Experts Seek Strategies to Ensure Quality in Sterile Compounding

2/7/2013

ASHP, The Pew Charitable Trusts, and the American Hospital Association brought together a group of stakeholders including top government officials, practitioners, and nationally recognized experts in compounding and manufacturing this week to discuss a wide range of issues surrounding sterile compounding and to recommend solutions to improve patient safety.

The ASHP—Pew—AHA Pharmacy Sterile Compounding Summit explored the scope of pharmacy sterile compounding and the associated risk factors, the differences between sterile production expectations under Current Good Manufacturing Practices and United States Pharmacopeia Chapter 797, and oversight roles for states and the federal government.

Recommendations from the Summit will be publicized and made available on the ASHP Sterile Compounding Resource Center in coming weeks.

Source found here

ASHSP FDA, States Discuss Pharmacy Compounding Regulatory Framework

February 1, 2013, AJHP News]

Kate Traynor

BETHESDA, MD 14 January 2013—FDA officials and representatives from all 50 states and the District of Columbia met December 19 to discuss state and federal roles in the oversight of compounding pharmacies.

FDA Commissioner Margaret A. Hamburg said the meeting was not intended to produce a consensus but instead to help the agency better understand gaps in regulatory oversight and identify new areas where a federal role may be appropriate.

Most of the all-day meeting consisted of group discussions among state pharmacy board representatives, grouped by regions, and was closed to the public. During the last two hours, pharmacy board officials presented a public synopsis of the group discussions.

In the states. State pharmacy boards painted a mixed picture of their current ability to adequately oversee pharmacy compounding.

John C. Kirtley, executive director of the Arkansas State Board of Pharmacy, said pharmacy boards in his region feel comfortable about their ability to regulate their local pharmacies.