To address concerns about the industry’s readiness to comply with the product identifier requirements under DSCSA, the FDA issued a draft compliance policy indicating that it will hold off on enforcing certain requirements for manufacturers, repackagers, wholesale distributors and dispensers.
The FDA issued draft guidance outlining its compliance policy for product identifier requirements and indicated that it doesn’t plan to take action against manufacturers that fail to meet the requirement until November 26, 2018. The agency is delaying by one year the enforcement of the requirement under the Drug Supply Chain Security Act (DSCSA) that manufacturers include a product identifier on product packages meant to be introduced in a transaction into commerce, which was initially slated to go into effect November 27, 2017. The decision follows feedback from manufacturers and their trading partners raising concerns about readiness to meet the requirements due to the limited number of vendors able to provide the IT systems and equipment needed. There were also concerns about contract facilities’ readiness to meet the requirements on behalf of manufacturers.
The compliance policy also indicates the FDA will not enforce the requirement that manufacturers use identifiers to verify product at the package level, when investigating suspect product or upon receipt of a verification request by the agency, for product introduced prior to the new enforcement date without a product identifier. Similarly, action won’t be taken against manufacturers that don’t verify a package or sealed homogeneous case of such product if it is meant for further distribution as a saleable returned product. However, the FDA notes that manufacturers must validate any applicable transaction history and information if it’s determined that a product it possesses or controls is suspect or if a verification request is received from the FDA or an authorized trading partner.
In recognition that downstream trading partners may want to acquire product introduced to market between the initial enforcement date and the new enforcement date that don’t bear an identifier, the FDA states that it does not intend to take action against repackagers, wholesale distributors or dispensers that:
- Take part in a transaction involving such product, irrespective of when the transaction takes place,
- Do not verify the product identifier for such product, or
- Do not verify the product identifier on each package or sealed homogeneous case of such product meant for distribution as a saleable return.
The FDA cautions, however, that there is an exception in instances in which a repackager’s transaction triggers an independent responsibility to include a product identifier. The compliance policy is not applicable to the requirement, slated to take effect November 17, 2018, that repackagers include a product identifier on each package or homogenous case of product meant to be introduced to market. As such, wholesalers or dispensers that acquire products from a repackager after the effective date should make sure they have product identifiers. The FDA encourages trading partners who believe product may be subject to the compliance policy to take steps to verify the product was introduced during the required time frame based on at least one document of the transaction history or other documentary evidence established by a trading partner in the ordinary course of business.