OIG Finds Most Drugs can be Traced Through Supply Chain Thanks to DSCSA

Regulatory NewsRegulatory News
| 26 February 2020 | By Zachary Brennan 

The Department of Health and Human Services’ Office of Inspector General (OIG) on Wednesday released a report finding it could trace more than 80% of the drugs it attempted to trace through the supply chain.

Of 44 selected drugs to be traced through the supply chain using drug product tracing information that the Drug Supply Chain Security Act (DSCSA) requires, OIG found all but seven could be traced back to the manufacturers.

Of the seven that could not be traced, OIG said: “Typically, this was because tracing documents exchanged between the wholesale distributor and manufacturer were missing or had mismatched tracing information. In one instance, a wholesale distributor refused to provide tracing documents.”

But for 21 of the 44 drugs, OIG could not trace their physical movement through the supply chain using tracing information.

“We could not identify the shipping locations of trading partners (e.g., manufacturers, wholesale distributors, and dispensers) or of third-party logistics providers that shipped or stored the drugs on behalf of the trading partners,” OIG said. “Although the DSCSA does not require this information, should FDA not have access to this information in case of a drug safety emergency, FDA and other investigators would need to request additional documents, which could delay investigations and hamper FDA's ability to identify sources of potentially harmful drugs in a timely manner.”

As far as recommendations moving forward, OIG said FDA should follow up with the wholesale distributor that did not provide tracing documents and that FDA should offer educational outreach to trading partners about required drug product tracing information and data standardization guidelines.

“Lastly, we recommend that FDA seek legislative authority to require information about a drug product’s complete physical path through the supply chain on tracing information,” the report said.

This is the third OIG report on the security of the drug supply chain. The previous two found that overall, select wholesale distributors and dispensers were moving toward full implementation of DSCSA requirements for drug product tracing, although some tracing documents were missing required information.

OIG Report


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