The integrity of patient care relies on the clear boundaries that protect evidence-based medicine from unregulated compounding.
At the center is the FDA approval process, the gold standard for ensuring that both brand and generic drugs are proven safe and effective, and manufactured according to rigorous quality standards. Patients depend on this ecosystem to develop, study, and manufacture medicines, the foundation of which is rigorous clinical trials to ensure that drugs are safe and effective. Once approved, drugs are subject to strict manufacturing requirements and distributed to patients in secure, "track and trace" supply chains.
Compounding is intended to be conducted using FDA-approved drugs, or to fill discrete needs for patients that approved drugs cannot meet. When mass-marketed compounders exploit loopholes to effectively act as unregulated manufacturers at unprecedented scale, they bypass these vital safety standards and offer untested drugs to patients—undercutting the balance of a system that develops and delivers safe and effective medicines to patients.
Compounding plays an essential role in patient care — meeting real clinical needs that FDA-approved medicines sometimes cannot, such as known allergies or pediatric dosage adjustments. But across the country, entities operating outside the intent of federal and state law are exploiting that narrow purpose at massive scale.
Often affiliated with med spas and telehealth platforms operating with little regulatory oversight, compounding pharmacies and outsourcing facilities mass-produce unapproved, untested drug products under the guise of "personalization" or "clinical need." These facilities frequently use non-compliant active pharmaceutical ingredients (APIs) sourced internationally (most commonly from China) and promote them with false, misleading, or opaque certificates of analysis and/or claims regarding safety, efficacy, and regulatory status.
CEBM exists to draw a clear line between legitimate compounding and exploitation of the system – and to work to close the gaps that let risky actors operate at unprecedented scale. By anchoring our mission in evidence-based medicines, we work to protect the vital guardrails that ensure patient safety.
The dangers of unchecked mass compounding are not theoretical. In 2012, contaminated compounded steroid injections from the New England Compounding Center caused at least 64 deaths and sickened hundreds more — a tragedy that exposed just how much damage weak oversight can enable.
This threat persists today.
Mass-compounded drugs—particularly compounded GLP-1/GIP receptor agonists—have been linked to more than 1,100 FDA adverse event reports as of July 2025, including hospitalizations and deaths.1 Recently publicly reported patient harms include:
Additional documented harms include bacterial sepsis, anaphylaxis, severe vomiting lasting five days, and ketoacidosis.5
These harms reflect systemic quality failures. Patients taking compounded GLP-1s were hospitalized over twice as often as those on FDA-approved versions and were 8.5 times more likely to experience product-quality-related adverse events.6
Seventy-two percent of FDA enforcement actions against API manufacturers targeted sites supplying only compounding pharmacies, despite those sites representing just 18% of the industry.7 State and FDA inspections and warning letters have documented dirty equipment, non-pharmaceutical-grade ingredients, release of batches despite bacteria "too numerous to count," and endotoxin-contaminated drugs that hospitalized patients.8,9 For example, California regulators filed more than 40 charges against a single pharmacy for patients becoming ill;10,11 and in Utah, a physician was indicted for allegedly receiving misbranded drugs from China and selling them to patients.12
CEBM advances evidence-based policy through direct advocacy, public comments, legislative testimony, educational resources, coalition building, scientific publications, and stakeholder engagement. Our positions are informed by the best available evidence and guided by our commitment to patient safety.
CEBM supports increased:
CEBM supports:
A sample of CEBM's testimony, public comments, and correspondence with state and federal policymakers.