Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-2 - Operations › Section 3796:3-2-02 - Processor packaging and labeling

Current through all regulations passed and filed through July 1, 2024
(A) A processor distributing medical
			 marijuana to a dispensary shall meet the following requirements:
(1) A processor shall place medical marijuana
			 in a child-proof, tamper-evident, light-resistant package approved by the
			 department prior to distribution to a dispensary. Approved packaging shall
			 maintain the integrity and stability of the medical marijuana, and shall comply
			 with the rules promulgated by the state of Ohio board of pharmacy pursuant to
			 Chapter 3796. of the Revised Code.
(2) A label shall be affixed to every package
			 and state in legible English:
(a) The name and
			 license number of the cultivator where the packaged plant material was
			 cultivated or the name and license number of the processor where the medical
			 marijuana products were manufactured;
(b) The name and license number of the
			 dispensary facility receiving the shipment;
(c) The product identifier;
(d) The registered name of the medical
			 marijuana plant material strain that was registered with the department or the
			 registered name, form, and dose of the medical marijuana product that was
			 registered with the department;
(e)
			 A unique batch or lot number as defined in paragraph (A) of rule
			 3796:1-1-01 of the
			 Administrative Code that will match the medical marijuana or medical marijuana
			 products with a batch or lot, in order to facilitate any warnings or recalls
			 the department deems appropriate;
(f) The dates of manufacture, final testing,
			 and packaging;
(g) The total weight
			 in grams of medical marijuana or medical marijuana products in each
			 package;
(h) The name and license
			 number of the independent testing laboratory that performed the required tests
			 on the batch or lot from which the medical marijuana or medical marijuana
			 products in the package were taken;
(i) The laboratory analysis and cannabinoid
			 profile, including the percentage content by weight or total milligrams and
			 milligrams per unit for:
(i)
											Delta-8-tetrahydrocannabinol;
(ii)
											Delta-8-tetrahydrocannabinolic acid;
(iii)
											Delta-9-tetrahydrocannabinol;
(iv)
											Delta-9-tetrahydrocannabinolic acid;
(v)
											Cannabidiol
			 (CBD);
(vi)
											Cannabidiolic acid (CBDA);
(vii)
											THC content as
			 defined in rule 3796:1-1-01 of the Administrative Code; and
(viii)
											Any other
			 cannabinoid determined by the department.
(j) The expiration date, which shall not
			 exceed one calendar year from the date of manufacture;
(k) If the product is edible, the following
			 additional information:
(i) A list of all
			 ingredients and subingredients, providing that all ingredients comply with the
			 standards of identity under rule
			 901:3-1-12
			 of the Administrative Code;
(ii) A
			 list of all major food allergens as identified in
			 21 USC 343;
			 and
(iii) A statement with the
			 following language: "Caution: When eaten or swallowed, the effects and
			 impairment caused by this drug may be delayed."
(l) If a marijuana extract was used in the
			 manufacture of the product, a disclosure of the type of extraction process and
			 any solvent, gas, or other chemical used in the extraction process or any other
			 compound added to the extract; and
(m) A statement with the following language:
			 "This product is for medical use and not for resale or transfer to another
			 person. This product may cause impairment and may be habit-forming. This
			 product may be unlawful outside the State of Ohio."
(n) If the product was manufactured using
			 plant material that was acquired from a dispensary pursuant to paragraph (B) of
			 rule
			 3796:3-2-01
			 of the Administrative Code, a statement with the following language: "This
			 product was manufactured using medical marijuana that exceeded the expiration
			 date defined in OAC 3796:1-1-01."
(o) The intended method of administration of
			 the medical marijuana product.