Minn. R. 4770.1850 - RECALL PROCEDURES
A. Each
manufacturer must establish a procedure for recalling medical cannabis that has
a reasonable probability of causing an unexpected or harmful response in a
patient population, despite appropriate use, that outweighs the potential
benefit of the medication. This procedure must include:
(1) factors that make a recall necessary;
(2) manufacturer's personnel who are
responsible for overseeing the recall; and
(3) how to notify affected parties of a
recall.
B. The
commissioner may order a manufacturer to undertake a recall of a dried raw
cannabis finished good. The commissioner's order must be based on a reasonable
suspicion that the finished good presents a risk of causing a serious adverse
incident. The commissioner must order the recall of a dried raw cannabis
finished good if testing under part 4770.3035 indicates the presence of
residues from a crop input prohibited under part 4770.1700 are present in the
finished good. A manufacturer must comply and cooperate with any recalls
ordered by the commissioner.
Notes
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