Current through Register Vol. 54, No. 44, November 2, 2024
(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.
This section cited in 28 Pa. Code §
1151a.22 (relating to plans of
operation).
