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Editorial
. 2025 Feb 5;17(2):e78541.
doi: 10.7759/cureus.78541. eCollection 2025 Feb.

Safety of Compounded Medications

Affiliations
Editorial

Safety of Compounded Medications

Rohini Garg et al. Cureus. .

Abstract

Compounded medications are medications that are prepared by compounding pharmacies to meet individual patients' needs that cannot be met by FDA-approved brand name or generic medications. This may be the case when a patient needs a different dose or route of administration or if a patient is allergic to a certain ingredient in an FDA-approved medication. While compounded medications help to fill a necessary gap, they can have significant safety issues. Due to lesser regulatory oversight, patient safety may be compromised due to contamination or inaccurate potency of compounded medications. Compounded medications should be prescribed only when an FDA-approved medication cannot be used, and the benefits outweigh the risks. Enforcement of adequate oversight by regulatory agencies and maintenance of strict safety precautions at the compounding facilities are needed to ensure patient safety.

Keywords: compounded medications; compounded medications adverse effects; compounded medicines; compounded versus fda approved medications; safety of compounding.

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Conflict of interest statement

Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

References

    1. Human Drug Compounding. [ Oct; 2024 ]. 2019. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/hum... https://www.fda.gov/drugs/guidance-compliance-regulatory-information/hum...
    1. Pharmaceutical compounding: a history, regulatory overview, and systematic review of compounding errors. Watson CJ, Whitledge JD, Siani AM, Burns MM. J Med Toxicol. 2021;17:197–217. - PMC - PubMed
    1. Potential risks of pharmacy compounding. Gudeman J, Jozwiakowski M, Chollet J, Randell M. Drugs R D. 2013;13:1–8. - PMC - PubMed
    1. Pharmacy compounding primer for physicians: prescriber beware. Sellers S, Utian WH. Drugs. 2012;72:2043–2050. - PMC - PubMed
    1. The role of pharmaceutical compounding in promoting medication adherence. Carvalho M, Almeida IF. Pharmaceuticals (Basel) 2022;15:1091. - PMC - PubMed

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