By Barbara Unger, Unger Consulting Inc.
FDA Provides Some Guidance for 503B Facilities
On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission.
Compounding pharmacy increasingly popular during flu season
Compounding pharmacy has become increasingly popular across Central Florida since the uptick in flu cases.
Eyewitness News reported last week that there is a shortage of the generic version of Tamiflu and the price of brand-name of Tamiflu has skyrocketed.
FDA Releases Compounding Priorities Plan
The U.S. Food and Drug Administration on Jan. 24 issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement key aspects of the Drug Quality and Security Act and other provisions of the law relevant to compounders.
Top Organizations Urge a Concerted Effort To Improve Safety in Hospital Compounding
Five years after the New England Compounding Center (NECC) tragedy that brought to light safety problems stemming from the compounding of pharmaceuticals and other therapies, a white paper was released today reflecting the recommendations of major stakeholders for additional steps needed to improve patient safety relative to compounded medicines. The paper was the outcropping of a milestone dialogue where top pharmacy, healthcare provider, hospital and patient organizations assessed progress made since the 2012 NECC tragedy and the subsequent enactment of the Drug Quality and Security Act by Congress.
Hospitals face shortage of IV bags amid flu outbreak
TREASURE VALLEY — Hospitals across the nation continue to battle a shortage of IV solution bags – now, amid an early and aggressive flu season.
CLEAN BENCHES
Providing Additional Clean Room Technology
The laminar flow clean bench is a work bench or similar enclosure which has its own filtered air supply. The clean bench was developed as an adjunct to clean room technology (the need to protect the work from contamination). In recent years, the use of the clean bench, laminar flow cabinet or laminar flow hood has spread from research and manufacturing to other fields such as aerospace, bioscience, pharmaceutical production and food processing.
FDA Unveils Guidance To Smooth Generic-Drug Path
Law360, New York (January 3, 2018, 5:48 PM EST) — The U.S. Food and Drug Administration on Wednesday unveiled draft guidance for the pharmaceutical industry and an internal manual of policies and procedures that it says will streamline the approval process for generic drugs, in part by reducing the number of times an application must be reviewed.
Compounding Aseptic Containment Isolator from Aseptic Enclosures
We would like to start the New Year by introducing our Compounding Aseptic Containment Isolator. These close isolators provide a better physical barrier to protect the health of laboratory workers, maintain the sterility of experimental materials, and prevent the contamination of the environment. Closed containment cabinets are safer to use in research laboratories to provide a clean work environment, prevent exposure of laboratory personnel, prevent aerosol contamination, avoid pathogenic microorganisms to escape or enter the cabinet, prevent cross-contamination of experiments, and protect the environment.
Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues
For Immediate Release
November 30, 2017
Contact
Consumers
Simple Diagnostics
1-877-342-2385
Announcement
Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.