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


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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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The Designated Representative Institute

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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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CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc - Enhanced for iPad
The Exemptee Institute

CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 - Available for iPad
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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