1.0Public Citizenhttps://www.citizen.orgDiane Krauthamerhttps://www.citizen.org/author/dkrauthamer/Comments on the FDA's Draft Guidances on the Prescription Requirement Under Section 503A and the Facilities Definition Under Section 503B - Public Citizenrich600338<blockquote class="wp-embedded-content" data-secret="w4pyQzM1eV"><a href="https://www.citizen.org/article/comments-on-the-fdas-draft-guidances-on-the-prescription-requirement-under-section-503a-and-the-facilities-definition-under-section-503b/">Comments on the FDA’s Draft Guidances on the Prescription Requirement Under Section 503A and the Facilities Definition Under Section 503B</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.citizen.org/article/comments-on-the-fdas-draft-guidances-on-the-prescription-requirement-under-section-503a-and-the-facilities-definition-under-section-503b/embed/#?secret=w4pyQzM1eV" width="600" height="338" title="“Comments on the FDA’s Draft Guidances on the Prescription Requirement Under Section 503A and the Facilities Definition Under Section 503B” — Public Citizen" data-secret="w4pyQzM1eV" 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>
Public Citizen supports policies contained in these two recent FDA guidances, which generally serve to clarify the line between traditional pharmacy compounding and drug manufacturing. In particular, we agree that Section 503A limits traditional compounding pharmacies from selling “office stock” in bulk to healthcare practitioners, approve of clear limitations on anticipatory compounding, and approve of the requirement that all products produced by outsourcing facilities comply with current good manufacturing practices.https://www.citizen.org/wp-content/uploads/public_citizen_shared_link.jpg1200628