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US FDA Puts Compounding Office Under CDER Compliance To 'Institutionalize' Maturing Program

 
• By Joanne S. Eglovitch

The US FDA plans to give its young drug compounding oversight program new leadership and move it from the drug center director's office down to the center's compliance office. Whether this move translates into heightened enforcement of drug compounders remains to be seen.

Side view of titration in a compounding pharmacy

The US Food and Drug Administration has announced plans to move the office that watches over the pharmaceutical compounding and outsourcing sectors from the office of the director of its Center for Drug Evaluation and Research, Janet Woodcock, down a level to CDER's Office of Compliance. The plan is meant to “institutionalize” the compounding regulatory program, which has evolved into a more mature program since it was established.

Woodcock announced the move in a 10 June staff memo. In the memo, she said that the FDA’s regulatory program for pharmacy compounding “has significantly evolved and matured since the...

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