What key information must be documented for compounded pharmaceuticals?

The documentation of compounded pharmaceuticals is crucial for ensuring safety, traceability, and regulatory compliance. The requirement to document the generic names and strengths of active ingredients is essential because it provides a clear understanding of what the compound consists of and helps in verifying that the correct ingredients in the appropriate strengths are used. This information is vital for both pharmacists and any regulatory bodies to ensure the safety and efficacy of the compounded product.

Documenting this information also aids in maintaining consistency among compounded batches and helps in evaluating the stability and potency of the ingredients over time. Moreover, it allows for adequate record-keeping, which is necessary in the event of an investigation or a quality control analysis.

While the name of the pharmacist, the date of preparation, and brand names may also be important for various reasons, the generic names and strengths specifically ensure clarity and safety around the fundamental components of the compound itself, which is the most critical aspect in compounding practices.