Definition

A distribution system that restricts access to a medicine to ensure it is only prescribed by qualified prescribers and dispensed to appropriate patients.

Example

The controlled access program requires: certified prescribers, enrolled pharmacies, patient consent acknowledging risks, and verification of safety requirements before dispensing.

Regulatory source

EU GVP Module XVI, FDA REMS

Common mistakes

Implementing controls that create barriers to legitimate patient access without proportionate safety benefit.

Inspector question

Describe your controlled access program. How do you balance safety restrictions with patient access?

Related terms