FDA Issues Proposed Rule for Early Notification of Essential Drug Supply Changes

The Food and Drug Administration has released a proposed rule that would require manufacturers of several vital prescription drugs to notify the FDA upon manufacturing interruptions or discontinuations likely to affect drug supply, according to a report from AHA News Now.

Advertisement

The rule also extends to medically important biologic products.

Sign up for our FREE E-Weekly for more coverage like this sent to your inbox!

In conjunction with the proposed rule, the FDA has sent Congress a plan for improving the FDA’s ability to react in response to drug shortages.

The FDA will accept comments on the rule until Jan. 3, and comments on the information collection requirements until Dec. 4.

More Articles on Quality:
Patient Safety Tool: Medication Error Reduction Scorecards
7 Findings on Patient-Controlled Analgesia Practices
10 Most Popular Patient Safety Tools Oct. 28 to Nov. 1, 2013

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Uncategorized

Advertisement

Comments are closed.