FDA warning letter · Drugs

pharmacygeoff.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.

Passage 3

By 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)