Thursday, December 5, 2013

CA Designated Representative License Application - CA Board of Pharmacy

Updated links: October 4, 2016

California Board of Pharmacy - Apply for a License: "Designated Representative (Exemptee)

Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations. The Designated Representative application forms may be obtained by download only."

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Wednesday, December 4, 2013

Full-line distributor sales topped $300 billion in 2012 - DQSA lot/item level tracking stats

Full-line distributor sales topped $300 billion in 2012, representing 91% of pharma sales - Pharmaceutical Commerce:

"The Factbook contains operational details often of high interest to vendors serving wholesalers’ infrastructure needs. One particular number to call out: two out of three HDMA members are already tracking lot-level barcodes through their systems for at least some of their products. Lot-level tracking is now the centerpiece of the Drug Quality and Security Act, which will mandate such tracking over the next four years. Data on item-level tracking (the next stage in DQSA) is occurring, but at significantly lower percentages."

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Monday, December 2, 2013

FDA Posts 3 New Draft Guidances RE: Human Drug Compounding

The FDA just published 3 new draft guidances related to compounding. 


In a nutshell, they cover: earlier guidance prohibitions; "outsourcing facilities" (OF) voluntary registration; and how OF's should report their compounded drugs.


Category Title Type Date
Procedural Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB) Draft Guidance 12/02/13
Procedural Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB) Draft Guidance 12/02/13
Procedural Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB) Draft Guidance 12/02/13

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What To Do When Your Florida CDR Quits

Here's what the Florida Division of Drugs, Devices and Cosmetics says . . .

Program FAQ 6:   "DIVISION OF DRUGS, DEVICES AND COSMETICS

My company is a prescription drug wholesale distributor (in-state or out-of-state). Our Certified Designated Representative (CDR) just quit. What do we do?

Notify the department within 10 business days from the CDR’s separation. Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period. After that period expires, however, your company must either (a) engage a replacement CDR and notify the department of same or (b) cease prescription drug distributions in or into Florida.

The Department can, upon written request to appropriate personnel, provide a list of all unaffiliated CDR’s."

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Sunday, December 1, 2013

Certified Designated Representative (CDR) - FL DBPR DDC Program

Certified Designated Representative (CDR) - FL Dept of Business and Professional Regulation:  

"DIVISION OF DRUGS, DEVICES AND COSMETICS

CERTIFIED DESIGNATED REPRESENTATIVE

All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment. Such person must have an active certification from the department (a “certified designated representative” or “CDR”)."

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