On May 6, 2014, the U.S. Food and Drug Administration (FDA) proposed a rule regarding the disposal of drugs refused for entry into the U.S. (79 FR 25758) Currently, when a drug is refused, the consignee or importer of record is given 90 days to re-export the drug or destroy it. If the proposed rule is finalized, FDA will have authority to destroy refused drugs valued at $2,500 USD or less without offering the opportunity for it to be re-exported. Before destroying the drug, FDA would be required to give the owner or consignee of the drug written notice of FDA’s intent and reasoning, and a hearing date. The owner or consignee would then be given the opportunity to contest the refusal and/or destruction of the drug and, if not already done at or before the hearing, provide evidence that they intend to bring the drug into compliance with FDA regulations prior to destruction.
Because of the value limit, the new rule would mainly affect small exporters and shipments of samples. FDA may refuse a drug admission to the U.S. for violations of FDA regulations such as adulteration, misbranding, and others. If and when the proposed rule is finalized, it will be increasingly important for small drug shipments to adhere to FDA regulations.
Registrar Corp can help drug establishments properly register and list their products, as well as modify product labels to comply with FDA regulations. We also assist companies whose products have been detained. For questions about the proposed rule or any other FDA drug regulations, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: https://www.registrarcorp.com/livehelp.