Wednesday, July 20, 2016

The DSCSA Explained by Dirk Rodgers (book)

If you're trying to fully understand all the nuances of the DSCSA, then you might be interested in this book:

The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances - by Dirk Rodgers





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Friday, July 15, 2016

Prescription Drug Take-Back Programs - Proposed Regulation by CA Board of Rx


Heads-up!

The California State Board of Pharmacy will have the opportunity to discuss the future of the proposed regulation and determine what course of action it wishes to pursue.

View the draft modifications to the drug take-back regulation (pdf)

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Tuesday, July 12, 2016

Medicare Cuts Will Disproportionately Harm COPD Patients - Morning Consult


Read the full article: Medicare Cuts Will Disproportionately Harm COPD Patients - Morning Consult:

"CMS has chosen to deeply reduce Medicare payments for the home oxygen services required to keep COPD patients healthy and out of the hospital and other costly facilities.  On January 1, CMS began applying the competitive bid rates used in urban areas to rural and other non-competitive bid areas.  This policy is being phased-in over only a 6-month period, taking full effect on July 1 and resulting in a 30-50 percent cut to home respiratory therapy. Additionally, another set of cuts of approximately 18 percent was just applied on July 1."

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Monday, July 11, 2016

The Race for Track & Trace: Are 3PLs ready for serialization? | Air Cargo World

Read the full article: The Race for Track & Trace: Are 3PLs ready for serialization? | Air Cargo World:

. . ."Phase II, which goes into effect beginning in November 2017, requires item-level serialization and poses a real challenge for 3PLs.

Brian Daleiden, vice president of industry marketing at TraceLink, a cloud-based track-and-trace network, warned that many 3PLs are only starting to realize the potential issues and complications they face. “If you’re a pharmaceutical company supplying products covered under DSCSA, working with 3PLs, and you are not today having any active conversations about what your plans and expectations are, you are creating serious risk for your ability to supply products and meet the serialization deadlines,” he said. “Not to say compliance cannot be reached, but you should be having the conversation today.”"

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