Wednesday, December 25, 2013

Merry Christmas to Designated Representatives & Exemptees


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Thursday, December 5, 2013

CA Designated Representative License Application - California Board of Pharmacy

California Designated Representative License Applications

Updated April 5, 2018

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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---------------

California Designated Representative Training Courses for wholesalers, 3PL, or reverse distributors - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses for wholesalers, 3PL, or reverse distributors - Approved by the California State Board of Pharmacy

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

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#approved #accepted #recognized #certified #online #web #training #certification #affidavit #course #class #program #webinar #seminar #workshop #event #elearning #certificate #provider #vendor #seller #register #registration

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

Updated April 19, 2022

All the links broke in the original post.

You'll be interested in:

- - -  original post follows below  - - -

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

What To Do When Your FL CDR Quits

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

Customer Help:   "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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Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com

SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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Wednesday, November 27, 2013

CVS Agrees to Buy Apria’s Coram Unit for $2.1 Billion - Bloomberg

Updated February 18, 2022

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

CVS Agrees to Buy Apria’s Coram Unit for $2.1 Billion - Bloomberg:

"The deal will bring CVS into the business of providing therapies such as antibiotics, nutrition and pain medicine through needles or catheters into patients’ veins. Such drugs are a growing part of the pharmacy market, and CVS can help clients control health costs by offering them at Coram’s more than 85 locations nationwide instead of at costlier hospitals."

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     California (earn a training completion certificate):

Monday, November 18, 2013

Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

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HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204 - FDA Law Blog

FDA Law Blog: HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204:

"With fingers crossed, attendees looked ahead to the future of track-and-trace. Panelists expressed that the national system will hopefully make it harder for bad actors to corrupt the integrity of the supply chain, as the current patchwork of state pedigree laws allows bad actors to shop around for more lenient states. It is hoped that this bill will put everyone on a level playing field and reduce loopholes."

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All Eyes On The U.S. Senate Tonight - RxTrace


Updated February 15, 2022

The original post didn't age well.

You might also be interested in:

---  the original post follows below  ---

Hold your breath. Let's see if the U.S. Senate will pass this bill, H.R. 3204 (An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws."

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Friday, November 15, 2013

Florida Certified Designated Representative Exam - Locate a Pearson Vue Test Center

Updated July 18, 2023

The original post didn't age well, and some links broke.

You might also be interested in:

---  the original post follows below  ---

Florida Certified Designated Representative candidates must take an examination that's administered at a Pearson Vue Test Center.

Here's how to find a Pearson Vue Test Center near you:
  1. Follow the "Locate a Test Center" link below
  2. Choose category. Click on "Government / State Regulated / Federal Government"
  3. Choose testing program. Click on "Florida Certified Designated Representative - Drugs, Devices and Cosmetics"
  4. Test Center Search. Enter your search information to run a search
Locate a Test Center: Locate a Test Center

"Pearson VUE delivers certification and licensure tests through the world’s largest network of test centers in 175 countries across the world."

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FL Certified Designated Representative - CDR Exam Prep Course


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Monday, November 11, 2013

Fingerprint Card Request - CA Board of Pharmacy

The CA Designated Representative application process includes fingerprint requirements. The Board will only accept fingerprint cards from residents outside of California (... in contrast, the board will only accept Live Scan Service Forms from California residents. Live Scan will be accepted from residents of other states if the Live Scan service is performed in California.).

Follow the link below to request fingerprint cards from the California Board of Pharmacy . . .

Publications, Brochures and Fingerprint Card Request - Pharmacy Board:

"To request publications, brochures and fingerprint cards, please select the desired forms and complete your name and address. When the information is complete, please click on the submit button"

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Saturday, November 9, 2013

End game for US medicines traceability bill? - SecuringIndustry.com

Updated Oct 28, 2015:  It passed, and is now enacted. Here's the full text:
Text of the Drug Quality and Security Act (govtrack.us)

= = = original post follows = = =

Prospects for the Drug Quality and Security Act (H.R. 3204) are not so promising . . .

SecuringIndustry.com - End game for US medicines traceability bill?:

"Govtrack.us is currently putting the chances of the bill being enacted at 42 per cent. The Congressional Budget Office (CBO) estimates that H.R. 3204 will authorise the collection of $27m in user fees for fiscal years 2014-2018."

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Thursday, November 7, 2013

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg


Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg:

"One lawmaker’s effort to alter Obamacare is holding up final action by Congress on legislation that would expand U.S. regulation of compounding pharmacies linked to meningitis deaths last year.

