How often must pharmacies that compound non-sterile products update their policy and procedures manual?

Pharmacies that compound non-sterile products are required to update their policy and procedures manual at least annually. This requirement ensures that the pharmacy maintains current practices that comply with regulatory standards and incorporates any changes in laws, guidelines, or best practices that may affect compounding processes.

By updating the manual annually, the pharmacy can confirm that its procedures reflect any advancements in compounding science, technology, or safety protocols, which is essential for ensuring the quality and safety of compounded medications. This annual review serves as a critical component of a pharmacy's quality assurance program, promoting consistent practices and adherence to regulations.

Updating the manual more frequently, such as monthly or quarterly, may be excessive and could create unnecessary administrative burdens, while less frequent updates, such as every six months, may not sufficiently address changes in the field. Thus, the annual requirement strikes a balance between regulatory compliance and operational efficiency. This approach protects both the pharmacy's operations and the patients who rely on these compounded products for their health needs.