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DSCSA and COVID-19

How is the pandemic response impacting the complex and evolving national traceability goals for pharmaceuticals?

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While DSCSA preparation has been quite the undertaking among pharmaceutical companies for the last several years, Tish Pahl, Principal at Olsson Frank Weeda Terman Matz PC, said the new elephant in the DSCSA room is the global pandemic. She spoke at HDA’s Distribution Management Webinar Series about how COVID-19 may affect some well-laid and long-standing plans.

COVID-19 is requiring a huge commitment from the FDA. Plus, “the same stressors we are all feeling in response to COVID-19 are also affecting the FDA,” she noted. “They're dealing with canceled schools and with having to work remotely and all of the pressures that are associated” with trying to work in this challenging environment. COVID-19 has complicated everything, including DSCSA [Drug Supply Chain Security Act] implementation. 

Still, Pahl explained, the FDA’s work on the DSCSA continues. The Agency is still currently underway with 20 DSCSA pilots with a variety of stakeholders.

Emergency drug exemptions

Tish Pahl, Principal at Olsson Frank Weeda Terman Matz PC.Tish Pahl, Principal at Olsson Frank Weeda Terman Matz PC.After Pahl spoke at the HDA webinar, the FDA released a guidance on exemptions and exclusions from DSCSA requirements during the COVID-19 public health emergency.

Pahl explained to Healthcare Packaging what the guidance means. The FDA guidance states that certain product distribution activities are exempt from the definition of “transaction” in the DSCSA, which means trading partners don’t have to exchange transaction data and the product does not have to be serialized. Other requirements, though, still apply, such as only doing business with authorized trading partners and having systems and processes for verification, including investigating and quarantining suspect and illegitimate product.

The guidance also states DSCSA requirements related to “wholesale distribution” do not apply to distribution activities that address the COVID-19 public health emergency. However, the FDA states it doesn’t interpret this exclusion from wholesale distribution to affect the ability of States to require licensure of trading partners as wholesale distributors under State law.

The guidance also describes what products are included in this exemption and exclusion.

  • Covered products include products that are under an emergency use authorization (EUA) or are approved by the FDA for COVID-19 prevention or treatment.
  • It also covers distribution of other products affected by the COVID-19 public health emergency, such as distribution of product to a high demand area where the product is in shortage and distribution to an authorized trading partner’s temporary facility.
  • Dispenser-to-dispenser transfers that are needed for COVID-19 care are also covered.

But Pahl noted that her caution from the webinar is still true. How does a distributor know what product is for a public health emergency? It’s probably fair to assume fentanyl going to a hospital in New York is going to help a patient on a ventilator. But to what extent, if at all, do you treat these products differently? Their sale may be exempt from DSCSA transaction requirements, but sometimes exceptions are more trouble than they’re worth. The option is there to take them out of DSCSA requirements if it makes sense for your logistics or business perspective.

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