FDA > DSCSA > Are you ready for the Drug Supply Chain Security Act?

Sign-up for a Board-approved California Designated Representative course now:
 - Wholesaler Training Course
 - 3PL Training Course
 - Reverse Distributor Training Course

Read the full article: Drug Supply Chain Security Act > Are you ready for the Drug Supply Chain Security Act? - FDA.gov:

"There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements."

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

14 Arrested in Meningitis Deaths Linked to New England Compounding Center - NYTimes.com

Read the full article: 14 Arrested in Meningitis Deaths Linked to New England Compounding Center - NYTimes.com:

"The arrests signal the beginning of criminal proceedings against the New England Compounding Center, whose contaminated drugs led to the deaths from fungal meningitis of 64 people in the fall of 2012. More than 680 people were sickened.

The contamination caused an uproar and prompted new legislation about compounding pharmacies, which make specialized formulations of drugs for patients with particular needs. Over the years, such companies have grown into mass manufacturers distributing medicine all over the country, virtually unregulated by the federal government."

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

American HomePatient (AHP) rumored to explore sale | HME News

• The top choice for CDR and Exemptee training! Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
  

Read the full article: AHP rumored to explore sale | HME News:

"American HomePatient (AHP) is reportedly considering a sale.

The Deal has reported that the provider has retained Jefferies & Co., to explore a sale.

AHP was acquired by Highland Capital Management in 2010 in an effort to avoid bankruptcy. At the time, it had $226 million in debt.

Like many companies in the HME industry, AHP has struggled with reduced reimbursement rates."

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• FDA Recommends New Testing Standards for Home Use Devices | RAPS

Who Are The Top 25 Healthcare Supply Chains - Health IT Outcomes

• California Designated Representative training programs approved by the California State Board of Pharmacy:  
  • Wholesaler Training Course
  • 3PL Training Course
  • Reverse Distributor Training Course

Read the full article: Who Are The Top 25 Healthcare Supply Chains - Health IT Outcomes:

"The top spot went to Cardinal Health for the fourth consecutive year, and it has the widest breadth among healthcare companies. The press release states Cardinal Health is “a manufacturer, wholesaler, distributor, retail pharmacy, and a connector at many points in between. Cardinal continues its heritage of customer collaboration, especially in medical products distribution by further integrating the acquisition of home healthcare company AssuraMed and in 2014 getting deeper into medical devices through the $320 million acquisition of AccessClosure.”

Rounding out the top ten spots were Mayo Foundation, Intermountain Healthcare, Owens & Minor, CVS Caremark, Mercy, Johnson & Johnson, AmerisourceBergen, McKesson, and Walgreens. Also in the Top 25 were Ascension Health (12),Advocate Health Care (13), Kaiser Foundation Hospitals (14), Cleveland Clinic (16), UMPC (17), Geisinger Health System (18), Providence Health & Services (22), and Banner Health (24)."

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

HMDR License Application

• People also search for California HMDR Exemptee license training certification - Buy now!

We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students.

HMDR Application Forms

Follow this link to the 3 application forms:  HMDR License Applications (Certificates and Licenses) - CA Department of Public Health (CDPH):

. . . "links to the current application forms for both the firm license application needed by each individual facility location where home medical devices (prescription Rx devices and non prescription devices) will be sold, leased or rented when ordered by a physcian or other prescriber.  The application for the HMDR exemptee is also linked here for firms who wish to sell prescription Rx devices such as respiratory equipment, medical oxygen and other equipment identified as dangerous or legend devices under California law."

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The link above gets you to the following PDF forms:

• HMDR California Facility License Application (PDF)
• HMDR Out of State Facility License Application (PDF)
• HMDR Exemptee Application (PDF)

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Training for California Home Medical Device Retailer (HMDR) Exemptee license applicants

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

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

Medtrade Spring features new format | HME News

• Buy now! California Exemptee Training Certification Course
• California HMDR Exemptee Training Certification - online training class for home medical device retailers. If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.

