President Obama signed the Drug Quality and Safety Act into law on November 27, 2013. This sent the United States pharmaceutical industry down a specific path to improve the lives of patients. The law was designed to combat counterfeiting, theft, and contamination in the drug supply chain through the use of serialization, aggregation, and track & trace.
The Impact of DQSA
Up until that point in 2013, drug pedigree laws were in about 30 states. Different state regulations were making it very difficult for manufacturers to manage. Without the drive of those states, particularly California, the DQSA would never have been signed into law.
Title II of the DQSA – the Drug Supply Chain Security Act– laid a path for not only manufacturers, but the entire supply chain, including distributors, 3rd party logistics providers, and pharmacies to participate in improving safety for consumers.
On the first day of 2015, one of the first deployments of the law, manufacturers were required to electronically store lot, or batch, data and be able to verify upon request where, when, and to whom each lot was shipped. They were required to produce what is known in the industry as T3 statements upon every sale. T3 documents comprise of transaction information, transaction history, and transaction statements. These electronic records must be kept for a minimum of six years after each sale.
Lot traceability and production of T3 statements also extended to re-packagers and wholesalers on that same day for every transfer of ownership of product. This meant all parties needed to know, electronically store, and upon notice, be able to verify who, when, and where every lot was purchased from and to whom, when, and where every lot was sold.
In 2016, lot traceability was extended to dispensers (or pharmacies.) Dispensers are not required to lot trace the prescription drug product to the end consumer. They only have to store documentation on their purchase of the product.
Serialization is a Change Soon to Come
November 27, 2017 was intended to be a date when manufacturers had to serialize all individual units of pharmaceutical drugs. However, the FDA pushed back the regulation by one year. There is debate about why the change was made. Many manufacturers are simply not ready. Some have opined that the FDA is not ready for enforcement. But, make no mistake, serialization is coming to the United States and the supply chain will have to conform.
If it sounds as if these regulations are making life more difficult for the industry, they simply are and are meant to be. Making the regulations strong and tight achieves the objective of the law, which is to improve consumer safety.
But, this is only part of the story for American manufacturers. Most of them market their products around the world. And many countries have their own regulations, like the European Union, for example. And, if any manufacturer wants to market their products in those countries, they will have to follow the local laws of that country. This makes it even more difficult as manufacturers are being asked to follow legislation across the globe.
Serialization Software and Implementation
What should make it easier for manufacturers is serialization software. Generally, software providers such as rfxcel, Axway and TraceLink will keep their packages current with functionality that is needed to meet the regulations in each country that a manufacturer does business in. This allows the manufacturer to focus more on their core business. But implementing any of these systems takes a great deal of planning, funds, and a well-executed project.
Adding to the challenge of a well-executed project is compliance or quality departments. Most software providers offer a cloud based SaaS solution and do validate their base solution. However, once a client starts to configure that solution, they are most likely going to have to conform to the guidelines of their quality departments to ensure the solution that gets implemented is in a validated state.
All of this leads to manufacturers –and other supply chain parties–having to get rolling on a solution that meets the needs of their business and government regulatory organizations. If they haven’t yet started this process, the pushback of the serialization requirement will help, but November 27, 2018 will be here before we know it. The time to act is now for all in the pharmaceutical industry. If this has spurred even more questions for you, send them our way!
By: Mike McGinty
Senior Consultant, Hawkins Point