A Golden Opportunity for Compounding Pharmacies: Navigating the Ozempic Shortage

Introduction

In 2023, the demand for a new class of weight-loss treatments skyrocketed. Initially approved for managing type 2 diabetes, glucagon-like peptide-1 receptor agonist drugs (GLP-1s) such as Wegovy, Zepbound, Ozempic, and Mounjaro have become popular for weight loss despite their high costs and limited insurance coverage. Wegovy, Saxenda, and Zepbound are FDA-approved for chronic weight management in adults, while others like Ozempic are frequently prescribed off-label for weight loss.

As a result of this massive demand, the FDA has placed Ozempic and Wegovy on its shortages list. This isn't just a bureaucratic update: it's a golden opportunity for compounding pharmacies. With the demand for semaglutide soaring and the supply of the brand name drug limited, pharmacies that can compound and distribute semaglutide-based medications are in an enviable position. This moment is being dubbed the "Gold Rush" of Ozempic, and those who navigate it wisely can expect substantial profits.

Some estimates project GLP-1 sales will exceed $100 billion by 2030. As a pharmacy owner, it's crucial to stay updated on the evolving regulatory landscape and reimbursement policies for these medications. Having a skilled attorney on hand is essential to navigate potential legal challenges. Here are key considerations to keep in mind.

State Prescribing Standards for Obesity Medication

We have written about the Increasing Regulatory Threats Compounding Pharmacies Face

Different states have specific requirements for prescribing weight-loss medications. Understanding these standards is crucial for ensuring compliance and avoiding legal repercussions.

The list of states where Boards of Pharmacy have imposed regulations on weight loss drug prescriptions and distribution is growing, and currently includes North Carolina, West Virginia, Mississippi, California, Florida, New Jersey, and Virginia.

It is always recommended to consult with a healthcare attorney who is aware of the ever-changing regulatory landscape to ensure your pharmacy's practices align with state laws to avoid penalties and maintain your professional license.

Telehealth Prescriber Requirements Also Vary By State

Telehealth standards also vary by state, including who can prescribe via telehealth and the technologies allowed for patient examinations and establishing patient-physician relationships.

A physician’s license was suspended in May 2023 by the Mississippi State Board of Medical Licensure for prescribing Ozempic through an instant-messaging platform. Several violations included failure to establish a valid physician-patient relationship, underscoring the importance of understanding the nuances of state-specific telehealth regulations.

As the trend of weight-loss-related prescribing grows, expect increased enforcement of these laws. Ensure your telehealth services comply with state regulations to avoid disciplinary actions. Your attorney can provide guidance on navigating these complex requirements.

Limitations on Off-Label Prescribing of GLP-1s

A recent analysis found that more than half of new Ozempic and Mounjaro users did not have type 2 diabetes.  Demand for GLP-1 drugs has surged, and some are in short supply. Some companies are prioritizing access for Type 2 diabetes patients over off-label weight-loss uses. Many patients are turning to online and out-of-country pharmacies to obtain the medications.

In June 2023, Anthem Blue Cross Blue Shield warned prescribers about off-label Ozempic prescriptions for non-diabetic patients, citing insufficient evidence of diabetes in 60% of cases. Off-label use that doesn't meet criteria exposes prescribers to potential insurance fraud claims and disciplinary actions.

In August 2023, the Mississippi Board of Medical Licensure prohibited unapproved use of GLP-1 medications specifically for weight loss based on FDA and state pharmacy board information.

If a prescription is falsely claimed as on-label when it is not, such a misrepresentation can expose the prescriber to potential insurance fraud accusations, which may result in civil and/or criminal penalties. Additionally, state professional boards may discipline prescribers for prescribing inappropriate medications or incorrect quantities.

FDA and State Restrictions on Compounding GLP-1s

Increased GLP-1 prescribing and compounding have attracted attention from state boards and the FDA. The Alabama Board of Medical Examiners voiced their “Concerns with Semaglutide and Other GLP-1 Receptor Agonists” and issued guidance against improper GLP-1 compounding, prohibiting the use of non-pharmaceutical grade ingredients or those not from FDA-registered establishments.

In 2023, the FDA clarified that compounded drugs could be made with fewer restrictions when listed on the FDA’s drug shortage list but warned against using salt forms of semaglutide that do not meet federal requirements.

Conclusion

The rise of GLP-1s for chronic weight management significantly impacts US obesity care. As these drugs become more accessible, federal and state regulators and payors are increasingly scrutinizing their use. As a pharmacy owner, staying informed about regulatory changes and ensuring your practices comply with federal, state, and payor requirements is crucial. Having a skilled attorney on hand will help you navigate the evolving landscape effectively, mitigate risks, and maintain the trust and safety of your customers.

Please contact us if you have any specific questions regarding your pharmacy or semaglutide program.