Are Compounded Medications Safe?

Compounded medications are not FDA-approved and do not undergo premarket review for safety, efficacy, or manufacturing quality, which means their safety profile is inherently less certain than that of FDA-approved drugs.[1-4] The risk profile differs between 503A pharmacies and 503B outsourcing facilities due to differences in regulatory oversight and manufacturing standards.

503A pharmacies are regulated primarily by state boards of pharmacy and must comply with United States Pharmacopeia (USP) standards, but are exempt from FDA cGMP requirements and federal premarket review. Safety concerns in 503A pharmacies include variability in compounding practices, environmental controls, and sterility, as highlighted by frequent FDA warning letters for issues such as inadequate facility design, poor cleaning protocols, and lack of valid patient-specific prescriptions.[5] The American College of Obstetricians and Gynecologists notes that drugs from 503A pharmacies are not reviewed by the FDA for safety, effectiveness, or quality.[3]

503B outsourcing facilities, in contrast, are registered with the FDA and must comply with cGMP standards, which are more stringent and include regular FDA inspections. These facilities can compound in bulk for office use and are intended to reduce risks associated with large-scale compounding, such as contamination and inconsistent potency. However, gaps remain, including undefined inspection intervals and incomplete follow-up on identified concerns.[6-7] The American Diabetes Association specifically cautions against the use of non-FDA-approved compounded incretin products due to safety and quality concerns, regardless of facility type.[2]

In summary, 503B outsourcing facilities generally offer a higher level of safety than 503A pharmacies due to FDA oversight and cGMP compliance, but both types of compounded medications carry greater risks compared to FDA-approved products.[1-7] Prompt reporting of adverse events and ongoing regulatory vigilance are essential to mitigate these risks.

1.A Pharmacist-Driven Food and Drug Administration Incident Surveillance and Response Program for Compounded Drugs.

Janusziewicz AN, Glueck SN, Park SY, et al.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists. 2021;78(15):1438-1443. doi:10.1093/ajhp/zxab176

2.Compounded GLP-1 and Dual GIP/­GLP-1 Receptor Agonists: A Statement From the American Diabetes Association.

Neumiller JJ, Bajaj M, Bannuru RR, et al.

Diabetes Care. 2025;48(2):177-181. doi:10.2337/dci24-0091.

Leading Journal

New Research

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3.Compounded Bioidentical Menopausal Hormone Therapy: ACOG Clinical Consensus No. 6.

Obstetrics and Gynecology. 2023;142(5):1266-1273. doi:10.1097/AOG.0000000000005395.

4.Update on Medical and Regulatory Issues Pertaining to Compounded and FDA-approved Drugs, Including Hormone Therapy.

Pinkerton JV, Pickar JH.

Menopause (New York, N.Y.). 2016;23(2):215-23. doi:10.1097/GME.0000000000000523.

5.Compounding Warning Letters to 503A Facilities Between 2017 and 2021.

Zhang Q, Liu X, Qian Y, et al.

Journal of the American Pharmacists Association : JAPhA. 2023 Sep-Oct;63(5):1583-1591. doi:10.1016/j.japh.2023.06.024.

6.Outsourcing Facilities and Their Place in the U.S. Drug Supply Chain.

Gianturco SL, Yoon S, Yuen MV, Mattingly AN.

Journal of the American Pharmacists Association : JAPhA. 2021 Jan-Feb;61(1):e99-e102. doi:10.1016/j.japh.2020.07.021.

7.Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety.

Qureshi N, Wesolowicz L, Stievater T, Lin AT.

Journal of Managed Care & Specialty Pharmacy. 2014;20(12):1183-91. doi:10.18553/jmcp.2014.20.12.1183.