FDA has issued guidance documents to help pharmaceutical stakeholders identify illegitimate products and remove them from the supply chain. Two of the documents are final, while another two are draft guidance.
“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain,” said Donald D. Ashley, director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research, in a statement.
The FDA introduced the Drug Supply Chain Security Act (DSCSA) requirements to identify and weed out illegitimate products.
The recent documents include recommendations for complying with DSCSA requirements and how to provide enhanced drug distribution security at the package level to comply with requirements that go into effect in November 2023. After that data, manufacturers and repackagers will need to apply a product identifier on drug packages, including a national drug code, serial number, lot number and expiration date.
The agency is currently soliciting feedback from pharmaceutical companies and relevant suppliers to support its mission to safeguard the supply chain.
“We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on,” Ashley said.
The guidance documents include the following:
- Final guidance: Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers.
- Final guidance: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.
- Draft guidance: Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA.
- Draft guidance: Enhanced Drug Distribution Security at the Package Level under DSCSA.