What Authorized Trading Partners (ATP) Need to Know

The pharmaceutical industry is currently undergoing a paradigm shift as it prepares to meet the new requirements of the U.S. Drug Supply Chain Security Act (DSCSA) to implement interoperable, aggregation-ready track-and-trace systems by November 2023.

Having access to end-to-end track-and-trace systems will allow supply chain members to streamline operations and prevent the spread of counterfeit medicines on the market. These systems will be immensely valuable in zeroing in on illegitimate drug products and understanding their origin and how they entered the supply chain.

However, if pharmaceutical supply chain members themselves take part in drug counterfeiting, the serialization and data-reporting guidelines will fall flat. Hence, to establish supply chain members as trustworthy, the U.S. Food and Drug Administration (FDA) has introduced many provisions to provide a critical legal enforcement mechanism to prevent the entry of illegitimate drug products into the supply chain by closing it off to disreputable companies.

While a great deal of attention is being paid to the aggregation and track-and-trace requirements, there hasn’t been much discussion about what the new requirements mean for Authorized Trading Partners (ATPs).

With the compliance deadline steadily approaching, now is an excellent time to take stock of what ATPs can expect in the coming months and what their responsibilities will be.

According to the FDA, an entity is an Authorized Trading Partner when it meets the statutory definition and fulfills all the identification requirements unique to the trading partner category it falls under:

• To be considered an Authorized Trading Partner, a manufacturer or repackager must have a valid registration in accordance with section 510 of the FD&C Act, and accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.

• To be considered an Authorized Trading Partner, a wholesale distributor must have a valid license under State law, or Section 583 of the FD&C Act, in accordance with Section 121 582(a)(6) of the FD&C Act, comply with the licensure reporting requirements in Section 122 503(e) of the FD&C Act, as amended by DSCSA, and accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.

• Similarly, to be considered an authorized trading partner, a 3PL must have a valid license under State law or Section 584(a)(1) of the FD&C Act, in accordance with Section 4 Section 581(22) of the FD&C Act. 5, and accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.

• A dispenser must have a valid license under State law and accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.

Also, if an entity is an ATPs under the DSCSA, it can participate in trade only with another authorized trading partners. If it is not an ATPs, its access to the pharmaceutical supply chain might be restricted or blocked altogether. Let’s understand the requirements you need to qualify as an ATPs.

It’s important to note that even though third-party logistics providers are not subject to many traceability requirements – because they don’t take ownership of products – they are still considered trading partners, and therefore, must be authorized.

IN SUMMARY

With only authorized pharmaceutical entities running the supply chain, the percentage of counterfeit drugs in the market will surely drop; however, to make sure your company is end-to-end compliant, it’s essential that you comply with the new DSCSA requirements.