Drugs

Secure Supply Chain Pilot Program

FDA launches Secure Supply Chain pilot program to enhance security of the supply chain: February 5, 2014

On August 20, 2013, FDA published a Federal Register notice announcing the launch of the Secure Supply Chain Pilot Program, which will enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products into the United States. 
 
The goal of the program is to enable FDA to focus its 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. In addition, participating firms will also demonstrate a commitment to securing their drug supply chains as participants in the Customs-Trade Partnership Against Terrorism (C-TPAT).
 
FDA selected these companies following a careful review of applications submitted by 15 firms since September 16, 2013. Each firm had the option to include up to five drugs that may benefit from expedited import under the pilot program. Accordingly, these pilot program participants will be able to receive expedited entry review for their prequalified imported drugs.
 
The firms that have been accepted into the pilot program are:
 
    • Pfizer, Inc.
    • GE Healthcare Inc.
    • AbbVie Inc.
    • GlaxoSmithKline LLC
    • Merck Sharp & Dohme Corporation
    • Celgene Corporation
    • Astellas U.S. Tehcnologies, Inc.
    • Novartis Pharmaceuticals Corporation
    • Bristol-Myers Squibb Company
    • Teva Pharmaceutcials USA, Inc.
    • Allergan, Inc.
    • Watson Laboratories, Inc.
    • Mylan Pharmaceuticals Inc.
 
The pilot program will run for two years, providing the FDA an opportunity to evaluate how effective the program is at enhancing imported drug compliance and the security of the drug supply chain. If the pilot is found to be effective, a more permanent program may be established and possibly extended to additional participants.
 
 

Notice update issued: October 31, 2013

On September 27, 2013, FDA issued a correction in the Federal Register because the August 20, 2013 notice announcing the start of the Secure Supply Chain Pilot Program listed an incorrect email address for the Secure Supply Chain Pilot Program mailbox. The September 27th Federal Register notice corrects that error.

 

Notice issued: August 20, 2013

On August 20th, FDA published a Federal Register notice announcing the launch of the Secure Supply Chain Pilot Program, which will enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products into the United States. 

The goal of the program is to enable FDA to focus its 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. In addition, participating firms will also demonstrate a commitment to securing their drug supply chains as participants in the Customs-Trade Partnership Against Terrorism (C-TPAT).
 
The Secure Supply Chain Pilot Program is a voluntary program open to 100 qualified applicants. Each firm accepted to participate in the program will be allowed to have up to five drugs subject to expedited import entry review. The Secure Supply Chain Pilot Program will be jointly administered by FDA’s Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA).
 
Firms that apply to participate in the pilot program must meet certain criteria that include, but are not limited to, the following:
 
  • The applicant must be the NDA/ANDA sponsor, or the foreign manufacturer, of the imported finished drug product or active pharmaceutical ingredient.
  • Foreign drug manufacturers and U.S. establishments receiving drugs must comply with good manufacturing practices and also be in compliance with the registration and listing requirements outlined in sections 510(i) and 510(j) of the Federal Food, Drug and Cosmetic Act.
  • Applicants must have a validated secure supply chain protocol per the U.S. Customs and Border Protection’s C-TPAT program as either C-TPAT Tier II or Tier III.
 
FDA will accept applications for participation beginning September 16, 2013, through December 31, 2013. The pilot program will run from February 2014 through February 2016. 

Page Last Updated: 11/06/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.