FDA issues draft guidance: product identifier requirements under the Drug Supply Chain Security Act―Compliance Policy.
The Food and Drug Administration Friday quietly issued draft guidance suggesting that the agency does not plan to enforce certain Drug Supply Chain Security Act (DSCSA) requirements for a full year from the November 27, 2017 start date.
“In brief, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018,” according to the newly issued compliance policy draft guidance. “This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers.”
The notice also applies to various downstream trading partners, including repackagers, wholesale distributors, or dispensers involved in the product transaction “regardless of when such a transaction occurs [during the intended one-year grace period], except where a repackager’s transaction triggers an independent responsibility to affix or imprint a product identifier.
The agency said it also does not intend to take action against repackagers or wholesale distributors who do not verify the product identifier on each package or sealed homogenous case that they intend to further distribute as a saleable return.
Some Breathing Room
The FDA pointed out that the new draft guidance applies solely to items without a product identifier during the period and that manufacturers must comply with other DSCSA requirements.
While the law itself has not changed―something that would take further action in Washington―it appears the FDA intends to provide some breathing room for those involved in the implementation process.
The product identifier presents a unique identity for individual prescription drug packages and cases that will allow trading partners to trace the packages as they move through the supply chain.
The identifiers are expected to include the product’s lot number, expiration date barcode, national drug code (or NDC), and a serial number.
The FDA emphasizes that its guidance documents do not establish legally enforceable responsibilities, but rather describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
(Source: U.S. Food and Drug Administration)
