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Compound Pharmacy

Posted On Tuesday, September 26, 2023

Compound Pharmacy

Compound pharmacy refers to the practice of combining or altering ingredients of a medication to create a customized medication for an individual patient. The FDA, or the U.S. Food and Drug Administration, has provided several recommendations regarding compound pharmacy practices.

Firstly, the FDA recommends that compound pharmacies should only engage in compounding medications that are not commercially available or are needed for specific patient needs. This means that compound pharmacies should not be producing medications that are already available in the market unless they are on the FDA shortage list.

Secondly, the FDA recommends that compound pharmacies should only use ingredients that are approved by the FDA. This ensures that the ingredients used in compounded medications are safe and effective.

Additionally, the FDA recommends that compound pharmacies should follow good manufacturing practices to ensure the quality and safety of the compounded medications. This includes maintaining proper cleanliness and hygiene in the compounding area, using appropriate equipment, and ensuring proper labeling and packaging of the medications. Furthermore, the FDA recommends that compound pharmacies should maintain proper documentation and records of their compounding activities. This helps in ensuring accountability and traceability of the compounded medications.

It is important to note that the FDA does not have the authority to regulate compound pharmacies in the same way it regulates traditional pharmaceutical manufacturers. However, the FDA does have the authority to take action against compound pharmacies that engage in unsafe or illegal practices.

In conclusion, compound pharmacy is a practice that involves customizing medications for individual patients. The FDA has provided recommendations to ensure the safety and quality of compounded medications, including the use of approved ingredients, adherence to good manufacturing practices, and proper documentation.

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