About Ro’s offering

Why is Ro offering a compounded semaglutide option?

Ro believes that everyone, for whom GLP-1s are clinically appropriate, deserves access to the medications paired with high-quality, provider-led care that together can help them reach their health goals and live healthier, longer lives.

What is the compounded formula offered by Ro?

Ro is offering a compounded formulation with semaglutide base, the same active pharmaceutical ingredient (API) that’s in branded semaglutide. Ro is not offering any compounded semaglutide salts.

Compounded drugs are permitted to be prescribed under federal law, but they are not FDA-approved nor do they require safety, effectiveness, or manufacturing review. Ro is committed to the measures outlined below to independently monitor the quality of the compounded formulation.

Who is eligible for compounded semaglutide treatment?

Compounded semaglutide, much like any GLP-1 medication in the Body Program, is available only to patients for whom  it is a medically safe and appropriate treatment, as determined by a licensed provider.

How does a patient get prescribed compounded semaglutide?

Before receiving a prescription, every patient must start by completing a Body Program online visit sharing details of their medical history and goals. A Ro-affiliated provider then reviews the online visit information and, if appropriate, orders a metabolic lab test to get additional information about the patient’s metabolic health. Next, a Ro-affiliated provider reviews the patient’s lab results in the context of their medical history to determine whether treatment is appropriate. If so, then the provider counsels the patient on risks and benefits of either branded semaglutide (Ozempic or Wegovy) or compounded semaglutide.

How does Ro support patients who are prescribed compounded semaglutide?

Every patient who is prescribed a GLP-1 medication, whether compounded or branded medication, receives ongoing care and support through the Body Program. This comprehensive program offers patients regular consultations with a licensed provider, ongoing 1-1 coaching from nurses, anytime messaging support, progress and side effect tracking, and an educational curriculum.

How we’re approaching quality of compounding

Who is making the compounded medication?

Committed to patient safety and high-quality products, Ro works closely with compounding pharmacy partners that are appropriately licensed, follow rules for sterile compounding, and source semaglutide base from FDA-registered Active Pharmaceutical Ingredient (API) manufacturers.

How will Ro assess the quality of this compounded treatment?

Ro, its vetted partners, and certified third-party labs run quality assurance and quality control checks for every batch of compounded semaglutide prescribed for Ro patients.

Some of these steps include but are not limited to:

• Reviewing and confirming the Active Pharmaceutical Ingredient (API) Certificate of Analysis for all semaglutide base lots, which are received from FDA-registered manufacturers;

• Storing the verified API frozen and sealed until use;

• Compounding with the API under aseptic processes to produce specific lots (vials);

• Holding the vials of compounded semaglutide in quarantine (representative samples are taken for testing);

• Using independent third-party laboratories to test the potency, sterility and endotoxicity of each lot of compounded semaglutide (among other criteria);

• Reviewing the results of these tests and, if satisfactory, releasing the validated vials from quarantine for dispensing; 

• Assigning each compounded lot a unique lot number and BUD (Beyond Use Date), which is added to the container and is tracked electronically;

• Scanning the lot information on the product at the time of dispensing, which ties a particular lot number to the patient’s file.

Those extensive quality assurance procedures occur before any medication is shipped to patients, and then we:

• Ship the compounded semaglutide medication to patients in temperature-controlled packaging;

• Track for any potential patient reports of adverse events, and have the ability to identify which lot the patient received, the date that lot was compounded, and the pharmacist responsible for that lot.

What happens if a patient experiences a side effect?

Through Ro’s platform, we are able to closely monitor a patient's care. Ro does so through a variety of measures, including, but not limited to required check-ins at specific cadences in order for patients to continue to receive treatment, enabling patients to message their healthcare provider 24/7, enabling them to schedule phone and video calls with their providers, and enabling patients to report side effects, in a structured format, that are reviewed by their healthcare providers. 

When side effects are reported, Ro’s platform enables timely review and response from a patient’s care team. Depending on the severity of a side effect, this may include, but not be limited to, sharing information about how to manage or mitigate a mild side effect, provider counsel on adjustments to a treatment plan, or for more serious side effects, directing a patient to seek in-person care from their primary care provider or, if urgent, an emergency department.

How will Ro track patient response to the compounded treatment?

Ro’s team and our affiliated providers will track side effects using the same process that it currently uses for all Body Program patients, as well as several additional steps. This process is enabled by frequent touchpoints between patients and their care team, including required check-ins and access to anytime messaging. When a patient reports a potential side effect/adverse event, it is both reviewed to determine the most appropriate response to the patient and escalated to assess the need for any further investigation.

In the case of compounded semaglutide, side effect data is linked with numbered individual lots of compounded semaglutide so that any possible adverse events can be monitored, traced, and responded to. Separately, the compounding pharmacies that Ro is working with have a process for documenting patient complaints, side effects, and adverse events that they may receive directly. Ro’s team and the pharmacies will both have visibility into each other’s documentation.