paragraph (1) of this subdivision without further product
remediation, unless otherwise authorized by the Office;
(3) be prepackaged, and not added to food or
any other consumable products at the point of retail sale;
(4) be shelf stable, unless otherwise
approved in writing by the Office, provided that nothing in this provision
shall prohibit a processor from storing non-cannabis components or ingredients
under refrigeration until use in product manufacturing;
(5) unless otherwise approved by the Office,
except for cannabis, contain only ingredients which are appropriate for the
cannabis product type and are, unless otherwise required to be pharmaceutical
grade based on the product type, at a minimum, food grade, meaning the
ingredient is generally recognized as safe (GRAS), pursuant to sections 201(s)
and 409 of the Federal Food, Drug, and Cosmetic Act, or meets internationally
recognized standards for the purity and identity of food ingredients;
(i) unless otherwise approved by the Office,
except for cannabis, no ingredient or component shall be used in the
manufacturing of an edible cannabis product unless that ingredient or component
is permitted by the United States Food and Drug Administration (FDA) for use in
food or food manufacturing, as specified in Substances Added to Food in the
United States, or is GRAS;
(ii)
unless otherwise approved by the Office, except for cannabis, topical cannabis
products shall only contain ingredients permitted for cosmetic manufacturing in
accordance with Title 21, Code of Federal Regulations, Part 700, subpart B
(section 700.11 et seq.);
(iii)
unless otherwise approved by the Office, cannabis products intended to be
inhaled shall only contain cannabis, cannabis concentrate, terpenes, rolling
paper, pre-roll filter tips, or ingredients permitted by the United States Food
and Drug Administration as an 'inactive ingredient' for inhalation, as
specified in the United States Food and Drug Administration Inactive
Ingredients Database; and
(iv) the
Office may determine additional standards related to the ingredients which may
be used in cannabis products, and such standards may include, but not be
limited to, the identification of ingredients which may only be appropriate for
certain product forms or the establishment of certain quality metrics which
must be met by specific ingredients in order to be used in cannabis
products;
(6) have a date
of expiration for unopened product and a use by date for opened product
established by available stability data from stability studies initiated by the
licensee, or from a reputable outside source, for the cannabis product form.
Each processor that is labeling cannabis products in their final form to be
sold to a consumer shall possess stability data for each cannabis product being
labeled which supports any unopened package date of expiration or opened
package use by date on the cannabis product's respective label. All stability
data shall be made available to the Office upon request;
(i) The processor shall complete any
stability testing of a cannabis product, requested by the Office, to
demonstrate the ongoing stability of the product produced over time.
(ii) For stability testing of unopened
cannabis products, each cannabis product shall retain a total THC and CBD
concentration in milligrams per single serving that is consistent with
paragraph (2) of this subdivision. If the product no longer retains a
consistent concentration of total THC and CBD pursuant to paragraph (1) of this
subdivision, the product shall be deemed no longer suitable for sale and shall
be destroyed pursuant to section
125.11 of this
Title.
(7) except for
cannabis flower products, have the total number of servings in the cannabis
product determined and displayed. For cannabis edible products or products
intended for oral ingestion, products that consist of more than a single
serving shall be either:
(i) if the cannabis
product is in solid form, the product shall be scored or otherwise delineated
by the processor to indicate one serving;
(ii) if the cannabis product is not in solid
form, the product shall be packaged in a manner such that a single serving is
readily identifiable or easily measurable and the package is resealable;
or
(iii) if the cannabis product is
a cannabis beverage product, the product shall not have more than a single
serving per package, provided, however, multiple cannabis beverage products can
be sold together.
