As indicated below, the Act imposes requirements on manufacturers, wholesaler drug
distributors, repackagers and dispensers to verify that all pharmaceutical products are
legitimate, utilizing identification and tracking procedures as well as maintaining systems that
recognize and report suspect products.
If you would like to view the complete DSCSA documents, it can be found on the FDA website.
The FDA web page outlines critical steps to build an electronic, interoperable system to identify
and trace certain prescription drugs as they are distributed in the U.S.
Ten years after enactment, the system will facilitate the exchange of information at the
individual package level about where a drug has been in the supply chain. The new system will:
- Enable verification of the legitimacy of the drug product identifier down to the package
level
- Enhance detection and notification of illegitimate products in the drug supply chain, and
- Facilitate more efficient recalls of drug products
Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily
pharmacies) will be called upon to work in cooperation with FDA to develop the new system
during this 10-year period which started in 2013.
Among key provisions that will be implemented over this 10-year period are requirements for:
- Product Identification: Manufacturers and repackagers to put a unique product
identifier on certain prescription drug packages, for example, using a bar code that can
be easily read electronically.
- Product Tracing: Manufacturers, wholesaler drug distributors, repackagers, and many
dispensers (primarily pharmacies) in the drug supply chain to provide information about
a drug and who handled it each time it is sold in the U.S. markets.
- Product Verification: Manufacturers, wholesaler drug distributors, repackagers, and
many dispensers (primarily pharmacies) to establish systems and processes to be able to
verify the product identifier on certain prescription drug packages.
- Detection and Response: Manufacturers, wholesaler drug distributors, repackagers, and
many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug
that has been identified as suspect, meaning that it may be counterfeit, unapproved, or
potentially dangerous.
- Notification: Manufacturers, wholesaler drug distributors, repackagers, and many
dispensers (primarily pharmacies) to establish systems and processes to notify FDA and
other stakeholders if an illegitimate drug is found.
- Wholesaler Licensing: Wholesale drug distributors to report their licensing status and
contact information to FDA. This information will then be made available in a public
database.
- Third-party Logistics Provider Licensing: Third-party logistic providers, those who
provide storage and logistical operations related to drug distribution, to obtain a state
or federal license.
The law requires FDA to develop standards, guidance documents, and pilot programs and to
conduct public meetings, in addition to other efforts necessary to support efficient and
effective implementation. FDA is developing a schedule for implementing the law’s
requirements. This system will enhance the FDA’s ability to help protect consumers from
exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The
system will improve detection and removal of potentially dangerous drugs from the drug supply
chain to protect U.S. consumers. Failure to comply with the requirements of the law can result
in penalties.