Considerations for the Use of Commercially Available Injectable Formulations in Hospital Pharmacy Practice

Introduction

Ensuring safe, effective, and efficient medication use remains central to hospital and health system pharmacy practice today. Although compounding injectable medications plays a critical role in addressing operational and patient specific needs, federal regulation, professional standards, and safety guidelines emphasize the use of commercially manufactured, FDA-approved formulations whenever available.¹ This white paper examines the safety, operational, and financial rationale for using commercially available formulations, particularly ready-to-use (RTU) injectables, over compounded alternatives.  With this quality framework, hospitals and health systems can potentially minimize risk and enhance operational efficiency through the adoption of RTU injectable formulations.

Background

Compounded injectable medications should only be used in patients whose medical needs cannot be met by an FDA-approved drug formulation.¹ Unnecessary use of compounded injectables may expose patients to potentially serious health risks. 

To minimize these risks, health systems have increasingly considered the adoption of commercially available, FDA approved RTU injectable formulations. These formulations are of particular benefit as they offer standardized, stable, and sterile formulations that can integrate seamlessly into hospital workflows to improve the medication-use system and ultimately support patient safety.  The adoption of RTU injectable formulations also promotes concentration standardization across health systems, which is in direct alignment with the Standardize 4 Safety initiative from the American Society of Health-System Pharmacists (ASHP) as well as supported by Institute for Safe Medication Practices (ISMP) guidelines.

Problem: Risks and Limitations of Compounded Injectable Medications

Safety Concerns

USP <797> establishes requirements for sterile compounding, including environmental controls, aseptic technique, and beyond-use dating for sites of human patient care, including hospitals and other healthcare institutions. These USP standards provide shorter stability assurances than FDA-approved products.³ Despite rigorous oversight, observational studies have noted that the incidence of preparation errors during sterile compounding may be as prevalent as 1 in 10 products being prepared incorrectly and complexity of prepared solutions may further increase the associated risk for error.²

Medications administered intravenously carry additional risk for error, especially during the administration process.  Risk for error can be due to multiple complexities within the compounding process, and calculating dosing or infusion rates based on concentration.⁴ Furthermore, lack of standardization of medication concentrations can add additional risk for error when patients transfer between levels of care or other institutions.⁵

Operational and Financial Burdens

Maintaining compliance with USP <797> necessitates extensive pharmacy resources: cleanroom certification, sterility testing, environmental monitoring, and staff training. Hospitals may incur additional hidden costs from compounding, including labor, drug waste, quality control testing, and liability risk.  These requirements can strain hospital pharmacy operations, potentially diverting personnel and financial resources from clinical functions. Although compliance with USP <797> is critically necessary to support injectable compounding, prioritizing use of commercially available FDA-approved formulations when available has the potential to lessen these hidden costs. 

Solution: Prioritizing Commercially Available Ready-To-Use Injectable Formulations

Regulatory and Professional Alignment

The FDA states that compounding of injectable medications is appropriate only in the absence of a commercially available alternative, except under documented clinical necessity.¹  The Institute for Safe Medication Practices further supports that hospitals minimize compounding to reduce error potential and only compound in the absence of FDA-approved formulations or during shortages.⁶ Additionally, the ASHP Standardize 4 Safety initiative promotes standardization of concentrations for continuous infusions in both adult and pediatric patients.  Adoption of standard concentrations may increase the utilization of RTU injectable formulations, which can further reduce risk and improve operational efficiency.^7,8

Literature Support For Adoption of RTU Injectable Products

Peer-reviewed studies consistently demonstrate that RTU injectable formulations improve safety and efficiency through:

Reducing Errors: A multicenter study found that adoption of RTU syringes reduced IV medication preparation and administration errors by 76% compared with compounded alternatives.⁹

Promoting Time & Cost Savings: Research in a critical care setting showed RTU formulations cut medication preparation time by 43%, enabling faster administration during emergencies.¹⁰

Improving Stability: FDA-approved RTU formulations provide validated stability data and sterility assurance, often offering longer beyond-use dating and reduced microbial risk compared to compounded preparations.¹¹

Operational and Financial Advantages

Numerous workflow, technological and cost-containment advantages have been noted by health systems as a result of the adoption of RTU injectable formulations including:

Workflow Integration: Commercially available RTU formulations can easily integrate within multiple systems, including the electronic health record (EHR), the medication administration record (MAR), barcode medication administration (BCMA) systems, and radiofrequency identification (RFID), enabling safer and more efficient clinical and operational workflows in addition to inventory management.

Waste Reduction: RTU packaging can minimize the need for additional supplies as well as waste during the compounding process, enhance compliance with the Drug Supply Chain Security Act (DSCSA), as well as reduce risk for diversion and burden of process tracking for controlled substances.

Cost Predictability: Transparent pricing benchmarks (WAC, AWP, ASP) exist with commercially available RTU formulations whereas costs associated with compounding are often hidden and may be variable.

