Copper Sulfate/Manganese Sulfate/Selenious Acid/Zinc Sulfate Shortage: What Providers and Prescribers Need to Know in 2026

Provider Briefing: The Ongoing Trace Elements Shortage in 2026

For clinicians managing patients on parenteral nutrition, the intermittent shortage of Copper Sulfate/Manganese Sulfate/Selenious Acid/Zinc Sulfate — marketed as Tralement (≥10 kg) and Multrys (<10 kg) — continues to present clinical and logistical challenges in 2026. This article provides a concise update on the shortage timeline, prescribing implications, current availability, and practical tools to help your patients maintain access.

Shortage Timeline and Background

Trace element injection shortages in the United States are not new. Key milestones include:

• 2013–2015: ASPEN published shortage guidance as Multitrace-4 and Multitrace-5 products — marketed without full FDA approval — experienced significant supply disruptions. Clinicians were forced to use individual trace element products or reduce supplementation frequency.
• July 2020: The FDA approved Tralement (NDA 209376) as the first FDA-approved multi-trace element injection for patients ≥10 kg. American Regent began commercial distribution in October 2020.
• 2021–2022: Multrys received FDA approval for neonatal and pediatric patients <10 kg, addressing a critical gap in pediatric parenteral nutrition.
• 2023–2025: Multitrace-4 and Multitrace-5 were fully discontinued. American Regent became the sole FDA-approved source. Intermittent allocation limits were reported by wholesalers.
• 2026: Trace elements remain on the ASHP Drug Shortages List. Supply has improved but has not fully stabilized due to single-source dependency and growing PN patient volumes.

Prescribing Implications

The shortage has several direct implications for prescribing clinicians:

Dosing Considerations

Tralement provides zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg per mL. The recommended dose for adults and patients ≥50 kg is 1 mL/day added to PN. Pediatric dosing for patients 10–49 kg is weight-based (0.2–0.8 mL/day). It is important to note that additional manganese supplementation is not recommended — accumulation of manganese in the brain can occur with doses exceeding 1 mcg/kg/day, particularly in patients with cholestasis.

Monitoring During Shortages

When trace element supply is inconsistent, consider:

• Increasing frequency of serum zinc, copper, selenium, and whole blood manganese monitoring
• Ordering ceruloplasmin as a functional marker of copper status
• Checking selenium via serum selenium or glutathione peroxidase activity
• Monitoring for clinical signs of deficiency: alopecia, dermatitis, and impaired wound healing (zinc); anemia, neutropenia, and osteoporosis (copper); cardiomyopathy and muscle weakness (selenium)

Special Populations

• Hepatobiliary disease: Copper and manganese accumulate in patients with cholestasis. Consider individual trace element products (omitting copper and/or manganese) or reducing dosing frequency. Tralement labeling advises monitoring and considering alternatives for these patients.
• Renal impairment: Aluminum content of parenteral products is a concern; Tralement contains no more than 6,000 mcg/L of aluminum. Monitor in patients with prolonged PN courses.
• Neonates (<10 kg): Use Multrys, not Tralement. Tralement does not provide adequate zinc, copper, or selenium dosing for this population and delivers excessive manganese relative to body weight.

Current Availability Picture

As of early 2026:

• Tralement and Multrys are in active production by American Regent but subject to periodic allocation by wholesalers
• Individual trace element products (zinc sulfate, cupric chloride, selenious acid, manganese sulfate/chloride) are available from multiple manufacturers and generally easier to source
• 503B outsourcing pharmacies (e.g., Empower Pharmacy) offer compounded multi-trace element solutions under FDA oversight
• No new multi-trace element product NDAs have been filed or approved from competing manufacturers

Cost and Access Considerations

Trace element injections are typically covered under the medical benefit as part of parenteral nutrition, not the pharmacy benefit. Key cost factors:

• Institutional pricing: $5–$25 per vial through GPO contracts
• Cash pricing: $10–$50+ per vial, higher during supply constraints
• Medicare Part B: Covers PN supplies, including trace element additives, for patients with permanent intestinal failure (defined as severe impairment of gut function lasting ≥3 months)
• Prior authorization: Required by most private payers for home PN; trace elements are included as part of the PN order

Patients facing financial barriers may benefit from resources through the Oley Foundation, NeedyMeds, or state Medicaid programs. American Regent does not currently offer a patient savings card for Tralement.

Tools and Resources for Providers

Medfinder for Providers helps clinicians and care teams locate trace element products that are currently in stock. This can significantly reduce time spent on phone calls to distributors and wholesalers during shortage periods.

Additional resources:

• ASHP Drug Shortages Resource Center: ashp.org/drug-shortages — for real-time shortage tracking
• ASPEN Shortage Guidance: Published recommendations for managing PN during trace element shortages
• American Regent Product Information: americanregent.com and artraceelements.com for product bulletins, dosing guides, and supply updates
• Oley Foundation: oley.org — patient support and advocacy for those on home PN

Looking Ahead

Until additional manufacturers enter the market with FDA-approved multi-trace element products, intermittent shortages are likely to continue. Advocacy efforts from ASPEN, the Oley Foundation, and clinician groups continue to push for supply chain diversification. In the meantime, proactive monitoring, early communication with home infusion pharmacies, and familiarity with alternative sourcing strategies remain the best tools in a provider's arsenal.

Final Thoughts

The Copper Sulfate/Manganese Sulfate/Selenious Acid/Zinc Sulfate shortage is a supply chain problem, not a clinical obsolescence issue. These trace minerals remain essential for every patient on parenteral nutrition. As providers, our role is to stay informed, monitor proactively, and help patients navigate access challenges. Use Medfinder for Providers to streamline your search and read our companion guides on helping patients find this medication and helping patients save money on trace elements.