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These medications are prepared by FDA-registered, inspected compounding pharmacies, which can often provide a more reliable supply when branded options are out of stock
But, the reality is that 503A pharmacies are also under FDA jurisdiction for compliance with requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act) for the compounded products they produce, noting that they are exempt from certain labeling requirements and current good manufacturing practices (cGMPs) applicable to FDA-approved drugs and 503B compounded drugs
(PubMed) Alkan Z, Duong FL, Hawkes WC
