{"id":14734,"date":"2025-02-28T10:40:12","date_gmt":"2025-02-28T15:40:12","guid":{"rendered":"https:\/\/whizkid.com\/a4pc\/?p=14734"},"modified":"2025-03-03T10:42:55","modified_gmt":"2025-03-03T15:42:55","slug":"state-advocacy-updates-feb-28-2025","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2025-02\/state-advocacy-updates-feb-28-2025\/","title":{"rendered":"State advocacy updates: Feb. 28, 2025"},"content":{"rendered":"<h3>NEBRASKA BILL: GOOD INTENTIONS, QUESTIONABLE EXECUTION<\/h3>\n<p>A bill in Nebraska meant to make compounding regulations clearer could have the opposite effect \u2014 something we pointed out in comments to the Nebraska Department of Health and Human Services. Here are some examples:<\/p>\n<ul>\n<li>The bill (LB697) requires \u201cany person authorized to compound\u201d to comply with USP &lt;795&gt; and &lt;797&gt; standards. You might see the problem: 503B compounding facilities don\u2019t operate under USP chapters; they instead must comply with FDA\u2019s Current Good Manufacturing Practices.<\/li>\n<li>The bill would also require that compounded meds produced by 503B outsourcing facilities be labelled \u201cnot for resale.\u201d That seems to conflict with FDA\u2019s summer 2023 draft guidance allowing 503B facilities to sell compounded preparations to 503A pharmacies for patient-specific dispensing under certain circumstances.<\/li>\n<li>A definition in the bill of what constitutes \u201cessentially a copy\u201d of an FDA-approved drug would only allow compounding in cases of a drug shortage or an allergic reaction, ignoring other legitimate clinical circumstances in which a prescriber determined that a compounded medication is medically necessary. Further, it gave the Nebraska HHS the power to decide when a drug was in shortage, rather than either the FDA\u2019s or ASHP\u2019s shortage lists. \u201cWe recommend revising this definition to better reflect FDA\u2019s guidance and clinical realities,\u201d we wrote.<\/li>\n<\/ul>\n<h3>IOWA TO AMEND 503B-503A SALES RULE<\/h3>\n<p>The Iowa Department of Inspections, Appeals, &amp; Licensing believes that its current rules do not allow 503Bs to sell to 503As. The good news is that the board is planning to amend those rules to allow for it, and that update should take effect this summer. In the meantime, licensees can <a href=\"https:\/\/dial.iowa.gov\/licenses\/medical\/pharmacy\" data-hs-link-id=\"0\">visit the BoP\u2019s website<\/a> and request a waiver that would allow the activity now; scroll down to \u201cPetition for Waiver\u201d.<\/p>\n<h3>MISSISSIPPI\u2019S BURDEN<\/h3>\n<p>Over in Mississippi, we had some serious concerns with a temporary rule issued by the state\u2019s board of nursing on January 30, 2025, that imposes additional API verification requirements on pharmacies supplying compounded weight-loss medications.<\/p>\n<p><a href=\"https:\/\/join.a4pc.org\/hubfs\/State-Resources\/MSBON-Letter-Feb2025.pdf\" data-hs-link-id=\"0\">Read the full letter here<\/a>; we\u2019ll keep you updated on what the Mississippi Board of Nursing has to say.<\/p>\n<h3>COMPOUNDING IS STILL COMPOUNDING IN FLORIDA<\/h3>\n<p>Recently, Novo Nordisk asked for a rule hearing about the Florida Board of Pharmacy\u2019s definition of compounding. Specifically, Novo wants the rule to prohibit 503B outsourcing facilities from \u201cthe preparation of drugs for sale or transfer to others for purposes of dispensing or distribution,\u201d claiming, without evidence, that allowing that \u201cwill lead to outsourcing facilities acting akin to traditional drug manufacturers, engaging in widespread wholesaling of compounded drugs for resale for uses outside a healthcare setting.\u201d<\/p>\n<p>Never mind that FDA draft guidance allows 503B facilities to provide compounded drugs to 503A pharmacies for use by specific patients under certain conditions \u2014 and none have suddenly become \u2018widespread wholesalers\u2019. It\u2019s obvious that Novo is looking for yet another way to limit compounding. But based on yesterday\u2019s board meeting, we don\u2019t expect the board to change course.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>News from Nebraska, Iowa, and Florida<br \/><span class=\"read-more\"><a target=\"_blank\" href=\"https:\/\/whizkid.com\/a4pc\/2025-02\/state-advocacy-updates-feb-28-2025\/\"><\/a><\/span><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-14734","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/posts\/14734","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/comments?post=14734"}],"version-history":[{"count":1,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/posts\/14734\/revisions"}],"predecessor-version":[{"id":14735,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/posts\/14734\/revisions\/14735"}],"wp:attachment":[{"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/media?parent=14734"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/categories?post=14734"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/tags?post=14734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}