Drug Shortages Are Now a Policy Problem—Not Just a Supply Problem
Why the ASHP list leads, how 503As & 503Bs can help, and how tariffs, state actions, disasters, and legislation shape patient access to drugs during a national shortage.
Drug shortages reached modern highs in 2024 and remain elevated, especially for sterile injectables used in time-sensitive care. See the latest ASHP statistics and FDA’s root-cause analysis. Operational decisions are now inseparable from policy choices—how shortages are defined, which compounding pathways are available, and how trade and manufacturing rules are sequenced.
The list you watch determines the action you take
Health systems typically track both the FDA shortage database and ASHP current shortages. These sources are complementary but not interchangeable: FDA’s list relies on manufacturer notifications and national-impact thresholds, which can introduce timing gaps, while ASHP’s practitioner-facing bulletins often reflect on-the-ground scarcity sooner. ASHP outlines the key differences between the lists.
Operational note: Use ASHP as early-warning for triage and FDA as the legal trigger for compounding decisions.
Where 503B outsourcing facilities fit—legally and practically
Section 503B created a CGMP-regulated pathway for outsourcing facilities to compound without patient-specific prescriptions, with transparent reporting and inspection. When a product appears on the FDA shortage list, 503Bs may compound versions—sometimes from bulk substances—under conditions summarized in FDA’s 503B bulks policy and the copies guidance. For 503A pharmacies, the patient-specific pathway remains foundational.
Implementation points: Build a documented process to monitor the FDA shortage portal and record the legal basis when invoking a shortage exception; pre-qualify multiple 503Bs with recent CGMP evidence; and deploy ready-to-administer or preservative-free formats where appropriate, consistent with FDA’s root-cause report emphasis on quality and standardization.
When hurricanes and floods become supply-chain events
Geography and utilities redundancy directly influence national access. After Hurricane Maria, the loss of sterile-solution capacity contributed to IV fluid scarcity until temporary imports and production shifts stabilized supply. These events argue for dual-sourcing critical injectables, pre-qualifying 503B surge capacity, and incorporating switch procedures into downtime playbooks.
Tariffs and on-shoring: aligning security and continuity
The current strategy pairs targeted tariffs with incentives to encourage U.S. and allied manufacturing. As outlined in NYT analysis and the federal supply-chain review, the goal is to harden essential-medicine supply chains. For hospital operators, the key is timing and transparency: phased measures, clear carve-outs for irreplaceable inputs, and early notice to procurement teams. Ongoing reporting in AP coverage and Reuters analysis underscores how operational predictability keeps patient care uninterrupted while domestic capacity scales.
State actions: experiments that help—and sometimes stall
States are testing levers to improve resilience and affordability. California’s CalRx initiative (including biosimilar insulin) aims to use public-buyer leverage to diversify supply; timelines have shifted as development and regulatory steps proceed. In parallel, FDA authorized Florida importation under Section 804; implementation requires drug-specific submissions, testing, relabeling, and ongoing reporting.
At the federal payment level, CMS finalized separate IPPS payments for certain small, independent hospitals to maintain a six-month buffer of specified essential medicines; see the buffer-stock policy and the MLN notice.
The human factor: last-mile escalation
Shortages translate into delayed procedures and high-risk workarounds. Patient-focused nonprofits such as Angels for Change operate hotlines and collaboration networks to locate supply for urgent cases, coordinating with providers and manufacturers to close last-mile gaps.
“List dynamics” and access: the semaglutide example
Recent court rulings upheld FDA’s removal of semaglutide from the shortage list, curtailing compounding under the exception. While manufacturers reported restored national supply, patient and provider reports described uneven access in some regions. Going forward, shortage-resolution determinations can reduce disruption when they apply a multi-source evidence standard—pairing manufacturer attestations with patient/provider access indicators (e.g., fill rates, backorders, wait-time trends)—and include time-bound transition steps before flexibilities are withdrawn. (Current status: see FDA’s drug shortages portal.)
Pending federal legislation: H.R. 5316 (119th Congress)
The compounding community advanced H.R. 5316 to adjust shortage-related flexibilities and definitions. As introduced, the bill would, among other provisions, allow limited urgent-use distributions by 503A pharmacies in defined circumstances, extend certain shortage-window considerations for compounding decisions, require annual updates to FDA’s evaluation of bulk substances for 503B, broaden the shortage definition to recognize demand surges, and update labeling and notification requirements to improve visibility. For text and status, see the bill docket.
What pharmacy and hospital leaders can do now
Monitor two lists. Ingest ASHP alerts for operations and track the FDA list for legal triggers.
Stand up a 503B playbook. Pre-qualify multiple facilities; request CGMP evidence and recent inspection outcomes; document the basis for invoking the shortage exception and align sourcing with 503B bulks.
Fund preparedness. If eligible, use the CMS buffer-stock payment; quantify the internal costs of canceled cases, substitutions, and overtime.
Stress-test disasters. Ask where critical SKUs are made; confirm utility redundancy and site diversity; pre-plan 503B surge sources; revisit Maria-era IV lessons.
Engage policy. Provide concrete input on tariff carve-outs; support advanced manufacturing incentives; and comment on H.R. 5316 provisions relevant to urgent-use distributions and shortage windows.
A synthesis for policymakers
Multiple federal reviews and practitioner resources describe a practical both-and approach: build diversified, domestic (and allied) capacity with modern manufacturing while using lawful 503A/503B compounding as a pragmatic bridge when commercial supply falters. Earlier visibility through ASHP alerts, clear legal triggers via the FDA database, support for buffer stock, and calibrated trade and state programs can collectively reduce the frequency, duration, and clinical impact of shortages.
Experiencing a shortage now?
RHC helps 503A and 503B organizations design resilient playbooks: shortage dashboards, 503B partner qualification, labeling & presentation strategies (RTA, PF), and inspection-ready documentation. Talk to RHC.
Disclaimer: This article is for general information and does not constitute legal advice. Always consult counsel on state and federal requirements.