FDA lifts drug supply chain security requirements for COVID-19 products

Regulatory NewsRegulatory News | 30 April 2020 |  By 

The US Food and Drug Administration (FDA) on Thursday issued guidance detailing exclusions and exemptions to certain requirements under the Drug Supply Chain Security Act triggered by the coronavirus disease (COVID-19) public health emergency.
FDA says the guidance is meant “to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19.”
The DSCSA was signed into law in 2013 and established requirements for manufacturers, distributors and other entities involved in the drug supply chain for product tracing, product identifiers, authorized trading partners and product verification.
Since its enactment, FDA has had to delay enforcement of certain provisions of the act to allow industry more time to adapt. (RELATED: FDA delays enforcement of product identifier requirements, Regulatory Focus 30 June 2017; FDA delays verification requirement for salable returned drugs, Regulatory Focus 24 September 2019).
Despite some of the challenges in implementing the act, it has been credited with improving the traceability of drugs throughout the supply chain. (RELATED: OIG Finds Most Drugs can be Traced Through Supply Chain Thanks to DSCSA, Regulatory Focus 26 February 2020).
COVID-19 guidance
In the nine-page guidance, FDA explains that, “Under the DSCSA, specific activities are automatically excluded from certain DSCSA requirements upon the declaration of a public health emergency.”
FDA says the distribution of a drug for emergency medical reasons is exempted from the definition of a “transaction” and excluded from the definition of “wholesale distribution,” meaning that certain DSCSA requirements do not apply to covered products during the public health emergency.
The exemption and exclusion apply to the distribution of drug under an emergency use authorization (EUA) and products that are approved to diagnose, cure, mitigate, treat or prevent COVID-19. FDA also says it will apply the exemption and exclusion to other affected products, such as those used to treat symptoms of COVID-19 or provide supportive care to patients with the disease.
FDA provides several examples of cases where the exemption and exclusion would apply to other affected products, including to facilitate the “distribution of a product to an area where there is limited availability locally of such product and there is higher demand for such product in that region as a result of COVID-19.”
As such, FDA says the product tracing and product identification requirements triggered by a transaction do not apply to the distribution of covered COVID-19 products. FDA stresses that trading partners distributing product for purposes unrelated to COVID-19 “must comply with all applicable DSCSA requirements,” and that the exemption does not affect requirements that are not triggered by a transaction.
FDA also explains that wholesale distributors are not required to comply with DSCSA licensure provisions, reporting requirements or wholesale distributor requirements for activities related to the distribution of covered COVID-19 products.
Additionally, FDA explains that that while “requirements to trade only with authorized trading partners still apply in most circumstances,” it does not intend to object to pandemic-related distribution involving entities that would normally meet the definition of wholesale distributors or distributions involving trading partners that are not authorized due to COVID-19-related circumstances, but who are working with or authorized by state authorities.
FDA cautions companies to be vigilant against fraudsters during the pandemic and to, wherever possible, work with trusted sources and ensure trading partners are appropriately licensed or registered or that they are actively working with state authorities.
“Trading partners in most circumstances remain obligated to take appropriate steps when suspect or illegitimate products are found to ensure that these products are not further distributed and do not reach patients,” FDA writes.


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