In July, when the FDA announced a one-year delay in enforcement of the DSCSA’s product identifier requirement, it also quietly moved the serialization date forward. Here’s the wording:
“FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018. This represents a one-year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. For the products that manufacturers introduce in a transaction into commerce before November 26, 2018, without a product identifier, FDA also does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level.”
Let’s unpack the guidance and examine how it impacts the serialization date.
Manufacturing Date/Packaging Date
The serialization “effective date” in the DSCSA doesn’t specify what that date is for manufacturers or repackagers. Manufacturers and repackagers track many different dates, such as purchase order, manufacturing, packaging, batch release, transaction, shipping, receiving, and others. These dates normally fall in different places on the calendar, each important and critical to their materials and the logistics planning.
Theses dates and other data elements (like lead time, run time, FIFO, FEFO, short dating, and inventory turn rate) feed into a complex calculation, resulting in planned purchase orders and planned work orders. Companies then place orders for raw materials and firm up work orders for production. They depend on the purchase orders and the work orders to run their businesses, ensuring they have enough materials to produce a sufficient finished goods inventory. It is a complex operation that requires seasoned supply chain professionals and significant computing power.
When the DSCSA was enacted, manufacturers and repackagers immediately asked the FDA to clarify the effective date. Later, they again requested that the FDA issue a “Grandfathering Guidance,” which would clarify the nature of the effective date.
In absence of “Grandfathering Guidance,” many manufacturers assumed that the serialization effective date is the packaging date, and they adopted plans to serialize drug products starting at November 27, 2017. Hence the talk about “stocking up” by pulling planned orders before November 2017 to build out safety stock. (I discussed the stocking-up topic in a previous blog.)
Then, in July, the FDA announced the delay and finally revealed the transaction date:
“FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018.”
For most manufacturers, the transaction date is the shipping date—the date the drug product is shipped to the downstream trading partner. To ship serialized product on November 27, 2018, means two things:
- The non-serialized drug product is depleted by November 26, 2018
- The serialized drug product is in inventory by November 26, 2018
November 26, 2018, is 66 weeks away. Will you consume all your non-serialized inventory in 66 weeks? If one of the following scenarios applies to you, you may end up with excess non-serialized inventory:
- I have slow-moving drug products.
- My inventory turn rate is less than 1.
- My products have very long shelf life.
- We only make/order once a year.
The Real Serialization Deadline
Manufacturers and repackagers: November 27, 2018 is NOT the day you turn your serialization packaging on. Your date is pulled forward at least by run time and lead time. The exact date should be calculated considering inventory on-hand, inventory turn, run time, lead time, purchase order lead time, and many other planning attributes. This is the time to collect your planning data and sit down with your supply chain experts to define the serialization roadmap per SKU. Keep in mind that each product has its own planning data, and each then has its own serialization deadline.
LSPEDIA Supply Chain Expertise
If you are challenged by serialization or supply chain planning, LSPediA is here to help. Our deep supply chain expertise, coupled with our turnkey serialization solution RxChain, enables our customers to meet the DSCSA compliance deadline while also improving business efficiencies and the bottom line. Contact us today to get started.
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of services and solutions that secure supply chains, protect against product counterfeiting, and help businesses comply with FDA regulations. Our customers are partners in the pharmaceutical supply chain, including manufacturers, wholesale distributors, dispensers, and reverse logistics providers. LSPediA helps customers define needs and implement best-of-breed supply chain and enterprise solutions that improve efficiency and comply with FDA and global standards.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals. Our expertise, experience, and technical know-how help customers derive maximum value from their investments, both now and well into the future.
For additional information, contact: Julianne Jahn [email protected]