April 6th 2025
3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.
US Court Delays FDA Drug Pedigree Requirements
December 21st 2006The US Food and Drug Administration has modified its requirements for drug pedigrees accompanying wholesale pharmaceutical transactions, following a US District Court preliminary injunction barring the agency from enforcing certain provisions of the rule that was to have gone into effect on Dec. 1.
Cardinal Health Reports on RFID Pilot
November 16th 2006Dublin, OH (Nov. 14)-A half-year Cardinal Health study of radio-frequency identification (RFID) tags "under real-world conditions has demonstrated that the technology has real promise to provide an added layer of safety," according Renard Jackson, the company's vice-president and general manager of global packaging services, in a prepared statement.
Pharmaceutical packaging and labelling for blind and partially sighted people
November 1st 2006A European Commission directive requires suppliers to incorporate information on medicines in formats suitable for blind and partially sighted people, although the associated standard has not been introduced yet. This article looks at some of the issues that will need to be addressed when the standard is adopted.
Developing First Disposable Injector for a Biopharmaceutical
October 26th 2006Robin Hwang, a senior principal scientist at Amgen (Thousand Oaks, CA), led the team that developed the first commercial disposable auto-injector for a biopharmaceutical: a prefilled three-step "SureClick" for delivering Enbrel (etanercept), a treatment for autoimmune diseases.
Cracking Down on Counterfeiting
August 2nd 2006Disappointed in progress thus far, the US Food and Drug Administration wants pharmaceutical manufacturers to make a greater effort to combat counterfeit products and recommends that they "move quickly" to implement radio-frequency identification technology.
FDA to Strengthen Fight Against Counterfeit Drug Products
June 15th 2006The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.