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State advocacy updates

NEBRASKA BILL: GOOD INTENTIONS, QUESTIONABLE EXECUTION

A bill in Nebraska meant to make compounding regulations clearer could have the opposite effect — something we pointed out in comments to the Nebraska Department of Health and Human Services. Here are some examples:

  • The bill (LB697) requires “any person authorized to compound” to comply with USP <795> and <797> standards. You might see the problem: 503B compounding facilities don’t operate under USP chapters; they instead must comply with FDA’s Current Good Manufacturing Practices.
  • The bill would also require that compounded meds produced by 503B outsourcing facilities be labelled “not for resale.” That seems to conflict with FDA’s summer 2023 draft guidance allowing 503B facilities to sell compounded preparations to 503A pharmacies for patient-specific dispensing under certain circumstances.
  • A definition in the bill of what constitutes “essentially a copy” 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’s or ASHP’s shortage lists. “We recommend revising this definition to better reflect FDA’s guidance and clinical realities,” we wrote.

IOWA TO AMEND 503B-503A SALES RULE

The Iowa Department of Inspections, Appeals, & 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 visit the BoP’s website and request a waiver that would allow the activity now; scroll down to “Petition for Waiver”.

MISSISSIPPI’S BURDEN

Over in Mississippi, we had some serious concerns with a temporary rule issued by the state’s board of nursing on January 30, 2025, that imposes additional API verification requirements on pharmacies supplying compounded weight-loss medications.

Read the full letter here; we’ll keep you updated on what the Mississippi Board of Nursing has to say.

COMPOUNDING IS STILL COMPOUNDING IN FLORIDA

Recently, Novo Nordisk asked for a rule hearing about the Florida Board of Pharmacy’s definition of compounding. Specifically, Novo wants the rule to prohibit 503B outsourcing facilities from “the preparation of drugs for sale or transfer to others for purposes of dispensing or distribution,” claiming, without evidence, that allowing that “will 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.”

Never mind that FDA draft guidance allows 503B facilities to provide compounded drugs to 503A pharmacies for use by specific patients under certain conditions — and none have suddenly become ‘widespread wholesalers’. It’s obvious that Novo is looking for yet another way to limit compounding. But based on yesterday’s board meeting, we don’t expect the board to change course.