On Sep. 9, 2018, the FDA released a Final Guidance regarding the use of product identifiers on packages and homogenous cases of product as mentioned in the Drug Supply Chain Security Act (DSCSA).
This guidance was released in response to a year-long delay in the product identifier requirement; which is defined by the FDA as, “a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed… including the standardized numerical identifier, lot number and expiration date of the product.”
The delay from 2017 to 2018 was done in part due to many manufacturers, and trading partners, expressing their concerns for the industry’s ability to meet the product identifier requirement. Their concerns ranged from a lack of expertise that would produce solutions, to the limitations at the manufacturing facilities.
Based on those concerns the FDA concluded that they would not take action if a product, or case of product, was packaged between Nov. 27, 2017, the original deadline, and Nov. 27, 2018, the new deadline.
However, manufacturers, wholesalers, and repackagers are still required to use a product identifier if the product is to be included in a transaction, and packaged or repackaged, after Nov. 27, 2018.
Some further exemptions were made for products that fall under the recent guidance on Grandfathered product; which introduced an exemption for product that was packaged prior to the Nov. 27, 2018 deadline.
The FDA also provides a draft Q&A Section to help clarify any looming questions or concerns.
For Hospital and Health System pharmacies concerned about complying with the product identifier deadline, please reference our DSCSA Compliance as a Service module.
The FDA would like to note that a guidance does not equate to legal authority.