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503B can generally compound bulk drug substances only if the substance appears on the 503B bulk list or if the drug appears on FDAs drug shortage list
Vendor documentation and lot records are maintained internally for traceability support
Studies have also shown that some drugs in this category can potentially lower the risk of heart diseases and kidney disease and improve blood pressure and cholesterol levels
Insurance often will not cover compounded products, so out-of-pocket costs can vary
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