In spring 2025, the Meals and Drug Administration (FDA) resolved and ended the GLP-1 medicines scarcity, subsequently releasing declaratory orders that neither outsourcing compounding pharmacies or pharmacies might compound medication that had been basically copies of both semaglutide (accessible below the model names Ozempic, Rybelsus, and Wegovy) and tirzepatide (accessible below the model names Mounjaro, and Zepbound). Learn extra about these declaratory orders and ongoing litigation surrounding compounding GLP-1 medicines in our prior weblog posts, “GLP-1 Medication: FDA Removes Semaglutide from the Drug Scarcity Record” and “GLP-1 Medication: FDA Sued Over Eradicating Tirzepatide from the Drug Scarcity Record.”
In response, state regulators have launched up to date steerage directed at suppliers, pharmacies, and outsourcing pharmacies relating to the manufacturing and distribution of those compounded medicines. For instance, in June 2025, Connecticut Lawyer Basic launched a assertion warning companies of allegedly or doubtlessly unfair and misleading conduct associated to compounding of GLP-1 medicines.
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ToggleOhio Board of Pharmacy FAQs
On July 17, 2025, the Ohio Board of Pharmacy adopted go well with, publishing FAQs to resolve potential confusion relating to the manufacturing and distribution of GLP-1 medicines. The FAQs talk about a reversion to establishment in that GLP-1s can now not be compounded as important copies. Though prescriber clinics or compounding pharmacies could proceed to dispense or personally furnish compounded GLP-1s that had been bought previous to the tip dates dictated by the FDA, compounding pharmacies and outsourcing pharmacies can’t dispense or distribute GLP-1s that had been compounded previous to the tip dates.
When GLP-1s could also be Compounded
According to the Meals, Drug, and Beauty Act (FDCA) (21 U.S.C. § 353b), the FAQs state that compounding medication, together with GLP-1s, is acceptable both when the drug is not commercially accessible (together with if there may be an FDA-declared scarcity) or “when the compounded drug features a change, made for an recognized particular person affected person, which produces for that affected person a big distinction, as decided by the prescribing practitioner, between the compounded drug and the commercially accessible product.” In brief, compounding pharmacies will now not have the ability to produce “copies” of commercially accessible medication, together with GLP-1s.
In accordance with the FAQs (and in line with the FDCA), pharmacies will now should make and doc identifiable modifications associated to a prescription for a person affected person with the intention to compound GLP-1 medicines. Additionally in line with the FDCA, prescribers at the moment are required to specify a motive, documented on the prescription, that the compounded drug would produce a big distinction from the commercially accessible product with the intention to justify compounding. Notably, “a prescription that identifies solely a affected person’s identify and drug product formulation is not enough to determine that the prescriber made the willpower that the formulation would produce a big distinction from the commercially accessible drug product.” In accordance with the steerage, acceptable justification and documentation may embody the next:
- “No Dye X, affected person allergy” (if the comparable drug comprises the dye)
- “Liquid kind, affected person canʼt swallow pill” (if the comparable drug is a pill)
- “6 mg, affected person wants larger dose” (if the comparable drug is barely accessible in 5 mg dose).
Lastly, the FAQs clarified that:
The FDA considers a compounded drug product to be basically a duplicate of a commercially accessible drug product if the compounded drug product comprises the identical [active pharmaceutical ingredient] as two or extra commercially accessible drug merchandise in the identical, related, or simply substitutable energy and if the commercially accessible drug merchandise can be utilized (no matter how they’re labeled) by the identical route of administration prescribed for the compounded drug.
Thus, including an extra commercially accessible drug, resembling B12, is inadequate to justify compounding a GLP-1 treatment.
How GLP-1s Have to be Compounded
The FAQs conclude by providing steerage for compounding GLP-1s when permissible. The FAQs refer out to Chapter 4729:7-2 relating to Pharmacy Compounding, Chapter 4729:7-3 relating to Prescriber Compounding, and Chapter 4729:6-10 relating to Outsourcing Amenities for in depth necessities for compounding. Additional, all GLP-1 merchandise are required to satisfy the next three circumstances:
- Adjust to an relevant United States Pharmacopeia (USP) or Nationwide Formulary (NF) monograph if one exists;
- Are parts of FDA-approved drug merchandise if an relevant USP or NF monograph doesn’t exist; or
- Seem on FDAʼs listing of bulk drug substances that can be utilized in compounding (the 503A bulks listing) if such a monograph doesn’t exist and the substance shouldn’t be a element of an FDA-approved drug product.
Lastly, the FAQs state that when compounding any medicines, together with GLP-1s, the energetic pharmaceutical ingredient should be bought from an Ohio licensed drug distributor.
Key Takeaways
The discharge of those FAQs together with steerage from different states indicators growing regulation (and presumably enforcement) of GLP-1 compounding. Suppliers and compounders will wish to pay shut consideration to enforcement tendencies and be certain that their practices are according to state and nationwide compounding necessities.
Foley continues to watch compounded GLP-1 treatment developments in Ohio and throughout the nation. For extra sources on GLP-1 medication and the way they may change the well being care & life sciences and expertise industries, click on right here to learn the opposite articles in our sequence.
Need to Study Extra?
- GLP-1 Receptor Agonists: Scientific Trial Issues
- GLP-1 Receptor Agonists: The Surge of M&A Exercise and the Way forward for Metabolic Well being
- GLP-1 Receptor Agonists: Drug Litigation Overview and Tendencies
- GLP-1 Receptor Agonists and Patent Technique: Securing Patent Safety for New Use of Outdated Medication
Foley is right here that will help you handle the short- and long-term impacts within the wake of regulatory modifications. Now we have the sources that will help you navigate these and different essential authorized issues associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship companion, our Well being Care & Life Sciences Sector, or to our Progressive Expertise Sector with any questions.
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