OTC Monograph definition

OTC Monograph means a monograph established by the FDA setting forth acceptable ingredients, doses, formulations, and labeling for a class of OTC drugs. When a final OTC Monograph is adopted by the FDA for a class of drugs, OTC drugs that conform to the monograph are considered to be generally recognized as safe and effective and do not need an approved drug application in order to be marketed.
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OTC Monograph means an over-the-counter drug monograph, as more fully described in 21 C.F.R. sections 330 et seq.;
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OTC Monograph means an over-the-counter drug monograph, as more fully described in 21 C.F.R. sections 330 et seq.; “OTC Product” a product approved by a relevant Governmental Entity as a medicine available for purchase by customers
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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  • DESI 6* – LTE/IRS drug withdrawn from market 07 = Prescription Pre-Natal Vitamin or Fluoride08 = Prescription Dietary Supplement/Vitamin/Mineral (Other than Prescription Pre-Natal Vitamin or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.


More Definitions of OTC Monograph

OTC Monograph means a monograph established by the FDA setting forth acceptable ingredients, doses, formulations, and labeling for a class of OTC drugs
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Related to OTC Monograph

  • OTC Markets means either OTC QX or OTC QB of the OTC Markets Group, Inc.

  • OTC Market means any over-the-counter market or over-the-telephone market in any country in any part of the world, and in relation to any particular Authorised Investment shall be deemed to include any responsible firm, corporation or association in any country in any part of the world dealing in the Authorised Investment which the Manager may from time to time elect.

  • Pink OTC Markets means the OTC Markets Group Inc. electronic inter-dealer quotation system, including OTCQX, OTCQB and OTC Pink.

  • OTC means Over-the-Counter.

  • published market means, for a class of securities, a marketplace on which the securities have traded that discloses regularly in a publication of general and regular paid circulation or in a form that is broadly distributed by electronic means the prices at which those securities have traded;

  • Catalogue means the catalogue of IT Products available for Order under the provisions of the Framework Agreement.

  • OTC Bulletin Board means the over-the-counter electronic bulletin board.

  • Bulletin Board means the Over-the-Counter Bulletin Board.

  • Radiograph means an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.

  • OTCQB means the OTCQB Market.

  • OTCQX means the OTCQX tier of the OTC Markets Group Inc.

  • Catalog means the available list of tangible personal property or services, in the most current listing, regardless of date, during the life of the contract, that takes the form of a catalog, price list, schedule, shelf price or other form that:

  • Magazines means magazines and other materials printed on similar paper.

  • phonogram means the fixation of the sounds of a performance or of other sounds, or of a representation of sounds, other than in the form of a fixation incorporated in a cinematographic or other audiovisual work;

  • Tape Defined in Section 7.2(b)(ii).

  • Bulletin means a revenue administrative bulletin.

  • Bureau means the Enforcement Bureau of the Federal Communications Commission.

  • OTCBB means the Over-The-Counter Bulletin Board.

  • Metadata includes all information created manually or automatically to provide meaning or context to other data.

  • Journal means the official Journal of the European Union or successor publication thereto.

  • Over-the-counter drug means a drug that contains a label

  • Student journalist means a student who gathers, writes, edits, photographs, records, video tapes, or prepares information for dissemination in student media.

  • securities dealer means a person or entity that is authorized under provincial legislation to engage in the business of dealing in securities or any other financial instruments or to provide portfolio management or investment advising services.

  • Publisher means any person or entity that distributes copies of the Document to the public.

  • Orange Book means the FDA publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” or any replacement thereof established or approved by the FDA.

  • Nasdaq National Market means the National Association of Securities Dealers Automated Quotation National Market or any successor national securities exchange or automated over-the-counter trading market in the United States.