Register Now for the FDLI Annual Conference--will cover the Park Doctrine and Counterfeiting and Fraud Initiative from Federal Government

Only at the FDLI Annual Conference: Will you be there?

FDLI SmartBrief | Apr 14, 2014

Dr. Robert Temple has been selected to receive the 2014 Harvey Wiley Award from the FDA Alumni Association! Dr. Temple serves as CDER's deputy center director for clinical science and also as acting deputy director of the Office of Drug Evaluation I (ODE-I). Dr. Temple will deliver remarks at the end of the opening session (just before lunch) on April 23. Don’t miss out. Register today.

Annual Conference highlight: Ethics CLE session on Park Doctrine

FDLI SmartBrief | Apr 11, 2014

In United States v. Park, the Supreme Court held that a responsible corporate official can be convicted of a misdemeanor based on his or her position of responsibility and authority to prevent and correct violations of the Food Drug and Cosmetic Act (FDCA). The U.S. Department of Justice and the FDA have taken an increasingly aggressive view of the Park Doctrine, bringing prosecutions against corporate officers even absent any proof of knowledge or intent to commit a violation under the FDCA. In this session, attendees will learn about recent prosecutions, including the Jensen Farms case, brought under the Park Doctrine. Register for FDLI's Annual Conference, April 23-24.

Annual Conference highlight: Counterfeiting and Fraud Initiatives from the Federal Government

FDLI SmartBrief | Apr 08, 2014

Counterfeit and fraudulent drugs, medical devices, food, cosmetics, tobacco and other personal products pose a threat to public health worldwide -- and have significant economic consequences. Combating this threat requires complex coordination between numerous government agencies. Hear from top representatives from the U.S. Department of State, Homeland Security Investigations, the Federal Bureau of Investigation, the U.S. Patent and Trademark Office, and the Food and Drug Administration to learn how each agency is structured to identify and protect against counterfeit and fraudulent goods; what types of products are currently posing a risk to public health; and best practices and remedies for counterfeiting, fraud and trade secret theft. Register for FDLI's Annual Conference, April 23-24.

Eye on the FDA: Release of CMS Medicare Payment Data a Sunshine Dress Rehearsal

April 15, 2014

There were two major healthcare stories last week.  One involved the announcement that Health and Human Services Secretary Kathleen Sebelius would be leaving and the nomination by President Obama of Office of Management and Budget Director Sylvia Mathews Burwell to replace her.  But also last week CMS made an unprecedented release of Medicare payments data.  For the first time since 1979, the public had access to information regarding which physicians received what kind of sums under Medicare. Media stories were extensive and primarily focused on the amounts of money that went to providers.

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Tainted drugs lead to closure of South Lyon pharmacy

Written by

Christopher Behnan

Gannett Michigan

A South Lyon compounding pharmacy has been ordered closed and fined $100,000 for distributing tainted dextrose injections last year.
The Michigan Board of Pharmacy Disciplinary Subcommittee last week permanently rescinded Specialty Medicine Compounding Pharmacy’s operating license and revoked owner Kenny Walkup Jr.’s pharmacist license for three years.
The $100,000 in fines represents a $50,000 fine to the pharmacy and a $50,000 fine to Walkup.
“Michigan citizens trust pharmacists to follow the laws designed to keep consumers safe, and these sanctions send the message that we’re serious about public safety and welfare,” state Attorney General Bill Schuette said in a statement.
The penalties follow discovery of fungi in vials of one of the pharmacy’s compounded, or combined, intravenous solutions at Henry Ford Hospital in Detroit in October.
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Pennsylvania Board of Pharmacy Agenda for April 15, 2014 Meeting

Agenda

Oregon Board of Pharmacy Minutes from March 2014 Meeting

read here

Ohio Board of Pharmacy Minutes from February 3, 2014 Meeting

read here

Ohio Board of Pharmacy Considering Rule Making Tramadol a Schedule IV Controlled Substance--Hearing Set for May 6, 2014

more information found here

Oklahoma Board of Pharmacy is hosting Major CE aimed at improving patient safety

OSBP-ISMP Pharmacy Practice Safety Conference.  The Oklahoma State Board of Pharmacy is hosting a major continuing education program in Oklahoma City aimed at improving patient safety for pharmacists.  The program, including lunch and ACPE-accredited continuing education, is being provided without charge to pharmacists to further the Board’s mission of protecting the health, safety and welfare of the citizens of Oklahoma.

Educational staff from the Institute of Safe Medication Practices (ISMP) will present four (4) hours of ACPE accredited continuing education on the topics of 1) Targeted Medication Safety Best Practices 2) Human Factors Involved in Medication Safety and 3) Improving Medication Safety with High Alert Drugs.  The ISMP staff making the presentations will be Dr. Donna Horn, R.Ph., D.Ph., the Director of Patient Safety - Community Pharmacy and Matthew P. Fricker, Jr., M.S., R.Ph., FASHP, ISMP Program Director.  Information presented will apply to both community retail pharmacy and hospital pharmacy practices.  

The conference will be held on Tuesday, June 17, 2014 at the Jim Thorpe Museum & Oklahoma Sports Hall of Fame, 2nd Floor Events Center, 4040 N Lincoln Blvd, Oklahoma City.  Sign-In begins at 11:45.  Lunch will be served at 12:00 p.m. and the continuing education program will start immediately after at 12:45 p.m.  

The Board has planned for 200 participants for the program, and is accepting reservations on a first-come basis.  Pharmacist may email sdozal@pharmacy.ok.gov with the following information to reserve a spot:

• Full Name
• OK Pharmacy Board License #
• Daytime Phone
• Birth Month
• Birth Day
• NABP e-Profile ID #

Oklahoma Board of Pharmacy Agenda for April 16, 2014 Meeting-- Listed is possible executive session discussion on case: OSBP vs. OK Compounding, LLC, #2-6161 – Case No. 1268

see complete agenda here

Texas lawmakers looking into compounding pharmacies

Texas lawmakers looking into compounding pharmacies