(8) if
such cannabis products, other than cannabis flower products, contain multiple
servings which are not individually wrapped, premeasured, separated, or
delineated, such cannabis product shall include a measuring device such as a
measuring cap, cup, or dropper with the product packaging, which shall be
provided with the cannabis product. Hash marks on the package shall not qualify
as a measuring device;
(9) if the
cannabis product is vaporized or inhaled, the vaporized or inhaled cannabis
product must meet the following additional requirements:
(i) if the cannabis product is vaporization
oil that cannot be separated from the associated vaporization device, the
vaporization device shall have internal or external temperature controls to
prevent combustion and have a heating element made of inert material such as
glass, ceramic or stainless steel and not plastic or rubber;
(ii) except for botanically derived terpenes,
ingredients used in vaporized or inhaled cannabis products shall be
pharmaceutical grade unless otherwise approved by the Office;
(iii) ingredients used in vaporized or
inhaled cannabis products shall not include:
(a) synthetic terpenes;
(b) polyethylene glycol (PEG);
(c) vitamin E acetate;
(d) medium chain triglycerides (MCT
oil);
(e) medicinal
compounds;
(f) illegal or
controlled substances;
(g)
artificial food coloring;
(h)
benzoic acid;
(i) diketones;
or
(j) any other compound or
ingredient as determined by the Office;
(iv) vaporized or inhaled cannabis products
cannot exceed more than 10% total terpenes; and
(v) licensees shall maintain records with
full information on the source of all botanically derived terpenes, which shall
include any cannabis derived terpenes, used in vaporized or inhaled cannabis
products and provide this information to the Office upon request; and
(vi) vaporized or inhaled cannabis products
shall not be flavored if such flavor is:
(a)
menthol or any type of mint;
(b)
cotton candy;
(c) bubble
gum;
(d) candy;
(e) clove;
(f) vanilla;
(g) chocolate;
(h) ice cream or gelato;
(i) soda;
(j) cereal;
(k) dessert;
(l) a concept flavor; or
(m) another flavor that is attractive to
individuals under twenty-one, as determined by the
Office.
(10)
except for cannabis flower products, be homogenous, with phytocannabinoid
content evenly distributed throughout the cannabis product. Unless otherwise
approved by the Office, a cannabis product shall not be considered homogenous
if the concentration of total THC and CBD in milligrams per single serving for
representative sampling submitted for testing, pursuant to Part 130 of this
Title, is not within 25% of the mean concentration of total THC and CBD in
milligrams per single serving for that submitted lot with the exception that,
for products with a specified total THC and CBD concentration less than two (2)
milligrams per single serving, the concentration of each sample for that low
concentration phytocannabinoid shall be within 0.5 milligrams per serving of
the mean concentration; and
(11) be
identified and categorized in a processor's inventory tracking system and
include information detailing the milligrams of total THC in the cannabis
product, to ensure compliance with article 20-C of the Tax
Law.
(g) Cannabis product
quality plans, master manufacturing records and batch product records.
(1) Product Quality Plan. A processor shall
implement and maintain a written product quality plan for each type of cannabis
product it manufactures. The product quality plan shall address the risks and
hazards associated with the premises and the manufacturing process that, if not
properly mitigated, may cause the cannabis product to be adulterated or
misbranded, may cause harm to individuals involved in the process, or may cause
the cannabis product to fail laboratory testing or quality assurance review and
shall include the following:
(i) a
comprehensive assessment of the overall manufacturing process, including all
steps from component intake through transfer of product from the
premises;
(ii) evaluation of the
potential risks associated with each manufacturing step, which includes
evaluation of potential risks to individuals completing the manufacturing step
and potential risks to cannabis product quality that could be introduced during
manufacturing operations, including, but not limited to, physical, biological,
microbiological or chemical hazards, or process failures that may lead to
product contamination, allergen cross-contact, packaging errors, labeling
errors, or other errors affecting cannabis product quality; and
(iii) identification of preventive measures
necessary to mitigate each potential risk identified, methods to evaluate the
effectiveness of the preventive measure and any action to take if a preventive
measure was unsuccessful.
(2) Master Manufacturing Protocol. A
processor shall develop, maintain and follow a written master manufacturing
protocol for each unique formulation of cannabis product manufactured, and for
each batch size, to ensure uniformity in finished batches and across all
batches produced. The master manufacturing protocol shall include the
following:
(i) the name and intended
phytocannabinoid content of the cannabis product to be manufactured;
(ii) a complete list of all ingredients to be
used and the weight or measure of each ingredient, which may include the
ability to adjust the weight or measure of phytocannabinoid-containing
ingredients in order to account for the variability of phytocannabinoid content
in cannabis;
(iii) the identity and
weight or measure of each ingredient that will be declared on the ingredients
list of the cannabis product, if different than above;
(iv) the expected yield of the finished
manufactured cannabis product, based upon the quantity of ingredients or
packaging to be used in the absence of any loss or error in actual production,
and the maximum and minimum percentages of expected yield beyond which a
deviation investigation of a batch will be necessary;
(v) a description of packaging and a
representative label, or a cross-reference to the location of the actual or
representative label, which may be maintained electronically;
(vi) the expected number of packages and
labels to be used, if the cannabis product will leave the manufacturing
premises in final form;
(vii)
written instructions for each point, step, or stage in the manufacturing
process; and
(viii) written
instructions for any action to mitigate risks identified in the product quality
plan.
