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DESI 6* – LTE/IRS drug withdrawn from market 07 = Prescription Pre-Natal Vitamin or Fluoride08 = Prescription Dietary Supplement/Vitamin/Mineral (Other than Prescription Pre-Natal Vitamin or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.
Thus, at the end of June, the foreign exchange placements of the banks to the non- government sector registered negative annual growth rate of 2.9%, for the first time since the beginning of the year.
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.
After marketing, the FDA may test the product or otherwise investigate the manufacturing and development of the product to ensure compliance with the OTC Monograph.
FDA refers to the OTC Monograph Drug user fee program as ‘‘OMUFA’’ throughout this document.
A product marketed pursuant to an OTC Monograph must be registered with the FDA and have a National Drug Code listing which is required for all marketed drug products.
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.