Bulk Drugs and Essential Copies — What’s New and What’s Coming

Compounded drugs serve an important role in patient care particularly if there is not an FDA-approved drug that treats the patient’s ailment.  Compounding is typically governed by state board of pharmacy laws and therefore, compounded drugs can pose a higher level of risk to patients.  With that being said, the Food Drug and Cosmetic Act does restrict the compounding of drug products that are essentially copies of commercially available or approved drug products. 

This presentation will discuss FDA guidance documents related to the compounding of essential copies and the use of bulk drug substances.

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