What is the maximum percentage of controlled substances allowed in a compounded medication?

The maximum percentage of controlled substances allowed in a compounded medication is set at 20%. This regulation is in place to ensure that compounded medications primarily consist of non-controlled substances, promoting safety and standardization in pharmacy practice. Compounding pharmacies must adhere to these limits to maintain compliance with both state and federal regulations, as excessive inclusion of controlled substances in compounded products may lead to potential misuse, diversion, and contribute to substance abuse issues.

Understanding this regulation reflects a pharmacist's responsibility to balance patient care with regulatory compliance, ensuring that compounded medications are used appropriately and within established guidelines. Additionally, this limit helps guide pharmacists in making clinical decisions regarding the formulation of compounded medications, ensuring they align with best practices and legal requirements.