FDA warning letter · Drugs

cheaptrustedpharmacy.com

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

On www.cheaptrustedpharmacy.com you offer for sale lenalidomide marketed as “Evermide 10 (Lenalidomide)” and “Evermide 25 (Lenalidomide)”. Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Multiple myeloma, Lepra reaction” and categorization “Life Saving Drugs / Anti Cancer”.

Passage 2

On www.cheaptrustedpharmacy.com you offer for sale combination abacavir, dolutegravir, and lamivudine marketed as “Inbec (Abacavir/Dolutegravir/Lamivudine)”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: HIV infection” and categorization “Life Saving Drugs / HIV-Aids [sic]”.

Passage 3

On www.cheaptrustedpharmacy.com you offer for sale injectable semaglutide marketed as “Semaglutide 0.5mg,” “Semaglutide 1mg,” “Semanize 4 Mg (Semaglutide),” and “Semanize 8 Mg (Semaglutide).” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Type 2 diabetes” and categorization “Diabetes Care / Diabetes Type 2”.

Passage 4

On www.cheaptrustedpharmacy.com you offer for sale tapentadol, an opioid, marketed as “Noosanta 100Mg (Tapentadol),” “Noosanta 200Mg (Tapentadol),” and “Noosanta 250mg (Tapentadol).” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Pain Reliever” and categorization under “Pain / Tapentadol”.

Passage 5

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 drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(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 201.128
  • 21 CFR 201.5
  • 21 CFR 201.115(a)