Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your 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 2these 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 3Describing the hydroxychloroquine products offered for sale on your website as “(FDA)‐approved” is particularly misleading because it implies that FDA has approved the version of hydroxychloroquine offered for sale by www.rx2go.com.
Passage 4Because the aforementioned drug is a prescription drug 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 product safely for its 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)