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Drug Quality Sampling and Testing Programs

Back to Regulatory Science at CDER

Background

FDA's requirements for approval of new and generic drugs and biologics are among the highest standards across the globe. Prior to FDA approval, manufacturers must prove thatLearn about CDER's Regulatory Science programs of research. their products are high quality, safe, effective, and free of contamination and defects. In addition, manufacturers of non-application products, such as over-the-counter and homeopathic products, are responsible for adhering to quality standards. Pharmaceutical manufacturers, no matter where they are located, are responsible for complying with Current Good Manufacturing Practice and ensuring that only quality products reach U.S. patients.

Learn more about how CDER keeps patients and consumers safe: CDER’s Drug Quality Sampling and Testing program

To help ensure that high-quality drugs are sold in the U.S., CDER maintains a comprehensive quality surveillance program. A critical function of this program is testing selected drugs in FDA laboratories. This includes testing active pharmaceutical ingredients (APIs). FDA laboratories generally test drugs to standards set by the U.S. Pharmacopeia (USP), an organization that publishes quality monographs for medicines including attributes such as:

  • Identity – is it the right drug as indicated on the label?
  • Assay – how much drug is there and is it consistent with the labeled amount?
  • Impurities – are impurities within established specifications?
  • Dissolution – does the active ingredient dissolve out of the dosage unit so that the drug is available for the body to absorb?

CDER’s quality surveillance program includes multiple tools that complement sampling and testing, including inspections, evaluation of post-market quality reports, signal detection, and data analysis.

We at CDER are committed to protecting patients and consumers from unsafe, ineffective or poor-quality drugs.

Testing

Read stories about the impact of regulatory science.

The FDA uses a risk-based approach to quality testing. This means that in cases where there is a known or likely safety, effectiveness, or quality issue with a product, FDA scientists perform specific tests for this vulnerability. As you can see in the results below, the majority of drugs FDA tests meet their specifications.

Beginning in 2018, CDER began using data analytics, including post-market quality data, to identify products that have potential quality risks. This more targeted, risk-based approach for sampling and testing has been effective in helping us identify more products per year that fail quality tests than in the years prior to 2018.

If drug products have unfavorable testing results, CDER works swiftly to protect the public from potential harm. CDER shares information with health care professionals and consumers to help them make decisions. In addition, CDER alerts the manufacturer of the need to take measures to correct the problem underlying the unfavorable test results. CDER continues to monitor the situation until the manufacturer demonstrates compliance with FDA rules and regulations.

These surveillance testing results are from CDER’s Drug Quality Sampling and Testing Program.

Results

Additional Resources

How to Contact FDA

Division of Drug Information

For general drug-related questions:

Alerting FDA to Potential Safety or Quality Issues

If you are concerned about a drug product or have experienced an adverse event from a medication, please tell your health care professional. Health care professionals and consumers are encouraged to report adverse events or quality problems experienced with the use of a product to FDA's MedWatch Safety Information and Adverse Event Reporting program:

FDA uses these reports to track potential public health risks and compare our scientific data with the information we receive to determine if further actions and analyses are necessary.

Request Information through FDA's Freedom of Information Office

If you cannot find the information you are looking for using FDA’s search function, you can make an information request under the U.S. Freedom of Information Act (FOIA). Such documents are not prepared specifically for public distribution, but are available upon specific written request. For more information:

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