Delaware: New law, new compounding regs

Compounders, take note: Delaware has updated its pharmacy practice statute. The goal is to ‘bring the state in line with current national standards,’ especially when it comes to compounding and outsourcing facilities. It doesn’t take effect for a year, but that’s a year you’ll want to use to prepare if you dispense to the state. 

Among the changes:

• "Compounding" and "outsourcing facility" are now formally defined in state law, creating clearer guardrails for practice and enforcement.
• Non-resident pharmacies and outsourcing facilities that ship into Delaware will need to be properly licensed or face penalties of up to $10,000 per day.
• Manufacturers, wholesale distributors, and medical gas distributors — including those involved in compounding — now face new licensure requirements and background checks for key personnel.
• A code of ethics is on the way, and violations can be grounds for discipline … including permanent license revocation.

The bottom line? If your practice compounds or distributes into Delaware, it’s time to review your licensure and compliance plans.