DETROIT, Feb. 14, 2012 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) maintains strict labeling requirements for Active Pharmaceutical Ingredients (APIs). If an API does not maintain adequate labeling as per section 502(f)(1) of the Act, the FDA will consider the material to be misbranded. Foreign APIs which are misbranded are subject to detention without physical examination under FDA's Import Alert 66-66 "Red List."
Once an API is placed on the Import Alert, further shipments into the United States are subject to additional paperwork, inspection and delay. The requirements for removal from the Red List are defined by the FDA and are very specific. The entire process can take a long time.
On behalf of a client, VPCI (Vectech Pharmaceutical Consultants International) is happy to announce the successful petition to the FDA for removal from the Import Alert. Acting as the project coordinator, VPCI provided assistance throughout the entire process.
"This was a big victory for our client," said Craig Kruman, CFO and Director of Regulatory Administration for VPCI. "Once a manufacturer is placed on the Import Alert it becomes very difficult to ship APIs into the United States. This becomes a financial and administrative burden for the manufacturer. And even more importantly, the resulting delays in the supply chain can lead to serious drug shortages."
Craig Kruman further went on to explain, "The best advice that VPCI gives to its clients is to avoid these issues in the first place. Make sure that everything is properly filed, formatted and submitted before a shipment is made to the United States. Make sure that all of the labeling requirements are met."
VPCI, Inc. (Vectech Pharmaceutical Consultants International) (www.vpcint.com) is a Pharmaceutical consulting firm that offers FDA regulatory guidance, manufacturing technology support, and high-level business development services. With a global network of scientific and technical experts, VPCI has a broad ability to serve its clients dealing with a number of regulatory agencies. VPCI offers audits and training to manufacturers, strictly following good manufacturing practices (GMP).
|SOURCE VPCI, Inc.|
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