FDA Drug Shortage: Furosemide Oral Solution (Current)

The FDA reports an ongoing shortage of furosemide oral solution due to unavailability of an inactive ingredient component. Furosemide, a loop diuretic used to treat fluid retention and hypertension, is on FDA's Essential Medicines List. The shortage affects oral solution formulations specifically, while tablet formulations remain available.

Regulatory Context

FDA maintains an active drug shortages list under authority of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 506C, which requires manufacturers to notify the agency of permanent discontinuances or interruptions in manufacturing that could lead to meaningful disruptions in supply. Drug shortages are defined as a period when demand or projected demand exceeds supply. FDA's Drug Shortages Staff coordinates with manufacturers, compounders, and other stakeholders to mitigate supply disruptions.

Furosemide oral solution is classified as a medically necessary drug due to its use in pediatric and geriatric populations who cannot swallow tablets. Shortages of such drugs trigger heightened FDA attention and potential exercise of enforcement discretion for alternative supply sources, including compounding or importation of foreign-approved versions under specific conditions.

Shortage Details

Product affected: Furosemide oral solution (all strengths)

Shortage reason: Shortage of an inactive ingredient component

Status: Current (shortage ongoing as of January 2025)

Availability: Not specified by FDA

The shortage stems from the supply chain for inactive ingredients (excipients) rather than the active pharmaceutical ingredient (API) furosemide itself. Inactive ingredients such as preservatives, flavoring agents, or stabilizers are essential for oral solution formulations but do not contribute to therapeutic effect. Because multiple manufacturers may source excipients from a limited supplier base, a disruption at one supplier can cascade across multiple finished drug products.

FDA has not disclosed which specific inactive ingredient is unavailable or whether the shortage affects domestic or international supply chains. Manufacturers of furosemide oral solution include Akorn (now part of Akorn Operating Company LLC following bankruptcy restructuring), Pharmaceutical Associates, and Morton Grove Pharmaceuticals.

Impact on Wholesale Distributors and 3PLs

Wholesale drug distributors holding furosemide oral solution inventory face several immediate operational considerations:

Allocation and priority dispensing: Distributors may need to implement allocation protocols for existing stock to ensure medically necessary cases (pediatric patients, hospice care, patients with dysphagia) receive priority access. This requires coordination with downstream pharmacies and prescribers to verify medical necessity.

Product substitution verification: Pharmacies and prescribers may request substitution guidance. Furosemide tablets remain available but are not therapeutically equivalent for patients unable to swallow solid dosage forms. Distributors should anticipate increased inquiries regarding compounded alternatives.

Supply chain documentation: Under DSCSA requirements (21 U.S.C. § 360eee-1), transaction history, transaction information, and transaction statements must accompany any distribution of furosemide oral solution during the shortage. Distributors should verify that any diverted or reallocated stock maintains full serialization and chain of custody.

Compounded alternatives: Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act govern compounding pharmacies. During shortages of commercially available drugs, FDA may exercise enforcement discretion to allow increased compounding volumes. Distributors should confirm that any compounded furosemide oral solution sourced from outsourcing facilities (503B) includes proper labeling and quality documentation.

Temperature control: Furosemide oral solution typically requires storage at controlled room temperature (20-25°C). 3PLs handling existing stock should verify that shortage-driven longer storage durations do not approach expiration dates or compromise stability under standard warehousing conditions.

What ColdChainCheck Data Shows

ColdChainCheck tracks 1,275 wholesale drug distributors and 3PLs across 51 jurisdictions. Of these, 1,234 hold active FDA registration — the baseline requirement for any entity distributing furosemide oral solution or alternative products during the shortage. The average compliance score across the directory is 51/100, placing most entities in the "Fair" tier (919 entities). This indicates moderate regulatory posture: most distributors maintain basic licensure and registration but lack broader verification signals like NABP accreditation.

During drug shortages, supply chain complexity increases. Distributors may source from secondary wholesalers, repackagers, or compounding facilities not in their usual trading partner network. The 63 entities holding NABP accreditation represent verified compliance with NABP's Verified-Accredited Wholesale Distributors (VAWD) program criteria, including facility inspections and annual re-verification. NABP accreditation provides additional assurance when vetting unfamiliar suppliers during shortage-driven sourcing.

The directory also tracks 73 entities with FDA recalls on record. While recalls do not disqualify an entity from distributing drugs, they serve as a historical compliance signal. During shortage conditions when procurement teams may bypass standard vendor qualification processes, checking an entity's recall history provides context for risk assessment.

Practical guidance for QA and compliance teams:

• Verify new trading partners: If sourcing furosemide oral solution from an unfamiliar distributor, check the entity's profile in the ColdChainCheck directory. Confirm active FDA registration, state licensure in relevant jurisdictions, and absence of recent enforcement actions.

• Document allocation decisions: If implementing priority dispensing or allocation protocols, maintain records showing compliance with DSCSA transaction documentation requirements (TI, TH, TS). ColdChainCheck profiles include license status by state — verify the distributor holds active licensure in the destination state.

• Assess compounding sources: If sourcing compounded furosemide oral solution from a 503B outsourcing facility, verify the facility's FDA registration status. ColdChainCheck tracks FDA registration for wholesale distributors; compounding facility registration can be confirmed via FDA's Outsourcing Facilities database.

• Monitor for repackaging: Some distributors may repackage furosemide tablets into alternative dosage forms. Repackagers must hold separate FDA establishment registration. Check whether the entity's registration lists repackaging operations.

ColdChainCheck continues to monitor FDA drug shortage announcements and enforcement actions. For additional guidance on wholesale distributor compliance during supply disruptions, see the DSCSA Compliance Guide linked above.

Disclaimer: This article provides informational context based on publicly available regulatory data. It is not legal or compliance advice. Verify all regulatory requirements with the relevant state boards of pharmacy and FDA guidance documents.