Answer questions about your current drug label to find out whether it meets FDA requirements under 21 CFR Part 201 — or where it puts your business at risk.
21 CFR Part 201 Instant Risk Check Protect Your Brand
1
Q1
2
Q2
3
Q3
4
Q4
5
Q5
6
Q6
7
Q7
8
Q8
✓
Result
Question 1 of 8
Does your label display the established name of the drug as required by FDA?
Question 2 of 8
Does your label declare the net quantity of contents in the FDA-required format?
Question 3 of 8
Does your label include the manufacturer, packer, or distributor name and address as required by FDA?
Question 4 of 8
Does your label declare all active ingredients in the manner required by FDA?
Question 5 of 8
Does your label list all inactive ingredients as required by FDA?
Question 6 of 8
Does your label include all required warnings, indications for use, and directions as required by FDA?
Question 7 of 8
If your product is an OTC drug, does your label include a Drug Facts panel in the current FDA-required format?
Question 8 of 8
Does your label declare inactive ingredients known to cause allergic reactions as required by FDA?
Assessment Complete
Your Label Risk Report
For informational purposes only. This is a preliminary risk assessment based on your answers. Only a professional review of your actual label by a qualified FDA specialist can confirm compliance.