Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS Chapter 13B, 217.015, 217.025, 217.035,
217.037, 217.039, 217.992, 2023 Ky Acts ch. 78
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
217.125(1) authorizes the
secretary of the Cabinet for Health and Family Services to promulgate
administrative regulations for the efficient administration and enforcement of
the Kentucky Food, Drug and Cosmetic Act,
KRS
217.005 through
217.215.
KRS
217.125(2) requires the
secretary to provide by administrative regulation a schedule of fees for
permits to operate and for inspection activities carried out by the cabinet
pursuant to KRS
217.025 through
217.390.
KRS
217.135 authorizes the secretary to establish
food standards by administrative regulation including a reasonable definition,
standard of identity, and designation of optional ingredients that shall be
named on the label. KRS 217.155 allows the cabinet
or its duly authorized agent free access at reasonable times for the purpose of
inspection any factory, warehouse, or establishment where foods, drugs,
devices, or cosmetics are manufactured or held for sale. This administrative
regulation establishes the permit requirements for retail sale of hemp-derived
cannabinoid products, including the permit fee, and methods for use of
hemp-derived cannabinoid as an additive to food products. Retail establishments
registered with the department prior to the effective date of this
administrative regulation shall be exempted from the permit fee requirement
until the annual renewal date. In accordance with 2023 Ky. Act ch. 78, in order
to limit the ability of minor children accessing adult-use hemp-derived
cannabinoid use products, this administrative regulation prohibits the sale of
adult-use products within 1,000 feet of an elementary, middle, or high school.
Retail establishments registered with the department prior to the effective
date of this administrative regulation shall be exempted from this location
requirement.
Section 1. Retail
Establishment and Food Service Establishment Registration.
(1)
(a)
Only approved cannabinoid products or class of products in accordance with 902
KAR 45:021 may be sold in retail and food service establishments. All other
cannabinoid products or class of products shall be prohibited.
(b) Adult-use cannabinoid products or class
of products shall be registered in accordance with 902 KAR 45:021, Section
1(5).
(c) A retailer shall ensure
that all cannabinoid products sold are properly registered with the
department.
(d) A retailer may
register a product in lieu of the processor or manufacturer.
(2) Retail establishments and food
service establishments offering adult-use cannabinoid products shall be
permitted by the cabinet in accordance with this administrative
regulation.
(3) The permit shall
be:
(b) Nontransferable in regard to person or
address;
(c) Renewed annually;
and
(d) Include a $2,000 annual
permit fee.
(4) All
retail establishments registered with the department prior to April 27, 2024,
shall have the fee required by subsection (3)(d) of this section waived until
the date of the next annual renewal.
(5) A retailer shall ensure all locations are
permitted by the cabinet.
(6)
Retail establishments and food service establishments offering adult-use
cannabinoid products at a temporary event or festival shall:
(b) Include a $250 temporary
event registration fee.
(7) Retail establishments offering adult-use
cannabinoid products shall not be located within 1,000 feet of an elementary,
middle, or high school. Retail establishments registered with the department
prior to April 27, 2024, shall be exempted from the location
requirements.
(8) A business that
distributes, sells, or serves adult-use hemp-derived cannabinoid products shall
not employ any person who is under twenty-one (21) years of age, unless the
person employed is at least eighteen (18) years of age and under the direct
supervision of a person twenty-one (21) years of age or older.
Section 2. Retail Sale of
Cannabinoid Products.
(1) All cannabinoid
products sold in a retail establishment shall:
(a) Be from an approved source;
(b) Be packaged and labeled in accordance
with 902 KAR 45:021, Section 3; and
(c) Have a valid printed certificate of
analysis available upon request.
(2) Cannabinoid retailers shall maintain
records of wholesale cannabinoid product purchase, including the name and
address of the cannabinoid processor or manufacturer, and the wholesaler or
distributor.
(3) The following
hemp-derived products shall not be marketed, sold, or distributed to any person
in the Commonwealth:
(a) Whole hemp
buds;
(b) Ground hemp floral
material;
(c) Ground hemp leaf
material; and
(d) Any hemp product
with a delta-9-THC concentration in excess of zero and three-tenths (0.3)
percent.
(4) All
adult-use cannabinoid products shall:
(a) Be
secured in the retail setting to prevent theft or other access to persons under
the age of twenty-one (21); and
(b)
Not be sold, gifted, or otherwise transferred to any person under the age of
twenty-one (21).
(5)
(a) Any person who sells adult-use
cannabinoid products at retail shall require proof of age of the buyer to
verify the buyer is age twenty-one (21) years or older; and
(b) May deliver or ship adult-use cannabinoid
products to consumers over twenty-one (21) years of age in packages clearly
marked "Adult-use only".
