FDA: Two new guidelines on supply chain security
The FDA has finalized two guidance documents to help ensure that prescription drugs are identified and traced properly while moving through the supply chain. The documents address how to comply with the DSCSA (Drug Supply Chain Security Act) requirements.
As part of this, manufacturers and repackagers have to put a product identifier on drug packages. This includes the product national drug code (NDC), serial number, lot number and expiration date on each package and homogenous case of product, in human- and machine-readable form. The machine-readable form is generally a two-dimensional data matrix barcode. Industry questions are clarified in the 20-page final guidance Product Identifiers Under the Drug Supply Chain Security Act, Q&As.
The second 20-page final guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification is intended to aid certain trading partners in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify the FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with the FDA. In addition, this guidance describes when manufacturers should notify the FDA of a high risk that a product is illegitimate.
These two final guidances come along with two draft documents on the same subject:
- Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA
It lays out the definition of terms, including the following: „counterfeit“, „diverted“, „stolen“, „fraudulent“ transaction“ and „unfit for distribution. - Enhanced Drug Distribution Security at the Package Level under DSCSA
It should assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level that go into effect in the year 2023. The guidance provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level.
The drafts are open for public consultation until 3 August 2021.
Source:
FDA: Press Announcement
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