Dry Springs Pharmacy

Selected passages from the FDA letter

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

Passage 1

While there are FDA-approved versions of oxycodone on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “OxyNorm” and “Oxycodone-Hydrochloride” offered by www.dryspringspharmacy.net.

Passage 2

While there are FDA-approved versions of alprazolam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Yellow Xanax” and “Yellow Xanax 2 mg Bars R039” offered by www.dryspringspharmacy.net.

Passage 3

While there are FDA-approved versions of amphetamine (MAS) on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Adderall” offered by www.dryspringspharmacy.net.

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 use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].

Passage 5

By offering the aforementioned drug products without requiring a prescription, www.dryspringspharmacy.net jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)].