Dream Pharmacy 24/7 Enterprises Limited 2018

Selected passages from the FDA letter

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

Passage 1

No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.

Passage 2

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. Consequently, the labeling for these drugs fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C Act.

Passage 3

By offering the aforementioned drugs without requiring a prescription, Dream Pharmacy 24/7 jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act.