On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to contract manufacturers (“co-manufacturers). The agency is taking this action to address situations where brand owners perform certain supply-chain program requirements on behalf of their co-manufacturers. This action extends the enforcement discretion FDA announced in November 2017, which was due to expire on November 6, 2019. Notably, FDA has not yet announced the length of time for this extension of the enforcement discretion but plans to do so in a forthcoming Federal Register notice. This memorandum provides a background on this issue and explains the FDA’s recent announcement.
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