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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

While preparing the patient’s compliance pack, the pharmacy misinterpreted the product to contain 500 mg of Calcium Carbonate when each tablet actually contained 500 mg of elemental Calcium. As a result, the patient received 2.5 times the intended dose and required intervention in a hospital.

FDA 40
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How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. Restatement §402A, comments a, d-e. A “chattel” is a “physical object.”