Thursday, December 24, 2015

Pharmacy delivery vans targeted by drug thieves - STAT

Read the full article:  Pharmacy delivery vans targeted by drug thieves - STAT:

"In the last two years, there have been nearly 100 last-mile pharmaceutical thefts nationwide, according to FreightWatch International, an Austin, Texas, firm that provides logistics security services to companies. That’s nearly four times the rate of similar incidents in 2012, although the company said some of that increase could be the result of better reporting. Pharmaceuticals made up 98 percent of all last-mile cargo thefts over the last two years, according to FreightWatch."

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Saturday, December 19, 2015

Is Amazon getting into the airfreight logistics business? | Technology | Business Review USA

Read the full article: Is Amazon getting into the airfreight logistics business? | Technology | Business Review USA:

"According to several reports, this month Amazon commenced with talks to lease 20 cargo planes. This is a move that would give Amazon full control over its transportation costs and its fulfillment schedules, by allowing the company to cut out the 3PL airfreight services that it currently relies on—services that, as these reports point out, have caused frustrations beyond Amazon’s control" . . .

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CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
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Wednesday, December 9, 2015

Need Annual Refresher Training? - Designated Representatives & Exemptees

Have a Designated Representative or HMDR Exemptee that needs refresher training?

You might have said yes, if:
  • it's been several years since they've reviewed applicable regulations 
  • ongoing training hasn't kept pace with company standard operating procedures (SOPs)
  • an inspector or auditor recommends that annual or refresher training needs to be taken, or
  • a recent violation results in mandated remedial training
We recommend the following training courses:
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CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Top 20 3PL and public refrigerated warehouses, 2015 - Article from Modern Materials Handling

Read the full article with stats: Top 20 3PL and public refrigerated warehouses, 2015 - Article from Modern Materials Handling:

"Armstrong’s Top 60 list includes 3,540 facilities with 763 million square feet, with the average company managing 59 warehouses averaging 215,456 square feet. Armstrong’s full 3PL listings reflect 9,000 U.S. commercial warehousing facilities with 1.9 billion square feet of space under management. As of this publication, Armstrong estimates the total U.S. warehousing market will be valued at $141 billion through 2015."

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The Designated Representative Institute

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Tuesday, December 8, 2015

UPS identifies new series of “Pain Points’’ in pharma supply chains - Article from Logistics Management

Read the full article: UPS identifies new series of “Pain Points’’ in pharma supply chains - Article from Logistics Management:

"The 2015 Pain in the (Supply) Chain survey recently conducted by UPS coincided this year with qualitative interviews of healthcare executives in North America to gain further insights into trends, challenges and opportunities having an impact on healthcare logistics.

Among the findings was that healthcare companies have made significant strides in just one year to address some top supply chain pain points."

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5 Industry Trends for U.S. Drug Wholesalers - Drug Channels by Adam Fein

Read the full article: Drug Channels: Five Industry Trends for U.S. Drug Wholesalers - Drug Channels by Adam Fein

"Modern Distribution Management just published my article 2015 MDM Market Leaders | Top Pharmaceuticals Distributors. It is an excerpt from the 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

Below, I republish the section highlighting five significant industry trends affecting the U.S. drug wholesaling industry. I think Drug Channels readers will enjoy this summary."

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Training for CA Designated Representative license applicants
Training for CA Designated Representative-3PL license applicants

Florida CDR Examination study course for CDR license applicants


CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
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The Designated Representative Institute

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Tuesday, November 24, 2015

CMS steamrolls ahead with vent overhaul | HME News

Read the full article: CMS steamrolls ahead with vent overhaul | HME News:

"Despite widespread opposition, CMS will replace five codes for ventilators with two, and reduce reimbursement significantly, says AAHomecare.

The new codes, E0465 (invasive) and E0466 (non-invasive), go into effect Jan. 1. CMS hasn’t released the fee schedule amounts yet, but Brummett says she expects the agency to make a reduction of about 33%."

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NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Friday, November 13, 2015

California Designated Representatives - Learn from these enforcement actions

Learn from these enforcement actions taken against wholesalers and California designated representatives, going back to 2007.

Go to:  The California Board of Pharmacy |  Enforcement Actions | Accusations Filed

Approach the "accusations filed" as case studies, and situations to learn from and avoid. These are real life examples of what can happen when applicable laws, rules, and regulations are not understood or followed.

There are a lot of cases, and there's quite a diverse mix of cases that are listed, including those involving wholesalers and designated representatives.  You'll want to sift through, and look for the cases that indicate:
  •  Site license: Wholesale Permit No. WLS #
  •  Personal license: Designated Representative License No. EXC #
The cases contain a lot of information, and I suggest starting out simply, by scanning these sections: case review of applicable rules and regulations; and the associated causes for discipline.

