W. Va. Code R. § 64-110-23

Current through Register Vol. XLI, No. 19, May 10, 2024

Section 64-110-23 - Complaints about or recall of medical cannabis

23.1. A dispensary shall notify the bureau and the grower/processor 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 cannabis purchased by the dispensary from the grower/processor. A grower/processor must investigate the report. The following apply:

23.1.a. A grower/processor must investigate a complaint to determine if a voluntary or mandatory recall of medical cannabis is necessary or if any further action is required; and

23.1.b. If a grower/processor determines that further action is not required, the grower/processor must notify the bureau of its decision and, within 24 hours, submit a written report to the bureau stating its rationale for not taking further action.

23.2. The following apply to voluntary recalls:

23.2.a. A grower/processor may voluntarily recall medical cannabis from the market at its discretion for reasons that do not pose a risk to public health and safety; and

23.2.b. If a grower/processor initiates a recall for a reason that does not pose a risk to public health and safety, the grower/processor must notify the bureau at the time the grower/processor begins the recall.

23.3. The following apply to mandatory recalls:

23.3.a. If a grower/processor discovers that a condition relating to the medical cannabis grown or processed at its facility poses a risk to public health and safety, the grower/processor must:

23.3.a.1. Immediately notify the bureau by phone; and

23.3.a.2. Secure, isolate and prevent the distribution of the medical cannabis that may have been affected by the condition and remains in its possession. The grower/processor may not dispose of affected medical cannabis prior to notifying the bureau and coordinating the disposal with the bureau.

23.3.b. If a grower/processor fails to cooperate with the bureau in a recall, or fails to immediately notify the bureau of a need for a recall under subdivision 23.1, the bureau may seek a cease and desist order under 64CSR109.20 (General penalties and sanctions) and the grower/processor may be subject to any other penalties or sanctions provided for in the Act or this rule.

23.4. A grower/processor's recall plan must include the following:

23.4.a. Designation of one or more employees to serve as the recall coordinators. A recall coordinator must be responsible for, among other duties, accepting the recalled medical cannabis;

23.4.b. Procedures for identifying and isolating the affected medical cannabis to prevent or minimize its distribution to patients, caregivers, and other medical cannabis organizations and approved laboratories;

23.4.c. Procedures to retrieve and dispose of the affected medical cannabis; and

23.4.d. A communications plan to notify those affected by the recall, including:

23.4.d.1. The manner in which the grower/processor will notify other medical cannabis organizations or approved laboratories in possession of medical cannabis subject to the recall;

23.4.d.2. The use of press releases and other appropriate notifications to ensure that patients and caregivers are notified of the recall if the affected medical cannabis was dispensed to patients and caregivers;

23.4.e. Procedures for notifying the bureau; and

23.4.f. Procedures for entering information relating to the recall into the grower/processor's electronic tracking system.

23.5. A grower/processor must follow the procedures outlined in its recall plan, unless the grower/processor obtains the prior written approval of the bureau. The grower/processor must conduct recall procedures in a manner that maximizes the recall of affected medical cannabis and minimizes risks to public health and safety.

23.6. A grower/processor must coordinate the disposal of recalled medical cannabis with the bureau. The bureau or its authorized agents may oversee the disposal to ensure that the recalled medical cannabis is disposed of in a manner that will not pose a risk to public health and safety.

23.7. The grower/processor must enter information relevant to the recall into the electronic tracking system as part of the daily inventory, including:

23.7.a. The total amount of recalled medical cannabis, including types, forms, harvest batches, harvest lots, and process lots, if applicable;

23.7.b. The amount of recalled medical cannabis received by the grower/processor, including types, forms, harvest batches, harvest lots, and process lots, if applicable, by date and time;

23.7.c. The total amount of recalled medical cannabis returned to the grower/processor, including types, forms, harvest batches, harvest lots, and process lots, if applicable;

23.7.d. The names of the recall coordinators;

23.7.e. From whom the recalled medical cannabis was received;

23.7.f. The means of transport of the recalled medical cannabis;

23.7.g. The reason for the recall;

23.7.h. 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;

23.7.i. The manner of disposal of the recalled medical cannabis, including:

23.7.i.1. The name of the individual overseeing the disposal of the recalled medical cannabis;

23.7.i.2. The name of the disposal company, if applicable;

23.7.i.3. The method of disposal;

23.7.i.4. The date of disposal;

23.7.i.5. The amount disposed of by types, forms, harvest batches, harvest lots, and process lots, if applicable; and

23.7.j. Any other information required by the bureau.

W. Va. Code R. § 64-110-23