Nonresident compounding pharmacies that ship non-FDA approved compounded medications into Ohio are now under heightened scrutiny from the Ohio Board of Pharmacy (“Ohio BOP”). Recent summary suspension orders issued by the Ohio BOP in May 2025 reflect a coordinated enforcement effort targeting compounded products, such as investigational GLP-1 drug therapies like retatrutide and peptides.
This article explores Ohio BOP’s enforcement priorities, highlights specific allegations made against compounding pharmacies, and outlines critical steps pharmacies can take in light of this development.
The Ohio BOP’s Enforcement Focus
The Ohio BOP has alleged that certain pharmacies have engaged in conduct posing a “clear and convincing threat of immediate and serious harm to others”—the legal threshold for emergency summary suspension under applicable Ohio law.
Broader Enforcement Trend: Nonresident Pharmacies Under Increased Scrutiny
The Ohio BOP is actively pursuing nonresident 503A pharmacies involved in dispensing investigational GLP-1 medications and peptides. While these pharmacies may believe they are compliant with federal law (such as §503A or §503B of the FDCA), like many states, Ohio imposes additional, state-specific requirements above and beyond those required by federal regulators. These include:
- Licensure: Pharmacies must maintain proper licensure as terminal distributors of dangerous drugs (TDDD) in Ohio.
- Responsible Person: Appointment of an Ohio-licensed pharmacist as the “Responsible Person” on the TDDD license.
- Bulk Substances: Use of only FDA-approved drugs or components, drugs having a USP/NF monograph or bulk substances on the 503A Bulks List or Category I on the Interim List for compounding.
- Labeling and Documentation: Adherence to Ohio’s labeling requirements and thorough documentation of prescription validation and patient-specific compounding.
- Inspection and Records: Timely and complete responses to Ohio BOP inspection and records requests.
- Drug Quality: Avoidance of misbranded or adulterated drug distribution.
- Federal Compliance: Ongoing compliance with FDA and DEA standards, regardless of the pharmacy’s physical location.
Failure to comply with any of these requirements can result in license suspension, revocation, and significant reputational harm.
Legal Process and Rights Following a Summary Suspension
Under R.C. §4729.571, the Ohio BOP may immediately suspend a pharmacy’s license if there is evidence of a serious risk to public health. However, pharmacies subject to summary suspension retain important legal rights, including:
- Administrative Hearing: The right to request a hearing under Ohio’s Chapter 119 procedures within 30 days of receiving notice.
- Written Defense: The opportunity to submit written defenses and evidence, including documentation of remedial measures.
- Legal Representation: The right to be represented by counsel.
- Consent Agreements: The ability to negotiate consent agreements, which may include probationary terms instead of full license revocation.
- Appeal: The right to appeal adverse rulings to the Ohio Court of Common Pleas.
Comprehensive legal responses supported by documentation of compliance efforts, drug sourcing records, marketing review, and evidence of good faith can help mitigate enforcement outcomes and preserve the ability to dispense into Ohio.
Practical Compliance Considerations for Compounding Pharmacies
Considering this enforcement environment, compounding pharmacies, especially nonresident pharmacies, should implement robust compliance strategies.
Conclusion
Ohio has made clear its intent to address what it views as unsafe or unlawful compounding of GLP-1 and peptide products. Pharmacies dispensing into Ohio should carefully review their licensure status, compliance protocols, and product offerings to minimize the risk of summary suspension and other enforcement actions.
How Frier Levitt Can Help Pharmacies with Board of Pharmacy Issues
Frier Levitt represents pharmacies nationwide in challenging Board of Pharmacy actions. Our attorneys, some of whom are pharmacists and former state licensing board attorneys, have extensive experience navigating state and federal pharmacy laws and advocating for pharmacy rights. If your pharmacy is facing adverse action from a Board of Pharmacy, contact Frier Levitt to speak with a knowledgeable Board of Pharmacy attorney.