The Senate is poised to approve the measure to broaden the U.S. Food and Drug Administration’s oversight of compounding pharmacies. Ninety-nine senators have agreed to pass the legislation that the House passed without a roll call vote, Democratic and Republican lawmakers said.

Republican Senator David Vitter of Louisiana wants the vote on compounding pharmacies coupled with consideration of his proposal to deny lawmakers and their staffs employer contributions when they buy medical insurance on the exchanges set up under the new health-care law. As a result, senators may have to spend a week on work that could be done in minutes."

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Drug Supplier Will Acquire Pharmaceutical Wholesaler - CEMag

Updated August 17, 2021

The original link broke.

You can still read about this story here:

---  the original post follows below  ---

Drug Supplier Will Acquire Pharmaceutical Wholesaler - CEMag:

"ScripsAmerica Inc. has signed an agreement to acquire PIMD International, LLC, a wholesale distributor of prescription drugs as well as medical supplies and devices.

Based in Miami, PIMD International LLC serves as a pharmaceutical wholesaler to pharmacies, hospitals, and physician's offices in the US. The company also sells medical supplies in all health care settings and online. PIMD, which will become part of ScripsAmerica, provides its customers with access to specific medications for their end users."

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Thursday, October 31, 2013

Rotech Creating 200 Jobs in Charlotte NC

PRESS RELEASE: Rotech Healthcare Inc. Creating 200 Jobs in Charlotte | NREIWire content from National Real Estate Investor:

"The company has already started hiring and will continue to do so until all jobs are filled, posting opportunities in the careers section at rotech.com. Positions include customer support managers, customer support supervisors, patient account specialists and customer support specialists."

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Cardinal Health and FedEx will provide combined 3PL services

Updated July 2023:

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

Strategic alliance between Cardinal Health and FedEx will provide combined 3PL services - PharmaceuticalCommerce.com:

"Noting that the two companies have been working together for over 10 years to provide 3PL services to healthcare products companies, the two will now offer combined global transportation, warehousing and distribution services. FedEx brings, among other things, the No. 1 air cargo airline; Cardinal brings its 40 distribution centers, and expertise in managing healthcare products shipping."

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Wednesday, October 9, 2013

Drug Supply Chain at Risk for Diversion & Counterfeit

  • If your company needs another California Designated Representative - Wholesaler, or a California Designated Representative - 3PL, they'll need Board-approved training to apply for their Designated Representative license application. Board-approved California Designated Representative courses: 

Prescription Drug Supply Chain at Risk for Diversion Schemes and Counterfeit... -- MOUNT PROSPECT, Ill., Oct. 9, 2013 /PRNewswire-USNewswire/ --:

"In "Wholesale Drug Distribution: Protecting the Integrity of the Nation's Prescription Drug Supply," NABP points to the roles of unscrupulous wholesalers in distributing counterfeit drugs and unapproved foreign-sourced drugs that have endangered patients across the country. To help safeguard the distribution chain, NABP has implemented updated criteria for the Association's Verified-Accredited Wholesale Distributors (VAWD) accreditation program"

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New CA Law - SB 294 Requires A Special License For Sterile Compounders

Updated June 26, 2023:

The original link broke.

You might also be interested in:

---  the original post follows below  ---

Governor Jerry Brown signed Senate Bill 294 into law. SB 294 will go into effect in July of 2014.

Highland News > Archives > News > Bill Increasing Oversight Of Sterile Compounding Pharmacies Signed Into Law:

"Specifically, SB 294 requires both in-state and out-of-state pharmacies that compound sterile drug products for California patients that will be inhaled, injected, or administered into the eye to apply for a special, additional license from the California State Board of Pharmacy. Under this new law, the board is required to inspect these facilities annually to provide consistent oversight and ensure compliance with pharmacy law."

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Friday, September 27, 2013

Congress Clarifies Drug Compounding, Tracking Policies

Updated 12/12/2022

The links in the original post broke.

You might also be interested in:

---  the original link follows below  ---

Congress Clarifies Drug Compounding, Tracking Policies:

"After months of public hearings and negotiations, Democrat and Republican leaders of the House Energy & Commerce Committee and the Senate Health, Education, Labor and Pensions Committee unveiled a compromise bill last week. No one gets all they wanted from H.R. 3204, the Drug Quality and Security Act, but it provides more clarity and predictability to drug oversight programs and moves forward initiatives designed to enhance the safety and quality of medicines in the US."

Follow this link to the draft bill, Drug Quality and Security Act (PDF)

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Thursday, September 26, 2013

US Senate & House - Drug Quality and Security Act

Updated May 3, 2023

You might also be interested in:

---  the original post follows below  ---

This is promising news, cooperation and agreement between the House and Senate (and across the aisle), to converge on what could likely become final legislation. Stay tuned!

