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Credit: Steven Harbour
The US Food and Drug Administration (FDA) has launched a program that allows certain companies to expedite the importation of drugs and drug ingredients.
Thirteen companies have been selected to take part in this 2-year program, called the Secure Supply Chain Pilot Program.
As the companies meet certain criteria, they are eligible to receive expedited entry for up to 5 drug products. These products can enter the US after electronic screening without undergoing human examination.
The FDA said its goal with this program is to allow the agency to focus its imports surveillance resources on preventing the entry of drugs that are most likely to compromise the quality and safety of the US drug supply.
The companies that have been accepted into the program are:
- 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 these companies met the 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 US 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
- Maintaining control over their drugs from the time of manufacture abroad through entry into the US.
Over the next 2 years, the FDA will evaluate whether this program enhances imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA deems the program effective, a more permanent program may be established and possibly extended to additional companies.
For more information, see the FDA’s notice about the program, published in the Federal Register last August. 
Credit: Steven Harbour
The US Food and Drug Administration (FDA) has launched a program that allows certain companies to expedite the importation of drugs and drug ingredients.
Thirteen companies have been selected to take part in this 2-year program, called the Secure Supply Chain Pilot Program.
As the companies meet certain criteria, they are eligible to receive expedited entry for up to 5 drug products. These products can enter the US after electronic screening without undergoing human examination.
The FDA said its goal with this program is to allow the agency to focus its imports surveillance resources on preventing the entry of drugs that are most likely to compromise the quality and safety of the US drug supply.
The companies that have been accepted into the program are:
- 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 these companies met the 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 US 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
- Maintaining control over their drugs from the time of manufacture abroad through entry into the US.
Over the next 2 years, the FDA will evaluate whether this program enhances imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA deems the program effective, a more permanent program may be established and possibly extended to additional companies.
For more information, see the FDA’s notice about the program, published in the Federal Register last August.
Credit: Steven Harbour
The US Food and Drug Administration (FDA) has launched a program that allows certain companies to expedite the importation of drugs and drug ingredients.
Thirteen companies have been selected to take part in this 2-year program, called the Secure Supply Chain Pilot Program.
As the companies meet certain criteria, they are eligible to receive expedited entry for up to 5 drug products. These products can enter the US after electronic screening without undergoing human examination.
The FDA said its goal with this program is to allow the agency to focus its imports surveillance resources on preventing the entry of drugs that are most likely to compromise the quality and safety of the US drug supply.
The companies that have been accepted into the program are:
- 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 these companies met the 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 US 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
- Maintaining control over their drugs from the time of manufacture abroad through entry into the US.
Over the next 2 years, the FDA will evaluate whether this program enhances imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA deems the program effective, a more permanent program may be established and possibly extended to additional companies.
For more information, see the FDA’s notice about the program, published in the Federal Register last August.