§ 1151a.42. Complaints about or recall of medical marijuana products.
(a) A dispensary shall notify the Department and the grower/processor from which it obtained the medical marijuana product in question immediately upon becoming aware of any complaint made to the dispensary by a patient, caregiver or practitioner who reports an adverse event from using medical marijuana products purchased by the dispensary from the grower/processor. A grower/processor shall investigate the report. The following requirements apply:
(1) A grower/processor shall immediately investigate a complaint to determine if a voluntary or mandatory recall of seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products is necessary or if any further action is required.
(2) If a grower/processor determines that further action is not required, the grower/processor shall notify the Department of its decision and, within 24 hours, submit a written report to the Department stating its rationale for not taking further action.
(b) The following requirements apply to voluntary recalls:
(1) A grower/processor may voluntarily recall seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products from the market at its discretion for reasons that do not pose a risk to public health and safety.
(2) If a grower/processor initiates a recall for a reason that does not pose a risk to public health and safety, the grower/processor shall notify the Department at the time the grower/processor begins the recall.
(c) The following requirements apply to mandatory recalls:
(1) If a grower/processor discovers that a condition relating to the seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products grown or processed at its facility poses a risk to public health and safety, the grower/processor shall:
(i) Immediately notify the Department by phone.
(ii) Secure, isolate and prevent the distribution of the seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products that may have been affected by the condition and remains in its possession. The grower/processor may not dispose of affected seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products prior to notifying the Department and coordinating the disposal with the Department.
(2) If a grower/processor fails to cooperate with the Department in a recall, or fails to immediately notify the Department of a need for a recall under paragraph (1), the Department may seek a cease and desist order under § 1141a.47 (relating to general penalties and sanctions) and the grower/processor may be subject to any other penalties or sanctions provided for in the act or this part.
(d) A grower/processor’s recall plan must include the following:
(1) Designation of one or more employees to serve as the recall coordinators. A recall coordinator shall be responsible for, among other duties, accepting the recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products.
(2) Procedures for identifying and isolating the affected seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products to prevent or minimize its distribution to patients, caregivers and other medical marijuana organizations and approved laboratories.
(3) Procedures to retrieve and dispose of the affected seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products.
(4) A communications plan to notify those affected by the recall, including:
(i) The manner in which the grower/processor will notify other medical marijuana organizations or approved laboratories in possession of seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products subject to the recall.
(ii) The use of press releases and other appropriate notifications to ensure that patients and caregivers are notified of the recall if affected medical marijuana products were dispensed to patients and caregivers.
(5) Procedures for notifying the Department.
(6) Procedures for entering information relating to the recall into the grower/processor’s electronic tracking system.
(e) A grower/processor shall follow the procedures outlined in its recall plan, unless the grower/processor obtains the prior written approval of the Department. The grower/processor shall conduct recall procedures in a manner that maximizes the recall of affected seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products and minimizes risks to public health and safety.
(f) A grower/processor shall coordinate the disposal of recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products with the Department. The Department or its authorized agents may oversee the disposal to ensure that the recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products are disposed of in a manner that will not pose a risk to public health and safety.
(g) The grower/processor shall enter information relevant to the recall into the electronic tracking system as part of the daily inventory, including all of the following:
(1) The total amount of recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products, including types, forms, harvest batches, harvest lots and process lots, if applicable.
(2) The amount of recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products received by the grower/processor, including types, forms, harvest batches, harvest lots and process lots, if applicable, by date and time.
(3) The total amount of recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products returned to the grower/processor, including types, forms, harvest batches, harvest lots and process lots, if applicable.
(4) The names of the recall coordinators.
(5) From whom the recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products were received.
(6) The means of transport of the recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products.
(7) The reason for the recall.
(8) The number of recalled samples or test samples, types, forms, harvest batches, harvest lots and process lots, if applicable, sent to approved laboratories, the names and addresses of the approved laboratories, the dates of testing and the results by sample or test sample.
(9) The manner of disposal of the recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products, including all of the following:
(i) The name of the individual overseeing the disposal of the recalled seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products.
(ii) The name of the disposal company, if applicable.
(iii) The method of disposal.
(iv) The date of disposal.
(v) The amount disposed of by types, forms, harvest batches, harvest lots and process lots, if applicable.
(h) The Department may initiate a mandatory recall upon receipt of information that a condition relating to the seeds, immature medical marijuana plants, medical marijuana plants, postharvest plant material, medical marijuana or medical marijuana products grown, processed or dispensed by a medical marijuana organization poses a risk to public health and safety.
Cross References This section cited in 28 Pa. Code § 1151a.22 (relating to plans of operation).
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