Archive for December, 2009
Tuesday, December 29th, 2009
At what cost could FDA be forced to change its tune on reimportation?
"The Administration supports a program to allow Americans to buy safe and effective drugs from other countries and included $5 million in our FY 2010 budget request for the Food and Drug Administration (FDA or the Agency) to ...
Posted in Bar Coding, Compliance Packaging, FDA, Healthcare Reform, Reimportation, Safety | No Comments »
Monday, December 28th, 2009
A new task group has been added to the Institute of Packaging Professional's (IoPP) Medical Device Packaging Technical Committee (MDPTC). The Sustainability Task Group was announced this month, with the intention of focusing on "the unique challenges sustainability brings to the medical packaging industry, reported MDPTC co-chairs Alison Tyler of ...
Posted in Medical Devices, Sustainability | No Comments »
Wednesday, December 23rd, 2009
Oliver-Tolas Healthcare Packaging (Grand Rapids, MI) has launched a range of technologies for brand identity reinforcement and protection from counterfeiting. The technologies can be used for overt visual assurance of a package's authenticity and in a multi-layered approach using a Micro Text solution that Oliver-Tolas has also announced.
"Medical device counterfeiting ...
Posted in security | No Comments »
Thursday, December 17th, 2009
There's been another case of metal-contaminated vials. What could be the cause?
The Medicines Company announced yesterday that it is voluntarily recalling eleven lots of Cleviprex injectable emulsion because of potential particulate matter observed in some vials during a routine annual inspection. The company has not received any product complaints or ...
Posted in Uncategorized | No Comments »
Friday, December 11th, 2009
Recent cases of syringe tampering have made me wonder: Should prefilled syringes carry tamper evidence as part of a risk-mitigation strategy?
Tamper-evident packaging is not required for prescription drugs. According to an FDA spokesperson, "the regulation that requires tamper-evident packaging (21 CFR 211.132) applies only to over-the-counter drugs, not prescription drugs." ...
Posted in Bar Coding, FDA, Hospital, Labeling, Medical Devices, REMS, Safety, security, Tampering, Theft | No Comments »
Monday, December 7th, 2009
Demerol has been victimized again.
The U.S. Department of Justice United States Attorney District of New Hampshire reported that Trinidad Smith, of Manchester, NH, pleaded guilty to an indictment charging her with violations involving consumer product tampering and obtaining a controlled substance by fraud or deception. Smith was a registered nurse ...
Posted in Safety, Tampering | 2 Comments »
Wednesday, December 2nd, 2009
Last week President Obama formed the Presidential Commission for the Study of Bioethical Issues. I wonder whether it will begin by defining Comparative Effectiveness Research (CER)? Critics argue that CER could be a tool for rationing healthcare. But I wonder whether CER could push for greater product and procedural innovation, ...
Posted in Compliance Packaging, Healthcare Reform | No Comments »
