Florida Certified Designated Representative (CDR) Application Available Online

Vitamin bottles and pillsHere’s how to find the FL CDR application form online.

Go to the following webpage:
Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics – Certified Designated Representative

Then scroll down to the bottom of the page, and click on:
Apply Using A Printable Application

If you need help, the page states:
If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.


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Florida Certified Designated Representative (CDR) Required For Wholesale Distributors

Law books, gavel, scaleThe Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics answers the question, “Does my company need a permit?”  Their answer includes a helpful chart, definitions, and a link to relevant Florida statutes

Prescription drug wholesalers need to have a Florida Certified Designated Representative (CDR):

“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”).”

Source: Certified Designated Representative – Florida Department of Business & Professional Regulation


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NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors – Drug Channels

Graphic of different kinds of medicines

“This year’s report—our sixth edition—has been updated, revised, reorganized, and expanded. It contains the latest industry and financial data, along with detailed information about the strategies and market positions of the largest public companies: AmerisourceBergen, McKesson, and Cardinal Health. It also includes many new elements.”

Read the full article: Source: Drug Channels: NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors


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Who Offers Designated Representative Training Courses?

Stethoscope on keyboard with a gavelSkillsPlus International Inc. offers California Designated Representative training courses (approved by the California State Board of Pharmacy). They’re very popular for their convenience, and availability 24 hours a day & 7 days a week!

Learn more: Designated Representative training & Exemptee training taught by SkillsPlus International Inc.

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Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce

Assorted drug capsules and tabletsHDMA’s 2014-15 Factbook updates member financial, operational performance.

The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was looking like in 2013 just as the Drug Supply Chain Security Act was passed; presumably, the report from a year from now will show how ready the industry was for the Jan. 1, 2015, deadline coming up for reporting transaction information to customers and FDA, per DSCSA requirements. ”

Learn more details, read the full article: via Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce.


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FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference

Workers in a warehouse“Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect.

Dr. Connie Jung, Acting Associate Director for Policy and Communications for the Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance, once again spoke at the conference and attempted to address some of their concerns.”

Read the full report-out: via FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference.


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It’s Holiday Season. Complete Designated Rep & Exemptee Training Before Year End!

Prepping vegetables in the kitchenThe holidays are coming!

Don’t let your Exemptee training or Designated Representative training hang over your head going into November and December.

Just get it done now, before:

  • the kids get out of school
  • you find yourself cooking in the kitchen
  • shopping for the holidays

Go to DREprof.com: The Designated Representative and Exemptee Training Website

Industry groups take issue with guidance on outsourcing facilities

FDA Inspection - Magnifying glass over FDA investigator badge“GPhA says compounders and outsourcing facilities should abide by the same inspection criteria as other drug manufacturers. “Drug manufacturers with U.S-based facilities are required to be inspected by FDA at least every 24 months,” GPhA says. “Compounders producing sterile products should be held to similar standards.”

Similarly, BIO disagrees with FDA’s proposed alternative approaches for reducing the need for laboratory testing of incoming components and to minimize the need for facilities to have an in-house laboratory.

“We believe that the alternative approach to testing should not be permitted exclusively for outsourcing facilities,” BIO says. “These sites should be accountable for maintaining the same level of control over their contract sites as would any other pharmaceutical manufacturer.””

Read the full article: via Industry groups take issue with guidance on outsourcing facilities.


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HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act

President Obama signing new law“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S.

The law will transform how the domestic supply chain operates to the benefit of healthcare providers and pharmacists — and their patients. HDMA and the nation’s primary pharmaceutical distributors have long advocated for this national solution.

With enactment of the law:

All existing state pedigree requirements that went above and beyond the Prescription Drug Marketing Act (PDMA) of 1987 are immediately preempted. The baseline requirements of the original law will remain in place until January 1, 2015, when statutory requirements, assisted by guidances currently being developed by FDA, will go into effect.

In 2015, enhanced product tracing requirements begin, which over 10 years, will lead to the establishment of a single system of federal electronic, unit-level traceability requirements across the entire supply chain.

National distributor licensure standards also have been strengthened. Instituting strong, consistent distributor licensing standards is a critical component in ensuring that the supply chain remains safe and secure.”

Read the full article, and reference a great collection of fact sheets and educational material about this subject: via HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Free Tips – Florida Designated Representative (CDR) Exam Prep

Typing on a laptop during an online courseSimply studying for the Florida Certified Designated Representative (CDR) examination isn’t enough!

  1. Many candidates only study the exam subjects and content, then take what’s considered a difficult exam. Some of these same candidates don’t pass the exam.
  2. As you prepare for the examination, you have to recognize that the official exam of 40 multiple choice questions (in 1.5 hours) is the critical step toward moving forward in the licensing application process. That’s roughly 2.5 minutes per question, hardly enough time to rethink or rehash the answer choices.
  3. The keys to exam preparation include: reinforcing complete mastery of the exam content, reducing your anxiety, gaining confidence, and developing test taking familiarity, rhythm, and pace.

In the past, I’ve taken many high pressured timed exams, including healthcare clinical and web technology certification exams. In my experience, I learned that scouring the universe for any and all available practice exams helped me tremendously to prepare for the official examinations. I strongly recommend practice exams.

The Key Learning. Only by preparing for the most important part of the examination process, that is, actually taking the test, can you increase the odds of successfully passing the exam. As Vince Lombardi (football coaching legend) says, “Practice does not make perfect. Only perfect practice makes perfect.” So we recommend candidates take as many practice exams before sitting for the official state exam.


Go to DREprof.com: The Designated Representative and Exemptee Training Website