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Too Difficult; You’ll Fail – The Difficult to Compound List
November 6, 2017
There’s an initiative that’s been underway, for both 503A and B’s abilities to be limited. If you’re not aware of the “difficult to compound” list and you’re a compounder, get out a paper and pen because you’ll want to take some notes. This most recent list has been around more or less since 2000, when the Pharmacy Compounding Advisory Committee submitted it to the FDA for consideration. The list included drugs and methods that prove to be “demonstrably difficult” to compound; ones that are so difficult that small compounding pharmacies shouldn’t attempt. 

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CDC tells Opioid Addiction Stories with Message: ‘It Only Takes a Little to Lose a Lot’
November 3, 2017
The Centers for Disease Control and Prevention is telling the personal stories of people who were addicted or knew someone who was addicted to prescription opioids in a new campaign called Rx Awareness.
The stories will be told through videos, radio spots, and social media, with the message that prescription opioids can be addictive and “it only takes a little to lose a lot.”

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What is Amazon Doing in Health and the Pharmacy Industry?
October 31, 2017

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Biocontainment: An Introduction to Control Levels & Practical Design Concepts
September 4, 2017
In part 1 of our article on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.

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State of Serialization: Where FDA & The Pharma Industry Currently Stand
September 1, 2017
Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually. A bigger issue for consumers, however, is that falsely labeled medicines can have a direct impact on life and health.

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