Updated October 18, 2020

COVID-19 has affected public gatherings.

You might also be interested in:

MedTrade - Home

- - -  the original post follows below  - - -

Read the full announcement: Medtrade Spring features new format | HME News:

"Medtrade Spring is mixing it up this year.

The three-day conference, slated for March 30–April 1 at the Mandalay Bay Convention Center in Las Vegas, has a new format aimed at reducing overlap between conference sessions and expo floor time. A majority of educational sessions have been moved to Monday, allowing attendees to browse the expo floor on Tuesday and Wednesday."

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• California HMDR Exemptee Training Certification - online training class for home medical device retailers. If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

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Expert cautions: DSCSA deadlines may cause drug shortages - in-Pharma Technologist

• Register now for the courses below, for:
       Wholesalers | 3PL | Reverse Distributors
• California Designated Representative Training Programs - for wholesalers, 3PL, reverse distributors. Board approved. Earns a training affidavit suitable for your California Designated Representative license application.

Read the full article: Expert cautions: DSCSA deadlines may cause drug shortages - in-Pharma Technologist:

"Supply chain consultant Dirk Rodgers wrote recently that wholesale distributors are having issues getting in touch with suppliers in order to meet one of the first deadlines of the DSCSA, which, after Jan. 1, 2015, requires all drugs transported through the supply chain to be accompanied by transaction information, transaction history and transaction statements.

“The real problem is that, despite many attempts by wholesale distributors to contact their suppliers to find out their ability to provide that information on that date, no response has been received from a significant percentage of those suppliers,” Rodgers says. "

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• It's Holiday Season. Complete Designated Rep & Exemptee Training Before Year End!
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Training Budget At Year-End - Use It or Lose It!

In A Nutshell
You would be wise to spend your allocated training budget dollars before year-end (this assumes your fiscal year-end is the same as the calendar end of year).

Why?

1. To make sure your expenses (e.g., invoices & purchases) are submitted prior to your company's closing cutoff dates, and recorded to the appropriate budget(s) for the closing year.
2. As they say, "Use it, or lose it."  If you don't spend all the allocated training dollars, many companies will simply "take" the money back (as if you were initially allocated less money for the year).
3. If you "lose it," some companies will penalize you in the upcoming budget year, because you weren't able to spend all the money previously allocated. Here's some food for thought, how can you possibly go into the upcoming year, and ask for more money, when you weren't able to spend what the company allocated to you in the prior year?!

So Buy Now!

• If it's not too late in your year-end processing cycle, consider buying now to spend down your allocated dollars.
• Now is a good time to buy a ticket or two for our popular Designated Representative & Exemptee training courses:
• Learn more about our courses
• Buy Now - CA Designated Representative & Exemptee Training Course
• Buy Now - FL Certified Designated Representative Exam Prep Course

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

California Board of Pharmacy - Fee Schedule

• California Designated Representative Training Courses (approved by the California State Board of Pharmacy) for: Wholesalers | 3PL | Reverse Distributors

View the full table of fees: California Board of Pharmacy - Fee Schedule:

The California Board of Pharmacy publishes its Fee Schedule on its website.

The tables display various fees for all licenses, permits, certificates, exams, renewals, and late & miscellaneous fees.

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- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Major Medical Centers ask Congress to Probe Genentech Distribution Shift - Pharmalot - WSJ

• Register to take a Board-approved California Designated Representative training course for:
          Wholesalers | 3PL | Reverse Distributors

Read the full article: Major Medical Centers ask Congress to Probe Genentech Distribution Shift - Pharmalot - WSJ:

"Last month, Genentech angered hospitals and academic medical centers around the country by changing distribution for three big-selling cancer medicines. The drug maker is now using a handful of specialty distributors, which are actually divisions of the same wholesalers that have already been distributing Avastin, Rituxan and Herceptin. Until recently, dozens of wholesalers stocked the drugs."

