503B Outsourcing Facilities Product Recall Procedures (Resolution 115-2-19)

June 3, 2019

Topics: Resolutions

RESOLUTION NO: 115-2-19
TITLE: 503B Outsourcing Facilities Product Recall Procedures
ACTION: PASS

WHEREAS, the recall procedures from United States Food and Drug Administration (FDA) for products prepared in 503B outsourcing facilities are inconsistent as compared to those for manufactured products; and

WHEREAS, it is important for the protection of the public health for FDA to provide adequate direction to all stakeholders, including, but not limited to, the state boards of pharmacy;

THEREFORE BE IT RESOLVED that NABP contact FDA and request that the recall procedures for products prepared in 503B outsourcing facilities be clarified and standardized in accordance with the recall procedures for manufactured products.

(Resolution passed at the 115th Annual Meeting in Minneapolis, MN.)