U.S. FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs.
Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.
The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.
It is believed that by creating incentives for manufacturers to adopt best practices for supply chain integrity, FDA can enhance the quality and safety of imported drugs. The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.
During these next two years, the FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.
The 13 prequalified companies accepted into the program that will receive expedited entry, are the following:
What were the Conditions that the above companies met to qualify to participate in FDA's Secure Supply Chain Pilot Program ?
Source : FDA
For more updates and trainings on FDA Compliance, logon to Compliance Trainings
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Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.
The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.
It is believed that by creating incentives for manufacturers to adopt best practices for supply chain integrity, FDA can enhance the quality and safety of imported drugs. The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.
During these next two years, the FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.
The 13 prequalified companies accepted into the program that will receive expedited entry, are the following:
- AbbVie Inc.
- Allergan, Inc.
- Astellas U.S. Technologies, Inc.
- Bristol-Myers Squibb Company
- Celgene Corporation
- GE Healthcare Inc.
- GlaxoSmithKline LLC
- Merck Sharp & Dohme Corporation
- Mylan Pharmaceuticals Inc.
- Novartis Pharmaceuticals Corporation
- Pfizer, Inc.
- Teva Pharmaceutcials USA, Inc.
- Watson Laboratories, Inc.
What were the Conditions that the above companies met to qualify to participate in FDA's Secure Supply Chain Pilot Program ?
- Commitment to comply with requirements of the Food, Drug, and Cosmetics Act (FDCA)
- Have a validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism (C-TPAT) program
- Have a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products
- Have an effective recall and corrective action plans in place
- Maintain control over their drugs from the time of manufacture abroad through entry into the United States
Source : FDA
For more updates and trainings on FDA Compliance, logon to Compliance Trainings
.
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