On November 26 2018, the US Food and Drug Administration (FDA) will enforce the drug supply chain security act (DSCSA). At this time, all market authorisation holders and contract manufacturing organisations (CMOs) must be compliant.
“Generally, the industry will be ready to ‘serialize’ products from November 2018,” said CEO of Excellis Health Solutions and member of the Regulatory Affairs Professionals Society (RAPS), Greg Cathcart.
However, according to Cathcart, serializing units is only a “small fraction of the work” required to meet the overall DSCSA timeline.
in-PharmaTechnologist (IPT) spoke with Greg Cathcart (GC) to discuss potential concerns and regulatory implications facing industry in the lead-up to the deadline.
IPT: How ready is industry for the DSCA?
GC: Generally, the industry will be ready to ‘serialize’ products from November 2018. It is important to note that companies were already granted an additional year to comply with this element of the DSCSA when the FDA announced it would not actively enforce the regulation from November 2017.
However, serializing units is only a small fraction of the work that needs to be completed across the industry to meet the overall DSCSA timeline, which spans from 2015 to 2023.
Overall, the biggest concern is that organisations do not understand what is required of them. Over the coming five years, many companies will have to implement a wide range of changes in order to be compliant. Companies need to keep on top of what is required, when the key deadlines are and how they can work towards achieving compliance.
IPT: What are the key deadlines?
- By November 27 2019, wholesale distributors must only buy and sell drug product that has been serialized, be able to verify product identifiers at the sealed homogeneous case level or the saleable unit level, and verify the product identifier of all returned product they intend to resell.
- As of 2020, pharmacies and hospitals dispensers can only buy and sell prescription medications that display a unique, serialized product identifier. And, in 2023, all product transaction and verification data must be in an electronic format.
- From November 27th 2023, the whole pharma supply chain will have to implement complete unit level traceability, which includes aggregation. Supply chain partners must also be able to trace the ownership of a product all the way back to the initial manufacturer or re-packager.
IPT: What advice would you give to firms that are simply not ready for the DSCSA? What are the implications for unprepared companies?
GC: I would suggest that manufacturers package as much finished goods product as possible prior to November 28, 2018, and put the products in warehouses so that they can qualify as ‘grand-fathered’ products.
An implication of not complying with the DSCSA is, of course, FDA enforcement. However, we still do not know how the FDA will react to non-compliance.
Firms must put a plan in place immediately and start working on the first phase, item level serialization.
Greg Cathcart is CEO of Excellis Health Solutions, a founding member of Global Track and Trace (GTT), and a member of the Regulatory Affairs Professionals Society (RAPS).