Florida Certified Designated Representative (CDR) Training And Wholesale Distribution Compliance

• Online Florida CDR Training by CDR Resource Center
• People also search for California Designated Representative wholesaler training

Over the years, we've fielded many questions revolving around the Florida Certified Designated Representative license.  Of chief interest, is how to go about preparing for the State of Florida Certified Designated Representative Laws & Rules Examination.

I've invited Dr. Sharon B. Roberts* (an expert in the regulatory realm of pharmaceuticals and wholesale drug distribution, and founder of CDR Resource Center) to share some thoughts and introduce the services that CDR Resource Center can provide:

• Florida Certified Designated Representative (CDR) laws and rules examination preparation
• Consulting expertise in prescription drug regulations and wholesale distribution compliance

Online Florida CDR Training By CDR Resource Center - Automated Online Training & Testing

All Prescription Drug Wholesale Distributors (including virtual BROKER -ONLY), companies that are seeking to do business in or with the State of Florida, are required to have a full-time Florida licensed Certified Designated Representative, (CDR). To become a FL licensed CDR a candidate must pass a laws and rules exam administered by the State of Florida.  CDR Resource Center has been training FL CDR candidates for over 12 years for the very difficult State exam.

Training for the State exam is offered in three ways:

1. CDR Resource Center offers online virtual training allowing the candidate to study at their own pace from any computer.  The virtual training consists of 15 modules of educational and study materials, 100s of sample test questions and timed mock 40 question final exam. Register for FREE on our website - Try a quick FREE sample of the module style online training. 
2. For the student who would prefer a live instructor, CDR Resource Center offers an 8 hour Webex with a live trainer.  The live training includes a bound law and rules manual, a pre-test, 7 hours of lecture and a post-test.   The live training can be purchased online in the Compliance Consulting section of the cdrresourcecenter.com. 
3. For the candidate who has taken the State exam already and does not want to take a full course, we offer hourly consulting.  Bring us all your questions and purchase as much time as you’d like.  We can discuss your questions and point you to the correct answers. 

Additional CDR Resource Center Services

CDR Resource Center also provides state licensing support for the drug industry. Our company's licensing support services is unique to the industry allowing companies to pay as they go with no upfront onboarding fees or contracts.

*About Our Guest Blogger - Sharon B. Roberts

Sharon Roberts, PharmD, JD, CDR

Sharon Roberts, PharmD, JD, CDR has over 25 years in the Pharmaceutical industry as a Registered Pharmacist and practicing Florida lawyer. She then became licensed as a Certified Designated Representative (CDR) and worked for the Department of Business and Professional Regulation Drug, Device and Cosmetics Program of the State of Florida where she was a State Inspector/Drug Agent inspecting businesses involved in the manufacture, purchase, storage and sale of prescription and over-the-counter drugs, devices and cosmetics. As part of this experience she became intimately familiar with the Florida Drug, Device and Cosmetic Act. The contents of this Act are the basis of the studies required to become a State Certified Designated Representative (CDR). Combining all her experience, she founded CDR Resource Center which offers over 25+ years of experience in the regulatory realm of pharmaceuticals and wholesale drug distribution.

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You might also be interested in:  California Designated Representative training programs for wholesalers, 3PL, reverse distributors

Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation

Read the full article: Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation:

"Ancestry.com, the popular genealogy site, is talking to the FDA about using DNA to estimate disease risk for the company’s member base. CEO Tim Sullivan revealed the news in an interview with The Verge, effectively announcing his company’s intention to eventually offer straight-to-consumer genetic testing.

Ancestry is currently in the "very early stages of a conversation with the FDA," Sullivan told The Verge. "We think it's totally appropriate that the FDA has stepped in to pretty aggressively regulate direct-to-consumer genetic tests—and we're just starting from that perspective, and trying to work very closely with them," he continued."

'via Blog this'

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FDA - Unusual Letter Sent To iPhone-Based Testing Device Co

FDA Sends Unusual Letter to Maker of iPhone-Based Testing Product:

"(FDA) revealed that it had sent off another type of letter to a medical device company, one rarely publicized by the agency."  . . .

"Prior FDA explanations make clear that the letters are part of a "triage" strategy practiced by the agency's device regulators in which the "It Has Come To Our Attention" letter follows a "call to clarify," preceding further actions such as an Untitled Letter, Inspection or Warning Letter."

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ICH Photosafety - FDA EU Draft Guidance

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Updated December 23, 2021

ICH Photosafety Guidance Aims to Bridge FDA, EU Differences:

"The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation  on the photosafety testing of drug compounds.

