Current through Register Vol. 54, No. 44, November 2, 2024
(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:
(1) Is
child-resistant.
(2) Is
tamper-proof or tamper-evident.
(3)
Is opaque. This requirement does not apply to packages containing dry
leaf.
(4) Is resealable.
(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:
(1) Be
easily readable.
(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.
This section cited in 28 Pa. Code §
1151a.36 (relating to transport
manifest); and 28 Pa. Code §
1161a.36 (relating to transport
manifest).
