How much of a controlled substance is allowed to be compounded in a pharmacy?

In the context of compounding medications in a pharmacy, particularly when it involves controlled substances, the regulations allow for a specific percentage of controlled substances to be included in compounded preparations. According to the guidelines, a pharmacy may compound a medication provided that no more than 20% of the total weight of the compounded preparation consists of controlled substances.

This limit is put in place to ensure that pharmacies are not primarily acting as manufacturers of controlled substances, which would require different licensing and regulatory compliance. The intention is to allow for compounding to meet specific patient needs without overstepping into the area of mass production, which is heavily regulated due to the potential for abuse and diversion of controlled substances.

Therefore, knowing that the correct percentage for compounding is set at 20% helps reinforce the importance of adhering to these limits while providing safe and effective pharmaceutical care. Understanding these regulations is crucial for pharmacy practice and ensures compliance with state and federal laws governing controlled substances.