How Are Over-the-Counter Drugs Regulated?
Key takeaways:
New over-the-counter (OTC) medications can hit the market after going through one of two processes. These include a new drug application (NDA) or OTC monograph.
The OTC monograph process focuses on active ingredient(s) within a therapeutic drug category. The NDA process focuses on a specific finished product.
OTC medications must have adequate labeling. This is so you can safely self-diagnose and treat your condition or symptoms.
Over-the-counter (OTC) medications are handy when you need quick relief from common issues like headache and nausea. They’re available at pharmacies, grocery stores, and even gas stations.
A prescription from a healthcare provider isn’t needed to buy OTC medications. But the FDA still requires these medications to be safe and effective for public use. This is done through two processes which we’ll discuss below. Read on to learn how OTC medications come to market.
How are OTC drugs regulated?
The Durham-Humphrey Amendment of 1951 divided medications into prescription-only and OTC. OTC medications are those available without a prescription. For a medication to be OTC, you should be able to self-diagnose and select an OTC product to treat your condition.
The FDA is responsible for regulating OTC medications. Today, new products go through one of two processes before hitting the market. These processes ensure that they’re safe and effective for public use. But these two pathways look quite different. Let’s dive into the differences next.
What is the OTC monograph process?
The first pathway is called the OTC monograph process. It was established to make OTC medication development more efficient. This is the primary process by which most OTC medications are marketed today.
You can view an OTC drug monograph as a “recipe.” It’s specific to one category of OTC medications (such as antihistamines, analgesics, antacids, etc.). Each monograph has information about that specific group of OTC medications. This includes ingredients, dosages, and formulations. There’s also information on labeling.
Clinical trials aren’t needed for an OTC medication going through this process. As long as it complies with the relevant drug monograph, the FDA doesn’t need to pre-approve it. That’s because safety and effectiveness of the active ingredient(s) were determined when the monograph was made.
For example, the OTC nighttime sleep aid monograph includes the active ingredient diphenhydramine (e.g., Unisom SleepMelts). This means diphenhydramine is generally considered safe and effective to use OTC for sleep. New OTC sleep aids containing diphenhydramine would need to comply with this monograph. As long as they do, they can be marketed.
The OTC drug monographs were initially created and edited through a three-phase public rulemaking process. It involved participation from various advisory panels and could be very time-consuming. This became a problem when urgent updates were needed. Urgent updates might include new uses, active ingredients, or side effects.
The March 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) addressed this issue. It granted the FDA the ability to establish and update drug monographs on its own.
What is the NDA process for approving new OTC drugs?
Some OTC medications aren’t covered under an OTC drug monograph. These must go through the new drug application (NDA) process. Prescription medications that are switching to OTC must also go through this process.
These medications must be approved by the FDA before coming to market. Companies must provide clinical studies showing safety and effectiveness of the medication. Labeling information and how it’s manufactured must follow FDA rules and guidelines, too.
What’s the process for prescription drugs switching to OTC?
Some medications make the switch from prescription-only to OTC. This is called an “Rx to OTC switch.” These medications must go through the NDA process.
The FDA considers three main factors when reviewing these requests:
Risk versus benefit. The overall benefit of the medication must outweigh the risk. It should have low potential for toxicity, abuse, and misuse.
Consumer-friendly labeling. The labeling information should be easily understood by all. This includes things like uses, directions, and warnings.
Comparable indication between prescription and OTC products. The new OTC medication’s indication (use) should be similar to its prescription counterpart. But people should be able to easily self-diagnose and treat their condition.
Several prescription medications have made the switch to OTC. Here are some examples:
Flonase Allergy Relief (fluticasone)
Nasacort Allergy 24HR (triamcinolone)
Plan B emergency contraceptive (levonorgestrel)
Miralax (polyethylene glycol 3350)
Nexium 24HR (esomeprazole)
Voltaren Arthritis Pain (diclofenac)
Pataday Once Daily Relief (olopatadine)
Differin Gel (adapalene)
What factors should be considered when buying an OTC drug?
OTC medications are generally safe and effective when used as directed. But they aren’t without risks. There are a few things you should consider before buying an OTC medication, including:
What is the use of this medication?
Is this an appropriate treatment option for my condition or symptoms?
What are the side effects of this medication?
Is there a potential drug-drug or drug-food interaction that I should be aware of?
What are the directions for taking this medication?
Is there a point I should stop taking this medication and contact my healthcare provider?
These questions can help you decide if a product is appropriate for your specific needs. And if you aren’t sure, ask your pharmacist or healthcare provider.
The bottom line
Before an OTC medication is deemed as safe and effective for public use, it must go through one of two processes. These include the NDA or OTC monograph process.
OTC medications are easily accessible at most stores. And they don’t require a prescription from your healthcare provider for purchase. However, OTC medications still carry risks for toxicity, side effects, and drug-drug interactions. Talk to your pharmacist or healthcare provider if you have questions about an OTC medication.
Contact your healthcare provider if your condition doesn’t improve or gets worse while taking an OTC medication. This could be a sign of a serious underlying problem that needs the attention of a healthcare professional.
Why trust our experts?
References
Chang, J., et al. (2016). Prescription to over-the-counter switches in the United States. Journal of Research in Pharmacy Practice.
Clarke, P. (2016). How FDA strives to ensure the safety of OTC products. U.S. Food and Drug Administration.
Congressional Research Service. (2021). FDA regulation of over-the-counter (OTC) drugs: Overview and issues for Congress.
U.S. Food and Drug Administration. (2018). Part III: Drugs and foods under the 1938 act and its amendments.
U.S. Food and Drug Administration. (2020). FDA approves three drugs for nonprescription use through Rx-to-OTC switch process.
U.S. Food and Drug Administration. (2020). Over-the-counter OTC | Nonprescription drugs.
U.S. Food and Drug Administration. (2020). Small business assistance: Frequently asked questions on the regulatory process of over-the-counter (OTC) drugs.
U.S. Food and Drug Administration. (2021). Over-the-counter (OTC) monograph M010: Nighttime sleep-aid drug products for over-the-counter human use.
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