What is a Certificate of Analysis (CoA)?

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A Certificate of Analysis (CoA) is a document that summarizes all the tests performed on a product and gives the needed reassurance to the customers. It is therefore an essential document for our compounding pharmacy.

Also, CoAs are critical documents in our industry, providing detailed information about the quality and composition of raw materials used in compounding medications. However, it's essential to recognize that CoAs may contain sensitive information, including proprietary formulations, trade secrets, and personally identifiable information (PII) of individuals involved in testing or manufacturing processes.  

A source of the ingredient is also proprietary and providing a COA specially for shortage drugs lets anyone know where they can source the product. 

In addition, CoAs are technical documents that may contain complex analytical data, scientific terminology, and abbreviations that are difficult to understand by most people outside the industry. This complexity can make it challenging for individuals without specialized training or expertise to interpret CoAs accurately. 

 Certificate of Analysis (CoA) plays a crucial role in our compounding pharmacy in several ways:

1. Quality Assurance/Ingredient Selection: We review every CoA to ensure that the ingredients we use meet the required standards and specifications. This helps maintain the quality and consistency of compounded medications.
2. Regulatory Compliance: State and Federal regulators require us to maintain records of CoAs for the raw materials used in compounding. CoAs serve as documentation to demonstrate compliance with regulatory requirements related to product quality and safety. This is one of the many documents requested during every inspection.
3. Batch Verification: Before using a batch of raw material in compounding, our pharmacists and our quality team review the corresponding CoA to ensure that the material meets specified quality criteria.
4. Patient Safety: By verifying the quality of raw materials through CoAs, our pharmacists can minimize the risk of adverse effects or therapeutic failures associated with poor-quality ingredients.

Also, we do purchase our ingredients from FDA-registered wholesalers and FDA-registered manufacturers.  The FDA conducts inspections and audits of foreign chemical manufacturing facilities and wholesaler establishments to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. These inspections may be conducted as part of routine surveillance, pre-approval inspections, or in response to specific concerns or reports of non-compliance.

In the United States, compounding pharmacies are not required to provide patients with a Certificate of Analysis (CoA) for compounded medications. Unlike commercially manufactured medications, compounded medications are prepared on a customized basis to meet individual patient needs, often involving unique formulations or combinations of ingredients.  Also, sometimes the compounding preparation is prepared using commercially available product (not bulk API) and so there is no COA and there are instances that API products may be obtained from wholesale suppliers and the original COA may not be available.   

However, healthcare providers may request or obtain CoAs from us for specific compounded medications, especially if they have concerns about an ingredient used. If you have concerns about the quality of a compounded medication, please, send us a detailed email to pharmacy@magnumcompounding.com with your prescription number, and the specific concern and we'll do our best to provide you with the applicable information.