FDA moves to limit ingredients for bulk drug compounding [Reuters (UK)]
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Source: Reuters
FDA moves to limit ingredients for bulk drug compounding | Reuters 3 Min Read BOSTON (Reuters) - The U.S. Food and Drug Administration on Friday took steps to restrict what pharmaceutical ingredients large compounding pharmacies can use to manufacture drugs in bulk that do not go through the agency’s approval processes. The agency issued draft guidance that officials said prioritized the use of FDA-approved drugs over more risky, custom-made medicines produced in bulk by certain compounding pharmacies for hospitals and doctors’ offices. It marked the latest effort to regulate the industry following a fungal meningitis outbreak in 2012 linked to tainted drugs made in bulk by a compounding pharmacy that sickened 793 people, including 76 who died. The guidance, if finalized, would limit the raw substances that large compounding pharmacies known as “outsourcing facilities” can use to make medicines in bulk that do not go through the FDA safety review process. The FDA said it would only al
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