FDA Break-Down: What is the FDA, FDA 21 CFR and How Do You Stay Compliant?

Multiple cartoon checklists for FDA


What is the FDA?

The Food and Drug Administration is a government agency that operates under the United States Department of Health and Human Services. The FDA is responsible for protecting and ensuring public health in relation to drug and food products. Additionally, they monitor the labeling and advertising of products that are sold in the United States. Whether the products are produced domestically or from foreign countries, the FDA assures that the labels on the products are factual and compliant. Also, The Federal Food, Drug and Cosmetic Act is under the FDA’s authority as well as the Fair Packaging and Labelling Act.

The products that are FDA approved range from human and veterinary drugs, to biological products, to medical devices and the United States’ food supply. The agency monitors bottled water, but not any alcohol products. The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau deals with all alcohol goods. The FDA is also responsible for regulating, the manufacturing and the marketing of other substances like tobacco. Moving away from the drug and food industry, the FDA also regulates cosmetics and pesticides. They keep up with trends and recalls on the food and pharmaceutical markets to keep the public informed.

The FDA gives their stamp of approval to companies that they have reviewed and conclude that the benefits of these products outweigh the risk of the public’s health. The FDA will deem these goods to be safe for consumers and will not cause bodily harm.

And the CFR? What is that?

Most of us in the packaging and labelling industry are familiar with the FDA and maybe what they do as a government agency, but what exactly is the FDA 21 CFR? Firstly, the Code of Federal Regulations (CFR) is a code that the U.S. Federal Government uses for general and permanent rules. By general, I mean that they edit the volumes periodically. They are created by the Federal Register by the executive departments. The titles of each CFR represent the different types of products that are reviewed by the FDA. The CFR 21 is titled as the Food and Drug Administration. There have been multiple volumes released of the Title 21 over the years, as each volume is revised every calendar year. The current and previous versions of the CFR 21 and other titles can be accessed in the E-CFR.

For anyone that hasn’t accessed the E-CFR before, Title 21 has been broken up into parts that also has links, so they can be viewed individually. In Chapter one, you will find all the information about labeling and packaging for food and drugs. For example, you can read about nutritional quality guidelines and current good practices by FDA approved companies. For any drug or food business that is looking to become FDA approved, this would be a good resource to use for researching.

What about FDA Compliance?

To maintain and ensure the safety of public health, the FDA has policies in place for FDA approved companies to remain compliant. The Compliance Program Guidance Manual (CPGM), gives instructions to those working for the FDA to evaluate businesses that are under the Federal Food, Drug, and Cosmetic Act. According to FDA, this document is available to the public under the Freedom of Information Act. All of the programs in this manual are divided into sections. For example, if you choose to view the Drug Compliance Program, there are subsections that describe how inspections are done and the what to look for during labelling reviews. They even have a subsection that discusses “Drug Repackers and Relabelers.” Any company or person can click on the links in this section to understand how the FDA conducts their compliance evaluations. The Food and Cosmetics Program is similar to the drug program, having different subsections for more specific information about compliance and inspections.

GlobalVision and the FDA

Did you know that GlobalVision works with many products that are FDA approved? Corporations such as Abbott Laboratories, Proctor & Gamble, Pfizer and WestRock all trust GlobalVision to make sure that their labels and packaging are error-free when they hit the market. Whether it’s the software or the hardware, GlobalVision has been able to help many companies in the pharmaceutical and food industries with their proofreading process. GlobalVision can help food, drug and cosmetic companies to remain compliant and hopefully take them on the road to be FDA approved.

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