Which of the following is a violation that could lead to FDA action regarding pharmacy compounding?

The option identifying that compounding large quantities without prescriptions can lead to FDA action is significant because it highlights a fundamental principle of the compounding regulations. According to FDA guidelines, compounding should be performed based on a specific prescription for an individual patient. When a pharmacy compounds large quantities of a drug without individual prescriptions, it may be interpreted as engaging in manufacturing rather than compounding, which raises regulatory concerns.

Compounding drugs that are commercially available is also a violation that could attract FDA scrutiny. The rationale behind this is that pharmacies should not compete with commercially available products, which are subject to rigorous regulatory oversight for quality, safety, and efficacy. By compounding a drug that already exists in a commercial form, a pharmacy may be undermining this system and could face action from the FDA.

Furthermore, compounding drugs that have been withdrawn from the market for safety reasons is a serious concern. When a drug is removed due to safety issues, compounding it again can pose significant health risks to patients, and the FDA has a vested interest in protecting the public by preventing the circulation of potentially harmful medications.

Thus, all these actions—compounding without prescriptions, compounding commercially available drugs, and compounding withdrawn drugs—are in violation of regulations that govern pharmacy comp