FDA Finalizes Grandfathering Guidance

On September 19, 2018, the Food & Drug Administration (FDA) posted finalized guidance around grandfathering product under the Drug Supply Chain Security Act (DSCSA). The final version of this guidance was originally circulated in draft form in November of 2018.

Background

DSCSA specifies that the FDA shall create and finalize guidance relating to the grandfathering of product under the product identifier (serialization) requirements. This newly issued guidance is the FDA’s final response to this requirement. It specifies circumstances where packages and homogeneous cases of product that are “in the pharmaceutical distribution supply chain at the time of the effective date of the requirements” of DSCSA shall be exempt from certain provisions of DSCSA product identifier “serialization” requirements.

Key Summary Implications

A drug package or homogeneous case not labeled with a product identifier will be exempt from the manufacturer serialization requirements if there is documentation that it was packaged by the manufacturer prior to November 27, 2018 or repackaged by a repackager prior to November 27, 2018.

The guidance specifies that a product or homogeneous case of product is considered to be “in the pharmaceutical distribution supply chain” if that product was packaged by the product’s manufacturer (or repackaged by a product’s repackager) before Nov. 27, 2018. Thus, a package or homogeneous case of product that is not labeled with a serialized product identifier is eligible for an exemption only if there is documentation that such packaging took place before Nov. 27, 2018. This documentation can include a sale date documented on Transaction History, Information, and Statement (T3) or the provision of a Transaction Statement accompanying a T3 attesting that this is compliant product even if it doesn’t have a serialized barcode. The manufacturer or repackager should retain internal packaging data documenting the packaging date and should provide such data to a trading partner if requested.

The other major implications are for the rest of the supply chain and allow wholesale distributors, dispensers, etc. an exemption from following related buy/sell transaction and verification requirements for product that is covered under grandfathering. For example, distributors can continue to buy/sell drug product without a product identifier past Nov. 27, 2019 and up until the expiration date, as long as the product was packaged by the manufacturer or repackager prior to Nov. 27, 2018.

Guidance Details

The following exemptions and modifications apply when there is documentation that the product involved in a transaction was in the pharmaceutical supply chain before Nov. 27, 2018:

Manufacturers

• Manufacturers that are investigating suspect product n their possession/control which is covered by grandfathering (i.e. w/o a product identifier), to determine if it is illegitimate, do not have to verify the product at the package level. All other suspect product investigation requirements still apply.
• Manufacturers do not have to respond to a request for verification of a grandfathered drug product at the package level by an authorized trading partner.

Wholesale Distributors

• Distributors may still engage in buy/sell transactions beginning Nov. 27, 2019 with grandfathered product that does not have a product identifier as long as such product was packaged before Nov. 27, 2018.
• Distributors are not required to verify grandfathered product at the package level using the product identifier beginning Nov. 27, 2019 for exempted product as part of a suspect/illegitimate product investigation.

Dispensers

• Dispensers may still engage in buy transactions beginning Nov. 27, 2020 with grandfathered product that does not have a product identifier as long as such product was packaged before Nov. 27, 2018.
• Dispensers are not required to verify grandfathered product at the package level using the product identifier beginning Nov. 27, 2020 for exempted product as part of a suspect/illegitimate product investigation.

Repackagers

• Repackagers may still accept ownership of grandfathered product that does not have a product identifier on/after Nov. 27, 2018 if it was packaged by the original manufacturer or repackager before Nov. 27, 2018.
• Repackagers may transfer ownership of product without a product identifier to another trading partner on/after Nov. 27, 2018 if such product was repackaged by the repackager before Nov. 27, 2018.
• Repackagers accepting ownership of grandfathered product (w/o product identifier) and repackaging such product on/after Nov. 27, 2018 must apply a serialized product identifier before transfer of ownership.
• Repackagers are not required to verify product at the package level using the product identifier beginning Nov. 27, 2018 for the grandfathered product as part of a suspect/illegitimate product investigation. All other suspect product investigation requirements still apply.
• If a repackager initially repackaged product without a product identifier before Nov. 27, 2018, they are exempt from the requirement to verify the product identifier when receiving a request to do so from an authorized trading partner for such product.

Across the Supply Chain

• Trading partners across the supply chain may engage in transactions (sales, purchase, etc.) regarding grandfathered product until the product expiration date. There is no sunset date for grandfathered product.

Saleable Returns

• For returns of saleable packages and sealed homogenous cases of product covered by grandfathering that were in the supply chain prior to Nov. 27, 2018, manufacturers, wholesale distributors and repackagers are not required to verify the product identifier prior to resale. Manufacturers and repackagers are also not required to add a new product identifier to grandfathered product prior to resale, if one did not exist, as long as the product remains in its original package or sealed homogeneous case form.