Michigan Laws 333.17706 – Definitions; M, O
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Terms Used In Michigan Laws 333.17706
- 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. See Michigan Laws 333.17706
- Official compendium: means the United States Pharmacopoeia and the National Formulary, or the Homeopathic Pharmacopoeia of the United States, as applicable. See Michigan Laws 333.17706
- person: may extend and be applied to bodies politic and corporate, as well as to individuals. See Michigan Laws 8.3l
- United States: shall be construed to include the district and territories. See Michigan Laws 8.3o
(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.
(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.