In the pharmaceutical industry, whether compounded pharmaceuticals or pharmaceutical manufacturers, quality assurance is paramount, particularly when it comes to Active Pharmaceutical Ingredients (APIs). APIs serve as the foundation of compounded preparations, making their quality critical to product efficacy, safety, and regulatory compliance. Let’s explore why each compounding pharmacy should place API quality as a top priority for your organization, whether your source of the API is from an FDA-registered chemical repackager or directly from the chemical manufacturer.

Why Source from FDA-Registered Facilities, whether manufacturer or repackager?

Purchasing APIs from FDA-registered and inspected facilities is the first step to help ensure that the ingredients meet strict regulatory standards for quality, safety, and purity. These facilities operate under Good Manufacturing Practices (GMP), providing an added layer of assurance that the components are free from contaminants and meet the intended specifications. A Certificate of Analysis (CoA) from such a facility verifies that the API has been tested against established criteria, reducing the risk of substandard ingredients entering the compounding process. For compounding pharmacies, conducting their own API sourcing directly from the manufacturer, testing— according to USP standards and other tests as appropriate, such as identity, potency, and impurity analysis—serves as a critical safeguard, ensuring the sourced materials align with both regulatory requirements and the high standards of patient care.

Why is verifying the quality of your APIs so critical to your practice?

1. Foundation of Compounded Preparations

APIs form the starting point of compounded medications and utilizing the highest quality aid in ensuring the clinical effect desired. Ensuring their quality not only meets industry standards but also confirms their suitability for the intended application.

2. Regulatory Compliance

Guidelines provided by the United States Pharmacopeia (USP), Food and Drug Administration (FDA), and the State Board of Pharmacy (SBOP) establish the benchmarks for API quality assurance. Key highlights include:

• USP: Sets comprehensive testing standards, including identity, impurities, and dissolution, tailored to the manufacturer's product attributes.
• FDA: Requires identity verification and conformity evaluation for APIs not classified as finished drug products.
• BOP: State Boards of Pharmacies have regulations in place to specifically require these standards for the states where you practice pharmacy. Organizations, such as the Alliance for Pharmacy Compounding (https://a4pc.org/state), are a great resource for the most current requirements for each state’s requirements.

3. Comprehensive Testing Beyond Potency and Identity

Determining API suitability involves more than potency and identity verification. Compendial test methods assess additional attributes such as:

• Organic and inorganic impurities
• Water Content
• Residual solvents and/or related compounds
• Microbial content and assay values

For instance, if a material contains hydrates or adsorbed moisture, adjustments in calculations for anhydrous equivalent weight are crucial.

4. Ensuring Product Integrity

Thorough testing with appropriate CoA ensures that APIs meet quality specifications, safeguarding the integrity and efficacy of the final product. Whether sourced from a new supplier or through repeat orders, robust CoA review and other verification processes are non-negotiable.

Verification Practices for 503A and 503B Pharmacies

Compounding pharmacies and outsourcing facilities follow different approaches for API verification:

• 503A Pharmacies:
  • Review supplier CoAs
  • Conduct vendor qualifications to confirm supplier reliability
  • Test drug components prior to compounding as appropriate
• 503B Outsourcing Facilities:
  • Test each API shipment or evaluate supplier CoAs in compliance with USP or NF standards
  • Confirm CoA reliability with annual (for active ingredients) or biennial (for other components) comprehensive testing
  • Perform at least one identity test for every batch received

Takeaway

By adhering to rigorous quality standards and testing protocols, companies can mitigate risks associated with subpar APIs. Verifying API quality not only supports regulatory compliance but also ensures product safety, efficacy, and trust in your practice.

Commit to quality, protect your customers, and solidify your place in the market by making API verification a cornerstone of your operations.

For more information or guidance on API testing protocols, contact one of the testing laboratories that have expertise in the compounding industry. Examples of these companies can be found in IJPC’s Compounders Resource Directory.

Thomas C. Kupiec, Ph.D. President 405.330.0094 Phone 122 N. Bryant Avenue, Suite B4 Edmond, OK 73034 tkupiec@ijpc.com IJPC.com Compounding​Today.com

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