FDA overdue on guidance as DSCSA deadline looms

Regulatory NewsRegulatory News | 19 April 2021 |  By 

Legal experts advised the pharmaceutical industry to start preparing now to meet the November 2023 deadline for having fully electronic interoperable systems in place for tracking  products through the supply chain under the Drug Supply Chain Security Act (DSCSA).
 
Food and drug law attorneys outlined ways the industry can meet these requirements at a 15 April traceability forum on DSCSA implementation sponsored by the Healthcare Distribution Alliance (HDA).
 
The experts advised beginning work immediately to build the systems to meet upcoming DSCSA requirements. However, said one attorney, FDA’s heel-dragging on issuing guidance is hampering industry efforts.
 
The law specifies that by November 2023, manufacturers must have interoperable, electronic tracing of products at the package level for exchanging products with their trading partners.  The data to be exchanged include transaction information and transaction statements. Also, by November 2023, manufacturers must have electronic systems in place for verifying saleable returns from wholesale distributors. Such returns must be verified by manufacturers before they can be resold.
 
Anita Ducca, senior vice president of regulatory affairs for had, said industry needs to focus on these requirements now because “they can be very complex.”
 
“We have heard repeatedly from supply chain experts that it will take a lot of lead time to prepare for this. Compliance cannot be done overnight or at the flip of a switch. It may mean careful considered decisions about resources and staffing,” said Ducca. She added that “compliance must also be coordinated with trading partners to establish electronic connections to transmit data accurately and securely with many, many trading partners.”
 
 
No Time to Waste
 Attorney Brian Waldman of Arent Fox concurred that manufacturers should be gearing up now for 2023 and advised manufacturers to “engage with your trading partners now because there is no time to waste. If you wait until then, it will be too late….make sure that someone in your company understands this.”
 
Waldman said that in 2023, all transaction data must be electronically exchanged using “aggregation” and “inference.”
 
Aggregation means that the unique identifiers attached to each product must be uniquely serialized to higher packaging levels. They must also have inference systems, or systems to allow trading partner to infer the contents of a large container of individual units without having to open it.
 
2023 Builds On Earlier Steps
 Waldman explained that the law takes a “layered” approach to supply chain security and builds on earlier steps. For example, starting in November 2018, manufacturers could only sell products to authorized trading partners, which include wholesaler distributors, dispensers and third-party logistics providers.
 
Yet while industry must make the push to get these systems in place, the FDA needs to make a similar thrust to issue long-overdue regulatory guidance, said one attorney.
 
Tish Eggleston Pahl, an attorney with the Washington food and drug law firm Olsson Frank Weeda Terman Matz PC, said that the FDA is behind in issuing the following:
 
  • Final guidance on what constitutes suspect and illegitimate products
  • Guidance on unit-level tracing
  • Finalize guidance on standards for interoperable data exchange
  • Conduct small business assessment for dispensers, and
  • Issue rulemaking on licensing standards for wholesale distributors and third-party logistics providers (3PLs).
 
Pahl said that the FDA is especially late in issuing licensing regulations for wholesale distributors and 3PLs, which were supposed to be in place by November 2015.
 
“Those regulations are not out and there is no indication why it did not come out…..Can the FDA do that, is it legal? No. they cannot. The FDA is in violation of the FD&C Act by not issuing these regulations.”
 
These licensing regulations need to be in place before wholesale distributors and 3PLs take possession of products. The law mandated that pharmaceutical manufacturers only accept drug products from “authorized trading partners” or parties that are properly licensed or registered to receive or transfer products. Authorized trading partners include manufacturers, repackagers, dispensers, wholesale distributors and 3PLs. 
 
Healthcare Distributors Association

 

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