Monday, June 4, 2012

CA Board of Pharmacy - June 12, 2012 Mtg - e-Pedigree Agenda Item

Here's the e-Pedigree agenda item.

California Board of Pharmacy - Enforcement Committee and E‐Pedigree Public Meetings - June 12, 2012 Agenda

II. Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication

a. Discussion about the Presence of Counterfeit Avastin and Altuzan in California Physician Offices and Clinics
b. Dysfunction In California’s Supply of Prescription Medication Discovered During Board of Pharmacy Investigations
c. Board of Pharmacy’s Letters to Federal Representatives and Senators on Elements Needed in any Proposal for Federal Legislation
d. Colloquy from Senators Enzi and Harkin in Support of Retaining Protections in California Law in Future Federal Requirements for Tracking Prescription Medications Through Pharmaceutical Supply Chain
e. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule 1. Robert Celeste, Director, Healthcare, GS1 US 2. Other Companies, Associations and Other Entities Wishing to Address the Committee on E‐Pedigree Issues
f. General Discussion
g. Discussion and Possible Action to Develop Regulation Requirements Specifying a Unique Identification Number for Prescription Medication Pursuant to California’s E‐Pedigree Requirements
h. Discussion and Possible Action to Develop “Grandfathering” Provisions for Non‐Pedigreed Dangerous Drugs Pursuant to Section 4163.2 of the Business and Professions Code
i. Discussion concerning Elements for Inference as Provided by California Business and Professions Code Section 4163.3
j. Closing Comments

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Thursday, May 31, 2012

Policies and Procedures - California HMDR Facilities Must Have Them

California HMDR facilities shall have written policies and procedures.  Make sure you know how to write them, have them in place, and follow them. Your staff should be well-versed with them, and you want to make sure that they are following them.  You might want to consider taking:
Writing Procedures: Drug and Device Wholesalers and HMDR - an online training course

CA HMDR Facilities Must Have Policies and Procedures | SkillsPlus International Info:  'via Blog this'
Section 111656.3 starts out with:  
"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "  
Notice the phrase, " . . . shall have written policies and procedures . . . "
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Tuesday, May 22, 2012

California Board of Pharmacy weighs in on RxTEC proposal

, U.S. Congressman.
Henry Waxman, U.S. Congressman.
 (Photo credit: Wikipedia)
More on potential e-Pedigree touchpoints . . .

SecuringPharma - California Board of Pharmacy weighs in on RxTEC proposal:

"The California Board of Pharmacy in the US has written an open letter to Representative Henry Waxman calling for a federal approach to pharmaceutical traceability that provides the same or greater protection to the public as its electronic pedigree system due to come into effect between 2015 and 2017.

The letter to Waxman - who serves as ranking member of the House Energy and Commerce Committee - also takes a swipe at the Pharmaceutical Traceability Enhancement Code (RxTEC) system enshrined in the Securing Pharmaceutical Distribution Integrity Act of 2012, saying that it is a "less robust, and less secure, supply chain infrastructure.""

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Thursday, May 17, 2012

Cardinal Health ends DEA inquiry with settlement

The Associated Press: Cardinal Health ends DEA inquiry with settlement:

"Pharmaceutical wholesaler Cardinal Health Inc. said Tuesday one of its Florida facilities will be barred from shipping controlled substances for two years under a settlement with federal authorities over alleged ineffective controls.

The Lakeland, Fla., facility will remain open and other operations will continue under the agreement with the Drug Enforcement Administration. Cardinal Health also intends to improve procedures that are designed to prevent prescription drugs from being abused.

The Dublin, Ohio, company said the DEA is not planning to take further actions against other Cardinal Health facilities."

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Tuesday, May 15, 2012

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