DSCSA Grandfathering Policy and Unique Product Identification (UPID)
Coinciding with the November 2017 serialization deadline in the US, the FDA has issued a new guidance document to take into account real-life circumstances on the pharmaceutical supply chain.
DSCSA requirements for manufacturers, wholesalers, repackagers and dispensers
The Drug Supply Chain Security Act (DSCSA) requires manufacturers to serialize and uniquely identify packages and homogenous cases of prescription drugs as of November 2017*. The DSCSA further requires actions to be taken by all subsequent participants of the supply chain as well. Thus, repackagers (beginning November 2018), wholesale distributors (beginning November 2019), and dispensers (beginning November 2020) have to verify the authenticity of a pharmaceutical product by checking its unique identifier before passing it on to the next link in the supply chain or even accepting it.
But what happens if they encounter a product that has no unique identifier after the deadlines?
Exemptions for grandfathered products depending on date of packaging
To avoid all medicines manufactured before the serialization and UPID deadline to be destroyed just because they took too long to travel through the supply chain, the new FDA guidance document sets out exemptions for so-called grandfathered products by putting emphasis on the date of packaging. If product documentation accompanying a not uniquely identified package or homogenous case proves that said unit or case was “packaged by a manufacturer before November 27, 2018”, it is exempt, as grandfathered, from certain provisions set out in section 582 of the DSCSA.
However, and this is very important to guarantee a safe drug supply chain, supply chain links cannot accept and forward medicines without a unique product identifier just because they look as if they might have been produced before November 2018! Diligent verification is still required and they need to “validate any applicable transaction history and transaction information in their possession and otherwise investigate the suspect product to determine if it is illegitimate. The exemption does not extend to these requirements of section 582(c)(4)(A)(i)(II).” It goes without saying that they cannot accept products past their expiry date either.
Repackagers may accept grandfathered packages and homogenous cases but will have to apply a product identifier if they transfer ownership to another member of the drug supply chain on or after November 27, 2018.
Please note that guidance documents do not generally annul requirements set out in the DSCSA nor do they “establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”
Detailed information on the exact requirements under the FDA Grandfathering Policy can be found in the official document, which we urge you to consult on the FDA website.
* A Guidance document published in mid-2017 however indicates that manufacturers will not be taken actions against for bringing non-serialized product to market before November 2018