“The S10 draft guidance document clarifies some points in the current EMA and FDA guidance that are known weaknesses, based on accumulated information and experience since those documents were issued in the mid-2000s,” Doug Learn, director of photobiology at Charles River, told In-Pharmatechnologist.com."

'via Blog this'

Read the guidance (updated link):

PHOTOSAFETY EVALUATION OF PHARMACEUTICALS - S10 (pdf) 

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FDA Guidance - Impact Resistant Lenses - Q and A

• FDA GMP QSR cGMP Online Training - GMP online training classes provided by SkillsPlus International Inc.

Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. As you read through the guidance, you'll find quite a number of useful hyperlinks to additional information and references.

Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(h)). These devices are subject to applicable device regulations under Title 21, Code of Federal Regulations. Impact-resistant lenses reduce the number of eye injuries from eyeglasses and sunglasses. Glass lenses, plastic lenses, or laminated glass lenses can be made impact resistant by any method. However, lenses generally must be capable of withstanding the impact test described in 21 CFR 801.410. This guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, lens testing apparatus, record maintenance, and exemptions to testing.

This guidance is a revision of “Impact-Resistant Lenses: Questions and Answers (FDA 87-4002),” issued September 1987. This guidance updates answers to questions that industry and consumers frequently ask FDA about impact-resistant lenses and FDA regulation of eyewear. The revision reflects the exemption of sunglasses from the Premarket Notification (510(k)) requirement effective February 19, 1998 (21 CFR 886.5850(b)). The revised document also includes a more detailed discussion about lens blanks, semi-finished, finished, and plano lenses, as well as import procedures. The terms "eyeglasses" and "spectacles" are used interchangeably in this document.

Eyewear products regulated by FDA are commonplace in the daily lives of the vast majority of the general public. FDA believes that impact-resistant lenses are an essential component of the safe design of these devices.  The use of impact-resistant lenses in eyeglasses and sunglasses is addressed in 21 CFR 801.410.

For more information on this topic, contact the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) by phone at 1-800-638-2041, by fax at 301-847-8149, by e-mail at dsmica@fda.hhs.gov, or write to the following address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Communication, Education and Radiation Programs
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Ave.
WO66-4613
Silver Spring, Maryland 20993

#FDA #GMP #training #cGMP

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HIV AIDS - 97 US Medicines in Testing - PharmaTimes

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Updated November 26, 2025

The original link broke.

You can still read about the same topic here:

U.S. Pharmaceutical Companies Developing 97 New Drugs and Vaccines to Fight HIV/AIDS - MedIndia:
https://www.medindia.net/health-press-release/US-Pharmaceutical-Companies-Developing-97-New-Drugs-and-Vaccines-to-Fight-HIVAIDS-53732-1.htm

---  the original post follows below  ---

This is a really nice snapshot of some of the clinical testing going on in the HIV AIDS field, PhRMA's Pharmaceutical Researchers Are Testing 97 Medicines And Vaccines for HIV and Related Conditions. The article provides a quick overview for medicines grouped by:

1. Anticancer
2. Antiviral
3. Gene therapy
4. Immunomodulators
5. Vaccines
6. Other

Previous Posts: Abzymes Pinpoint The HIV Achilles Heel 109 HIV Drugs And Vaccines Under Development Listen To People With AIDS and HIV (audio)

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Integrating Human Factors Engineering Into Medical Devices (video)

Checkout this free video, Integrating Human Factors Engineering Into Medical Devices. Human factors is the science and the methods used to make devices easier and safer to use. The FDA has a patient safety mission of distributing information about the design, testing, and selection of usable medical devices for clinical and home settings. The FDA works with manufacturers to help ensure the application of Human Factors engineering to the design of new products. It also helps device users through identification and investigation of use-related errors. This is a nice primer and video lesson on all things about human factors.

   

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Jan Is Natl Radon Action Month - Are you safe?

Updated November 1, 2025

Radon is a colorless, odorless, tasteless, and chemically inert radioactive gas. It is formed by the natural radioactive decay of uranium in rock, soil, and water. Naturally existing, low levels of uranium occur widely in Earth's crust. It can be found in all 50 states. Unless you test for it, there is no way of telling how much is present. If your house has high levels of radon, you need to explore ways to reduce your family's risk of lung cancer. Here are some resources you need to check out . . .

• The EPA's National Radon Action Month website with consumer information
• EPA radon webpages with coupons for radon testing kits

Has your house ever been tested for radon?