US Senate Committee on Health, Education, Labor, & Pensions: Newsroom - Press Releases:

" “This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards. This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together.” "

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Wednesday, September 25, 2013

Survey Finds S.B. 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession


New Poll Finds Senate Bill 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession | Business Wire:

"A recent poll of independent compounding pharmacies by PCCA shows that 4 in 10 of the pharmacies surveyed would be required to abandon the pharmacy profession under the terms of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act."

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Thursday, September 19, 2013

CA To Amend Track-and-Trace Law re: ‘Drop Shipments’

California to amend track-and-trace law to deal with ‘drop shipments’:

"The proposal specifies that in the case of a drop shipment, the manufacturer would “omit data elements from the pedigree showing transfers of ownership to and from the wholesale distributor, including any certifications of receipt and delivery of the drug by the wholesaler.”

The electronic pedigree, however, would need to be “conveyed directly from the manufacturer to the authorized purchaser prior to or contemporaneously with the delivery” of the drug, according to the board."

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Alert - Individuals Posing as Delivery Driver or Cardinal Health Employees - CSHP

Updated March 2, 2022

Unfortunately, the linked alert is no longer available.

---  the original post follows below  ---

Alert - Individuals Posing as Delivery Driver or Cardinal Health Employees - California Society of Health-System Pharmacists:

"In recent days, Cardinal Health has been notified by a number of customers in the Los Angeles area that an individual has presented himself as a Cardinal Health employee. The individual has attempted to enter pharmacies by announcing that a new Cardinal Health policy has been put in place that will provide our customers a refrigerator for the storage of cold chain packaging that needs to be returned. On one known occasion, the individual was allowed into the controlled area of a pharmacy to study a possible location for the refrigerator."

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Monday, September 16, 2013

House Version of Compounding Legislation Emerges, Contrasts With Senate Approach


House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach:

"Now legislators will be tasked with negotiating out differences in their legislative approaches. The PQSA is significantly more rigorous toward the compounding industry than the Compounding Clarity Act, and also includes track and trace legislative measures. The significant differences and approaches between the two pieces of legislation mean it could be months before any legislation stands a chance of reaching President Barack Obama's desk."

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Friday, September 13, 2013

On-Line Change of Address Form - CA Board of Pharmacy


Change of Address Form (online) - California Board of Pharmacy

The following link will take you to a webpage that gives an overview of the California laws and regulations governing Board of Pharmacy address change reporting requirements:

Board of Pharmacy - Technical Help:

"You are required to notify the board of any change in your address within 30 days. Change of address may be made on-line or in writing to the board."

If you are a licensed California Designated Representative, or other affected party, follow this link to the California Board of Pharmacy - On-line Change of Address Form.

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Wednesday, September 11, 2013

Former Owner of LA Medical Equipment Supply Co Pleads Guilty to $2.6 Million Medicare Fraud

Former Owner of Los Angeles Medical Equipment Supply Company Pleads Guilty to $2.6 Million Medicare Fraud Scheme:

"From approximately June 7, 2006, through Sept. 28, 2009, Afolabi, through Emmanuel, submitted approximately $2,668,384 in fraudulent claims to Medicare for power wheelchairs and related services, and Medicare paid Emmanuel approximately $1,490,532 on those claims."

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Business Owners May Face $100-Per-Day Penalty Under ObamaCare | Fox

Business Owners May Face $100-Per-Day Penalty Under ObamaCare | Fox Small Business Center:

"Small business owners who thought they were off the hook for ObamaCare regulations until 2015 may be in for an expensive wake-up call next month.

Beginning Oct. 1, any business with at least one employee and $500,000 in annual revenue must notify all employees by letter about the Affordable Care Act’s health-care exchanges, or face up to a $100-per-day fine."

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Tuesday, September 3, 2013

Drug Channels: 12 Fastest-Growing, Private Specialty Pharmacies

Drug Channels: Say Hello to the 12 Fastest-Growing, Private Specialty Pharmacies:

"The 2013 Inc. 500 list, which is based on 2012 revenues, includes 12 specialty pharmacies. The pharmacies and their key stats are listed below, along with recent specialty forecasts. Diplomat Pharmacy again topped the specialty pharmacy list, with revenues of $1.1 billion, up 42% vs. 2011. The other 11 pharmacies had total revenues of $1.3 billion.

Pay attention: these companies are the vanguard of tomorrow’s pharmacy industry."

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