As the demand for personalized medications grows, so does the scrutiny on compounding pharmacies.

Here are the top 5 compliance issues that could impact your pharmacy’s operations:

1. Inadequate Documentation: One major slip-up is not keeping thorough records of formulations, processes, and patient prescriptions. Proper documentation supports quality control and regulatory compliance.

2. Failure to Meet Sterility Standards: With strict standards outlined in USP Chapters 795 and 797, some pharmacies struggle to maintain the required environment for sterile compounding, risking contamination.

3. Insufficient Staff Training: Ongoing education on the latest compounding practices and regulatory changes is crucial. Without it, pharmacies may fail to comply with current standards, leading to errors and potential health risks.

4. Lax Handling of Controlled Substances: Proper protocols for managing and documenting the use of controlled substances are often overlooked, which can lead to significant legal issues and safety concerns.

5. Ignoring State-Specific Regulations: Each state may have additional requirements beyond federal guidelines. Non-compliance with local laws can lead to operational interruptions and penalties.

Prevention Tip: Regular audits and continuous staff training are key strategies to avoid these pitfalls and ensure your pharmacy remains compliant and efficient.