Tag Archives: California Board of Pharmacy

Board of Pharmacy

How To Make The Semi-Centralized Track & Trace Model A Reality

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Last week I attended the Enforcement Committee meeting of the California Board of Pharmacy.  The value of attending these meetings is hard to extract.  It helps to have a solid knowledge of the language of the pedigree law, understanding of the standards and technology being considered to meet it, and the history of how we got where we are today.  Even with all that on your side it takes a lot of concentration during the meeting and after it is over to put it all into perspective and find the value.

I will provide you with my thoughts on what Continue reading How To Make The Semi-Centralized Track & Trace Model A Reality →

Drug recalls

We Should Be Ashamed Of The U.S. Approach To Pharma Recalls

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Flicker / Akulawolf

That’s right.  We should all be ashamed of the way our supply chain handles drug recalls and we should do something about it.  I will explain, but first, what is a drug recall?

Today, when the manufacturer decides that a recall is necessary—either on their own or through a request by the FDA—they issue a recall for it.  The FDA website is a great resource for learning about what a recall is (see “What is a recall?”, and “FDA 101: Product Recalls – From First Alert to Effectiveness Checks” and their recalls homepage at “Drug Recalls”).

Recalls can be issued for a number of reasons including Continue reading We Should Be Ashamed Of The U.S. Approach To Pharma Recalls →

Conferences

How To Maximize The ROI Of Attending A Conference

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I’ve been doing a lot of traveling in the last few months since I left Cardinal Health.  Right now my wife and I are just finishing up a visit to Culver City, CA where we arrived just in time for the birth of our first grandchild.  This was a non-business trip, of course, but all of my other recent travels have been to attend conferences or public meetings of one kind or another.

One of the ways I maximize the return on investment (ROI) of attending conferences is to take lots of notes and then publish internally an analysis of the things that I thought had some important significance to my company.  This technique has resulted in a searchable record of my impressions of every speaker and networking contact that struck me for any reason in almost every Continue reading How To Maximize The ROI Of Attending A Conference →

Board of Pharmacy

InBrief: California Board of Pharmacy Webcasts

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.The next meeting of the Enforcement Committee of the California Board of Pharmacy is next Tuesday, September 11, 2012.  The Enforcement Committee meetings are where the Board has been discussing issues related to the implementation of the pedigree law.  The full agenda for next week’s meeting can be found here, but here is the extract of the pedigree content:

II. Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication    (10 a.m.)

(a) Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule

(b) Update on the Status of Proposed Regulations to Continue reading InBrief: California Board of Pharmacy Webcasts →