(3) Batch
Production Record. Processors shall develop, maintain and follow, a written
batch production record for every batch of a cannabis product manufactured,
which shall include any batch specific remediation or relabeling. The batch
production record shall:
(i) accurately
follow the appropriate master manufacturing protocol, and each step of the
protocol shall be performed in the production of the batch;
(ii) document complete information relating
to the production and control of each batch, including, but not limited to:
(a) lot number of the finished batch of
cannabis product, and unique identification numbers or barcodes of all cannabis
used in the batch as captured by the inventory tracking system of
record;
(b) specific equipment and
processing lines used in producing or remediating the batch;
(c) the identity and weight or measure of
each component used;
(d) the actual
yield and the percentage difference from expected yield at appropriate phases
of manufacturing as identified in the master manufacturing protocol;
(e) the actual results obtained during any
monitoring operation, if the product quality plan identifies any monitoring
needed to ensure product safety at a specific manufacturing step;
(f) the date and time of when each step of
the master manufacturing protocol was performed, and the initials of the
person(s) performing each step;
(g)
an actual or representative label or other identification of the label to be
used for the cannabis product;
(h)
the actual quantity of the packaging and labels used, and the difference from
the expected number to be used, if the cannabis product will leave the
manufacturing premises as a final cannabis product;
(i) documentation that quality control
personnel reviewed the batch production record, including all required
monitoring operations, test results for components, if applicable, and finished
batches of cannabis product, and either approved and released, or rejected, the
finished cannabis product, including any remediated, repackaged or relabeled
cannabis product; and
(j)
documentation, at the time of performance, of any investigation identified in
the product quality plan or master manufacturing protocol, including
investigations into deviations from the expected yield or package and label
count.
(iii) contain
actual values and observations, as appropriate, during verification activities
and be accurate and legible and be created concurrently with performance of the
activity documented; and
(iv)
include sufficient detail to provide a history of work performed, including the
date each step was performed, and the signature, electronic signature, or
initials of the employee performing the activity.
(4) Product quality plans, master
manufacturing protocols and batch production records shall be readily available
for employee reference and made readily available to the Office upon
request.
(h) Cannabis
product testing.
(1) Prior to a cannabis
product being distributed, a licensee authorized to process shall test a
representative sample of cannabis products in accordance with required sampling
protocols pursuant to Part 130 of this Title and determined by the Office and
maintain a certificate of analysis for all lots of cannabis product tested for
a period of five (5) years from the date of expiration.
(2) All cannabis product testing shall be
consistent with acceptable limits as determined by the Office, pursuant to Part
130 of this Title.
(3) The licensee
shall retain a subset of each lot of cannabis product to allow for testing in
the future if requested by the Office, as follows:
(i) retained samples shall be stored unopened
as indicated on the label pursuant to Part 128 of this Title and in the
original packaging;
(ii) retained
samples shall be readily identifiable as belonging to its specific lot;
and
(iii) the quantity retained
shall be a number of representative samples to allow for complete testing of
the product at least two (2) times and shall be retained by the processor for
at least thirty (30) days following the date of expiration, or longer if
directed by the Office.
(i) Cannabis product quarantine and
remediation.
(1) any cannabis product lot not
meeting the minimum testing standards for contaminants, shall be rejected and
destroyed by the licensed processor pursuant to section
125.11 of this Title, except that a
cannabis product lot that has not met the minimum testing standards for
contaminant testing may be remediated and repurposed provided that:
(i) the licensee must notify the Office of
their intention to remediate or repurpose a cannabis product prior to
initiating the remediation or repurposing process;
(ii) the cannabis products shall be
resubmitted for laboratory testing in a manner set forth in subdivision (h) of
this section; and
(iii) after
completing the required analyses of a representative sample obtained from a
remediated or repurposed cannabis lot, the laboratory shall report the results
to the Office in the manner set forth in Part 130 of this
Title.
(2) a cannabis
product lot may only be remediated or repurposed for extraction once. If the
lot fails to meet minimum testing standards for contaminants after the
remediation or repurposing process, the entire lot shall be destroyed by the
licensed processor pursuant to section
125.11 of this Title.
(3) when a failed cannabis product lot is not
remediated or reprocessed in any way it cannot be retested. Any subsequent
testing results produced without remediation of the failed lot will not
supersede the initial regulatory testing results.
(j) A processor shall not package any other
good in the same package as a cannabis product, unless such good complies with
all requirements of section
129.3 of this Title and is:
(1) a rechargeable vaporization device that
is closed system, has internal or external temperature controls to prevent
combustion, and has a heating element made of an inert material such as glass,
ceramic or stainless steel and not plastic or rubber;
(2) a measuring device such as a measuring
cup, cap, or dropper;
(3) matches;
or
(4) otherwise approved by the
Office.
Notes
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