333.17748f Licensure of a pharmacy as a wholesale distributor or manufacturer; requirements.
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333.17748f Licensure of a pharmacy as a wholesale distributor or manufacturer; requirements.
Sec. 17748f.
(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.
History: Add. 2020, Act 142 , Imd. Eff. July 14, 2020 ;-- Am. 2021, Act 130 , Imd. Eff. Dec. 17, 2021
Popular Name: Act 368