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The Legal Differences Between Prescriptions and OTC Products

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We find ourselves wandering into the pharmacy now and then, and we know the basics of prescription and over-the-counter drugs. The simplest difference is the script from your doctor to fill up, rather than just grabbing that aspirin or supplement.

However, there are huge legal differences between the two that some people may not be aware of, whether you are just trying to get the right medicine for you or are getting into the health and wellness field.

FDA Regulations


All prescription or over-the-counter (OTC) medications in the United States are evaluated to some degree by the Food and Drug Administration (FDA). However, they are regulated under two different processes. Pharmacy-distributed medication is evaluated through the New Drug Application (NDA) process. It’s the formal step a drug sponsor takes to ask the FDA to consider approval for a new drug for marketing. An NDA includes all animal and human data and analyses of those figures. This also includes information about how the drug impacts overall health, as well as its manufacturing.

Over-the-counter drugs are regulated by the FDA through OTC drug monographs. These are a kind of “recipe book” that covers acceptable ingredients and formulations. The book is continuously updated with the results of clinical studies. OTC products conform to a monograph that may be marketed without further FDA clearance.

For example, some of the best HGH supplements go through that OTC monograph process to promote the variety of health benefits it suggests to increase the body’s production of human growth hormone in lieu of HGH injections. This includes, but is not limited to:

  • Weight loss and reduction of body fat
  • Increased energy levels
  • Muscle gain
  • Improved libido

Medical Diagnosis


Dietary supplements can have their impact on the human body, with some HGH supplements helping to build lean muscle and aid in fat loss. While some medicines can be obtained as easily as walking down the right aisle in the grocery store, other medications require prescriptions based on medical diagnosis.

There is a legal issue withstanding for any medical professionals when they write a script for a particular drug or a particular potency. As the active ingredients in some medications must be closely monitored, prescriptions require a medical diagnosis and understanding of a patient’s physical performance with particular active ingredients in their system. For example, Malliha Wilson, the former Assistant Deputy Attorney General of the Canadian province of Ontario, specializes in human rights, labour law, and other complex litigation. This includes an understanding of the legalities of medicine and malpractice law that assure a doctor or nurse practitioner’s safety net.

Wilson, the Senior Partner at the law firm Nava Wilson LLP in Toronto, understands that doctors have a responsibility in assuring that patients receive the proper dosage of a pharmaceutical drug. This includes the regular monitoring of a patient’s health and potential side effects.

Drug Interactions


There are legal grounds within the FDA that alert patients and their medical team alike to possible interactions with drugs before using a powerful prescription rather than an OTC medicine. Over-the-counter drugs have a wider margin of safety, as they are more associated with treating minor ailments.

Drug manufacturers take many legal efforts to protect themselves from liability in the event of potentially harmful interactions. You may have noticed the litany of “may cause” symptoms at the end of a commercial that was probably established by a litigator beforehand to protect the company.

Understanding the interactions with other drugs is for your own safety. It is much like safety tips to keep in mind before buying a new bike, where you must be wary of potential issues. In the case of a new bike, it is important to invest in a proper helmet to protect yourself on the road, as well as headphones to prevent hearing loss while driving. The good news is there are very simple steps to take to keep yourself and your overall health safe.