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

FDA blows off GS1 Healthcare for facility identification schema

Read the full article: FDA blows off GS1 Healthcare for facility identification schema - Pharmaceutical Commerce:

"What’s left unsaid in the document is how establishment location data necessary for tracking drug shipments (as opposed to filing paperwork with FDA) will be reconciled with DUNS. GS1’s interlocking numbering systems—GTIN for product identification, GLN for physical locations, and the EPCIS system for communicating transaction information (among others)—is looked on as the likely choice for structuring drug traceability under the Drug Supply Chain Security Act (DSCSA); additionally, many of the leading group purchasing organizations (GPOs) have been pushing suppliers (including pharma companies) to use GS1’s GLN and GTIN format for recording shipments to member organizations. GLN has the advantage over DUNS (which originated as a way to track the financial records of companies) of providing a high degree of precision on location—the specific loading dock at a hospital pharmacy, for example."

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Read the document:
FDA Guidance - Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (PDF)

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  FDA publishes Q&A on DSCSA provisions - SecuringIndustry.com
• 
  
  

FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA - News - National Association of Boards of Pharmacy® (NABP®)

Read the full article: FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA - News - National Association of Boards of Pharmacy® (NABP®):

"FDA is issuing this document, “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers,” (PDF) to help stakeholders understand the immediate effects of the law and to clarify section 585’s effect on state product tracing requirements, and on standards, requirements, and regulations related to licensing wholesale distributors and/or third-party logistics providers (3PLs)."

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• FDA publishes Q&A on DSCSA provisions - SecuringIndustry.com
• FDA Q&A Draft Guidance Clarifies Issue of DSCSA Preemption of State Track and Trace and Licensing Requirements
• FDA Releases Q&A on DQSA

CAMPS Co-Locates 2015 Meeting at Medtrade -- HME Business

• For Home Medical Device Retailers. If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application - Buy now!.

Read the full article: CAMPS Co-Locates 2015 Meeting at Medtrade -- HME Business:

"The California Association of Medical Product Suppliers (CAMPS) will combine its annual meeting with Medtrade Spring, scheduled for March 30-April 1, 2015.

 “This co-location agreement saves CAMPS members time and money by allowing them to go to one trade show instead of two in 2015,” said Kevin Gaffney, group show director, Medtrade. “CAMPS members will have full access to the Medtrade Spring show floor and all educational sessions, and we will have the privilege of welcoming CAMPS members to what will be an excellent show at the Mandalay Bay Convention Center in Las Vegas.”"

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

ONLINE EXEMPTEE EDUCATION - CAMPS ONLINE EXEMPTEE TRAINING

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Genentech's distribution change for cancer drugs upsets hospitals | Modern Healthcare

Read the full article: Genentech's distribution change for cancer drugs upsets hospitals | Modern Healthcare:

"Drugmaker Genentech is changing the way it ships three high-profile cancer drugs to hospitals, which are concerned that the new process will grossly inflate their already high costs and potentially affect patient care. Genentech contends the change is designed to ensure patient safety and access to the drugs involved.

In a Sept. 16 letter to hospital pharmacy directors (PDF), Genentech, a U.S. subsidiary of Swiss healthcare giant Roche, said effective Oct. 1, hospitals can receive Avastin, Herceptin and Rituxan only through six authorized specialty distributors. The approved companies are ASD Healthcare, BioSolutionsDirect, Cardinal Health Specialty Distribution, McKesson Plasma and Biologics, Morris & Dickson Specialty Distribution and Smith Medical Partners.

For hospitals, this means they will have to contract with one of those specialty distributors if they want to continue receiving those three cancer drugs. Previously, hospitals purchased the drugs through wholesale distributors, which offer hospitals discounts based on purchase volume."

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Will The FDA Delay The DSCSA? - Rx Trace

Read the full article:  Will The FDA Delay The DSCSA? - Rx Trace:

"More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA).  On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is not even due to publish guidance on how to do that until November 27" . . .

