Investigational drugs
Why can't a compound with promising research data just be sold once someone believes it works?
Plain English first, then the primary source. Education, not legal advice.
Interpretation
In short: approval is product-specific and evidence-driven. No education, credential, or label substitutes for it.
Plain English
Under 21 U.S.C. 355, a new drug generally cannot be introduced into interstate commerce unless FDA has approved a marketing application demonstrating it is safe and effective for its intended use. This applies regardless of how promising early research looks.
Approval requires substantial evidence from adequate and well-controlled investigations, which is a much higher bar than laboratory data, animal studies, or informal human trials.
Selling an unapproved new drug is a distinct violation from misbranding or adulteration, and it applies even to products that are honestly labeled and accurately described.
Why it matters
- This is the core reason RUO chemicals cannot legally be marketed or sold as treatments no matter how strong the underlying science looks.
Where the answer becomes fact-specific
The Foundation does not manufacture legal conclusions. These points change the analysis and may require qualified regulatory counsel.
- Whether a specific compound already has an approved use, an IND in progress, or no regulatory history at all changes what is permitted.
View the source
- 21 U.S.C. 355, new drug applications, 21 U.S.C. § 355
- 21 CFR Part 312, investigational new drug application, 21 CFR Part 312