Report No. 1 of 3 for Regulatory Project 2016-6 — Marijuana Pharmacy
§2443. Marijuana products
D. Packaging and Labeling Requirements.
1. Packaging.
a. The producer shall ensure every product intended for dispensing to a patient is placed within a child-resistant, light-resistant, tamper-evident container prior to sale or transport to the pharmacy.
i. A package shall be deemed child-resistant if it satisfies the standard for ‘special packaging’ as set forth in the United States Consumer Product Safety Commission’s Poison Prevention Packaging as found in 16 CFR 1700.1(b)(4) or its successor.
ii. A package shall be deemed light-resistant if it satisfies the standard set forth in Chapter 671 – Containers: Performance Testing of the United States Pharmacopeia (USP).
iii. A package shall be deemed tamper-evident if it clearly indicates prior access to the container.
b. Any product containing pharmaceutical grade marijuana or its principal psychoactive constituent tetrahydrocannabinol (THC) shall be packaged so that one dose contains no more than 10 milligrams of THC.
c. If it is not intended for the entire product to be used at a single time, the packaging must be resealable in a manner that maintains its child-resistant property for multiple openings. Single doses may be placed in a package with other single doses; however, the total amount of active THC contained within the larger packaging shall not exceed 100 milligrams.
d. No single container shall contain more than a one month supply of marijuana.
e. Packaging selected by the producer shall be subject to the following restrictions.
i. Shall not specifically target individuals under the age of 21 years;
ii. Shall not bear any resemblance to a trademarked, characteristic or product-specialized packaging of any commercially available candy, snack, baked good or beverage;
iii. Shall not use the words “candy” or “candies”; iv. Shall not use a cartoon, color scheme, image, graphic or feature that might make the package attractive to children; and v. Shall not use a seal, flag, crest, coat of arms or other insignia that could reasonably lead any person to believe the product has been endorsed, manufactured by, or used by any state, parish, municipality, or any agent thereof.
2. Labeling.
a. Each product shall be labeled by the producer prior to its sale to the marijuana pharmacy. Each label shall be securely affixed to the package and shall include, at a minimum:
i. The batch or lot number assigned by the producer to the marijuana plant(s) from which the marijuana used in the product was harvested;
ii. A complete list of solvents, chemicals, and pesticides used in the creation of any marijuana concentrate;
iii. A complete list of all ingredients used to manufacture the product, which may include a list of any potential allergens contained within, or used in the manufacture of, a product;
iv. The potency of the THC and CBD in the product, expressed in milligrams for each cannabinoids;
v. The net weight, using a standard of measure compatible with the LMMTS, of the product prior to its placement in the shipping container;
vi. A product expiration date, upon which the product will no longer be fit for use. Once a label with an expiration date has been affixed to a product, the producer shall not alter that date or affix a new label with a later date; and
vii. A statement the product has been tested for contaminants, that there were no adverse findings, and the date of such testing.
b. The labeling text on any marijuana product shall not make any false or misleading statements regarding health or physical benefits to the consumer. Further, each label shall include all of the following statements:
i. “Contains Marijuana. For Medical Use Only. KEEP OUT OF THE REACH OF CHILDREN.”
ii. “Marijuana can impair concentration, coordination, and judgment. Do not operate a vehicle or machinery under the influence of this drug.”
iii. “There may be additional health risks associated with the consumption of this product for women who are pregnant, breastfeeding, or planning to become pregnant.”
iv. A statement that it is illegal for any person to possess or consume the contents of the package other than the patient for whom it was recommended.
c. The labeling text required by this Section shall be no smaller than 1/16 of an inch, shall be printed in English, and must be unobstructed and conspicuous.
http://www.pharmacy.la.gov/assets/docs/Cmtes/RegRev/RegProj2016-6_OversightCmteRpt1.pdf
