What is the scope of biomedical law regarding the regulation of pharmaceuticals?

Biomedical law in Maryland regulates the manufacture, labeling, sale and distribution of pharmaceuticals and other drugs that are used in medical treatments and therapies. Pharmaceuticals must be approved by the U.S. Food and Drug Administration (FDA) before they can be sold. Biomedical law also outlines safety standards for the storage and disposal of pharmaceuticals, and the requirements for pharmacists to be licensed. Additionally, the law sets forth labeling requirements for medications, such as listing the manufacturer’s name, the active ingredients and their amount, and expiration dates. Pharmaceuticals also need to be labeled with warnings about the potential side effects and the proper usage of the drug. Biomedical law also includes regulations for clinical trials, which are studies done on potential drugs to determine their effectiveness and safety. Pharmaceutical companies must have their clinical trials approved by the FDA before they can be conducted. Furthermore, biomedical law ensures that the rights of research subjects in clinical trials are respected, and that it is done in a safe and ethical manner. Finally, biomedical law also covers the responsibility of physicians when prescribing pharmaceuticals. Physicians must understand the potential side effects, and make sure that a patient is not taking any medications that could interact negatively. Furthermore, physicians must obtain informed consent from the patient before prescribing certain medications. This means that the patient must be informed of the associated risks before they begin taking the medication.

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