FDA Posts Information on New Import Authorities From 2018 Law
The Food and Drug Administration recently posted a new webpage on its additional import authorities under a law enacted in October. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (aka, the Support Act), enacted Oct. 24, 2018, makes improvements to the infrastructure and resources of international mail facilities (IMFs), and grants FDA new authorities related to active pharmaceutical ingredients and drugs from importers with a pattern of violations.
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Under the Support Act, FDA now has the authority to treat any good as a drug if it contains an API that is FDA-approved or an analog of that API, provided that the ingredient presents a “significant public health concern,” FDA said. “FDA is currently focusing on implementation of this authority in the IMFs,” it said. FDA can also now treat as illegal any shipments of drugs from a person that FDA has determined is “engaging in a pattern of illegally importing adulterated or misbranded drugs from the same manufacturer, distributor, or importer,” the webpage said.
FDA can also now debar importers convicted of a felony involving illegal importation of drugs or controlled substances, or “who has engaged in a pattern of importing certain adulterated or misbranded drugs or controlled substances,” the agency said. “Once debarred, that person is prohibited from being involved in any future drug importation for up to five years. Violation of a debarment order is a criminal offense.”