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FDA Approved! Approve or Not? Pt 2

It is not uncommon for people to take notice on product labels, company websites, commercials promoting a new product or treatment or hear some marketers saying the word’s “FDA approved!” However, what does that even mean and is it really FDA approved? How can you know for sure what the US Food and Drug Administration approves? This article will discuss two aspects that the FDA Approves and does not approve. And subsequent articles will look at how the FDA regulates products and what it does and doesn’t approve.

FDA approves new drugs and biologics

Before companies can market new drugs and certain biologics in interstate commerce, they require FDA approval. Such drugs and biologics must be proven safe and effective to the FDA’s satisfaction. Some examples of biologics that require approval are:

  • Therapeutic proteins
  • Cellular therapies
  • Vaccines
  • Blood and blood products

Manufacturers must also prove that they are able to make the drug product according to federal quality standards.

It is important to note that the FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal and human clinical testing done by manufacturers. FDA approval means the benefits of the product outweigh the known risks for the intended use.

FDA does not approve compounded drugs

Drug compounding is the process of combining, mixing or altering ingredients to create a medication specific to the needs of an individual patient. Some reasons for compounding drugs is to create medicines that meet an individual patient’s needs. For example, a patient may be allergic to ingredients in an FDA-approved medicine. Or the person may be unable to swallow an FDA-approved pill. The FDA does not approve compounded drugs. This means that the agency does not review applications for compound drugs to evaluate their safety, effectiveness or quality.


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