Tuesday, March 27, 2012

How To Schedule FL CDR Exam? - Permitting FAQ 15 - FL DBPR

According to . . .

Permitting FAQ 15 - Florida Department of Business and Professional Regulation (DBPR):

"DRUGS, DEVICES AND COSMETICS PROGRAM

HOW DO I SCHEDULE THE CERTIFIED DESIGNATED REPRESENTATIVE (CDR) EXAM?

Initially, you must submit the Application for Certification of Designated Representative, Personal Information Statement and $150.00 fee.  If the Drugs, Devices and Cosmetics Program does not have your fingerprint results on file, you must also submit a fingerprint card along with the $47.00 fee.  Prior to scheduling the exam, our office must deem you eligible to sit for the exam and send authorization to our computer based testing vendor.

Once you have been deemed eligible to sit for the exam, you may contact Pearson Vue to schedule the exam, 1-888-204-6230.  Once you have schedule the examination, please make sure you arrive to the exam site on time, with two forms of identification."

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Monday, March 26, 2012

I'm an RPh, must I take the CDR exam? - FL DBPR - Permitting FAQ 18

According to . . .

Permitting FAQ 18 - Florida Department of Business and Professional Regulation:

"DRUGS, DEVICES AND COSMETICS PROGRAM

I AM A LICENSED PHARMACIST.  AM I EXEMPT FROM TAKING THE CERTIFIED DESIGNATED REPRESENTATIVE EXAM?

No; To become a Florida Certified Designated Representative, you must receive a passing score of at least 75 percent on an examination given by the Department regarding state and federal laws and rules governing the distribution of prescription drugs."

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Saturday, March 24, 2012

Role of the pharmacist in preventing distribution of counterfeit meds - Amer Pharmacists Assoc

Counterfeit drugs
Counterfeit drugs (Photo credit: Wikipedia)
American Pharmacists Association - Article: - Role of the pharmacist in preventing distribution of counterfeit meds

"Summary: The taskforce recommends that pharmacists (1) purchase medications from known, reliable sources; (2) warn patients of the dangers of purchasing medications over the Internet; (3) confirm with distributors that products were purchased from manufacturers or other reliable sources; (4) monitor counterfeit product alerts; (5) examine products for suspicious appearance; (6) work with the pharmaceutical industry, distributors, and the Food and Drug Administration (FDA) to close gaps in the supply chain, especially for drugs in short supply; (7) use scanning technology in the pharmacy as part of a prescription verification process; (8) educate themselves, coworkers, and patients about the risks of counterfeit medications; and (9) report suspicious medications to FDA, the distributor, and the manufacturer.

Conclusion: The consequence of a patient receiving a counterfeit medication in the United States could be catastrophic, and pharmacists must play an active role in preventing such an event from occurring."

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Source:
Journal of the American Pharmacists Association
Issue: Volume 52, Number 2 / March-April 2012
Pages: 195 - 199

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Thursday, March 15, 2012

Florida Claims Success Against 'Pill Mills'

According to the stats, the 'oxy express' is getting shut down.

Florida Claims Success Against 'Pill Mills' - NYTimes.com:

"Before the crackdown, Florida had 90 the nation's top 100 oxycodone-purchasing doctors and 53 of its top 100 oxycodone-purchasing pharmacies. Those numbers have dropped to 13 of the top 100 doctors and 19 of the top 100 pharmacies, Scott said.

The number of pain clinics in the state has dropped to 500, from 800 in a year, he said."

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Wednesday, March 14, 2012

DMEPOS State License Directory - California HMDR Exemptee License

English: Example CPAP Mask
Image via Wikipedia
This directory is a great resource that helps identify licenses you need.  I've selected this particular California page in the directory.  Note that there are quite a number of CA HMDR Exemptee mentions.

DMEPOS State License Directory - California:

"MUST HAVE a EXEMPTEE HMDR , or a Pharmacist license, if providing the following items: Legend devices (RX only label), oxygen, TENS units, CPAP, Nutritional feeding kits (w/syringes), IV pumps. (Any item that has a caution (legend) that is only for sale by or by order of a physician. It is not an item that can be purchased over the counter but must be prescribed.) The EXEMPTEE or Pharmacist must be an employee and under full control of these items during dispensing of prescription devices."

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Sunday, March 11, 2012

Court blocks DEA's Florida suspension of Cardinal

It looks like there's a chance things could drag out for a very long time . . .

Court blocks DEA's Florida suspension of Cardinal - chicagotribune.com:

"The appeals court in Washington late Friday granted Cardinal's request and issued a stay pending further proceedings. The court ordered Cardinal to file its emergency motion by March 14 and the DEA to file its response by March 16, according to the court docket.

An administrative hearing of Cardinal's Lakeland license is scheduled to begin at the DEA on April 3. That process could take as long as a year to play out as both sides present their cases.

The DEA judge will then make a recommendation to the DEA's administrator, Michele Leonhart, who will make a ruling. Leonhart signed the initial order to suspend Cardinal's license.

The case is Cardinal Health Inc v. Justice Department et al in the U.S. Court of Appeals for the District of Columbia Circuit, No. 12-5061."

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E-Pedigree Agenda Item - CA Pharmacy Board Meeting 3-21-2012

Updated 4/19/2012 with the following:


The CA Board of Pharmacy just emailed this out:

"On behalf of the Board of Pharmacy, the Department of Consumer Affairs today added to its website the webcast of its March 21, 2012 Enforcement Committee/e-Pedigree Meeting.  At this meeting, presentations were made by FDA and multiple supply chain members.  . . .

To view the webcast of the March 21, 2012 meeting go to:
http://www.dca.ca.gov/publications/multimedia/pharm_20120321.wmv  "


Note:  I hope you've got patience with the wmv download.  I didn't have 2 hours worth of patience to wait for the download.

- - - - original post follows - - - -

According to this California Board of Pharmacy NOTICE OF MEETING AND AGENDA - Enforcement Committee and E‐Pedigree Public Meeting - March 21, 2012:

Here's what's listed under this agenda item, Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication:

a. Discussion about the Presence of Counterfeit Avastin in California Physician Offices
b. Presentation and Discussion of a Proposal for Federal Legislation by the Pharmaceutical Distribution Security Alliance
c. Presentation by Connie T. Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Center for Drug Evaluation and Research, US Food and Drug Administration
d. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule 1. Kimberly Fleming, Senior Manager, Product Security, EMD Serono, Inc, 2. Robert Celeste, Director, Healthcare, GS1 US 3. Other Companies, Associations and Other Entities Wishing to Address the Committee on E‐Pedigree Issues
e. General Discussion
f. Discussion and Possible Action to Develop Regulation Requirements Specifying a Unique Identification Number for Prescription Medication Pursuant to California’s E‐Pedigree Requirements
f. Discussion and Possible Action to Develop “Grandfathering” Provisions for Non‐Pedigreed Dangerous Drugs Pursuant to section 4163.2 of the Business and Professions

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Thursday, March 1, 2012

Cardinal Health Blocked From Shipping Painkiller in Florida

Cardinal Health Blocked From Shipping Painkiller in Florida - Bloomberg:

"Last year Cardinal shipped enough oxycodone to pharmacies in Sanford, Florida, that could supply a population eight times its size, Clifford Reeves, a Justice Department lawyer, said today. Sanford has a population of 53,000 and the supply would support 400,000, he said.
“There’s no data than can explain those kinds of red flags that went ignored by Lakeland,” Reeves said."

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