Are compounded drugs required to be FDA approved before reaching patients?

Compounded drugs are typically not subject to FDA approval in the same manner that commercially available pharmaceuticals are. This is primarily because compounding is a practice designed to meet the specific needs of individual patients, and it allows pharmacists to create customized medications that may not be available in standard forms. The FDA has established guidelines indicating that while the safety and quality of compounded drugs are critical, these drugs are not "reviewed" or approved by the FDA before being dispensed.

This does not mean that compounded drugs are exempt from all regulatory oversight; they must still adhere to specific standards set forth by the United States Pharmacopeia (USP) and comply with state pharmacy laws. However, the foundational idea is that the compounding process is based on patient-specific prescriptions rather than a one-size-fits-all approach, which is the hallmark of FDA-approved medications.

The options suggest differing scenarios about FDA approval related to compounded drugs, but the key takeaway is that these specially prepared formulations are not required to undergo the same rigorous approval process as mass-produced drugs because they are intended for unique patient requirements.