US FDA Puts Compounding Office Under CDER Compliance To 'Institutionalize' Maturing Program
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.
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Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.
Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.
FDA Warns Consumers Not To Use Sterile Drugs Made By Pacifico National After Firm Refuses Recall Requests
After Melbourne, Florida, outsourcer resisted entreaties to recall sterile drugs over contamination and eye infections, the FDA warned consumers not to use sterile drugs compounded by the firm, Pacifico National, doing business as AmEx Pharmacy.