FDA Outlines Policy for Distributing Drug Samples During Pandemic

The FDA yesterday released a temporary final guidance allowing drug companies to ship samples directly to a patient’s home during the pandemic, as long as their practitioner has given permission.

The agency also clarified that pre-pandemic regulations don’t specify where a practitioner is allowed to receive delivery of requested drug samples, so they do not prevent having samples shipped to their homes.

Retail pharmacies are still not allowed to receive drug samples, even during the pandemic. The guidance clarifies that only hospital or healthcare entity pharmacies may have drug samples shipped to them if requested by a practitioner.

The agency said it will not take action against drugmakers or distributors using carriers that opt for alternative methods to verify the delivery and receipt of drug samples instead of obtaining a signature from the recipient.

Read the full guidance here: www.fdanews.com/06-09-20-Guidance.pdf. — James Miessler