Examples of OTC Monograph in a sentence
For drugs with a COD status of OTC Monograph Tentative or Final, this is the FDA’s regulatory citation for the OTC.
For drugs with a COD Status of OTC Monograph Final, the first four characters are a constant of “PART”; the last three characters are the numeric values for the appropriate regulatory citation for the product (e.g., “225”).
For drugs with a COD Status of OTC Monograph Tentative, the first four characters are a constant of “PART”; the last three characters are the numeric values for the appropriate regulatory citation for the product, or three zeros if a Monograph Number is not available.
DESI 6* – LTE/IRS drug withdrawn from market 07 = Prescription Pre-Natal Vitamin or Fluoride08 = Prescription Dietary Supplement/Vitamin/Mineral (Other than Prescription Pre-Natal Vitamin or Fluoride)09 = OTC Monograph Tentative 10 = OTC Monograph Final11 = Unapproved Drug – Drug Shortage12 = Unapproved Drug – Per 1927(k)(2)(A)(ii) 13 = Unapproved Drug – Per 1927(k)(2)(A)(iii)*NDCs with a COD Status of DESI 5/6 are not eligible for coverage or rebates under the Medicaid Drug Rebate Program.
The Pay.gov feature is available on the FDA website after completing the OTC Monograph User Fee Cover Sheet and generating the user fee ID number.
Renu Lal, Pharm.D., “User Fees and the Future of the OTC Monograph System,” FDA/CBER SBIA Chronicles, July 6, 2016, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM510074.pdf.
Such products that meet each of the conditions established in the OTC Monograph regulations and the other applicable regulations may be marketed without prior approval by the FDA.
Our products not subject to and in compliance with an OTC Monograph are new drugs and require prior FDA approval.
FDA refers to the OTC Monograph Drug user fee program as ‘‘OMUFA’’ throughout this document.
The CARES Act and OTC Monograph ReformThe OTC Drug Review created by FDA in 1972 was one of the agency’s largest and most complex regulatory programs.64 While it was intended to provide an efficient mechanism through which OTC drugs could be marketed without individual FDA evaluation and approval, the program encountered several challenges.