Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1An example of an unapproved botulinum toxin drug product you offer for sale on www.celestapro.com is botulinum toxin type A marketed as "Nabota 200 Unit".
Passage 2Because the aforementioned drug is a prescription drug 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.
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)