We’re warning you: 503As can’t distribute

You may have seen solicitations circulating recently offering tirzepatide injections for sale or for office use — solicitations that claim the drug was sourced from 503B outsourcing facilities prior to the FDA's March 19, 2025 enforcement cutoff.

Use extreme caution. These offers may carry significant legal risk.

Even if these entities actually have purchased their tirzepatide from 503Bs before the cutoff, it may not matter. While some interpretations of guidance suggest 503As may continue to dispense patient-specific prescriptions using products received from a 503B before that date, FDA hasn’t said whether that’s permissible. And given the ambiguity, taking a chance could expose you to, shall we say, regulatory risk.

To be clear:

• 503A pharmacies may not transfer, sell, or redistribute 503B-sourced tirzepatide to other pharmacies, clinics, or prescriber offices for office use or further dispensing.
• Even when a 503A receives a GLP-1 agonist prepared by a 503B before March 19, 2025, any non-patient-specific transfer by that 503A likely violates FDA’s wholesaling prohibition. 
• Perhaps more importantly, state laws vary. Some do not permit 503B-to-503A transfers at all, so it’s essential to understand your state’s specific requirements.

Obviously you should avoid any transaction that may breach FDA policy. Don’t take a chance — consult legal counsel or your compliance team before acting on any solicitation. Meanwhile, APC will continue to advocate for clear guidance and will update members as soon as more definitive information becomes available.