Reminder: Compounded Drugs, Medications and Preparations are Not FDA Approved. If a sales or marketing representative or compounding pharmacy or pharmacists is representing them as such they are misrepresenting them.

From the FDA website:

4. Are compounded drugs approved by the FDA?

Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective and made in accordance with Federal quality standards. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.

Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA⁹, although FDA retains some authority over their operations. However, outsourcing facilities that register under section 503B are regulated by FDA and must comply with CGMP requirements and will be inspected by FDA according to a risk-based schedule.

 

quoted from here