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.
Founded in 2001 as a validation services provider, Quality Solutions has grown into a leading compliance and support partner for the biotech, healthcare, and pharmaceutical industries. With offices in Maryland and Utah, we execute projects both nationally and internationally, offering tailored, cost-effective solutions to meet FDA regulations, USP 797/USP 800 guidelines, and broader quality management needs. Our comprehensive services—including facility design, calibration, validation, and environmental certification—ensure seamless compliance and operational efficiency. With an integrated certification team and in-house lab, we deliver fast, reliable results, minimizing risks and costly delays. At Quality Solutions, we take a long-term partnership approach, acting as your insurance policy for maintaining compliance while maximizing the financial return on quality investments.
