The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs

FDA in 2014 to Revise Quality, Labeling and Package Insert Regs

Jan. 17, 2014

The FDA has set a deadline of November 2014 to revise its current good manufacturing practice (cGMP) regulations to strengthen its oversight of pharma supplier quality.

In its 2014 regulatory agenda, published Jan. 7, HHS outlined several regulatory actions the FDA plans, including two proposed revisions to cGMP regulations to address supplier quality deficiencies. The first would aim to improve the agency’s ability to detect and respond to safety problems posed by quality deficiencies. The second will specifically address the nature of required supplier quality controls.

The FDA Safety and Innovation Act clarified that cGMP includes having oversight and control over excipients and other components used in manufacturing drug products. This provision went into effect immediately after the law was signed in 2012, and the agency is now revising existing cGMP regulations to be consistent with the law.

Other pharma-related items on tap for 2014 include:

  • A proposed rule to be issued this month requiring electronic package inserts for prescription drugs and biologics in lieu of the current paper inserts;

  • A proposed rule to be issued before July addressing acetaminophen safety in OTC drug reviews;

  • A proposed rule planned for June outlining changes to the final monograph for OTC cough/cold products to address safety and efficacy issues associated with pediatric dosing;

  • A final rule slated for May that will amend labeling of prescription drugs and biologics to better communicate the risks to pregnant users and nursing mothers;

  • A final rule planned in June updating safety and effectiveness criteria for OTC cough/cold products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant; and

  • A proposed rule to be issued by December establishing safety and effectiveness criteria for antimicrobial agents in hand wash products. The agency recently announced plans to regulate antibacterial soaps and body washes like OTC drugs.

FDA declined to provide further details about the planned rule revisions.

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