FDA Compounding Regulations in 2026: What Has Changed

The regulatory landscape for pharmaceutical compounding has been in continuous evolution since the Drug Quality and Security Act (DQSA) was enacted in 2013. For medical practices that depend on compounded medications, staying current on FDA regulatory developments is not optional — it is a compliance requirement.

This post covers the key regulatory developments affecting compounding in 2026 and what they mean for your practice.

The Drug Quality and Security Act (DQSA) of 2013 created the current two-track compounding framework:

Section 503A — Traditional compounding pharmacies that prepare patient-specific medications based on valid prescriptions. Primarily regulated by state boards of pharmacy, with some federal oversight.

Section 503B — Outsourcing facilities that can produce larger batches without patient-specific prescriptions. Registered with and inspected by the FDA. Subject to CGMP standards.

This framework has been the foundation of compounding regulation for over a decade, but the FDA's implementation and enforcement of this framework has continued to evolve.

The FDA's shortage designations for semaglutide and tirzepatide have been among the most consequential regulatory developments for the compounding industry. The permissibility of compounding these compounds is directly tied to their shortage status.

The FDA has updated these designations multiple times, and the current status affects what compounders can legally produce. Practices need to work with supply partners who actively monitor shortage designations and can advise on current permissibility.

The FDA has issued guidance on which bulk drug substances can be used in compounding. The "503A bulks list" and "503B bulks list" specify which substances are permitted for use in compounding under each track.

Practices should ensure their supply partners are only using bulk drug substances that are on the appropriate list for their compounding track.

The United States Pharmacopeia has updated its compounding standards, including:

• USP <795> (Non-sterile preparations): Updated standards affecting BUD dates and quality requirements
• USP <797> (Sterile preparations): Updated standards with significant implications for sterile compounding
• USP <800> (Hazardous drugs): Standards for handling hazardous drug substances in compounding

Compounders that have not updated their practices to comply with the revised USP standards are operating out of compliance.

The FDA has increased inspection activity at 503B outsourcing facilities. Inspection findings have resulted in warning letters, import alerts, and in some cases facility shutdowns. Practices that source from 503B facilities should verify that their suppliers have not received recent warning letters or other enforcement actions.

You can check FDA warning letters and enforcement actions on the FDA's website.

In addition to federal developments, state regulatory activity has increased significantly. Multiple states have enacted new rules affecting:

• Compounding pharmacy licensing requirements
• Out-of-state pharmacy registration requirements
• GLP-1 prescribing standards
• Telehealth prescribing requirements

The patchwork of state regulations means that compliance in one state does not guarantee compliance in another.

Before ordering from any compounding supplier, verify:

1. 503A pharmacies: Current state board of pharmacy license in good standing; licensed in your state
2. 503B facilities: Current FDA registration; no recent warning letters or enforcement actions; CGMP compliance
3. All suppliers: Current COA process; appropriate bulk drug substance sourcing

Your practice's compliance documentation is your first line of defense in any regulatory inquiry. Maintain:

• Prescription records for all 503A orders
• Patient-prescriber relationship documentation
• Supply chain documentation (COA, supplier licenses)
• Clinical protocols and rationale

If you prescribe compounded GLP-1s, monitor FDA shortage designations for semaglutide and tirzepatide. Your supply partner should be tracking these and advising you proactively.

In a rapidly evolving regulatory environment, your supply partner's legal expertise is part of your compliance infrastructure. A supply partner that cannot advise you on regulatory developments is a liability, not an asset.

At MedClinic Partners, our founding team includes mass-tort attorneys who have litigated against pharmaceutical companies for 15+ years. We track FDA regulatory developments and advise our clients proactively.

Contact us to discuss your compliance questions →

This content is for informational purposes only and does not constitute legal advice. FDA regulations change frequently. Consult with qualified legal counsel regarding your specific compliance obligations.