Learning objectives
By the end of this lesson, you can:
- Tell five product-status groups apart.
- Explain what FDA approval covers.
- Explain why compounded drugs are not FDA-approved.
- Use “unknown” when you cannot check the exact product.
Classify before evaluating
First, identify the exact product group. Products with a similar ingredient name can have very different evidence and rules.
- FDA-approved drug or licensed biological product: approval covers one finished product and its labeled uses.
- Compounded drug: a pharmacy makes it for a patient need. The finished drug is not FDA-approved.
- Investigational product: researchers are studying it. Being studied does not mean it works or is approved.
- Research-use-only material: it is labeled for laboratory work, not personal treatment.
- Unknown or unclear: use this group when key product details cannot be checked.
Four items that do not prove approval
A National Drug Code, or NDC, is a product listing code. An NDC alone does not prove FDA approval.
A certificate of analysis reports selected test results. It does not prove that a product is safe or works in people.
A patent protects an invention. It is not medical approval. A ClinicalTrials.gov record lists study information. It does not prove that the study succeeded.
For example, a seller may show a trial number and say, “clinically approved.” The number shows that a study was registered, not that the product was approved.
Verify the exact finished product
To check U.S. drug approval, search the exact name in Drugs@FDA. Open the approval record and official label.
Match the ingredient, finished product, route, approved use, and maker. Do not rely on a search preview or a similar name.
ClinicalTrials.gov is a study registry and results database. Check whether the study is active, finished, or stopped. Then look for posted results and published reports.
Keep these
Lesson takeaways
- Approval belongs to one product and its labeled uses.
- Compounded drugs are not FDA-approved.
- A trial record, NDC, patent, or certificate does not prove approval.
Workbook action
Put the lesson to work.
Classify one real or made-up claim. If details are missing, choose “unknown” and list what you need to check.
Knowledge check
Check what you can explain.
Answer all 3 questions. Get at least 2 correct to complete this module. You can retake the check after any result.
Primary references