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

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• 
  The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace

Free Download - Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to support DSCSA - GS1 US

• California Designated Representative Training (for wholesalers, third-party logistics providers) - Approved by the California State Board of Pharmacy - Earns a training affidavit
• Register for a course now, for:  Wholesalers | 3PL | Reverse Distributors

Updated January 4, 2019

The original link got outdated and broke.

You might also be interested in:

GS1 US DSCSA Implementation Suite - Request a copy

-----  original post follows below  ------

Request to download the free guide: Implementation Guideline - Applying GS1 Standards to US Pharma Supply Chain Business Processes to support DSCSA - GS1 US:

"This guideline offers pharmaceutical industry stakeholders best practices for meeting immediate lot-level management deadlines, and sets the foundation for serialized item-level traceability. Release 1.1 of the GS1 Healthcare US Implementation Guideline, “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to support DSCSA”, will help companies comply with early term, mid term and later requirements defined in the 2013 DSCSA law."

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California Designated Representative Training Courses (wholesaler, third-party logistics provider, 3PL) - Approved by the California State Board of Pharmacy - Earns a training affidavit

- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  HDMA - Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act
• 
  FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop
• 
  Drug Supply Chain Security Act - Drug Supply Chain Security Act (DSCSA) Implementation Plan
• 
  
  

What's In The Exam? - Florida Certified Designated Representative Exam

Updated September 8, 2021

• People also search for Florida CDR examination preparation & training (by CDR Resource Center)

What's In The Exam - FL CDR Exam

About The FL CDR Examination:

• The examination consists of forty (40) scored multiple-choice questions.
• All questions are equally weighted. The minimum percentage score needed to pass has been set at seventy-five percent (75 %)
• Your examination(s) will be administered on an electronic testing system. Before you begin the examination, you will have an opportunity to go through a tutorial on the computer. 
• You will be given ninety (90) minutes (1.50 hours) to complete the examination. Not including the thirty (30) minutes for the tutorial.

Examination Questions Cover The Following Content Areas (and the % of the exam):

• Product Integrity (27.5%)
• Records (25%)
• Inspections (12.5%)
• Authorized Recipients (10%)
• Lawful/Unlawful Products (10%)
• Permits and Renewals (10%)
• CDR Requirements (5%)

Specifically, The Examination Covers (updated 9/8/2021):

Chapter 499 Florida Statutes:

• All sections relating to prescription drugs

Rule Chapter 61N-1 (formerly 64F-12), Florida Administrative Code:

• All sections relating to prescription drugs

21 Code of Federal Regulations (CFR):

• 205.2 
• 205.3 
• 205.4 
• 205.50 
• 205.6
• 205.8
• Part 1301.71 and 72

21 United States Code (USC):

• 321
• 331
• 333
• 351
• 352
• 353
• Chapter 9 Subchapter V Sections 360eee – 360eee-2

Source:
State of Florida - Candidate Information Booklet for the Certified Designated Representative Laws and Rules Examination:  CAUTION - there are old versions of the candidate information booklet (CIB) that can be found on the internet. Be sure you're referencing the most current version. Here's how to find it.  Go to the home page of the Florida Department of Business & Professional Regulation:  http://www.myfloridalicense.com/dbpr/   In the search box, enter "candidate information booklets." Choose English. Then click "DDC - Certified Designated Representative."

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

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative (CDR) Exam Prep Course 

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

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Controlled Substances Authorities - State Profiles - NASCSA

United States (Photo credit: Wikipedia)

• Who Are You Going To Call? These Collaboration Partners (for all things pharma & drug distribution related)

The National Association of State Controlled Substances Authorities (NASCSA) is an educational organization, that focuses on increasing the effectiveness and efficiency of state and national efforts to prevent and control drug diversion and abuse.

