Current through Register Vol. 54, No. 45, November 9, 2024
Section 1151a.34 - Packaging and labeling of medical marijuana products(a) A grower/processor shall package and label at its facility each form of medical marijuana products prepared for sale. The original seal of a package may not be broken, except for quality control testing at an approved laboratory, for adverse loss investigations conducted by the Department or by a dispensary that purchased the medical marijuana products.(b) A grower/processor shall package the medical marijuana products in a package that minimizes exposure to oxygen and that: (2) Is tamper-proof or tamper-evident.(3) Is opaque. This requirement does not apply to packages containing dry leaf.(5) Clearly distinguishes the contents of the package from the contents of any other package of similar appearance.(6) Lists all product ingredients and includes a warning for known allergens, such as tree nuts.(c) A grower/processor shall identify each process lot of medical marijuana with a unique identifier.(d) A grower/processor shall obtain the prior written approval of the Department of all packaging and the content of any label to be affixed to a medical marijuana product package. Each label must meet all of the following requirements:(2) Be made of weather-resistant and tamper-resistant materials.(3) Be conspicuously placed on the package.(4) Include the name, address and permit number of the grower/processor.(5) List the form, quantity and weight of medical marijuana included in the package.(6) List the number of individual doses contained within the package, the species and percentage of THC and CBD and other cannabinoids as enumerated in § 1151a.29 (relating to limit on medical marijuana processing), and the individual terpenes and corresponding percentages, if greater than 0.0%. CAS numbers need not be displayed on the label.(7) Contain an identifier that is unique to a particular harvest batch of medical marijuana, including the number assigned to each harvest lot or process lot in the harvest batch.(8) Include the date the medical marijuana product was packaged.(9) State the employee identification number of the employee preparing the package and packaging the medical marijuana product.(10) State the employee identification number of the employee shipping the package, if different than the employee described in paragraph (9).(11) Contain the name and address of the dispensary to which the package is to be sold, except where a clinical registrant sells medical marijuana products to another grower processor and the intended dispensary is not known. In this case, the grower processor selling to a dispensary is required to affix a label bearing the dispensary name and address to the outer packaging, notwithstanding paragraph (17).(12) List the date of expiration of the medical marijuana product.(13) Include instructions for proper storage of the medical marijuana product in the package.(14) Contain the following warning stating: This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant's pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.(15) Contain a warning that the medical marijuana product must be kept in the original container in which it was dispensed.(16) Contain a warning that unauthorized use is unlawful and will subject the purchaser to criminal penalties.(17) Be firmly affixed to the container directly holding medical marijuana product, except when the product is being used for a blinded research program, and be firmly affixed to outer packaging if used.(18) List THC as the first number when THC and CBD are listed on a label as a ratio.(e) Labeling by a grower/processor of any medical marijuana product may not bear: (1) A resemblance to the trademarked, characteristic or product-specialized packaging of any commercially available food or beverage product.(2) A statement, artwork or design that could reasonably lead an individual to believe that the package contains anything other than medical marijuana.(3) A seal, flag, crest, coat of arms or other insignia that could reasonably mislead an individual to believe that the product has been endorsed, manufactured or approved for use by any state, county or municipality or any agency thereof.(4) A cartoon, color scheme, image, graphic or feature that might make the package attractive to children.Adopted by Pennsylvania Bulletin, Vol 53, No. 09. March 4, 2023, effective 3/4/2023 This section cited in 28 Pa. Code § 1151a.36 (relating to transport manifest); and 28 Pa. Code § 1161a.36 (relating to transport manifest).