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Friday, November 6, 2015

OIG targets orthotics and vents | HME News

Read the full article: In brief: OIG targets orthotics and vents, Rep. Tipton throws support behind rural providers | HME News:

"Orthotics and vents are among the HME that the Office of Inspector General plans to focus on in fiscal year 2016, according to a work plan published last week."  . . .

"In addition to orthotic braces and vents, the OIG plans to examine provider compliance with payment requirements for power mobility devices, and nebulizer machines and related drugs."

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Read the "work plan" referenced above:
WORK PLAN Fiscal Year 2016 - OFFICE OF INSPECTOR GENERAL - U.S. Department of Health and Human Services (PDF)

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Where is Rule Chapter 64F-12, Florida Administrative Code? - FL CDR Exam

Question:
I'm studying for the Florida Certified Designated Representative Laws and Rules Examination, and I can't locate the text of Rule Chapter 64F-12, Florida Administrative Code. Where can I find it?

Answer:
The text could be hard to find because Rule Chapter 64F-12 F.A.C. was transferred into Rule Chapter 61N-1 Florida Administrative Code.

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Wednesday, November 4, 2015

Application for Home Medical Device Retailer Exemptee License

Application for Home Medical Device Retailer Exemptee License

Important Tip:  State The Truth And Be Accurate

HMDR employers and exemptee applicants that don't follow this approach could run into problems. The applicant and employer signatures indicate certification "to the truth and accuracy of all statements, answers and representations made . . ."

HMDR License Applications:

Go to the Home Medical Device Retailer (HMDR) License Applications:
  • HMDR California Facility License Application
  • HMDR Out of State Facility License Application
  • HMDR Exemptee Application

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Tuesday, November 3, 2015

MIA launches pharmaceutical transport certification program | Miami Herald

Read the full article: MIA launches pharmaceutical transport certification program | Miami Herald:

"Miami International Airport, already a major hub for pharmaceutical imports and exports, is the first U.S. airport to partner with the International Air Transport Association’s global certification program for handling and shipping pharmaceutical products.

To avoid spoilage of sensitive pharmaceutical products and boost international trade, IATA, the international airline trade association representing about 260 air carriers, is providing assessment and training in cold-chain pharmaceutical transportation to certify participants in MIA’s air cargo supply chain, including air cargo carriers, logistics companies, truckers, freight forwarders and warehouses."

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Monday, November 2, 2015

Didn't Pass The Florida Certified Designated Representative (CDR) Examination?

Question:
I took the Florida Certified Designated Representative Laws and Rules Examination, and did not pass. What could happen next?

One Possible Answer:
"If the applicant has not passed the CDR examination within six (6) months of the eligibility notification, the department may deny the application." (source: FL DBPR DDDC )

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Thursday, October 29, 2015

Increase in Outsourcing of Bio Pharmaceutical Labeling and Packaging to 3PL & 4PL

Read the full news release:  Global Bio Pharma Logistics Market 2015-2019 - Increase in Outsourcing of Bio Pharmaceutical Labeling and Packaging... -- DUBLIN, Oct. 28, 2015 /PRNewswire/ --:

"The market is witnessing certain trends that are expected to contribute to its growth during the forecast period. One of these trends is the increase in outsourcing of bio pharma labeling and packaging activities to 3PL and 4PL companies. This helps the manufacturing companies to focus on core activities like the procurement of raw materials and distribution of the products."

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GMP training courses & workshops taught by SkillsPlus International Inc.

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The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Drug Wholesaler AmerisourceBergen Building New Data Bridges to Manufacturers - The CIO Report - WSJ

Read the full article: Drug Wholesaler AmerisourceBergen Building New Data Bridges to Manufacturers - The CIO Report - WSJ:

"AmerisourceBergen Corp. CIO Dale Danilewitz says the global drug wholesaler is working on a number of projects meant to deliver more data to its pharmaceutical manufacturers, a move that would give drugmakers more visibility into their supply chain and help manage inventory.

“We’re trying to deliver more information about product access, product utilization, and product pricing to them,” he said during an interview at the Technology Business Management Council conference in Chicago.  The delivery methods, which could include “real-timeonline access,” is part of the company’s “roadmap for better integration with manufacturer systems."

