Wednesday, December 17, 2014

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

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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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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Wednesday, December 10, 2014

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

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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Thursday, November 20, 2014

HMDR License Application

Follow this link to the 3 application forms:  HMDR License Application - 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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Wednesday, November 19, 2014

Tuesday, November 18, 2014

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

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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You might also be interested in:
Dirk Rodgers on the Rx Trace Blog

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Monday, November 17, 2014

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!
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Wednesday, November 12, 2014

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

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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Thursday, November 6, 2014

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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Thursday, October 16, 2014

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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Friday, October 3, 2014

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

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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Thursday, October 2, 2014

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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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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