Michigan Laws 333.17709 – Definitions; S to W
Current as of: 2023 | Check for updates
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Terms Used In Michigan Laws 333.17709
- 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
- Oversight: Committee review of the activities of a Federal agency or program.
- person: may extend and be applied to bodies politic and corporate, as well as to individuals. See Michigan Laws 8.3l
(1) “Sign” means to affix one’s signature manually to a document or to use an electronic signature when transmitting a prescription electronically.
(2) “Sterile pharmaceutical” means a dosage form of a drug that is essentially free from living microbes and chemical or physical contamination to the point at which it poses no present risk to the patient, in accordance with USP standards. As used in this subsection, “dosage form” includes, but is not limited to, parenteral, injectable, and ophthalmic dosage forms.
(3) “Substitute” means to dispense, without the prescriber’s authorization, a different drug in place of the drug prescribed.
(4) “Surveillance system” means a real-time, continuous audio and visual camera system that connects a pharmacist at a parent pharmacy with a remote pharmacy for the purposes of providing oversight and security surveillance.
(5) “Telepharmacy system” means an interoperable computer system that meets all of the following requirements:
(a) Shares real-time data and uses a real-time audio and video link to connect a pharmacist at a parent pharmacy with a remote pharmacy operated by the parent pharmacy.
(b) Uses a camera that is of sufficient quality and resolution to allow a pharmacist at a parent pharmacy who is reviewing a prescription to visually identify the markings on tablets and capsules at the remote pharmacy.
(6) “USP standards” means the pharmacopeial standards for drug substances, dosage forms, and compounded preparations based on designated levels of risk as published in the official compendium.
(7) “Wholesale distributor” means a person, other than a manufacturer or wholesale distributor-broker, that supplies, distributes, sells, offers for sale, barters, or otherwise disposes of, to other persons for resale, compounding, or dispensing, a drug or device salable on prescription only that the distributor has not prepared, produced, derived, propagated, compounded, processed, packaged, or repackaged, or otherwise changed the container or the labeling of the drug or device. A wholesale distributor does not include a pharmacy unless the pharmacy meets the requirements of section 17748f.
(8) “Wholesale distributor-broker” means a person that meets both of the following:
(a) The person facilitates the delivery or trade of a drug or device salable on prescription only, other than a controlled substance, between pharmacies, or between a pharmacy and a qualified pharmacy as that term is defined in section 17748e, for the purpose of filling a prescription for an identified patient.
(b) The person does not take possession or ownership of a drug or device salable on prescription only or coordinate warehousing of the drug or device.