The FDA has extended the deadline for manufacturers, repackagers, and other distributors to place a drug product identifier at the individual package level for each product introduced into interstate commerce.

Beginning November 27, 2017, manufacturers are required to “affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction into commerce.” Likewise, wholesalers and dispensaries (pharmacies) should not accept pharmaceutical products missing product identifiers (i.e. a bar code).

Following the industry’s concern that manufacturers and trading partners are not ready to comply with this rule, the FDA decided to postpone the implementation of the rule until November 28, 2018. The FDA has stated – in the proposed guidance available below – that it will not take action against repackagers, wholesalers, and dispensers who engage in the transactions involving a product that does not have a product identifier.

FDA’s guidance: “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.”