NeuAge Institute (NAI)

Over-the-Counter vs Prescription Drugs in Pharmaceutical Regulatory Affairs

At the NeuAge Institute, students have the opportunity to earn their Pharmaceutical Regulatory Affairs Certification in a 24-week long post-graduate program. This program provides students with knowledge and insight into the current U.S. Professional Regulatory Affairs pathways for prescription and over-the-counter drugs and also includes modules on biologics, medical devices, combination products, technical writing, and more. Students will explore topics in promotion, packaging, labelling, patents, and exclusivity, all while gaining practical experience that will help them excel in a role in the pharmaceutical industry.

The emphasis on learning the difference between prescription and non-prescription drugs is an important aspect of the NAI program, giving students a basis for understanding what classifies a drug as each type. It also helps students learn more about the processes required for each type of drug and how consumers are able to access them. Continue reading to discover more about the key differences between over-the-counter and prescription drugs.

Main Differences in Drug Classes for Pharmaceutical Regulatory Affairs

Non-prescription drugs, also called over-the-counter drugs, do not require a prescription from a doctor to obtain, which is arguably the most stand-out difference compared to prescription drugs. Additionally, according to the FDA, over-the-counter drugs are able to be bought off the shelves in drug stores and pharmacies with little oversight. These drugs are still monitored by the FDA through drug monographs, which are continually updated to reflect current acceptable ingredients, doses, formulations, and labelling.


Prescription drugs, on the other hand, require the acquisition of a prescription as suggested by a doctor or prescribing pharmacist. They must be bought at a pharmacy and aren’t available on the shelves at drug stores. They are prescribed to and intended to be used by one person due to the specific desired treatment of their ailment. Pharmaceutical regulatory affairs are set by the FDA through the New Drug Application (NDA) Process, which includes all of the drug’s relevant data from animal and human research, as well as information about what the drug does within the body.

During regulatory affairs courses, you’ll discover the differences between prescription and non-prescription drugs.

A Look at the Drug Application Process for Non-Prescription Drugs

Two regulatory pathways exist to bring an over-the-counter drug to the market: the OTC monograph process and the new drug application process. The OTC drug monograph establishes the conditions that need to be met for drug approval, such as the active ingredients, uses and indications, dosages, routes of administration, and testing requirements. Once all of the conditions are met, then the drug may be recognized as generally safe and effective for the intended use. For example, once a sunscreen is tested and proven to satisfy the conditions, then it can be brought to the market for consumers to buy. 

As mentioned above, both prescription and non-prescription drugs use the NDA process. However, the key difference to note in regulatory affairs courses for over-the-counter drug applications is the need for consumer studies that demonstrate that the general public can use the product safely and effectively. This use must be without the help or guidance of a healthcare provider to demonstrate true understanding and proper usage on one’s own.

Various FDA regulations protect both prescription and non-prescription drugs.

Switching from Prescription to Over-The-Counter Classification

Drug sponsors may, from time to time, wish to change the classification of drugs from prescription to non-prescription. This process is commonly referred to as the Rx-to-OTC switch and is mediated through the NDA process as well. Sponsors are able to choose if they want to make a full switch or a partial switch. The full switch entails the drug being transferred to the non-prescription classification entirely, while a partial switch entails certain parameters for the drug to market as non-prescription and others remain a prescription status.

In order for drugs to be approved during an Rx-OTC switch, the FDA must be able to determine that the prescription status isn’t necessary to protect the health of the public. When you pursue regulatory affairs courses, you’ll notice that the priority is always public safety, making your role within the pharmaceutical industry one of value and importance for consumers in North America and worldwide. 


Interested in earning a regulatory affairs certificate?

Contact the NeuAge Institute for more information!





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