Sec. 17706. (1) “Manufacturer” means a person that prepares, produces, derives, propagates, compounds, processes,
packages, or repackages a drug or device salable on prescription only, or otherwise
changes the container or the labeling of a drug or device salable on prescription
only, and that supplies, distributes, sells, offers for sale, barters, or otherwise
disposes of that drug or device and any other drug or device salable on prescription
only, to another person for resale, compounding, or dispensing. Manufacturer does not include a pharmacy unless the pharmacy meets the requirements
described in section 17748f. 1
(2) “Official compendium” means the United States Pharmacopoeia and the National Formulary, or the Homeopathic Pharmacopoeia of the United States, as applicable. If an official compendium is revised after September 30, 2014, the department shall officially take notice of the revision. Within 30 days after taking notice of the revision, the department, in consultation
with the board, shall decide whether the revision continues to protect the public
health as it relates to the manner that the official compendium is used in this act. If the department, in consultation with the board, decides that the revision continues
to protect the public health, the department may issue an order to incorporate the
revision by reference. If the department issues an order under this subsection to incorporate the revision
by reference, the department shall not make any changes to the revision.
(3) “Outsourcing facility” means that term as defined in 21 USC 353b.
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