BIO Comments on FDA Draft Guidance on Grandfathering Policy for Packages and Homogenous Cases of Product Without Product Identifier
January 26, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.
BIO and its member companies are committed to meeting the requirements of the Drug Supply Chain Security Act (DSCSA) and ensuring the U.S. drug supply chain is secure, patients are receiving authentic products, and legitimate medications continue to move without unnecessary delays.
The use of the package date for determining whether an un-serialized product would be grandfathered is critical to a smooth transition under DSCSA from un-serialized to serialized inventory. It’s important these products can be sold and distributed until the product has reached its expiration date.
BIO thanks the FDA for listening to stakeholder concerns on the implementation of the grandfathering provisions of the DSCSA. This draft guidance will help ensure legitimate product can move through the supply chain and help negate potential issues as stakeholders begin implementing the serialization requirements.
Download Full Comments Below
2018-01-26 BIO Comments On DSCSA Grandfathering Policy FINAL
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.
BIO and its member companies are committed to meeting the requirements of the Drug Supply Chain Security Act (DSCSA) and ensuring the U.S. drug supply chain is secure, patients are receiving authentic products, and legitimate medications continue to move without unnecessary delays.
The use of the package date for determining whether an un-serialized product would be grandfathered is critical to a smooth transition under DSCSA from un-serialized to serialized inventory. It’s important these products can be sold and distributed until the product has reached its expiration date.
BIO thanks the FDA for listening to stakeholder concerns on the implementation of the grandfathering provisions of the DSCSA. This draft guidance will help ensure legitimate product can move through the supply chain and help negate potential issues as stakeholders begin implementing the serialization requirements.