Michigan Laws 333.17702 – Definitions; A to C
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Terms Used In Michigan Laws 333.17702
- 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
(1) “Agent” means an individual designated by a prescriber to act on behalf of or at the discretion of that prescriber as provided in section 17744.
(2) “Automated device” means a mechanical system that performs an operation or activity, other than compounding or administration, relating to the storage, packaging, dispensing, or delivery of a drug and that collects, controls, and maintains transaction information.
(3) “Biological drug product” means a biological product as that term is defined in 42 USC 262.
(4) “Brand name” means the registered trademark name given to a drug product by its manufacturer.
(5) Except as otherwise provided in subsection (6), “compounding” means the preparation, mixing, assembling, packaging, and labeling of a drug or device by a pharmacist under the following circumstances:
(a) Upon the receipt of a prescription for a specific patient.
(b) Upon the receipt of a medical or dental order from a prescriber or agent for use in the treatment of patients within the course of the prescriber’s professional practice.
(c) In anticipation of the receipt of a prescription or medical or dental order based on routine, regularly observed prescription or medical or dental order patterns.
(d) For the purpose of or incidental to research, teaching, or chemical analysis and not for the purpose of sale or dispensing.
(6) “Compounding” does not include any of the following:
(a) Except as provided in section 17748c, the compounding of a drug product that is essentially a copy of a commercially available product.
(b) The reconstitution, mixing, or other similar act that is performed pursuant to the directions contained in approved labeling provided by the manufacturer of a commercially available product.
(c) The compounding of allergenic extracts or biologic products.
(7) “Compounding pharmacy” means a pharmacy that is licensed under this part and is authorized to offer compounding services under sections 17748, 17748a, and 17748b.
(8) “Current selling price” means the retail price for a prescription drug that is available for sale from a pharmacy.