FDA Issues Draft Guidance Proposing Risk-Based Enforcement Approach to Drug Products Labeled as Homeopathic – APhA submits compounding comments to FDA

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FDA Issues Draft Guidance Proposing Risk-Based Enforcement Approach to Drug Products Labeled as Homeopathic – APhA submits compounding comments to FDA. – (866) 348-2889

In a new draft guidance for FDA staff and industry, FDA describes how the agency intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the US without the required FDA approval. As indicated in the guidance document, Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry, FDA has determined that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to drug products labeled as homeopathic and marketed in the US without the required FDA approval, consistent with FDA’s risk-based regulatory approaches.

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