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Wednesday, October 28, 2015

License Fee Analysis Report - Includes CA HMDR Exemptees

Report To The Legislature - Drug Manufacturing, Medical Device Manufacturing, And Home Medical Device Retailer Licensing Costs And Fee Analysis Annual Report For 2015 (PDF) - posted on the CDPH HMDR website

If you follow these kinds of California HMDR Exemptee proceedings, you'll be interested in how annual license fees are determined. They're based on estimated program costs, taking into account the costs for inspections, investigations, enforcement, and other required activities.

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FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Tuesday, October 27, 2015

Wednesday, October 21, 2015

Ready for a makeover: What’s trending in the global pharma logistics? – The Financial Express

Read the full article: Ready for a makeover: What’s trending in the global pharma logistics? – The Financial Express:

"From using data analytics to developing cold chain capabilities, pharma companies, in tandem with logistics firms, are leaving no stone unturned to tackle the mounting challenges. Since payers and consumers are likely to continue demanding effective and proficient healthcare, the part of the supply chain that handles the last mile of delivery is changing.

Outsourcing to third-party logistics providers (3PLs)
 “More companies are outsourcing logistics than we have seen in many years”
– Joe Carlier, Senior VP – Sales, Penske Logistics (June 2015)"

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The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

The Designated Rep and Exemptee Professionals Blog
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Tuesday, October 20, 2015

7 New Opportunities for Today's DME Entrepreneur | HomeCare Magazine

Read about all seven ideas: 7 New Opportunities for Today's DME Entrepreneur | HomeCare Magazine:

"With the multitude of changes and challenges in today's durable medical equipment (DME) marketplace, successful entrepreneurs are seeking new opportunities where they can employ their skill and experience. Ask yourself: What opportunities and markets are right for my company, my customers, and myself? How do I successfully enter new, parallel markets without jeopardizing my current DME operation?"

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FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Friday, October 16, 2015

Avoid Delays In License Applications & Renewals - CA Board of Pharmacy

The California Board of Pharmacy just posted a hyperlink on their home page about possible license delays.

The California Department of Consumer Affairs provides the details, Attention New Applicants And Renewing Licensees - Avoid Unnecessary Delays In Your License Issuance Or Renewal:

In summary:
"The Department of Consumer Affairs is scheduled to transition additional Boards and Bureaus to the new BreEZe online licensing and enforcement system in January 2016. The transition to the new system will require a temporary shutdown of all licensing processes for several business days, and could result in delays in processing initial license applications, license renewals, and changes such as name changes or changes of address."

If you're scheduled to renew, or are planning to submit a license application within the next 3-4 months, you'll want to read the details for more information, and how it might affect your situation. I suggest that you learn more right away, so that you can plan your next steps in a timely fashion.

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The Designated Representative Institute

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Wednesday, October 7, 2015

FDA Posts Wholesale Distributor and 3PL License Database | RxTrace

Read the full article: FDA Posts Wholesale Distributor and 3PL License Database | RxTrace:

 . . ."anyone who buys drugs from wholesale distributors should include a step in their “purchasing” Standard Operating Procedure (SOP) to check this database to confirm that the company they are placing an order with is properly licensed in the jurisdiction they are located in."

'via Blog this'

References:
FDA - Wholesale Distributor and Third-Party Logistics Providers Reporting
FDA - Wholesale Distributors and Third-Party Logistics Providers Search

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FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Tuesday, October 6, 2015

Florida CDR Exam - What To Expect - Free Test Taking Tips

Avoid surprises!

Review the entire CDR CIB carefully. It contains far more information than what you see below in this post.

This post focuses on what to expect when you sit down in front of the Pearson VUE testing computer.


The CDR Candidate Information Booklet (CIB) says:
(STATE OF FLORIDA - Candidate Information Booklet for the CERTIFIED DESIGNATED REPRESENTATIVE LAWS AND RULES EXAMINATION - Always check for the latest published version)

Introduction:
  • Before you begin the examination, you will have an opportunity to go through a tutorial on the computer.
    • You'll have 15-30 minutes to take the tutorial (the CIB is inconsistent on the duration; 15 vs 30 mins).
    • The time you spend on the tutorial will NOT reduce the time allotted for taking your examination. When you feel comfortable with the computer testing unit, you may begin your examination. The time of the examination begins the moment you look at the first question on your examination.
  • You'll have 90 minutes to take the exam
    • The exam consists of 40 multiple choice questions  
Test Taking Advice:
  • Read all instructions carefully.
  • For best results, pace yourself by periodically checking your progress. This will allow you to make any necessary adjustments.
  • Be sure to record an answer for each question, even the items about which you are not completely sure. You can note the questions you wish to reconsider on the computer testing system and return to them later.
  • Alert a Proctor or Test Center Manager to any problems that may occur during the examination. Do not wait until the examination is over to inform someone about a problem.
Scoring Procedures and Notification of Results:
  • All questions are equally weighted. The minimum percentage score needed to pass has been set at seventy-five percent (75 %.)
  • All candidates will receive an official photo-bearing exam result report immediately following completion of their examination.

