Unapproved prescription drugs propose a significant risk for patients since they haven’t been reviewed for quality, safety, and effectiveness by the Food and Drug Administration (FDA). Without FDA review, consumers and patients have no way of knowing if a drug is safe and effective and if they were manufactured with consistent quality. In the past, unapproved drugs have led to patient harm and the FDA works to protect consumers from any drug risks.

The FDA balances goals to eliminate unapproved prescription drugs from the market with giving patients access to medically necessary drugs. The agency permits some unapproved drugs to be marketed if they’re relied on by health care professionals. Some drugs are to treat serious medical conditions when there is not an FDA-approved drug available to treat the condition or the current FDA-approved drug supply is low1.

FDA approval of all new drugs is required by law in the United States to ensure they are effective and safe for the market. Many patients and health care professionals are unaware that some prescribed drugs are not FDA approved. Some unapproved prescription drugs can be marketed under the following conditions:

  • There is an insufficient supply of an FDA approved drug
  • A drug is subjected to an open drug efficacy study implementation program
  • Health care professionals rely on the drug to treat serious medical conditions when there is no FDA-approved drug to treat the condtion1.

These conditions, of course, must be verified by the FDA and notification submitted to the agency.

The agency utilizes a risked based approach to enforcing priority to drugs that are high risk to the public. All marketed drugs in the United States can be identified under the National Drug Code Directory, Orange Book, and Drugs@FDA1. EMMA International can help prepare your company for FDA drug approval and guide your organization to drug market success. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (June 2021) Unapproved Drugs, Retrieved 04/11/2022 from https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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