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FDA web page regarding "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks"

Reddit r/medicine·u/Nerd-19958·about 1 month ago
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FDA web page regarding "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks" If any of your patients are considering injecting themselves with unapproved, untested injectable peptides, please inform them that: 1. Such products are drugs, but they have not been reviewed or approved by the US Food and Drug Administration (FDA). 2. There are no clinical studies meeting FDA standards for approval, showing that such products are safe and effective for their labeled uses as required by Federal law. In fact, these products are specifically labeling as NOT intended to human consumption and / or for research use. 3. It is vitally important that injections be manufactured to be sterile and be prepared and injected under aseptic conditions. These products are manufactured in factories which have NOT been inspected by the US FDA and they might not be sterile. This could cause a serious infection in the end user.…

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