The Pearson VUE Webpages Share Information For Test Takers:

About Pearson VUE Exams:  This tutorial is provided to help you become familiar with Pearson VUE exam software. Remember, the CIB says the exam consists of 40 multiple choice questions.

Pearson VUE Computer-Based Testing Demo:  This demo prompts you to interact with what you see on the computer screen. By clicking around, you'll get more comfortable with the testing software.

Test Taker Tips (video) - Free tips and advice on how to get ready for the exam.

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The Designated Representative Institute

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AmerisourceBergen to Buy PharMEDium for $2.6 Billion - WSJ

Read the full article: AmerisourceBergen to Buy PharMEDium for $2.6 Billion - WSJ:

"PharMEDium maintains four compounding facilities and serves more than 3,000 hospital clients, according to a news release."

'via Blog this'

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NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
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FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Monday, October 5, 2015

New NCPA Report Highlights How Drug Wholesalers, Independent Drugstores Profit From Generic Price - PRNewswire

Read the full article: New NCPA Report Highlights How Drug Wholesalers, Independent Drugstores Profit From Generic Price... -- WASHINGTON, Sept. 28, 2015 /PRNewswire-USNewswire/ --:

"NCPA's report outlines several reasons for generic drug price increases within the supply chain and offers new insights into both wholesalers and pharmacies:"

'via Blog this'

. . .  specifically, the article calls out:
  • Drug Wholesalers, and
  • Independent Drugstores and the "Gray Market."
Note:  in this article, NCPA means the National Center for Policy Analysis

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FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Friday, October 2, 2015

UPS, FedEx and DHL bet big on health-care logistics - CNBC

Read the full article: UPS, FedEx and DHL bet big on health-care logistics - CNBC:

"UPS isn't the only logistics player working for health-care companies. FedEx and DHL have made significant investments in their health-care supply chains as well. "

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Florida CDR Required For Out-Of-State Prescription Drug Wholesalers

Source: Permitting FAQ 8 - Florida Department of Business & Professional Regulation - Division of Drugs, Devices and Cosmetics:

"DIVISION OF DRUGS, DEVICES AND COSMETICS

IS AN APPLICANT FOR AN OUT-OF-STATE PRESCRIPTION DRUG WHOLESALE DISTRIBUTOR PERMIT REQUIRED TO HAVE A FLORIDA CERTIFIED DESIGNATED REPRESENTATIVE?

Yes, having a Certified Designated Representative is one of the minimum requirements for the Out-of-State Prescription Drug Wholesale Distributor permit."

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Thursday, October 1, 2015

UPS Opens Its First Facility To Offer Comprehensive Medical Device Replenishment Services - MarketWatch

Read the full article: UPS Opens Its First Facility To Offer Comprehensive Medical Device Replenishment Services - MarketWatch:

"As part of its long-term strategy to support medical device manufacturers, UPS® UPS, +0.06% today announced the opening of a new healthcare-compliant distribution and warehousing facility in New Jersey to support the growth of its customers. The multi-client hub is the first in UPS's network to offer medical device companies comprehensive logistics services such as autoclave capabilities, instrument inspection and surgical set replenishment, among other services.

The 208,000-square-foot facility is healthcare-dedicated and strategically located near UPS's air hub at Philadelphia International Airport."

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Wednesday, September 30, 2015

Amazon Flex Program is Like Uber for Last-Mile Delivery - TruckingInfo.com

Read the full article: Amazon Flex Program is Like Uber for Last-Mile Delivery - News - TruckingInfo.com:

"On average, e-commerce now accounts for an average of 11.85% of North American 3PLs' revenue, and CEOs predict it will increase to 20.85% in three years.

The survey also noted that ride-sharing companies, most notably Uber, are believed to potentially pose a threat to aspects of the 3PL industry in the future by providing last-mile delivery services and taking business away from small-volume couriers."

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Tuesday, September 22, 2015

New Cardinal and McKesson Customer Deals Show A Changing Generic Channel - Drug Channels

Read the full article: Drug Channels: New Cardinal and McKesson Customer Deals Show A Changing Generic Channel:

"These latest deals show how generic purchasing consortia are accelerating business alignment between pharmacies and their wholesaler suppliers.

The deals also signal further generic purchasing consolidation. For both brand-name and generic drug manufacturers, a robust channel strategy function is more important than ever."

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CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
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