FDA Enforcement on GLP-1 Compounding Intensifies as Drug Shortages Resolve

With semaglutide and tirzepatide shortages resolved, the FDA is implementing strict enforcement on compounded GLP-1 medications, ending the legal gray zone that previously existed. The rapid growth of compounded alternatives now faces closer scrutiny as innovator drug supplies stabilize.

Research has identified 33 unique compounded GLP-1 products, many featuring nonstandard formulations. These include sublingual delivery, orally disintegrating tablets (ODT), and combinations mixed with vitamins, antiemetics, or laxatives. Little evidence supports the added ingredients or alternative routes of administration, and safety and efficacy data remain largely unknown compared with FDA-approved products.

Transparency concerns have emerged around compounded formulations. Less than 20% of products reported beyond-use dates, and less than 30% reported storage conditions. This lack of standardized information raises questions about quality control and patient safety.

Compounded semaglutide formulations can be customized in strength and delivery method to reflect individual patient differences. Sublingual delivery allows medication to be absorbed through tissues under the tongue rather than passing through the digestive system, which may improve bioavailability and provide more consistent absorption for some individuals. Compounded formulations use USP-grade semaglutide to help ensure purity and consistency.

Some compounded products incorporate advanced absorption bases such as SubMagNA to enhance delivery. By tailoring both the active ingredient and the delivery system, pharmacists can address individual preferences and tolerances. Sublingual compounded semaglutide may appeal to patients who prefer not to use injectable medications, expanding access to alternative treatment options.

Weight management strategies using compounded medications may include consideration of nutritional supplementation and lifestyle factors when developing personalized plans. No two patients share the same medical history, metabolism, or weight loss objectives, and compounded formulations can be adjusted to reflect those differences.

However, when evidence, dosing standards, and safety data lag behind innovation, patients may be exposed to unnecessary risk. The focus on pharmaceutical standards is presented as an important factor in delivering reliable outcomes and maintaining patient trust as regulatory enforcement intensifies.