Tuesday, September 30, 2014

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):
     Florida:

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

     California (earn a training completion certificate):


Thursday, September 18, 2014

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

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The original link got outdated and broke.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
California Designated Representative Training Courses (wholesaler, third-party logistics provider, 3PL) - Approved by the California State Board of Pharmacy - Earns a training affidavit

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):


Thursday, September 11, 2014

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

Updated September 8, 2021

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):
     Florida:

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

     California (earn a training completion certificate):


Tuesday, September 9, 2014

Controlled Substances Authorities - State Profiles - NASCSA

United States
United States (Photo credit: Wikipedia)
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
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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Monday, September 8, 2014

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

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

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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):
     Florida:

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

     California (earn a training completion certificate):


Friday, September 5, 2014

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

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."

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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):
     Florida:

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

     California (earn a training completion certificate):

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