What are OTC Drugs and OTC Drugs Approval Process

Over-the-Counter Medicines | What are OTC Drugs? | Nonprescription Drugs | OTC Drug Monograph | OTC Drugs Approval Pathways

Over-the-counter (OTC) medicines are those which anyone can buy without a prescription. OTC medicines help to treat a number of symptoms due to sickness such as pain, coughs and colds, itches, diarrhea, acidity, constipation, acne, and fungal infections. These drugs are usually located on shelves in pharmacies, grocery stores, and even online. Some OTC medicines prevent or cure diseases, like tooth decay and athlete's foot and some helps manage problems, like migraines and allergies.

Worldwide most commonly used over-the-counter medicines are available in following categories:

Allergies         

Cold/Cough/Sore Throat

Eye Care

Gastrointestinal (antacids, anti-gas etc)

Gynecological

Laxatives/Anti-diarrheal

Probiotics

Skin Care

Pain Relief/Topical Pain Relief

Vitamins/Supplements

First-Aid/Miscellaneous

Worldwide most commonly used over-the-counter medicines used include:

Acetaminophen

Ibuprofen

Cetirizine

Fexofenadine

Loratadine

Hydrocortisone creams

Dextromethorphan

Pseudoephedrine

Bismuth subsalicylate

Guaifenesin

Worldwide most commonly used branded over-the-counter medicines include:

Advil

Tylenol

Zantac

Claritin

Cortaid

Gaviscon

Lotrimin AF

Maalox Antacid

Midol

Motrin IB

Orajel

Food and Drug Administration (FDA) determines that some products are safe and effective for use by a consumer or patient without prescription by a qualified health care professional or doctor. These drug products can be marketed without a prescription (i.e., nonprescription) or over-the-counter (OTC). 

Nonprescription Drug Products, in General:

• do not need a health practitioner prescription for safe and effective use
• can be used by consumer or patient for self-diagnosed conditions
• should have a low or little potential for misuse and abuse 

There are more than 300,000 over-the-counter drug products marketed in the U.S. These include nearly 800 active ingredients in over 80 therapeutic categories such as analgesics and allergy treatment products. The majority of these products are regulated under an OTC monograph and include active ingredients, such as acetaminophen or hydrocortisone.

 

Nonprescription drug products are generally recognized as safe and effective and are not required to be individually reviewed and approved by the FDA before U.S. marketing. For example, OTC drug in a given therapeutic category (e.g., sunscreen and antacid) is generally recognized as safe and effective (GRASE) for its proposed use.

OTC Drugs Approval Pathways

 

A nonprescription drug may be marketed either as:

 

1)    Direct-to-Nonprescription

Direct-to-nonprescription (also known as direct-to-OTC)

A new drug application [NDA] or abbreviated new drug application [ANDA]) may be submitted to market a drug as nonprescription (direct-to-OTC) without first receiving approval as a prescription drug.

2)    Prescription-to-Nonprescription Switch

Prescription-to-nonprescription switch (also known as Rx-to-OTC switch)

Many nonprescription drugs that have an approved NDA or ANDA were first approved as prescription drugs, before eventually receiving FDA approval to be marketed as nonprescription (an Rx-to-OTC switch).

If nonprescription drug products that do not meet the criteria of the OTC monograph (e.g., drugs containing a new active ingredient or dosing regimen) generally must go through the NDA process.

95% of nonprescription drug products marketed under an approved NDA or ANDA previously were marketed for the same indication by prescription, whereas 5% originally were approved for nonprescription use.

OTC Monograph and Drug Facts Label

 

The Drug Facts label uses an easy-to-read format and plain-speaking language to help people select OTC medicines and follow dosing instructions.   

The following information must appear in OTC Monograph in this order:

• Product's active ingredients, with the amount in each dosage unit
• Purpose of the product
• Uses (indications) for the product
• Specific warnings, when the product should not be used also describes side effects
• Dosage directions - when, how, and how often to take the product
• The product's inactive ingredients - information on ingredients that may cause an allergic reaction.

Precautions while taking OTC medicines are:

• These medicines could interact with other medicines, food supplements, foods, or drinks
• Certain medicines are not good for people with specific medical conditions such as high blood pressure.
• Some people may have allergic reaction to certain medicines
• Many medicines are not safe in children and during pregnancy. 

If you have any question after reading an OTC medicine label, talk to your doctor, pharmacist, or other health care professional.

Most Common minor side effects of OTC drugs are:

Diarrhea.

Heart issues (palpitations, irregular heartbeats)

Hives.

Nausea and vomiting.

Rash.

References

1. Drug Application Process for Non-prescription Drugs.  Accessed online from https://www.fda.gov/drugs/types-applications/drug-application-process-nonprescription-drugs.