1.0Public Citizenhttps://www.citizen.orgDiane Krauthamerhttps://www.citizen.org/author/dkrauthamer/rich600338<blockquote class="wp-embedded-content" data-secret="c5qCd8nSNg"><a href="https://www.citizen.org/article/comments-on-the-fdas-draft-guidance-regarding-evaluation-of-bulk-drug-substances-nominated-for-use-in-compounding-under-section-503b-of-the-federal-food-drug-and-cosmetic-act/">Comments on the FDA’s Draft Guidance Regarding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.citizen.org/article/comments-on-the-fdas-draft-guidance-regarding-evaluation-of-bulk-drug-substances-nominated-for-use-in-compounding-under-section-503b-of-the-federal-food-drug-and-cosmetic-act/embed/#?secret=c5qCd8nSNg" width="600" height="338" title="“Comments on the FDA’s Draft Guidance Regarding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act” — Public Citizen" data-secret="c5qCd8nSNg" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript"> /* <![CDATA[ */ /*! This file is auto-generated */ !function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document); /* ]]> */ </script> In general, Public Citizen strongly supports the policies proposed in the draft guidance document. In particular, the proposed guidance seeks to appropriately limit, under section 503B, the use of bulk drug substances by outsourcing facilities in pharmacy compounding of human drug products that are not on the FDA’s drug shortage list.https://www.citizen.org/wp-content/uploads/public_citizen_shared_link.jpg1200628