The FDA is launching a voluntary pilot program focused on promoting the safety of drugs manufactured outside of the United States. The program's goal will be to determine whether the development of a secure supply chain program for importation is practical and feasible.
The program, if successful, will have two key benefits: It will speed the importation for medications that meet program criteria, and it will make it tougher to import drugs that do not meet FDA criteria. It will also help alleviate problems such as medication counterfeiting.
The new Secure Supply Chain pilot program will enroll 100 participants. Companies that wish to be included will need to submit an application and meet certain specific requirements, and can apply to have up to five different drugs included in the program. For example, participants will have to show that they will remain in control of drug products throughout the entire process, from manufacture to importation to the United States.
U.S. Customs and Border Protection helped develop the project, which the FDA plans to continue for two years.
- read the FDA release