Approved Medications (2024)

By Michael Berry, M.D., Federal Air Surgeon

Source: FAA Safety Briefing, Jan/Feb 2020

Probably the most consistent question I get when talking to airmen is, “Why isn’t there a list of approved medications from the FAA?” The answer was always that the request was actually far more difficult than most people understood. Having an approved list means having one not only for you, but also for every other pilot across all classes of medical certification as well as alternative qualifications. But that has changed.

The Challenges

Several major issues have always made this holy grail of aerospace medicine a herculean task. First, every medication can have different effects on different people. Any list of approved medications would have to cover any potential impairment for any airman. In many cases, medications that seem innocuous (e.g., Diphenhydramine/Benadryl®) can have dangerous side effects. Next is the fact that no two illnesses/diseases are identical. That leads to point three: the underlying condition for which you are taking the medication could be disqualifying. These issues only scratch the surface of our required considerations.

But we understand that there is a challenge for airmen as well. Ultimately, an airman is responsible for determining whether they are fit for flight under Title 14 Code of Federal Regulations (14 CFR) section 61.53. We understand that such a list is a valuable resource in making that determination.

The Long Awaited Prize

The General Aviation Joint Steering Committee (GAJSC) requested a list as part of an effort to educate pilots on the dangers of certain medication use while flying. Working with the GAJSC, the Office of Aerospace Medicine has produced a document to help guide pilots in making that fitness decision.

The guide opens with a preamble that discusses factors you should know and consider when using it. First, evaluate your condition, then examine the medication for obvious warnings such as “Do not operate machinery.” Next you need to be able to determine what exactly you are taking. The document provides a guide to over the counter (OTC) drug labels that should help because you can often find the same active ingredient in many different brand names and sometimes for treating different symptoms. Prescription drugs won’t feature the standardized label, but do indicate what they are and usually a common trade name.

Approved Medications (1)

Multiple Choice

When evaluating a possible medication, keep in mind the two primary concerns for aeromedical fitness are subtle and sudden incapacitation. Will this medication degrade your performance in a way that you will be unable to detect? Will this medication cause you to lose consciousness with little or no warning? When you have a choice, this guide can help you pick an option that should be safe to use.

For example, let’s take a look at some common cough/cold medications. Most medications not labeled “PM” are usually safe for flight, but there are some exceptions. It’s important to look at all the active ingredients. Anything that contains dextro-methorphan (that includes Dayquil®) is not allowed. Another common ailment is gastrointestinal illness. Medications containing bismuth subsalicylate like Pepto-Bismol® or Kaopectate® are fine, but those containing Loperamide, like Imodium®, are not. It’s a good idea to test out a medication prior to using it while flying in case you have an adverse reaction.

It would be easy to view all of those medications as roughly equivalent, but from an aerospace medicine point of view, they are not. This is why this guide has such great potential to help airmen treat illness while staying safe. The guide is a reference, but ultimately, you are still the final authority.

Learn More

What OTC Medications Can I Take and Still Be Safe To Fly? - www.faa.gov/go/pilotmeds

Dr. Michael Berry received an M.D. from the University of Texas Southwestern Medical School, and a master’s in preventive medicine from Ohio State University. He is certified by the American Board of Preventive Medicine in aerospace medicine. He served as an FAA senior aviation medical examiner and vice-president of Preventive and Aerospace Medicine Consultants for 25 years before joining the FAA. He also served as both a U.S. Air Force and NASA flight surgeon.

Approved Medications (2024)

FAQs

How to check if a medication is FDA-approved? ›

Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number. Look up the drug in the Orange Book or the biological product in the Purple Book.

What does approval medicine mean? ›

FDA approval of a drug means that data on the drug's effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

What is FDA-approved medication? ›

When the FDA approves a drug, it means the agency has determined that: The drug is safe and effective for its intended use. The benefits of the drug outweigh its risks when used according to its approved labeling.

How many approved drugs are there? ›

There are over 19,000 prescription drug products approved for marketing.

Is Tylenol FDA-approved? ›

approved 1955. Though it was initially discovered in 1878, acetaminophen was not used therapeutically until the early 1950s, shortly after researchers at Yale and New York University had revealed it to be a safer alternative to acetanilide and aspirin that possessed the same analgesic and antipyretic properties.

Do all drugs need FDA approval? ›

FDA Approval is Required by Law

Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval.

What is FDA registered vs approved? ›

However, it's important to note that FDA registration does not imply any approval or clearance of their products. It's simply a regulatory requirement for businesses that produce regulated medical products in the medical and biotech industries.

How do you get a medicine approved? ›

Drugs undergo laboratory and animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.

What are the 4 phases of drug approval? ›

Four phases of drug development. Drug development can be divided into four phases: discovery, preclinical studies, clinical development and market approval. The image below provides an overview of the process, including an estimated timeline for each step.

What is the meaning of Med approved? ›

Understanding the Marine Equipment Directive (MED)

It aims to harmonize standards across EU member states, guaranteeing that approved equipment meets the necessary safety requirements. The MED covers a wide range of equipment, including life-saving appliances, fire protection equipment, navigation devices, and more.

What is an approved drug with an example? ›

An approved drug is a medicinal preparation that has been validated for a therapeutic use by a ruling authority of a government. This process is usually specific by country, unless specified otherwise.

What products are not FDA-approved? ›

The ingredients (except certain colors) and labeling of cosmetics, such as many perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval.

What is the approved name of a drug? ›

Drug brands

For drugs that make it all the way through development, testing, and regulatory acceptance, the pharmaceutical company then gives the drug a trade name, which is a standard term in the pharmaceutical industry for a brand name or trademark name.

What things are approved by the FDA? ›

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary food and drugs, biological and tobacco products, medical devices, cosmetics, and products that emit radiation.

What is a list of drugs approved for coverage known as? ›

A drug list, also called a formulary, is a list of prescription drugs covered by your health plan.

How is a drug approved? ›

The drug approval process requires four phases, which include preclinical investigation, clinical investigation, review of the new drug application, and postmarketing surveillance.

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