FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA - News - National Association of Boards of Pharmacy® (NABP®)

Read the full article: FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA - News - National Association of Boards of Pharmacy® (NABP®):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

'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

• 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• FDA Q&A Draft Guidance Clarifies Issue of DSCSA Preemption of State Track and Trace and Licensing Requirements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.”"

'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  
• 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

Related articles

• 
  Wishful Thinking?! Both Work Experience AND Training Are Required
• 
  CA Home Medical Device Retailer (HMDR) FAQs
• 
  CA Designated Representative & Exemptee Training Course - Enhanced for iPad
• 
  Industry groups take issue with guidance on outsourcing facilities

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."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog