The FDA's Juпe issuance of а draft guidance, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy, had drug manufacturers scratching their heads оп how and when to comply. In November 2017, the FDA published yet another draft guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, which clears up some of the questions that we have all had on these issues.
DSCSA non-enforcement draft guidance
The full compliance policy still hasn’t been published, as it’s going through review as a draft to accept challenges, recommendations and a critique (the comment period closed in January). The primary reason for seeking further guidance dealt with enforcement of DSCSA, specifically with regards to manufacturers applying serialization to products. The deadline for compliance here remains Nov. 27 of 2017, but in the draft the FDA states they will not enforce the manufacturers’ product identifier requirements under the DSCSA for another full year. While this buys some manufacturers, wholesalers, and repackagers some more time, it begged the question about what “introduced in a transaction into commerce before Nov. 26, 2018” meant.
Specifically, from lines 37-41 of the draft guidance:
‘In brief, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogeneous case of products intended to be introduced in a transaction into commerce before Nov. 26, 2018. This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers.’
What does that mean? A less conservative approach might assume that as long as the batch is released before Nov. 27, 2018, then there is no requirement for compliance, even if shipping that product after the deadline. The more conservative approach would have meant to consider each and every product individually. Fortunately, the November 2017 Grandfathering draft guidance clears this up.
The Grandfathering draft guidance specifically states (from lines 122-124):
‘For the purposes of this guidance, a package or homogenous case of product is “in the pharmaceutical distribution supply chain” if it was packaged by the product’s manufacturer before November 27, 2018.’
The key word is “packaged”. Any product “packaged by the product’s manufacturer” before the deferred compliance enforcement date (November 27, 2018) will be exempt from enforcement of DSCSA requirements for affixing a Product Identifier. Subsequently, this draft guidance exempts any trading partner requirements relating to Product Identifier as it relates to product supplied by a manufacturer if that product was packaged by the manufacturer before November 27, 2018 without affixing a Product Identifier to that package or homogenous case. This includes the following:
Exemptions for Product Packaged by a Manufacturer without a Product Identifier before 11/27/18:
The investigation of suspect product, that is verifying product at the product level using the Product Identifier (this applies to manufacturers, as well as their downstream trading partners).
Wholesaler requirements that they engage in transactions involving only product encoded with a Product Identifier beginning November 27, 2019.
Dispenser requirements that they engage in transactions involving only product encoded with a Product Identifier beginning November 27, 2020.
Repackager requirements that they accept ownership of product encoded with a Product Identifier beginning November 27, 2018.
However, it is important to understand what is not exempted.
Not Exempted (for any manufacturer or downstream trading partner):
There is no extension of compliance dates for the requirements for investigation/verification of product at the package level using the Product Identifier Product packaged by a manufacturer (or repackager) prior to November 27, 2018 that has had a Product Identifier affixed to its labeling.
There is no exemption from the requirement to validate any applicable transaction history and transaction information in their possession and otherwise investigate any suspect product to determine if it is illegitimate.
And specifically, for repackagers:
If a repackager wishes to transfer ownership of a package or homogenous case of product without a product identifier on or after November 27, 2018, it must first add a product identifier to the package or homogenous case of product. Basically this is saying that all product packaged after November 27, 2018 must be serialized (have a Product Identifier), regardless if it is packaged by a manufacturer or a repackager.