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Expert Articles

The Food and Drug Administration (FDA) recently issued a draft guidance, a final guidance, a proposed rule, and two revised nominations for the bulk drug substance lists. These documents are meant to clarify the FDA’s position on compounded products. The draft guidance consists of guidelines regarding compounded products manufactured in outsourced facilities per Section 503B. […]

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The Food and Drug Administration (FDA) is drafting a new regulation that enables a pharmaceutical company to register an outsourcing facility with the FDA. This regulation, called 503B, is part of the Drug Quality and Security Act. It is also issuing an associated guidance that further clarifies its position on outsourcing facilities and current Good […]

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Because of the dangers of misbranding and the associated recalls of such devices, it is important for manufacturers to have the appropriate labeling.  Because the Food and Drug Administration (FDA) has some specific regulations regarding what can and cannot be included, it is important for manufacturers to know what to include and how to include […]

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