FDA Final Rule Enables Detention of Drugs during Inspections
Before this summer, the U.S. Food and Drug Administration (FDA) already had the authority to detain potentially adulterated or misbranded tobacco, food, and medical devices encountered during inspections. That authority has now been expanded to include drugs. On June 30, 2014, a new final rule issued by FDA became effective that enables the agency to detain drugs encountered during inspections that FDA inspectors have reason to believe are adulterated or misbranded. The purpose of the rule is to prevent drugs that are non-compliant with FDA regulation from being distributed and used throughout the U.S. while FDA considers what actions to take concerning the drugs and, if necessary, as the agency initiates legal action.
During the detention period, drugs detained by FDA may not be used, altered, tampered with, or moved from the place they were detained unless approved by the FDA representative who issued the detention order. If a detained drug is not in its final form for shipment, it may also be moved in order to be put in final form. In this case, the person responsible for moving the drug must separate it from other drugs and orally notify the FDA representative who issued the detention order of its movement.
The new final rule requires FDA to issue a detention notice to the owner, operator, or agent of the place where a drug is detained as quickly as possible once the decision to detain a drug is made. If the owner or user of a detained drug is a different individual than the owner, operator, or agent of the place, FDA must notify them as well. Anyone who is issued a detention notice will also be notified when the detention is terminated by the responsible FDA representative or when the detention expires, whichever occurs first.
Under most circumstances, detention periods may not exceed 20 calendar days after a detention order is issued, but the FDA District Director of the district where a detained drug is located may add 10 days to a detention period if he or she determines it will take longer to consider or follow through with necessary actions regarding the detained drug.
Having products detained can be a frustrating experience. It can disappoint clients and can cost a company a significant amount of money due to lost sales and the costs of bringing a product into compliance. Foreign companies exporting drugs to the U.S. should be aware of this new rule, seeing as 40 percent of finished drugs and the majority of active ingredients come from overseas. Under The Generic Drug User Fee Amendments of 2012 (GDUFA), FDA is increasing the amount of foreign drug manufacturer inspections. By FY 2017, FDA inspections of foreign drug manufacturers are to be nearly equal to the amount of inspections of domestic drug manufacturers, which have been required to be inspected every two years.
Registrar Corp’s Drug Labeling and Ingredient Review service can help companies ensure their products meet FDA requirements. Our regulatory specialists will review your product labeling against the Code of Federal Regulations, FDA issued warning letters, and more, and provide revised labeling for those products that may be marketed in the US. Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulation. If you have any questions about FDA drug regulation, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.