On their website, they publish a great resource, "State Profiles." On the NASCSA State Profiles webpage, when you click on a state of your interest on the map of the USA, you're presented with state-specific information, such as:

• State controlled substances authorities & their contacts
• State laws, statutes, regulations, and rules
• State prescription monitoring programs (PMP) & contacts

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

HMDR & Medical Device Contacts - (CA Dept Public Health - Food & Drug Branch)

• Buy Now! California Exemptee License Training Course
• California HMDR Exemptee Training - online training certification class for home medical device retailer (HMDR) Exemptee license applicants. This online course is also recommended for HMDR supervisors and leadership. State-approved by the CDPH.

Updated May 6, 2022

For questions regarding:

• Medical Device Safety Inspection         
• HMDR Safety Inspection         
• Medical Device Export/ Export Document Program        
• Industry Education and Training        
• HMDR Out of State Registration        
• HMDR Exemptee Licenses 

Source: Home Medical Device Retail Program

Contact

Telephone Number:
(800) 495-3232

Overnight Mailing Address:
​​California Dept. of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
Sacramento, CA 95814

Regular Mailing Address:
California Dept. of Public Health
Food and Drug Branch
PO Box 997435, MS 7602
Sacramento, CA 95899-7435

FDB Email Address:
FDBMedDevice@cdph.ca.gov

Return Home:  The Designated Representative and Exemptee Blog

• California HMDR Exemptee Training - online training certification class for home medical device retailer (HMDR) Exemptee license applicants. This online course is also recommended for HMDR supervisors and leadership. State-approved by the CDPH.

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  About The HMDR Licensing Program
• 
  CA Home Medical Device Retailer (HMDR) FAQs
• 
  California HMDR Laws

The Drug Supply Chain Security Act Explained (eBook) - RxTrace

• Register now to take one of these Board-approved California Designated Representative online training courses for:  Wholesalers | 3PL | Reverse Distributors

Updated September 12, 2016

The link in the original post below didn't age well.  You might also be interested in:

The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances - by Dirk Rodgers





- -  original post follows below  - -

Learn more & purchase this eBook: The Drug Supply Chain Security Act Explained - RxTrace:

"The Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA, is the most complex pharma track and trace law ever enacted.  Its many layers of complicated rules and regulations provide challenges that companies will need to untangle.  But now, Dirk Rodgers explains it all.

"The Drug Supply Chain Security Act Explained" is a clear, section-by-section explanation of the Drug Supply Chain Security Act (DSCSA), with important implications for companies in the U.S. supply chain, by writer and founder of RxTrace.com, Dirk Rodgers, an expert in healthcare supply chain technologies.

"The Drug Supply Chain Security Act Explained" will guide readers through the process of complying with the DSCSA.  It includes thousands of hyperlinks to the definitions of terms and other sections within the DSCSA as well as to the original DSCSA text. It also includes pages of references to external material.  An abbreviated version of the Table of Contents is below."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Google Agrees to Create $250 Million Program to Fight Rogue Online Drug Sellers - News - National Association of Boards of Pharmacy® (NABP®)

• Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
  

Updated December 7, 2020

You might also be interested in:

Rogue Rx Activity Report - Rogue Online Pharmacies in the Time of Pandemic: Capitalizing on Misinformation and Fear - NABP (PDF)

- - -  original post follows below  - - -

Read the full article: Google Agrees to Create $250 Million Program to Fight Rogue Online Drug Sellers - News - National Association of Boards of Pharmacy® (NABP®):

"Google will create a $250 million internal program to “disrupt rogue online pharmacies,” as part of a deal to end shareholder litigation over its alleged placement of advertisements offering to sell prescription drugs from outside the United States, Reuters reports. Google has also agreed to make content about prescription drug abuse more visible, and to “work with legitimate pharmacies to counter marketing by rogue sellers,” according to documents filed in an Oakland, CA federal court. The original litigation stemmed from a 2011 settlement with the federal government over the issue."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  CA Home Medical Device Retailer (HMDR) FAQs
• 
  California HMDR Laws
• 
  About The HMDR Licensing Program