Compounded drugs next on FDA's list for reform

11 December 2018

From opioids to biosimilars, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has announced proposals on a huge range of issues across the drug industry since taking over the role 18 months ago.

The latest of these is compounded drugs, with Dr Gottlieb and Deputy Commissioner Anna Abram announcing new efforts to assure the quality of these products on Monday.

Revised draft guidance has been published with recommendations for protecting patients from the risk of contaminated or otherwise substandard products produced by outsourcing facilities, which are permitted under law to compound and distribute certain compounded drugs without receiving patient-specific prescriptions.

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