From the FDA website:
- 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
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