Related Posts:
Alert - Granite Countertops - They are HOT - Radiation and Radon Risk

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FDA Draft Guidance On Process Validation

The FDA recently released a draft guidance for new process validation. The guidance says that manufacturers would have to increase sampling and testing, and monitor process performance more closely during the early stages of commercial manufacturing, according to the FDA's Guidance for Industry - Process Validation: General Principles and guidance. Once finalized, this guidance replaces the FDA's process validation guidance issued in 1987. The new guidance applies to pharmaceuticals, biologics and active pharmaceutical ingredients. It will cover the 3 stages of process validation — process design, process qualification and continued process verification. Are you ready? 

Related Posts: Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending FDA Data Guidance - When patients withdraw from clinical trials View more FDA Guidance Documents (free) FDA Draft Guidance On Proprietary Names New FDA Guidance - Residual Solvents in Drug Products New FDA Guidance - New Contrast Imaging Indication Considerations New FDA Guidance - cGMP Practice for Phase 1 Investigational Drugs FDA Guidance Documents - FDA Current Thinking (free) Sign up for FDA Guidance Documents email updates. 

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Testing Approved Drugs In The Real World With Real People

Updated November 25, 2022

The original link broke.

You can still read about the same topic here:

New Arena for Testing of Drugs: Real World - TuscaloosaNews.com

---  the original post follows below  ---

In the drug development process, drugs are clinically tested in very select patient populations. This means that once a drug gets approved, the drug is often given to quite a different kind of patient population, and the results of drug treatment could be different. For the big picture, read this compelling Star News Online article, "New Arena for Testing of Drugs: Real World." I find the story so compelling for the following reasons . . .

1. Patients, health care professionals, and the pharmaceutical industry bring their own unique health and business issues or needs to the table
2. It's ultimately about the patient, and there's a need to know whether approved drugs help or harm in the real world

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Residual Solvent Coalition Formed - Gets FDA Attention On USP Chapter 467

Updated May 31, 2021

The original link broke.

You can read more about this topic here:

FDA Answers Key Residual-Solvent Testing Questions - PharmTech.com

---  the original post follows below  ---

When the FDA published its recent guidance document on residual solvents in drug products, it resulted in confusion and generated many questions. This recent PharmTech Talk post does an excellent job of framing the difficult situation, "Residual Solvent Concerns Lead to Coalition." In a nutshell, here are some of the important points PharmTech Talk makes . . .

1. Industry has experienced a number of problems and confusion regarding the draft guidance and communications received from FDA’s Office of Generic Drugs, that seem to conflict with Chapter 467
2. There have been so many problems that some core industry groups formed the Coalition for Rational Implementation of USP General Chapter <467>
3. The coalition had four key areas of concern: 1) testing versus control, 2) identification of Class 3 solvents, 3) use of Class 1 solvents, and 4) need for immediate relief while awaiting revised guidance.

Stay tuned, as there's hope the FDA will respond within the next couple of weeks. 

Previous Posts: The Health, Drug, Prescription, and GMP Supersite: New FDA Guidance - Residual Solvents in Drug Products 

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Home Medical Testing Kits - Overview and Recommendations (video)

 I really like this MSNBC video, "Medical Testing At Home." It provides an introduction to home testing and includes some important tips, such as:

• Read the label and instructions carefully
• Use only FDA-approved tests
• Follow all instructions
• Keep good testing records
• Call the 800 number for questions

I was surprised by the breadth of tests available, for example, blood pressure, blood sugar, drugs of abuse, cholesterol, fertility, etc. In some cases, brand recommendations are made.

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Drug Testing - The cat and mouse game!

Updated May 24, 2016 - broken elements removed

This brings back memories of my days working in the emergency room. This is the ongoing saga of who's gaming whom, read this news article found on the CBS website, "Drug-Test Cheats Try New Tricks - Experts Say Internet And Household Products Bring New Challenges To Drug Testing." In my opinion, it's a leap-frog phenomenon. The tests and testers get better, then the cheaters get craftier, and on and on it goes.

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21 CFR Part 11 - Masking Real Data For Testing

Creating test data for clinical computing or software is always a challenge. I found this interesting and helpful article on the 21 CFR Part 11 blog, "Protecting test data privacy when testing protocol amendments," which describes how to mask real data. This is important for a couple reasons. First, it's all so important to guard protected health information (PHI). Therefore, it's critical to avoid the easy path of testing with real live, production information about people. Second, creating meaningful, usable, test data from scratch can be an arduous task. Protect the privacy of the health information, and happy testing.

Prior 21 CFR Part 11 Posts:
The Health, Drug, Prescription, and GMP Supersite: Resource List - FDA Part 11 - Electronic Records and Signatures

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