Michigan Laws 333.17748f – Licensure of a pharmacy as a wholesale distributor or manufacturer; requirements
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Terms Used In Michigan Laws 333.17748f
- 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
- person: may extend and be applied to bodies politic and corporate, as well as to individuals. See Michigan Laws 8.3l
(1) A pharmacy shall obtain a license as a wholesale distributor under this part if the total number of dosage units of all prescription drugs distributed by the pharmacy to a person during any consecutive 12-month period is more than 5% of the total number of dosage units of prescription drugs distributed and dispensed by the pharmacy during the same 12-month period. The calculation of the 5% threshold described in this subsection must not include a distribution of a prescription drug that is exempt from the definition of wholesale distribution under 21 USC 353(e)(4).
(2) A pharmacy shall obtain a license as a manufacturer under this part if, during any consecutive 12-month period, the total number of dosage units of all prescription drugs that are prepared or compounded by the pharmacy for the resale, compounding, or dispensing by another person is more than 5% of the total number of dosage units of prescription drugs prepared by the pharmacy during the same 12-month period.