FDA warning letter · Drugs

buy-pharma.md

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your website offers drug products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID‐19 in people.

Passage 2

these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 355(a)].

Passage 3

these products are misbranded drugs under section 502 of the FD&C Act [21 U.S.C. § 352].

Passage 4

Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended uses.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.5
  • 21 CFR 201.115(a)