Pennsylvania Code & Bulletin
COMMONWEALTH OF PENNSYLVANIA

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28 Pa. Code § 1161.28. Labels and safety inserts.

§ 1161.28. Labels and safety inserts.

 (a)  Medical marijuana products dispensed by a dispensary must only be identified by the name of the grower/processor, the name of the dispensary, the form and species of medical marijuana, the percentage of THC and CBD contained in the medical marijuana product, and any other labeling required by the Department.

 (b)  A dispensary shall dispense medical marijuana products to a patient or caregiver in a sealed and properly labeled package.

 (c)  The dispensary shall inspect the label to ensure that the label:

   (1)  Is easily readable.

   (2)  Is conspicuously placed on the package.

   (3)  Includes the name, address and permit number of the grower/processor.

   (4)  Lists the form and quantity of medical marijuana.

   (5)  Contains 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.

   (6)  Lists the number of individual doses contained within the package and the species and percentage of THC and CBD.

   (7)  Contains a warning that the medical marijuana product must be kept in the original container in which it was dispensed.

   (8)  Contains a warning that unauthorized use is unlawful and will subject the purchaser or user to criminal penalties.

   (9)  Includes the name and address of the dispensary.

   (10)  Includes the identification number of the sales clerk dispensing the medical marijuana products to the patient or caregiver and the patient identification number.

   (11)  Lists a use by or expiration date.

   (12)  Lists the packaging date.

   (13)  Includes instructions for proper storage of the medical marijuana product in the package.

   (14)  Contains any other information required by the Department.

 (d)  The dispensary shall inspect the label to ensure that the label does not bear:

   (1)  Any resemblance to the trademarked, characteristic or product-specialized packaging of any commercially available food or beverage product.

   (2)  Any statement, artwork or design that could reasonably lead an individual to believe that the package contains anything other than medical marijuana.

   (3)  Any 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)  Any cartoon, color scheme, image, graphic or feature that might make the package attractive to children.

 (e)  When a dispensary dispenses medical marijuana products to a patient or caregiver, the dispensary shall also provide the patient or caregiver with a safety insert developed and approved by the Department that includes the following information:

   (1)  The method or methods for administering individual doses of medical marijuana products.

   (2)  Any potential dangers stemming from the use of medical marijuana products.

   (3)  How to recognize what may be problematic usage of medical marijuana products and how to obtain appropriate services or treatment for problematic usage.

   (4)  The side effects and contraindications associated with medical marijuana products, if any, which may cause harm to the patient.

   (5)  How to prevent or deter the misuse of medical marijuana products by an individual under 18 years of age or others.

   (6)  Any other information determined by the Department to be relevant to enhance patient safety.

Source

   The temporary provisions of this §  1161.28 amended January 13, 2017, effective January 14, 2017, expire on January 14, 2019, 47 Pa.B. 217; amended May 11, 2018, effective May 17, 2018, expire on May 12, 2020, 48 Pa.B. 2793. Immediately preceding text appears at serial pages (385972) to (385973).

Cross References

   This section cited in 28 Pa. Code §  1161.36 (relating to transport manifest).



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