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 a monograph established by the FDA setting forth acceptable ingredients, doses, formulations, and labeling for a class of OTC drugs
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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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Examples of OTC Monograph in a sentence

  • EBSA and CMS investigated MHPAEA violations in the following categories: (1) Annual dollar limits: dollar limitations on the total amount of specified benefits that may be paid in a 12-month period under a group health plan or health insurance coverage for any coverage unit (such as self-only or family coverage).

  • FDA refers to the OTC Monograph Drug user fee program as “OMUFA” throughout this document.

  • Nexafed and Nexafed Sinus Pressure + Pain products are marketed pursuant to the FDA’s OTC Monograph regulations, which require that our product have labeling as specified in the regulations.

  • Nexafed and Nexafed Sinus Pressure + Pain products are marketed under FDA’s regulations applicable to OTC Monograph products.

  • A core component of OTC monograph reform is the introduction of a user fee program, the OTC Monograph User Fee Act (OMUFA).As noted previously, the process of completing and updating monographs had moved at a glacial pace in large part due to FDA’s lack of resources.

  • The FDA regulates certain non-prescription drugs using an OTC Monograph which, when final, is published in the Code of Federal Regulations at 21 C.F.R. Parts 330-358.

  • Should the FDA determine that a product is not marketed in compliance with the OTC Monograph or is advertised outside of its regulations, the FDA may require corrective action up to and including market withdrawal and market recall.

  • If the FDA disagrees with our determination that certain of our products meet the over-the-counter, or OTC, Monograph requirements, once those products are commercialized, they may be removed from the market; the FDA or the U.S. Federal Trade Commission, or FTC, may object to our advertisement and promotion of the extraction characteristics and benefits of our Nexafed 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.

  • Product Labeling for Impede Technology Products Nexafed and Nexafed Sinus Pressure + Pain products are marketed pursuant to the FDA’s OTC Monograph regulations, which require that our product have labeling as specified in the regulations.


More Definitions of OTC Monograph

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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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 are traded, if the prices at which they have been traded on that marketplace are regularly

  • 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.

  • 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.

  • Images means all types of visual content, including without limitation still photography, motion film or video and may include audio elements, whether generated optically, electronically, digitally or by any other means, and shall include all metadata, keywords, descriptions and captions associated therewith. Any reference to Images includes the whole or the part.

  • Websites means all Internet websites, including content, text, graphics, images, audio, video, data, databases, Software and related items included on or used in the operation of and maintenance thereof, and all documentation, ASP, HTML, DHTML, SHTML, and XML files, cgi and other scripts, subscriber data, archives, and server and traffic logs and all other tangible embodiments related to any of the foregoing.