Blog

The pharmaceutical industry is entering a new era of regulatory scrutiny when it come to plastic packaging systems used for drug products . With the implementation of USP <661.1> and <661.2> , pharmaceutical companies must demonstrate that their packaging materials and systems are suitable for their intended use and do not compromise product quality or patient safety. In practice, regulatory authorities such as the FDA now expect companies to demonstrate compliance with USP <661.2> when qualifying plastic packaging systems used with drug products. What Is USP <661.2> USP <661.2>, titled "Plastic Packaging Systems for Pharmaceutical Use," establishes requirements for evaluating plastic packaging systems that contain pharmaceutical products. These packaging systems include bottles, containers, closures, unit dose packages and other components that come into direct contact with the drug product. The chapter focuses on ensuring that packaging systems are chemically suitable and safe for drug storage and administration . Unlike USP <661.1> which evaluates the materials of construction , USP <661.2> evaluates the entire packaging system and its interaction with the drug product. FDA Expectations and Regulatory Requirements The U.S. Food and Drug Administration (FDA) require pharmaceutical manufacturers to demonstrate that container closure systems are safe, compatible, and suitable for their intended use under current Good Manufacturing Practices (cGMP). USP standards ae recognized by the FDA as official compendial requirements . As a result, companies must either: Comply with USP <661.2>, or Demonstrate an equivalent scientifically justified approach In regulatory submissions such as NDAs, ANDAs, and BLAs , packaging systems are expected to be supported by extractables, leachables, and physicochemical testing consistent with USP <661.2> requirements. Because of this, USP <661.2> testing has effectively become as regulatory expectation for pharmaceutical companies developing or manufacturing drug products using plastic packaging systems. Why This Standard Matters Packaging is often overlooked in pharmaceutical quality discussions, but it plays a critical role in maintaining product integrity. Plastic packaging components can potentially release chemicals into the drug product through processes such as leaching or migration . USP <661.2> addresses this risk by requiring scientific evaluation of packaging systems to ensure they do not introduce contaminants or alter drug stability. These requirements help manufacturers demonstrate: Chemical compatibility between packaging and drug products Control of extractables and leachables Biological safety of packaging materials Overall suitability of the container closure system Ultimately, these tests protect patients by ensuring that packaging does not compromise drug safety or efficacy. Required Testing Under USP <661.2> To comply with USP <661.2>, pharmaceutical companies typically perform a combination of physicochemical, biological, and extractable studies. Examples of tests include: Physicochemical Tests UV absorbance Acidity/alkalinity Total Organic Carbon (TOC) Solution appearance Transmittance and polymer identification markers Extractables & Leachables Studies Identification of compounds that may migrate from packaging into the drug product Quantification of potential contaminants Biological Reactivity Testing In vitro biological tests to confirm the packaging does not cause harmful biological responses. Regulatory Timeline The revised USP chapters USP <661.1> and <661.2> became official on December 1, 2025 , replacing the older USP <661> standard. These new chapters require separate evaluation of packaging materials and packaging systems to demonstrate suitability for pharmaceutical use. This means pharmaceutical companies must ensure their packaging qualification strategies include both material-level testing and full packaging system evaluation. When Testing Is Required USP <661.2> testing is typically required when: Introducing new packaging systems for drug products Making changes to packaging materials or components Launching new drug formulations or dosage forms Responding to regulatory requests during submissions or inspections In Conclusion: USP <661.2> represents a significant step forward in ensuring the safety of pharmaceutical packaging systems. With FDA expectations aligned with USP compendial standards , pharmaceutical companies must take a proactive approach to packaging qualifications. In today's regulatory landscape, testing plastic packaging systems under USP <661.2> is no longer optional—it is a critical component of regulatory compliance and patient safety. If you have any questions regarding your required regulations - call Bird Dog Laboratories at 717-615-9022 or email info@birddoglaboratories.com .

What sets a great package testing lab apart from a merely good one? Learn the key benchmarks, from advanced equipment to compliance expertise, to look for.

Do You Understand USP <661.2> and Why It's Crucial for Packaging in the Pharmaceutical Industry?

Product Stability Depends on the Quality of Your Container-Closure Seal.

Do You Understand USP <661.2> and Why It's Crucial for Packaging in the Pharmaceutical Industry?