Submissions for Over the Counter Drug Products

EAS Consulting Group develops filing submissions and responses to Agency initiatives concerning OTC drugs, monographs, and petitions to request a specific change to a monograph.

Rx to OTC Switch, or Direct to OTC NDA: There are two regulatory pathways through which OTCs can be legally marketed – OTC Drug Monograph or New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). 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 comply 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.

Citizen Petitions: A Citizen’s Petition is used to request a change to a monograph at any phase of its development, but can only be used for ingredients that would have been eligible for inclusion in the original monograph (i.e., were marketed for the same purpose prior to 1972 when the OTC Drug Review process began). Through a Citizen Petition (CP) Process, the FDA can be petitioned to amend a drug monograph either during development or after final publication. For the petition to be considered, submitted data must include information that demonstrates that a product is generally recognized among scientific experts as safe and effective.

OTC Time and Extent Applications: The TEA is used for OTC drug products marketed under certain conditions “to a material extent” and “for a material time” and generally applies to products marketed under an NDA in the U.S. after the OTC Drug Review process began, or have only been marketed outside of the U.S.