WASHINGTON (CN) – Sole manufacturers of life sustaining medications must report even temporary cessations of production to the Food and Drug Administration, at least 6 months beforehand, if the discontinuance could lead to a disruption in supply.
In cases in which a drug maker cannot provide 6 months notice, such as in the case of drug contamination, it is to report the discontinuance as soon as it knows the problem “necessitates a temporary discontinuance of manufacture of the product.”
This action is in response to Barack Obama’s Oct. 31, Executive Order 13588 to avert drug shortages. The order directs the FDA to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines” and noting that “one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible.”
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