(6) All persons located in another state or
country who deliver, ship, or cause to be delivered or shipped cannabinoid
products directly to any Kentucky consumer shall hold a valid hemp cannabinoid
wholesaler or distributor permit issued by the Commonwealth.
Section 3. Ingestible Cannabinoid
Products at Food Service Establishments.
(1)
Only registered, pre-packaged adult-use ingestible cannabinoid products may be
offered as ready-to-consume or for direct consumption at food service
establishments.
(2) Adult-use
cannabinoids shall not be added to an ingestible food product at a food service
establishment.
(3) Non-intoxicating
cannabinoids may be added to an ingestible product prior to retail sale at a
food service establishment.
(4) The
non-intoxicating cannabinoid shall be obtained from an approved
source.
(5) The food service
establishment shall obtain a valid certificate of analysis from the approved
source and provide a copy upon inspection.
(6) A food service establishment offering
non-intoxicating cannabinoid products in a finished food product shall provide
to consumers upon request:
(a) The common name
of the product; and
(b) The
manufacturer or distributor of the product.
(7) A food service establishment shall notify
the cabinet within twenty-four (24) hours of becoming aware or within
twenty-four (24) hours of when the food service establishment should have been
aware of any serious adverse event to a hemp-derived cannabinoid product sold
by the establishment.
Section
4. Inspection and Enforcement.
(1)
(a)
Retail establishments offering adult-use cannabinoid products shall be
inspected by the cabinet or its duly authorized agent; and
(b) Retail establishments offering only
non-intoxicating cannabinoid products may be inspected by the cabinet or its
duly authorized agent upon complaint, receipt of a report of a serious adverse
event, or at the discretion of the cabinet.
(2) The location of the permitted
establishment, all general business records, including employee records, and
vehicles utilized to transport products are subject to reasonable
inspection.
(3) All cannabinoid
establishments, whether permitted or not, shall cooperate with the cabinet or
its duly authorized agent during any inspections, complaint investigation,
requests for information or data, in order to verify compliance with this
administrative regulation.
(4)
Products not in compliance with this administrative regulation shall be seized
and destroyed by the cabinet or its duly authorized agent.
(5) The permit holder shall take immediate
steps to correct conditions that have caused an imminent health
hazard.
(6)
(a) The permit holder shall notify the
cabinet within twenty-four (24) hours of the knowledge of an imminent health
hazard that cannot be controlled by immediate corrective action or if product,
product packaging, cosmetic, or cosmetic packaging has become contaminated
because of an imminent health hazard.
(b) Notification to the cabinet shall be made
by:
1. Email to food.safety@ky.gov;
or
2. Phone to (502)
564-7181.
(7)
If the cabinet has evidence that a permit holder has failed to act to correct
an imminent health hazard:
(a) The permit
shall be suspended immediately; and
(b) The permit holder may request an
administrative hearing in accordance with KRS Chapter 13B.
(8) A permit holder shall notify the cabinet
within twenty-four (24) hours of becoming aware of any serious adverse event to
a cannabinoid product sold or transferred by the permit holder.
(9) In all other instances of violation of
this administrative regulation, the cabinet shall serve the permit holder with
a written notice specifying the violation and afford the holder an opportunity
to correct.
(10) If a permit holder
has failed to comply with the written notice within the timeframe granted, the
cabinet shall issue a notice of intent to suspend the permit.
(11)
(a)
The notice in subsection (11) of this section shall include notification that
the permit shall be suspended at the end of ten (10) days following service of
the notice, unless a written request for an administrative hearing is filed
with the cabinet by the permit holder within the ten (10) day period;
and
(b) The administrative hearing
shall be conducted in accordance with
KRS
13B.080.
(12) For a permitted establishment that has
had a suspended permit two (2) or more times within a five (5) year period, the
cabinet shall initiate permit revocation proceedings. Prior to this action, the
cabinet shall notify the permit holder in writing, stating the reasons for
which the permit revocation is being sought and advising that the permit shall
be permanently revoked at the end of ten (10) days following service of the
notice, unless a request for an administrative hearing is filed with the
cabinet pursuant to KRS Chapter 13B by the permit holder within the ten (10)
day period.
(13) Any person who
violates any provision of this administrative regulation may be fined, found
guilty or a criminal offense, or both pursuant to
KRS
217.992.
(14) State and local law enforcement officers
shall have concurrent jurisdiction to enforce violations of this
section.
STATUTORY AUTHORITY:
KRS
217.125,
217.127,
217.135,
217.155