National Adoption Trends of RTU Injectable Formulations

The National Infusion Collaborative™ (“NIC”) organized by Bainbridge Health, is a nationwide network of pharmacy and medication safety leaders committed to advancing the safe practice of medication use. The NIC’s mission is to unlock the power of this unique national network to improve the safety and stewardship of medications. A review of NIC data over the past 12 months highlights:

• The use of RTU formulations has been demonstrated to drive standardization. For continuous infusions that have an RTU available on the market, greater than 90% of health systems utilize that concentration. For example, greater than 99% of hospitals administer dexmedetomidine at a concentration of 4 mcg/mL¹²
• Injectable medications that do not have a commercially available RTU formulation often vary widely in concentration. Some continuous infusions administered have more than 8 different concentrations¹²
• Commercially available RTU injectable products show less variability in formulation use, concentration and infusion container size¹²
• Health systems are actively continuing to evaluate their ability to implement newly available RTU injectable formulations, including the impact on drug cost, infusion waste, pharmacy resource allocation, infusion line changes, and delivery of clinical patient care¹²

Conclusion

Commercially available, FDA-approved RTU injectable formulations offer many advantages, including improved patient safety,² enhanced regulatory compliance,³ operational efficiency,¹⁰ standardization across health systems,^7,8 and increased financial stewardship¹⁰ when compared to hospital compounded products. Compounding remains an indispensable practice in addressing drug shortages and patient-specific needs; however, its risks underscore the importance of restricting its use to limited, justified scenarios. By prioritizing adoption of RTU injectable formulations, health systems can minimize risk and further support high-reliability of injectable medication delivery.

References

1. Food and Drug Administration (FDA). Compounding and the FDA: Questions and Answers. Updated 2023. Available at: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
2. Institute for Safe Medication Practices. Safe practices in pharmacy sterile compounding areas. ISMP Medication Safety Alert! 2011;16(11):1-4.
3. United States Pharmacopeia (USP). USP <797>: Pharmaceutical Compounding – Sterile Preparations FAQs. Updated December 11, 2023. Available at: https://go.usp.org/USP_GC_797_FAQs?_gl=1*1c0amxo*_gcl_aw*R0NMLjE3NjI4ODYyMzIuQ2p3S0NBaUEyc3ZJQmhCLUVpd0FSV0RQam9ScWVkSXpIMDgzZVVuT1k4QzFWTVpXYTQ1Y0d0czhvay1tQTBXR0JNQ2pLQXpmT25XU0Job0N0MjRRQXZEX0J3RQ..*_gcl_au*MTU0NjQxMjA2NS4xNzYyODg2MjI1*_ga*NDkxMDg5MDI5LjE3NjI4ODYyMjU.*_ga_DTGQ04CR27*czE3NjI4ODYyMjQkbzEkZzEkdDE3NjI4ODY2ODEkajYwJGwwJGgw
4. Hedlund N, Beer I, Hoppe-Tichy T, Trbovich P. Systematic evidence review of rates and burden of harm of intravenous admixture drug preparation errors in healthcare settings. BMJ Open. 2017; 7(12): e015912.
5. Lucas AT, Rowe E, Eckel SF. Determining the Need for Standardized Infusions and Concentrations at Hospitals within North Carolina. Hosp Pharm. 2016 Mar;51(3):237-245
6. Institute for Safe Medication Practices (ISMP). Guidelines for Safe Preparation of Compounded Sterile Preparations. 2016.
7. American Society of Health-System Pharmacists.  Standardize 4 Safety Initiative: Adult Continuous Infusion Standards. September 2025. Available at: https://www.ashp.org/-/media/assets/pharmacy-practice/s4s/docs/Adult-Infusion-Standards.pdf
8. American Society of Health-System Pharmacists.  Standardize 4 Safety Initiative: Pediatric Continuous Infusion Standards. September 2025. Available at: https://www.ashp.org/-/media/assets/pharmacy-practice/s4s/docs/Pediatric-Infusion-Standards.pdf
9. Hertig JB, Degnan DD, Scott CR, Lenz JR, Li X, Anderson CM. A comparison of error rates between intravenous push methods: a prospective, multisite, observational study. J Patient Saf. 2018;14(1):60-65.
10. Borms M, Taneja A, Weiss M, Girgis H, Frolet C, Lucaci JD. Improving Efficiency and Safety with Prefilled Syringes: A Model-Based Economic Evaluation for US Healthcare Settings. ClinicoEconomics and Outcomes Research. 2025;17:673–685.
11. Ormsby J, Wagner T, Gupta R, Millson T, Phillips B. Safe Injection, Infusion, Medication Vial, and Point-of-Care Testing Practices in Health Care (2025). American Journal of Infection Control. 2025;53(9):985-996.
12. Data on file. Amneal Pharmaceuticals LLC.

About Amneal Pharmaceuticals

Headquartered in Bridgewater, N.J., Amneal Pharmaceuticals is a U.S.-based, diversified global pharmaceutical company committed to making healthy possible. The company ranks among the leading providers of complex generic, biosimilar and innovative branded medicines for the U.S. market, with a portfolio of more than 280 products across multiple therapeutic categories. Amneal operates FDA-approved manufacturing facilities in the U.S., India and Ireland, maintaining a secure, reliable supply chain and in-house expertise in complex drug development and production.

About Bainbridge Health

Bainbridge Health is the leader in medication management solutions for the pharmacy supply chain. Bainbridge partners with hospitals, health systems, and manufacturers to unlock the value of real-world data to improve the safety, efficiency, and reliability of medication use. Through a data-driven approach, Bainbridge supports hospitals and health systems with the evaluation and adoption of ready-to-use injectable products to ensure continued alignment with their clinical practice standards and servicing of patient care needs.