Over-the-counter (nonprescription) drug products are medicines considered safe and effective for use by the general public without the necessity of first seeking treatment from a healthcare provider.
There are two regulatory pathways through which these products can be legally marketed:
- OTC Drug Monograph
- New Drug Application (NDA) or Abbreviated New Drug Application (ANDA)
OTC drug monographs are categorized by therapeutic classes and provide a “recipe” for allowable active ingredients, dosages and labeling. Products that meet the requirements of an OTC drug monograph do not need FDA preapproval prior to marketing.
The other pathway is the application process, either through submission of a “direct to OTC” NDA or an “Rx to OTC Switch” process.
In addition, homeopathic medicines may be marketed over-the-counter provided they are indicated only for self-limiting, self-diagnosable conditions and meet the requirements outlined in FDA’s Compliance Policy Guide Sec. 400.400.
In all cases, the products must be manufactured in FDA-registered facilities and electronically submitted in FDA’s Drug Registration and Listing system.
EAS Consulting Group can assist your company in understanding and complying with the requirements applicable to OTC drug monographs, the NDA or ANDA application process, homeopathic drug marketing, as well as facility registration and drug listing submissions.