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A warning letter by any other name can be just as chilling

This article was originally published in The Gold Sheet

Executive Summary

FDA chose simply to warn any company manufacturing unapproved formulations of hydrocodone with a notice in the Oct. 1 Federal Register rather than try to mail them all warning letters, Deborah Autor, director of CDER's Office of Compliance, said at the recent PDA/FDA regulatory affairs meeting in Washington. In the notice, the agency said how it intends to use its enforcement discretion against manufacturers and shippers of some 200 unapproved hydrocodone-containing cough suppressants. Enforcement was to begin Oct. 31 against anyone still manufacturing or shipping unapproved hydrocodone products labeled for use by children under the age of six. Enforcement against other unapproved hydrocodone products with listed NDC numbers will begin Dec. 31 for manufacturers and March 31 for shippers. The agency will continue to allow marketing of the seven approved hydrocodone cough suppressants. Hydrocodone is a Schedule II narcotic under the Controlled Substances Act, and a Schedule III narcotic when combined with non-narcotic active ingredients
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