Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

FDA Initiates the Secure Supply Chain Pilot Program

Published: Friday, February 21, 2014
Last Updated: Thursday, February 20, 2014
Bookmark and Share
13 prequalified companies accepted for participation.

The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program.

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.

“By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “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 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.

Each of the 13 companies met multiple participation conditions, including:

• committing to comply with requirements of the Food, Drug, and Cosmetics Act (FDCA);
• having a validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism (C-TPAT) program;
• having a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products;
• having effective recall and corrective action plans in place; and,
• maintaining control over their drugs from the time of manufacture abroad through entry into the United States.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,300+ scientific posters on ePosters
  • More than 4,900+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treating Tuberculosis
FDA to host a public workshop to review scientific issues in clinical trial design for treating tuberculosis.
Monday, July 06, 2009
FDA's Current Ability to Regulate Genetic Testing is Problematic, FDLI-AAAS Colloquium Attendees Say
Personalized medicine stakeholders’ meeting elicits varying perspectives.
Tuesday, June 30, 2009
Scientific News
FINCH Filgotinib Phase 3 Program Initiated
Galapagos NV reports the initiation of the FINCH global Phase 3 program in rheumatoid arthritis patient populations.
Stem Cell Therapy Heals Injured Mouse Brain
A team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage.
Zika Vaccine Testing in Humans
The NAAID has initiated a clinical trail of a vaccine candidate for the prevention of the Zika virus infection.
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Viable HIV Vaccine Confirmed by Study
HIV Study in macaques confirms clinically viable vaccine opening the way for future treatment in humans.
PREVAIL Treatment Trial for Men with Persistent Ebola Viral RNA
The six-month study will enroll 60 to 120 EVD survivors.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Investigational Malaria Vaccine Protects Healthy U.S. Adults
Researchers at NIH have found that the malaria vaccine protected a small number of healthy, malaria-naïve adults in the U.S. from infection for more than one year after immunization.
AACR 2016: Cancer Immunotherapy and Beyond
At this year's meeting there was a palpable buzz around subjects ranging from microbiomics to the tumor microenvironment and cancer vaccines, big data to in vitro and in vivo modeling and drug delivery (to name just a few).
New Database for Sharing MS Clinical Trial Data
A new database containing nearly 2500 patient records from the placebo arms of nine multiple sclerosis (MS) clinical trials is now available for research by qualified investigators.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!