United States: FDA Announces Start Of Voluntary Supply Chain Pilot Program
Last Updated: March 10 2014
Article by Kathleen M. Murphy and Mollie D. Sitkowski
In a February 18, 2014, news release, the U.S. Food and Drug Administration (FDA) announced the launch of its Secure Supply Chain Pilot Program (SSCPP) and the names of the 13 companies selected to participate in the program. The FDA originally proposed the pilot in 2009 and officially announced the start of the program and the selection criteria for participation in August 2013. The pilot is scheduled to run for two years, until February 2016.
As background, the FDA designed the program with the intent to reduce scrutiny of low-risk imports so that it may increase its attention on less trustworthy foreign-made medicine. It hopes to create incentives for manufacturers to adopt best practices for supply-chain safety so that it can enhance the quality and safety of all imported drugs. Its aim is to stop the importation of contaminated, misbranded or unapproved medications.
Under the pilot program, the 13 companies selected will receive expedited entry for up to five selected drug products imported into the United States. These drug products will be the only drug shipments allowed entry into the U.S. without human review and will be entered automatically with a "system" entry decision. In return for this expedited treatment, the drugs must be imported from the manufacturer identified on the companies' initial pilot applications, must arrive through a designated port of entry, must use the identified customs broker or entry filer from the applications, and must be intended for the designated ultimate consignee.
The participating companies had to meet several conditions to participate, including:
continue to read here
As background, the FDA designed the program with the intent to reduce scrutiny of low-risk imports so that it may increase its attention on less trustworthy foreign-made medicine. It hopes to create incentives for manufacturers to adopt best practices for supply-chain safety so that it can enhance the quality and safety of all imported drugs. Its aim is to stop the importation of contaminated, misbranded or unapproved medications.
Under the pilot program, the 13 companies selected will receive expedited entry for up to five selected drug products imported into the United States. These drug products will be the only drug shipments allowed entry into the U.S. without human review and will be entered automatically with a "system" entry decision. In return for this expedited treatment, the drugs must be imported from the manufacturer identified on the companies' initial pilot applications, must arrive through a designated port of entry, must use the identified customs broker or entry filer from the applications, and must be intended for the designated ultimate consignee.
The participating companies had to meet several conditions to participate, including:
continue to read here
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