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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Thursday, September 18, 2014

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

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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Thursday, September 11, 2014

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

Chapter 499 Florida Statutes:
  • All sections relating to prescription drugs
Rule Chapter 64F-12, Florida Administrative Code:
  • All sections relating to prescription drugs
21 Codes of Federal Regulations (CFR):
  • 205.2 
  • 205.3 
  • 205.4 
  • 205.50 
  • 205.6
  • 205.8
21 United States Code (USC):
  • 321
  • 331
  • 333
  • 351
  • 352
  • 353
Source:
State of Florida - Candidate Information Booklet for the Certified Designated Representative Laws and Rules Examination (PDF)

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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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Monday, September 8, 2014

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

Source: California Department of Public Health - Food and Drug Branch: Contact Us - Medical Device and HMDR Contacts:

"Program Contacts - 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 
Phone: (916) 650-6500
Fax: (916) 650-6650
Email: FDBMedDevice@cdph.ca.gov

Consumer Complaints (Medical Device and HMDR Products):
(800) 495-3232

Mailing Address: 
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435"

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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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