FDA jurisdiction
Is an 'adulterated' drug the same thing as a contaminated one?
Plain English first, then the primary source. Education, not legal advice.
Interpretation
In short: adulteration is a quality and manufacturing problem. Correct paperwork does not cure it.
Plain English
Adulteration under 21 U.S.C. 351 is broader than contamination. A drug can be adulterated if it contains a filthy or decomposed substance, if it was manufactured under conditions that do not meet current good manufacturing practice, if its strength or purity differs from what it purports to be, or for several other reasons listed in the statute.
Manufacturing process and facility conditions matter as much as the final chemical composition. A pure compound made in an uncontrolled environment can still be legally adulterated.
Why it matters
- Suppliers who focus only on certificate-of-analysis purity may still face adulteration exposure if manufacturing controls are inadequate.
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 current good manufacturing practice requirements apply, and which ones, depends on the product category and its regulatory status.
View the source
- 21 U.S.C. 351, adulterated drugs and devices, 21 U.S.C. § 351