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Regulatory Focus™ > News Articles > FDA Issues Delayed DSCSA Grandfathering Guidance

FDA Issues Delayed DSCSA Grandfathering Guidance

Posted 27 November 2017 | By Michael Mezher 

FDA Issues Delayed DSCSA Grandfathering Guidance

The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA).

While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases take effect, FDA in June issued draft guidance saying it would delay enforcement of product identifier requirements by one year.

Under the DSCSA, manufacturers and repackagers are required to affix or imprint a product identifier to each package and homogenous case of product by 27 November 2017. The Act also restricts repackagers, wholesale distributors and dispensers from receiving or transferring ownership of drugs that lack a product identifier as of 27 November 2018, 2019 and 2020, respectively.

But the Act allows for grandfathered packages and homogenous cases of drugs to be exempted from certain product identifier requirements if they are "in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of [section 582 of the DSCSA]."

Draft Guidance

Under the newly issued draft guidance, FDA says it will consider packages and homogenous cases of drugs to be "in the pharmaceutical distribution supply chain" if they were packaged by the manufacturer before 27 November 2018.

FDA says that packages or homogenous cases of product that do not bear a product identifier should be accompanied by documentation that it was packaged before 27 November 2018. "Manufacturers retain packaging date information in the ordinary course of business and as a part of batch recordkeeping, and they should provide the packaging date to subsequent trading partners if they request it," FDA writes.

The guidance goes on to detail the specific requirements that grandfathered products are exempted from for manufacturers, wholesale distributors, dispensers and repackagers to clarify each parties' responsibilities in a transaction involving grandfathered products.

Additionally, the guidance clarifies that saleable returned packages and homogenous cases of product are exempt from certain product identifier requirements if they were in distribution prior to 27 November 2018.     

Draft Guidance


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