Archive for the ‘FDA’ Category
Friday, May 4th, 2012
The U.S. Pharmacopeial Convention (USP) has pulled together a broad swath of stakeholders for a workshop this month on the complexities of protecting the supply chain.
The May 22-23 event in Rockville, MD will feature regulatory officials from Europe, South American, and Africa, and coverage of developing track-and-trace standards, among other ...
Posted in Bar Coding, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Fraud, Medical Devices, Recalls, Reimportation, Safety, security, serialization, standards, supply chain, Tampering, Theft | No Comments »
Friday, April 13th, 2012
The Pharmaceutical Distribution Security Alliance (PDSA) has succeeded in bringing together several manufacturers, wholesalers, and pharmacy chains in support of a federal law automating pharmaceutical tracking. Its proposed RxTEC Act would replace the "pedigree" requirements of the Prescription Drug Marketing Act as well as any state laws with ...
Posted in Counterfeiting, FDA, security, supply chain | No Comments »
Wednesday, February 1st, 2012
Pfizer took to the Internet today to address its voluntary recall of approximately one million packs of birth control pills. Recalled are 28 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States.
Pfizer's Chief Medical Officer Freda Lewis-Hall explained ...
Posted in Blisters, FDA, Inspection, Recalls, Safety | No Comments »
Monday, December 19th, 2011
The United States Pharmacopeia is placing supply chain security at the forefront with a new general chapter on best practices for ensuring supply chain integrity and protecting consumers from poor quality and counterfeit medicines.
USP General Chapter <1083>, Good Distribution Practices-Supply Chain Integrity, with the recently published USP General Chapter <1079>, ...
Posted in Bar Coding, Cold Chain, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Handling, Hospital, Imports, Inspection, Internet, Outsourcing, Reimportation, RFID, Safety, security, serialization, standards, supply chain, Tampering, Theft, Transporation | No Comments »
Wednesday, November 30th, 2011
If pharmaceutical electronic pedigrees and track and trace are on your radar, December will be a busy month for you. California's State Board of Pharmacy (CA BoP) has announced that it will discuss implementation of the state's electronic pedigree requirements during its board meeting on December 6. In addition, GS1 ...
Posted in Counterfeiting, Diversion, Electronic Pedigrees, FDA, security | 1 Comment »
Wednesday, November 30th, 2011
As the end of 2011 nears, we'll all be looking back to ensure we've wrapped up any unfinished business and making resolutions for 2012.
Is preventive maintenance on your list?
Or has your schedule slipped? If so, how do you know whether your machinery is still operating to your specifications? Could product ...
Posted in FDA, machinery, Recalls, Safety | No Comments »
Thursday, September 29th, 2011
The Institute for Safe Medication Practices (ISMP) has surveyed pharmacists and purchasing agents on drug shortages and the "gray" market again, and the bad news is that we could have just reposted our blog on last year's survey and been just as timely. Hospitals continue to struggle with drug shortages, ...
Posted in Compliance Packaging, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Handling, Hospital, Inspection, Medical Devices, Quality, Recalls | No Comments »
Wednesday, September 14th, 2011
GS1 Healthcare standards are gaining traction. As the latest country to support GS1, India has called for serialized codes following GS1 data formats for exported pharmaceuticals. Most of the top pharmaceutical and medical device companies, wholesalers, and many hospital systems in the US have embraced GS1 Healthcare’s system for product ...
Posted in Bar Coding, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Labeling, Medical Devices, Medical Errors, Printing and Coding, Recalls, Safety, security, serialization, standards, Theft | No Comments »
Thursday, August 25th, 2011
Before proposing regulations for unique device identifiers (UDIs), FDA wants to hear from all stakeholders about any barriers and incentives to UDI adoption and use. The agency is holding a public workshop September 12-13 in Bethesda, MD, and while this workshop will not address FDA's UDI regulatory framework, it will ...
Posted in FDA, Medical Devices, Medical Errors | 1 Comment »
Tuesday, July 26th, 2011
FDA has issued draft guidance to help medical device manufacturers understand when a change to a previously cleared 510(k) device may require a new premarket notification submission. According to the agency, most packaging changes do not require a new 510(k). But there are some areas you should study closely.
In the ...
Posted in FDA, Labeling, Medical Devices, sterilization | 1 Comment »
