The FDA (Food and Drug Administration) may seem like it’s been around forever, but it was only just over 100 years ago. It was created as a result of the Pure Food and Drug Act of 1906, which prohibited the sale of adulterated or misbranded drugs. At that time though, the law did not yet require that drugs be approved by the FDA.
It wasn’t until 1938 that the Federal Food, Drug, and Cosmetic Act was passed, requiring that new drugs be found safe. It took another 24 years after that for amendments to be made to the law stating that drugs must be both safe and effective in order to be approved.
What does this have to do with the prescriptions you take today? Well, believe it or not, some prescription drugs still on the market today have been in use since the early 1900s. When the law was changed in 1962, the drugs that were approved in that 24 year gap (between 1938 and 1962) were reviewed by the FDA for effectiveness, in addition to safety.
However, that still left drugs approved before 1938 in a bit of a grey area. These “unapproved” medications haven’t had the thorough evaluation required by the FDA today, but they were “grandfathered” in under the law, meaning they were not required to go through the same approval process as new drugs.
Are generic medications considered unapproved?
No. Generic medications and the companies that make them go through an extensive process in order to be approved by the FDA. Generic drugs must be proven bioequivalent (that they work the same) as the brand name medication.
Many unapproved drugs are marketed without brand names and have been available for many years, causing people to often assume that these unapproved drugs are generic drugs; however, this is not correct.
How do I know if my medication is FDA approved?
If you want to double check and make sure your medication is FDA approved, you can use the FDA Approved Drug Products tool.
If you don’t see your drug, it may be unapproved. Keep in mind though, some other types of specialty or biologic medications may also not return results—those are approved through a different process with the FDA.
Is the FDA doing anything about these unapproved medications?
Yes. In 2006, the FDA started an initiative to remove these unapproved medications from the market. Basically, the FDA is telling companies who manufacture these unapproved medications to get their medication approved or remove it from the market.
The FDA also came up with a final guidance document that outlines how they plan to put all unapproved medications through the approval process, starting with those medications that pose the greatest health risk to the public.
The following medications are given the highest priority:
- Drugs with potential safety risks
- Drugs that lack evidence of effectiveness
- Health fraud drugs
- Drugs that present direct challenges to the new drug approval and OTC drug monograph systems
- Unapproved new drugs that are also violative of the Act in other ways
- Drugs that are reformulated to evade an FDA enforcement action
Since this initiative began in 2006 the FDA has removed around 550 unapproved drugs from the market—and worked with manufacturers to get the approval process started for others.
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What are examples of some unapproved medications?
A few current (and some previously) unapproved medications include:
- nitroglycerin tablets
- morphine concentrated solution
- morphine sulfate solution
- chloral hydrate
- pheniramine maleate and dexbrompheniramine maleate (in cough and cold combination drugs)
Are there any downsides to unapproved medications getting FDA approval?
For the most part, it’s a good thing—it means the medication you’re taking has been evaluated and approved under modern standards.
However, the approval process can be very expensive, and it can mean that a drug that was previously very inexpensive might increase in price. Colchicine, for example, is a gout medication that was unapproved until 2009. It was only available as brand-name Colcrys for some time after that, at a much higher price.
Now, there is an authorized generic available—but even the new generic colchicine still costs over $100 for a 30-day supply at most pharmacies.
I’m taking an unapproved medication—should I be worried?
If you find out you are on an unapproved medication, don’t stop taking it without talking to your health care provider! Your doctor or pharmacist will be the best person to answer any questions you might have about your prescription.
If you are worried, bring up your concerns, and they can take into consideration your response to the drug, the benefits and risks, and whether any FDA-approved alternatives are available.
Where can I find more information on unapproved medications?
Here are a few references to get you started:
- What are unapproved drugs and why are they on the market?
- Unapproved Drugs Initiative
- FDA Issues Revised Guidance on Marketed Unapproved Drugs
- Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval
- Unapproved Prescription Cough, Cold, and Allergy Products
- Questions & Answers: FDA’s Removal of Unapproved Prescription Drug Products Containing Codeine and Dihydrocodeine from the Market
- Do You Take Unapproved Drugs?