Sunday, December 23, 2012

FDA and States Meet On Regulation of Drug Compounders

F.D.A. and States Meet About Regulation of Drug Compounders - NYTimes.com:

"Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how the states see the federal role. Some states said they would prefer to see the F.D.A. handle large-scale compounders like the New England Compounding Center, or N.E.C.C., the Massachusetts pharmacy that was the source of the outbreak.

“The consensus in our group was that there is a role for the F.D.A. to be involved in facilities like N.E.C.C.,” said Cody Wiberg, the executive director of the Minnesota Board of Pharmacy. “If you’re talking about compounding, most states have the authority and resources to handle that. If you’re talking about nontraditional compounding,” he said, referring to large-scale enterprises like N.E.C.C., “fewer states may have the resources to do that.”"

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Tuesday, December 18, 2012

CA Board of Pharmacy - Use Of GS1 EPCIS - Pedigree

Follow the link below, to Dirk Rodgers post on the December 4th Board meeting, that touches on some important points surrounding CA pedigree law. . .

California Board of Pharmacy Clarifies Use Of GS1 EPCIS:

". . . transcribed the exchange below as it happened because I think it provides a number of important clarifications about the technologies that can successfully be used to meet the California pedigree law and I think it should be read by everyone who has an interest in that."

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Thursday, December 13, 2012

FDA on Making Medical Devices Safer at Home

Follow the link below for additional free consumer information and resources:

Consumer Updates > Making Medical Devices Safer at Home:

""(Home use) devices once were designed only to keep you alive. Now they're designed to keep you as independent as possible," according to Mary Brady, MSN, RN, a senior policy analyst at FDA's Center for Devices and Radiological Health (CDRH).

However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.

There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn't hear an alarm on his ventilator signaling that the tubing had become disconnected."

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Monday, December 10, 2012

How To Get CA CDPH HMDR Exemptee Training

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Friday, December 7, 2012

Safe Doses Act - Penalties for Pharma Cargo Thefts - Statement by HDMA Pres. John Gray

Follow this link to read John Gray's statement on the passing of the Safe Doses Act . . .

HDMA - Press Releases - 10/09/12:

"President Obama signed into law the Strengthening and Focusing Enforcement to Deter Organization Stealing and Enhance Safety Act of 2011 (SAFE DOSES Act, H.R. 4223/S. 1002). The legislation is sponsored by Congressman Sensenbrenner (R-Wis.) in the House, as well as Senators Schumer (D-N.Y.) and Kyl (R-Ariz.)"

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Monday, December 3, 2012

Public Citizen to FDA - RE: Compounding Pharmacies

This is interesting reading for those of you who are following the role of the FDA in compounding pharmacy oversight.

Public Citizen to FDA: Reinspect Compounding Pharmacies Across the Country | The Legal Examiner Cleveland:

"In an 11-page letter to FDA Commissioner Margaret Hamburg, consumer watchdog group Public Citizen asked the agency to follow up on warning letters it issued to compounding pharmacies committing NECC-like violations.

Since 2003, the FDA has sent at least 18 warning letters to 16 compounding pharmacies, Public Citizen’s letter stated. In light of the 2012 fungal meningitis outbreak, the group would like the FDA to either reinspect those pharmacies or to verify that recent reinspections confirmed that those pharmacies cleaned up their act."

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You might be interested in:
Public Citizen's Letter to the FDA re:  Compounding Pharmacies (PDF)

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