GLP-1 Medication: Ohio Board of Pharmacy Points FAQs for Compounders

In spring 2025, the Meals and Drug Administration (FDA) resolved and ended the GLP-1 drugs scarcity, subsequently releasing declaratory orders that neither outsourcing compounding pharmacies or pharmacies might compound medication that have 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 drugs 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 steering directed at suppliers, pharmacies, and outsourcing pharmacies relating to the manufacturing and distribution of those compounded drugs. For instance, in June 2025, Connecticut Lawyer Normal launched a assertion warning companies of allegedly or probably unfair and misleading conduct associated to compounding of GLP-1 drugs.

Ohio Board of Pharmacy FAQs

On July 17, 2025, the Ohio Board of Pharmacy adopted swimsuit, publishing FAQs to resolve potential confusion relating to the manufacturing and distribution of GLP-1 drugs. The FAQs focus on a reversion to established order 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 have been bought previous to the top dates dictated by the FDA, compounding pharmacies and outsourcing pharmacies can’t dispense or distribute GLP-1s that have been compounded previous to the top 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’s 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.” Briefly, 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 must make and doc identifiable modifications associated to a prescription for a person affected person to be able to compound GLP-1 drugs. Additionally in line with the FDCA, prescribers are actually required to specify a purpose, documented on the prescription, that the compounded drug would produce a big distinction from the commercially accessible product to be able to justify compounding. Notably, “a prescription that identifies solely a affected person’s identify and drug product formulation is not ample to ascertain that the prescriber made the willpower that the formulation would produce a big distinction from the commercially accessible drug product.” In accordance with the steering, applicable justification and documentation may embody the next:

• “No Dye X, affected person allergy” (if the comparable drug accommodates the dye)
• “Liquid type, affected person canʼt swallow pill” (if the comparable drug is a pill)
• “6 mg, affected person wants increased dose” (if the comparable drug is simply 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 accommodates the identical [active pharmaceutical ingredient] as two or extra commercially accessible drug merchandise in the identical, comparable, or simply substitutable power 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 a further commercially accessible drug, equivalent to B12, is inadequate to justify compounding a GLP-1 medicine.

How GLP-1s Should be Compounded

The FAQs conclude by providing steering 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 situations:

1. Adjust to an relevant United States Pharmacopeia (USP) or Nationwide Formulary (NF) monograph if one exists;
2. Are elements of FDA-approved drug merchandise if an relevant USP or NF monograph doesn’t exist; or
3. Seem on FDAʼs record of bulk drug substances that can be utilized in compounding (the 503A bulks record) if such a monograph doesn’t exist and the substance is just not a element of an FDA-approved drug product.

Lastly, the FAQs state that when compounding any drugs, 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 steering from different states indicators rising regulation (and presumably enforcement) of GLP-1 compounding.  Suppliers and compounders will wish to pay shut consideration to enforcement traits and be sure that their practices are according to state and nationwide compounding necessities.  

Foley continues to observe compounded GLP-1 medicine developments in Ohio and throughout the nation. For extra sources on GLP-1 medication and the way they’ll change the well being care & life sciences and know-how industries, click on right here to learn the opposite articles in our sequence.

Need to Be taught Extra?

• GLP-1 Receptor Agonists: Medical Trial Concerns
• 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 Developments
• GLP-1 Receptor Agonists and Patent Technique: Securing Patent Safety for New Use of Outdated Medication

Foley is right here that can assist you deal with the short- and long-term impacts within the wake of regulatory modifications. We’ve the sources that can assist 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 accomplice, our Well being Care & Life Sciences Sector, or to our Revolutionary Expertise Sector with any questions.