Michael Kelly, Author at Med Safety Board

Patient Safety Issues with 503B Labeling and Packaging: Making the Case for Outsourcers to Follow FDA Guidance

by Michael Kelly | Oct 3, 2023 | News

Becky Lamis, PharmD, FISMPManager, Med Safety Board (MSB) While 503B outsourcing facilities must meet current good manufacturing practice requirements, they are not subjected to the same labeling and packaging safety standards and review process as recommended or...