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.
Passage 3By offering the aforementioned drugs without requiring a prescription, www.pharmacygeoff.md jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act.
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)