The pharmaceutical landscape is poised for significant shifts in 2025, introducing potential challenges to drug supply chains. It's crucial to assess and adapt your procurement strategies accordingly.
Key Developments to Monitor:
- Proposed Import Tariffs: The current administration has signaled intentions to impose tariffs of 25% or more on pharmaceutical imports, aiming to bolster domestic production. This policy shift could significantly impact the cost structures of foreign manufacturers, particularly those in India and Europe, potentially leading to reduced competitiveness or market withdrawal, and will inevitably lead to higher prices.
- DSCSA Compliance Deadlines: The Drug Supply Chain Security Act (DSCSA) mandates comprehensive tracking and tracing of prescription drugs throughout the U.S. supply chain. Recent FDA guidance has introduced a phased approach to compliance:
- Manufacturers and Repackagers: Compliance by May 27, 2025
- Wholesale Distributors: Compliance by August 27, 2025
- Dispensers with 26 or more employees: Compliance by November 27, 2025
Implications for Your Pharmacy:
- Supply Reliability: Manufacturers and repackagers unable to meet the DSCSA deadline will likely have their product turned away from wholesalers and not be available for purchase through normal channels. Wholesalers are advising health systems between 5 – 20% of manufacturers will not be compliant with the DSCA requirements at the May 27 deadline.
- Cost Management: Tariffs could result in higher procurement costs for imported pharmaceuticals, affecting budget allocations and financial planning. Manufacturers facing increased operational costs due to compliance requirements or tariffs may reassess their participation in the U.S. market, potentially leading to supply disruptions. This will likely start to play out in the second half of 2025 onward as existing domestic supplies are exhausted.
Strategic Considerations:
To mitigate these risks, consider reassessing your normal inventory sourcing practices:
- Advance Procurement Planning: Proactively adjusting procurement timelines and inventory levels can safeguard against unforeseen shortages as we navigate these uncertain next few months.
- Engage with Quva as your trusted compounding partner: Partnering with Quva will provide a buffer against potential supply chain disruptions. With the largest catalogue and manufacturing capacity, Quva is ideally positioned to assist in ensuring continuous access to essential medications. Consider the allocation of your compounding between in-house and outsourcing to maximize the versatility of your in-house resources, and avail yourself of Quva’s direct purchasing arrangements with drug manufacturers which won’t be adversely impacted by the DSCSA disruption, and minimal direct exposure to overseas sourced drugs.
Staying informed and agile in response to these developments is essential. By proactively adapting your procurement strategies, you can ensure the continued delivery of quality care to your patients.
