Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

Compounding GLP-1 Drugs - Recent Updates

Client Alert

More individuals are utilizing weight loss medication than ever before. With the rise in usage, providers must be aware of when, how, and why they are able to prescribe or create compounded GLP-1 drugs.       

Recent guidance from the Ohio Board of Pharmacy (“BOP”) indicates that providers should generally use the FDA approved GLP-1 drug, rather than a non-FDA approved compounded version of the medication. Importantly, if a GLP-1 drug is commercially available, it cannot be copied through compounding. Currently, compounded copies of Tirzepatide and Semaglutide are not permitted.  

There are two exceptions that allow a provider to compound a GLP-1 drug: (1) if the drug is not commercially available, and (2) if the compounded drug “includes a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the commercially available product.” The identified change must be documented appropriately on the prescription or order.

The BOP also prohibits a provider from using certain ingredients in compounding. For example, Retatrutide and Cagrilintide are not permitted to be used in compounding. In addition, providers cannot use salt forms when compounding GLP-1 drugs. 

While compounded GLP-1 drugs do serve a purpose, such as serving an individualized patient need, the United States Food and Drug Administration (“FDA”) has stated its concern with using any non-FDA approved GLP-1 drug. According to the FDA, one of the potential concerns is that the compounded drug may contain the incorrect amount of an active ingredient, leading to adverse effects. If using a compounded GLP-1 medication, providers will want to ensure that they are creating and storing the compounded drugs correctly, that they are not utilizing drugs labeled “for research purposes only,” and that any active ingredients purchased are from an FDA registered and Ohio licensed distributor.

To learn more about how drug compounding regulations can impact your practice, please contact BMD Member Jeana Singleton at jmsingleton@bmdllc.com or 330-253-2001. 


January 2025 Notice of Proposed Rulemaking Brings Notable Changes to HIPAA Security Rule

In January 2025, the U.S. Department of Health and Human Services proposed amendments to the HIPAA Security Rule, aiming to enhance cybersecurity for covered entities (CEs) and business associates (BAs). Key changes include mandatory compliance audits, workforce training, vulnerability scans, and risk assessments. Comments on the proposed rule are due by March 7, 2025.

Corporate Transparency Act Effective Again

The federal judiciary has issued multiple rulings on the enforceability of the Corporate Transparency Act (CTA), which took effect on January 1, 2024. Previously, enforcement was halted nationwide due to litigation in Smith v. U.S. Department of the Treasury. However, on February 18th, the court lifted the stay, reinstating the CTA’s reporting requirements. Non-exempt entities now have until March 21, 2025, to comply. Businesses should act promptly to avoid civil penalties of $591 per day and potential criminal liability.

Status Update: Physician Noncompete Agreements in Ohio

Noncompete agreements remain enforceable in Ohio if they meet specific legal requirements. While the AMA and FTC have challenged these restrictions, courts continue to uphold reasonable noncompete provisions for physicians. Recent cases, like MetroHealth System v. Khandelwal, highlight how courts may modify overly restrictive agreements to balance employer interests with patient care. With ongoing legal challenges to the FTC’s proposed ban, Ohio physicians should consult a healthcare attorney before signing or challenging a noncompete agreement.

Immigration Orders and Their Economic Impact on Small Business: Insights from Attorney and Former Immigration Judge Rob Ratliff

President Trump's recent executive orders, targeting immigration policies, could significantly impact small businesses in Ohio, particularly those owned by undocumented immigrants. With stricter visa vetting, halted refugee admissions, and potential deportations, these businesses face uncertainty, workforce disruption, and closures. Ohio's immigrant-owned businesses, especially in food services and transportation, contribute billions to the state economy, and any disruption could result in economic ripple effects.

Corporate Transparency Act Ruling from the U.S. Supreme Court

The U.S. Supreme Court recently ruled on the enforceability of the Corporate Transparency Act (CTA), lifting an injunction previously imposed by the Fifth Circuit. However, a separate nationwide injunction remains in effect, meaning businesses are still not required to comply with the CTA’s reporting requirements. FinCEN continues to accept voluntary reporting while enforcement remains paused.