Ozempic Compassionate Use and Expanded Access: A Complete 2026 Guide

What Ozempic's FDA approval covers

Ozempic injection was approved under NDA 209637 on December 5, 2017 [1]. The application lists several pen presentations, and one 2 mg/1.5 mL presentation is listed as discontinued [1]. Semaglutide is also sold as Rybelsus tablets (NDA 213051, September 20, 2019), Wegovy injection (NDA 215256, June 4, 2021) and Wegovy tablets (NDA 218316, December 22, 2025) [3][6][7].

The Ozempic label effective June 1, 2026 lists three indications [2]:

1. An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
2. Reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease.
3. Reducing the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.

Ozempic has no weight-loss indication, and its safety and efficacy have not been established in pediatric patients [2].

Why expanded access does not describe Ozempic

Expanded access is the FDA pathway that lets a patient receive an investigational drug outside a clinical trial. Ozempic is not an investigational drug. It has been approved since 2017 and is listed as a prescription product [1].

The trials the label rests on

The cardiovascular indication is supported by SUSTAIN-6, a 104-week trial of 3,297 adults with type 2 diabetes. The composite of cardiovascular death, non-fatal heart attack or non-fatal stroke occurred in 6.6% on semaglutide 0.5 or 1 mg versus 8.9% on placebo (HR 0.74, 95% CI 0.58 to 0.95) [8]. The kidney indication rests on FLOW, which followed 3,533 adults with type 2 diabetes and chronic kidney disease for a median of 3.4 years. Kidney failure, a 50% or greater eGFR drop, or kidney or cardiovascular death occurred in 18.7% on semaglutide 1 mg versus 23.2% on placebo (331 vs 410 first events; HR 0.76, 0.66 to 0.88) [9].

Weight loss belongs to a different semaglutide product

Wegovy injection and Wegovy tablets are separate approved semaglutide products with their own applications [6][7]. Ozempic's label carries no weight-loss indication [2].

Yes, there is an oral Ozempic

Ozempic tablets in 1.5 mg, 4 mg and 9 mg strengths sit under the Rybelsus approval, NDA 213051 [3]. The label effective January 30, 2026 covers both Rybelsus and Ozempic tablets. Both are indicated for glycemic control and for reducing major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk [10]. The label says the two tablet brands are not substitutable mg for mg [10].

Per the label, Ozempic tablets start at 1.5 mg once daily for 30 days, a dose the label says is not effective for glycemic control. The dose is then 4 mg for days 31 to 60, then 4 mg or 9 mg from day 61 [10]. The label says to take them once daily on an empty stomach in the morning with up to 4 ounces of plain water and to swallow them whole. It says to wait at least 30 minutes before food, other drinks or other oral medicines, and to skip a missed dose and take the next dose the following day [10].

Compounded semaglutide: what FDA says

FDA announced on February 21, 2025 that the semaglutide injection shortage was resolved, and the enforcement grace periods for compounders have since ended [11]. Compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness or quality before marketing [4]. FDA says it had received 990 adverse event reports for compounded semaglutide as of May 31, 2026, a figure the agency says likely undercounts. It also describes dosing errors in which patients measured the wrong dose or clinicians miscalculated [4]. FDA states that semaglutide sodium and semaglutide acetate salts are different active ingredients from the approved drug, with no lawful basis for use in compounding that the agency is aware of [4].

On copying an approved product, FDA says it does not intend to take action against a compounder that fills four or fewer prescriptions in a calendar month for a product that is essentially a copy of a commercially available drug. It also describes an exception where a prescriber determines and documents a significant difference for an identified patient [11]. FDA says semaglutide does not appear on the list of bulk drug substances that outsourcing facilities may compound with [11]. On April 30, 2026 the agency proposed excluding semaglutide from that list, finding no clinical need. Comments were due June 29, 2026, and no final decision has been made [5].

FDA's stated position is that compounded drugs should be used only when a patient's medical needs cannot be met by an FDA-approved drug [4].