{"id":264,"date":"2024-03-14T21:11:45","date_gmt":"2024-03-14T21:11:45","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-support\/?p=264"},"modified":"2024-03-14T21:11:45","modified_gmt":"2024-03-14T21:11:45","slug":"key-terms-under-mocra","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-support\/2024\/03\/14\/key-terms-under-mocra\/","title":{"rendered":"Key Terms under MoCRA"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">FDA requires every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US to submit <a href=\"https:\/\/www.fdahelp.us\/fda-mocra-registration-listing-cosmetic-facility.html\">cosmetic facility registration<\/a> with FDA. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA also requires that for each cosmetic product, the\nresponsible person must submit to FDA a <a href=\"https:\/\/www.fdahelp.us\/fda-mocra-registration-listing-cosmetic-facility.html\">cosmetic\nproduct listing<\/a>. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Key terms under MoCRA:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CONTRACT MANUFACTURER \u2014 a facility that manufactures or\nprocesses a cosmetic product on behalf of another entity. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/cosmetics.html\">COSMETIC\nPRODUCT<\/a>&#8211; a preparation of cosmetic ingredients with a qualitatively and\nquantitatively set composition for use in a finished product. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/duns-number-fda-registration-faq.html\">DUNS NUMBER<\/a> \u2014 The Data Universal Numbering System (DUNS) number is a unique nine-digit identification number issued by D&amp;B. The DUNS Number is sites specific. Therefore, each distinct physical location of an entity (such as branches, divisions, and headquarters) may be assigned a DUNS number. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FACILITY &#8211; any establishment (including an establishment of\nan importer) that manufactures or processes cosmetic products distributed in\nthe United States. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Excluding:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Beauty shops and salons<\/li><li>Cosmetic product retailers<\/li><li>Hospitals, physicians\u2019 offices, and health care\nclinics<\/li><li>Public health agencies and other nonprofit\nentities that provide cosmetic products directly to the consumer<\/li><li>Entities (such as hotels and airlines) that\nprovide complimentary cosmetic products to customers incidental to other\nservices<\/li><li>Trade shows and other venues where cosmetic\nproduct samples are provided free of charge<\/li><li>An establishment that manufactures or processes\ncosmetic products that are solely for use in research or evaluation, including\nfor production testing and not offered for retail sale<\/li><li>An establishment that solely performs one or\nmore of the following with respect to cosmetic products: <\/li><li>Labeling<\/li><li>Relabeling<\/li><li>Packaging<\/li><li>Repackaging<\/li><li>Holding<\/li><li>Distributing<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">FEI &#8211; FDA Establishment Identifier &#8211; It is also known as the\nFirm or Facility Establishment Identifier. The FEI number is a unique\nidentifier assigned by the FDA to identify firms associated with FDA-regulated\nproducts. FDA intends to use a facility\u2019s FEI number as the cosmetic product\nfacility\u2019s registration number. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MANUFACTURING OR PROCESSING OF A COSMETIC PRODUCT &#8211; means\nengaging in one or more steps in the making of any cosmetic product by\nchemical, physical, biological, or other procedures, including manipulation,\nsampling, testing, or control procedures applied to the product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">OPERATOR &#8211; a person who has management authority over an\nestablishment. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">OWNER &#8211; a person who has an ownership interest in an\nestablishment. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">RESPONSIBLE PERSON &#8211; the manufacturer, packer, or\ndistributor of a cosmetic product whose name appears on the label of such\ncosmetic product in accordance with section 609(a) of the FD&amp;C Act or\nsection 4(a) of the Fair Packaging and Labeling Act. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SMALL BUSINESSES \u2014 means responsible persons, and owners and\noperators of facilities, whose average gross annual sales in the U.S. of\ncosmetic products for the previous 3-year period is less than $1,000,000,\nadjusted for inflation, and who do not engage in the manufacturing or\nprocessing of certain cosmetic products:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual<\/li><li>Cosmetic products that are injected<\/li><li>Cosmetic products that are intended for internal use<\/li><li>Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/\"><em>Liberty Management Group Ltd.<\/em><\/a><em> can help you with FDA MoCRA regulations &amp; US Agent service. <\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Namrata <\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Regulatory Consultant<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>support@libertymanagement.us<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">http:\/\/www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA requires every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US to submit cosmetic facility registration with FDA. FDA also requires that for each cosmetic product, the responsible person must submit to FDA a cosmetic product listing. Key terms under &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-support\/2024\/03\/14\/key-terms-under-mocra\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Key Terms under MoCRA&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13,38],"tags":[70],"class_list":["post-264","post","type-post","status-publish","format-standard","hentry","category-cosmetics-regulations","category-us-fda-registration","tag-mocra"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/264","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/comments?post=264"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/264\/revisions"}],"predecessor-version":[{"id":265,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/264\/revisions\/265"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/media?parent=264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/categories?post=264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/tags?post=264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}