Are You Prescribing Unapproved Drugs?

CAPT Charles E. Lee, MD

March 03, 2011

Editorial Collaboration

Medscape &

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Hello, my name is Dr. Charles Lee. I'm a medical officer in the Office of Compliance at the US Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research. I'm speaking to you as part of the FDA Expert Video Commentary Series on Medscape.

I'd like to address the issue of prescription drugs that are currently available in the marketplace even though they have not been approved by the FDA. This concept may be surprising to you as many healthcare providers are unaware that unapproved drugs exist and that they can pose a significant public health risk.

Many of these products have been on the market for a significant period of time, some for decades. In 1938, the federal Food, Drug, and Cosmetic Act (FDCA) required that drugs be proven safe, and in 1962, additional requirements were added that drugs be proven effective as well as safe. These changes were enacted in the wake of significant tragedies involving unapproved prescription drugs, yet many unapproved prescription drugs remain on the market illegally.

Marketed unapproved prescription drugs are a significant public health concern because they have not been evaluated by FDA, and may not meet modern standards for safety, effectiveness, manufacturing quality, and labeling. For example, FDA recently warned 2 companies to stop marketing unapproved nitroglycerin sublingual tablets, as FDA had seen significant quality and effectiveness problems with unapproved nitroglycerin products. A second example demonstrates how product labeling of an unapproved drug impacted public health. FDA received reported cases of confusion with unapproved morphine concentrated oral solution (100 mg/5 mL) and morphine sulfate oral solution (10 mg/5 mL and 20 mg/5 mL). Analysis of the errors suggested that the numerical similarity of the concentrations (20 mg/mL vs 20 mg/5mL) and visual similarity of the packaging may have contributed to the errors. After approval of morphine oral solution (100 mg/5 mL) in January 2010 -- which included changes in product labeling and packaging feature revisions intended to reduce the risk for medication errors -- firms manufacturing and distributing unapproved morphine oral solution were required to stop distributing the unapproved products.

The next 2 topics I would like to discuss with you regard some common misconceptions surrounding unapproved drugs. Some healthcare providers believe that unapproved drugs are "generic drugs." This is not true. Generic drugs are evaluated and approved by FDA, and are required, among other things, to be bioequivalent to a brand-name reference product. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand-name drugs. Healthcare professionals and consumers can be assured that FDA-approved generic drug products have the same high quality, strength, purity, and stability as brand-name drugs. Proven safety, efficacy, manufacturing quality, and labeling are not ensured with unapproved drugs.

Many healthcare providers are unaware of the unapproved status of some drugs that are marketed and continue to unknowingly prescribe these drug products. Determining whether a drug is unapproved is not always an easy task because the labeling does not disclose that the product is not approved by FDA. Additionally, healthcare providers may assume that because a product bears a National Drug Code (NDC) number that it must be an approved product. This is not true. The law requires that owners of drug manufacturing facilities register their establishments and provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution. The NDC number is the number used for listing drugs with the FDA under this requirement and is required for both approved and unapproved drug products. Therefore, the presence of an NDC number on the product label does not denote approval by FDA of a marketed product; it only indicates that the drug is listed with FDA.

FDA is working to address this public health issue. In June 2006, FDA announced a new drug safety initiative to eliminate unapproved drugs in the marketplace. This initiative is a top priority for FDA. Since that time, FDA has taken a number of actions resulting in the removal of approximately 550 unapproved products from the market, and has worked with firms to bring other unapproved drugs into the approval process. FDA is continuing its work toward eliminating all unapproved drugs from the market and remains committed to ensuring that safe and effective drugs are available to protect and promote the health of the American people.

As healthcare providers, you can help us to protect the public's health by checking to see whether a product is approved by FDA when you consider prescribing it. FDA provides various resources that list approved drugs, including Drugs@FDA. To access these resources and further information regarding unapproved drugs, visit our Website at

Thank you for tuning in.


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