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FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act: One key condition: Facility generally cannot compound drugs using bulk drug substances unless that substance appears on the FDA's '503B Bulks List' (substances for which there is a demonstrated clinical need) or the compounded drug is on the FDA's active drug shortage list

What this means in plain terms: The broad, shortage-based window that allowed large-scale compounding of these medications has closed

Changes unfold slowly

The research and development activities are supported by increasing investments and technological advancements

Our goal is to provide evidence-based information that helps laboratories better understand peptide science and best practices

Vitamin K2 and calcium are a great example of this in the world of essential nutrients