The Food and Drug Administration proposed a risk-based framework to enhance oversight of pharmacy compounding practices, according to an AHA News Now report.
FDA Commissioner Margaret Hamburg, MD, testified at a House Energy and Commerce subcommittee hearing on last year's fungal meningitis outbreak due to contaminated products from a compounding pharmacy. To date, the tainted drugs have caused 51 deaths and sickened more than 730 people, according to Dr. Hamburg's testimony.
Dr. Hamburg presented a risk-based framework for improving the safety of compounded drugs. Under the framework, the FDA would categorize compounding practices as either traditional — such as combining ingredients to develop a prescribed and medically necessary medication — or non-traditional, such as compounding that is for a medical need but poses higher risks.
Oversight of traditional compounding would be the purview of state regulation, whereas non-traditional compounding would have to meet federal standards, according to the testimony.
Survey: 11% of Pharmacists Reported Contamination of High-Risk Compounded Sterile Products in Past Year
Institute for Safe Medication Practices Issues Guidelines on Sterile Compounding
FDA Commissioner Margaret Hamburg, MD, testified at a House Energy and Commerce subcommittee hearing on last year's fungal meningitis outbreak due to contaminated products from a compounding pharmacy. To date, the tainted drugs have caused 51 deaths and sickened more than 730 people, according to Dr. Hamburg's testimony.
Dr. Hamburg presented a risk-based framework for improving the safety of compounded drugs. Under the framework, the FDA would categorize compounding practices as either traditional — such as combining ingredients to develop a prescribed and medically necessary medication — or non-traditional, such as compounding that is for a medical need but poses higher risks.
Oversight of traditional compounding would be the purview of state regulation, whereas non-traditional compounding would have to meet federal standards, according to the testimony.
More Articles on Sterile Compounding:
Health Groups Recommend 5 Ways to Make Sterile Compounding SaferSurvey: 11% of Pharmacists Reported Contamination of High-Risk Compounded Sterile Products in Past Year
Institute for Safe Medication Practices Issues Guidelines on Sterile Compounding
