FDA reiterates support for semi-distributed tracing model under DSCSA

Regulatory NewsRegulatory News | 03 November 2021 |  By 

The US Food and Drug Administration (FDA) recommends that trading partners use the semi-distributed model to trace drug products though the drug distribution chain because of this model’s flexibility and advantages over other data architecture models. The Drug Supply Chain Security Act (DSCSA) requires that trading partners have these systems in place by November 2023.
Connie Jung, acting associate director for policy and compliance in FDA’s Office of Drug Security, Integrity, and Recalls in the Office of Compliance at the Center for Drug Evaluation and Research, discussed this preference and other issues related to DSCSA implementation at a 1 November traceability seminar sponsored by the Healthcare Distribution Alliance.
She said that while the agency is “encouraged” by industry’s progress in implementing DSCSA but said that “there is a lot of work to be done.”
Agency supports semi-distributed model
Jung focused her remarks on FDA’s draft guidance outlining the agency’s expectations for the system attributes necessary for secure tracing of products by the 27 November 2023 deadline called for in DSCSA. (RELATED:  FDA details plans for DSCSA implementation in four guidances, Regulatory Focus 4 June 2021)
Jung reiterated the agency’s support for a semi-distributed data architecture model as the preferred system for tracing products though the supply chain.
The guidance defines a centralized data architecture model as a “configuration in which required trading partner data is stored in one database” whereas a distributed data architecture model “refers to a configuration in which required trading partner data is stored across multiple databases.” It says that a semi-distributed data architecture model “refers to a configuration in which required trading partner data is stored in a few select databases.”
The guidance recommends using the distributed or semi-distributed model “based on stakeholder feedback about current industry practices and preferences.” Jung elaborated on the agency’s rationale for supporting the semi-distributed model. She said that this model “allows for flexibility” and “seems to meet the needs of different trading partners” by allowing partners to have their own systems but also the ability to communicate with other systems.
“When we talk about a centralized model, that is everything going into one place, and it does not look like this will happen. And we will not be fully decentralized,” said Jung, acknowledging that “there has been some confusion and misunderstandings” about the different models.
HDA, which represents pharmaceutical distributors, said in comments to FDA on the guidance that such a distributed or semi-distributed model does not exist, and requested FDA withdraw the guidance, saying the agency overreached its statutory authority in seeking access to private electronic tracing information among trading partners. (RELATED: Industry calls for withdrawal of FDA electronic tracing guidance, Regulatory Focus, 10 September 2021.
The deadline for commenting on the guidance was 2 September. (RELATED:  FDA grants industry 30-day extension to comment on track and trace guidance, Regulatory Focus, 2 August 2021).
Who is covered?
Lastly, Jung addressed which products are exempt from tracing under DSCSA. She said that the agency continues to “field a lot of questions on what products are covered and what products are not covered by DSCSA.”
She clarified that blood or blood components intended for transfusion, radioactive drugs or biologics, imaging drugs, certain products for intravenous administration, medical gas, homeopathic drugs and compounded drugs are not subject to the law’s tracing requirements. The law also exempts the transfer of products between distributors, distribution among hospitals under common control, public health emergencies and drugs dispensed pursuant to a prescription.
More guidances forthcoming
Jung also sought to reassure the industry that guidance will soon be forthcoming on standards for interoperable data exchange; FDA also plant to issue a rule on licensing standards for wholesale distributors and third- party logistics providers (3PLs).
The agency has been criticized for delays in issuing these and other guidances. An attorney said last year that FDA’s foot dragging on issuing guidance is hampering industry efforts to comply with the law. (RELATED: FDA overdue on guidance as DSCSA deadline looms, Regulatory Focus, 19 April 2021)
Folks need to “get serious”
Lastly, Jung advised industry to “get serious” about meeting next year’s deadline. “Our goal is to meet these goals to have an interoperable system down to the packaging level by 2023. We are so close to 2023 now that we need to get serious.”
She also acknowledged a heavy workload in getting these systems ready for 2023, adding, “We know that this is going to be challenging and we know that there is a lot of work to be done but we are optimistic that we will have enhanced drug distribution security by November 2023.”
FDA plans to hold a public meeting on DSCSA implementation on 16 November. The workshop is full, but a recording will be available.
HDA Traceability Seminar


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