What distributors need to know.
By Christina Lavoie, Director of Policy, Health Industry Distributors Association
If your company, like most medical products distributors, sells some pharmaceutical products (such as lidocaine or vaccines), you’re required to comply with the new Drug Supply Chain Security Act (DSCSA). The FDA recently gave healthcare suppliers a 12-month grace period in which to complete implementation of DSCSA requirements. It is important for all stakeholders in the medical supply chain to use this time to make final preparations for adoption of this new regulation.
Congress passed the Drug Supply Chain Security Act (DSCSA) in 2013 as part of the Drug Quality and Security Act. The DSCSA outlined steps to identify and trace certain prescription drugs as they are distributed in the United States. Its intended purpose was to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
Over the past decade, all stakeholders in the medical supply chain have been making steady progress on adoption of this track and trace system. However, any break in compliance could threaten the entire supply chain and prevent patients from accessing much-needed medicines. Therefore, HIDA and other industry leaders have urged the Food and Drug Administration (FDA) to provide sufficient time to come into compliance and avoid sharp disruptions to drug distribution.
In an August 2023 regulatory announcement, FDA declared that there would be a 12-month enforcement discretion and system stabilization period for the final phase of the DSCSA, but the law will still take effect on November 27, 2023. DSCSA is a federal law, and the FDA does not have the authority to change statutory deadlines – that requires an act of Congress.
FDA created this stabilization period in response to concerns raised by HIDA and others in the medical supply chain. The agency determined the entire industry would not be ready to meet all requirements by November 27, 2023. As a result, those trading partners would not have been able to legally ship or receive pharmaceuticals beginning on November 27. The FDA announced the stabilization period so that the pharmaceutical industry could avoid supply chain disruptions, drug shortages, and negative impacts on patients.
FDA stressed the following takeaways as part of the 12-month stabilization period:
- The FDA urges trading partners to view the extra 12 months as a stabilization period to finish implementation, troubleshoot problems, and otherwise prepare their systems for accurate, secure, electronic data exchange.
- The FDA reiterates that this guidance should not be used as a justification for trading partners to postpone implementation efforts.
- The FDA can still penalize companies for noncompliance.
- The 12-month stabilization period applies to pharmaceutical manufacturers, wholesale distributors, and dispensers.
- The FDA released additional guidance regarding wholesale distributor verification of returned saleable product, waiver and exemption process, and package level tracking requirements.
HIDA continues to be a voice for the healthcare distribution industry, bringing together stakeholders and federal partners to ensure that our medical supply chain functions properly. We will work with our members during this 12-month stabilization period to educate them on best-practices to ensure full compliance.