Legal expert: FDA inspections will start looking at DSCSA compliance

Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes full effect this November, the US Food and Drug Administration (FDA) will begin inspecting firms to verify their compliance, asserted Howard Sklamberg, a partner at Arnold & Porter.
 
He outlined what FDA will be looking for in inspections at a 22 February webinar sponsored by the Food and Drug Law Institute (FDLI). Sklamberg was the director of FDA’s Office of Compliance in 2013, when DSCSA was enacted.
 
Sklamberg and a panel of legal experts spoke about the compliance and enforcement considerations in preparing for DSCSA.

He observed that while FDA has been slow to enforce DSCSA due to the law’s gradual phase in of requirements, this is expected to change once the interoperability requirements take effect on 27 November 2023. On this date, manufacturers are expected to use an interoperable data exchange to track products through the supply chain.
 
So far, the agency has issued just one warning letter citing DSCSA violations to drug distributor McKesson in February 2019.
 
“It is likely that with the upcoming interoperability requirements taking effect, that FDA will use its inspection force to evaluate DSCSA compliance as a normal part of inspections,” he said.
 
For example, inspectors will be looking to see whether firms have systems in place for determining that they are only accepting products from authorized trading partners (ATPs). DSCSA mandates that pharmaceutical manufacturers only accept drug products from ATPs, or parties that are properly licensed or registered to receive or transfer products. ATPs include manufactures, repackagers, dispensers, wholesale distributors and third-party logistics providers (3PLs).
 
“Failure to use an authorized APL or licensed 3PL can led to enforcement, it is a prohibited act, which means that the full range of [Federal Food, Drug, and Cosmetic Act] FDCA penalties are available and include civil or criminal penalties. I think that the most common can be a warning letter. Criminal penalties would be reserved for something that is intermixed with fraud and people being harmed. But you don’t want to get a warning letter because that can take some time to dig out of.”
 
Firms should also ensure that systems are in place for preventing suspect and illegitimate products from entering the supply chain. For example. they will be looking to see that products have product identifiers. “A failure to include a product identifier means that a product is misbranded and could lead to a full range of FDCA penalties.”
 
Inspectors will also be checking to see that firms have systems in place for exchanging data with trading partners at the time the product moves through the supply chain, and that firms are serializing products.
 
Inspectors will also be looking to see that firms have systems for responding to verification requests and systems for handling returned goods. Overall, FDA will be looking for standard operating procedures (SOPs) for DSCSA compliance.
 
These inspections will either be conducted onsite or through a request for written records.
 
He also asserted that while firms should have discrete systems in place for managing their compliance with DSCSA, there are some areas of overlap with good manufacturing practices (GMPs) and should not be viewed as a totally separate workstream. Some overlapping regulatory requirements are in the areas of evaluating product complaints, adverse events, labeling issues, recalls and field alerts.
 
“Our experience with clients is that sometimes they see DSCSA compliance as a separate workstream from things like evaluation of complaints and adverse events,” said Sklamberg. For example, “When you’re evaluating a complaint you realize that one of the triggers for DSCSA” has been set off. “Make sure that both parts of these processes talk to each other and ideally that they’re in SOPS so that nothing is missed.”
 
There is also “substantial overlap” in the types of documents required for both types of inspections; and FDA can “basically add a new inspection module to it typical GMP inspections.”
 
Sklamberg also advised companies to “always be inspection ready” and to conduct mock inspections. Firms should decide prior to the inspection who will be the scribe and will be responsible for retrieving documents. Most importantly, he said that firms should ensure that the staff who are involved in DSCSA are included in meetings.
 
FDLI webinar