Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128