FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review

FDA letters on building blocks

“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page.  Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December 2014 policy document that: “The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.””

Read the full article: Source: FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review


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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.

#designated #representative #training #exemptee #3PL #pharmacy #HMDR


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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

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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.


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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.


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FDA Law Blog: And So It Begins: FDA Issues First DSCSA Guidance

The FDA just published:  Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF)

William Koustas (FDA Law Blog) writes, “The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending ways trading partners can identify and determine whether product is suspect; and (3) creating a process for trading partners to terminate illegitimate product notifications.  FDC Act § 582(h)(2).  The Draft Guidance addressed each of these three issues as follows:” . . .

Read the full article: via FDA Law Blog: And So It Begins: FDA Issues First DSCSA Guidance.


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Your Florida CDR just quit. What do you do?

State Seal of Florida - Public Domain - Wikipedia

“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.”

View the full article, complete with references: via 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?.


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