Prolonged Power Outages Can Be Deadly for People Who Rely on Durable Medical Equipment | Huffington Post

English: Biloxi, Miss., September 4, 2005 -- T...

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“Already this year, American communities have experienced floods, tornadoes and wildfires. Our country needs a better way to protect medically fragile people so natural disasters don’t become medical emergencies.

Thousands of people in the United States rely on electrically powered DME to meet their medical needs at home. While they can manage their medical conditions well on a day-to-day basis, in prolonged power outages, that’s when they need our help the most.

Each of us can make a difference during emergencies for people whose lives depend on electrical medical equipment. If you use electrically-powered medical equipment or care for someone who does, please take action today to be prepared for power outages.”

Read the full article: via Prolonged Power Outages Can Be Deadly for People Who Rely on Durable Medical Equipment | Nicole Lurie, M.D., M.S.P.H..


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Your Florida CDR just quit. What do you do?

State Seal of Florida - Public Domain - Wikipedia

“My company is a prescription drug wholesale distributor (in-state or out-of-state).  Our Certified Designated Representative (CDR) just quit.  What do we do?

Notify the department within 10 business days from the CDR’s separation.  Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period.  After that period expires, however, your company must either (a) engage a replacement CDR and notify the department of same or (b) cease prescription drug distributions in or into Florida.

The Department can, upon written request to appropriate personnel, provide a list of all unaffiliated CDR’s.”

View the full article, complete with references: via My company is a prescription drug wholesale distributor in-state or out-of-state. Our Certified Designated Representative CDR just quit. What do we do?.


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Medicare to expand ‘prior authorization’ for device coverage | TheHill

“In a shift from the current system, Medicare is proposing to rule on seniors’ coverage for home medical devices before the supplies are delivered or claims for payment are submitted. The Centers for Medicare and Medicaid Services CMS is planning to expand the use of “prior authorization” for power scooters and wheelchairs, and introduce the process for several other categories of medical goods used at home.

Officials said the effort is targeting improper payments and fraud in the system, when Medicare foots the bill for products aggressively marketed to patients and doctors who do not need them.”

Read the Full Article: via Medicare to expand ‘prior authorization’ for device coverage | TheHill.


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The Differences Between The DSCSA, FDA Rules and Guidance – RxTrace

How To Approach, Read, and Interpret the DSCSA
Another great educational snippet from Dirk Rodgers (RxTrace). Follow the link below to read his full article.

“So let’s apply that to the exchange of Transaction Information TI, Transaction History TI, and Transaction Statements TS that all U.S. pharma supply chain trading partners must do beginning on January 1 of next year (dispensers don’t have to do it until July 1 of next year) (see “DQSA: How Should Transaction Data Be Exchanged?”).  First, the DSCSA that contains this requirement is a law, which means non-exempt trading partners are obligated to follow those requirements or be exposed to penalties.

The DSCSA also obligates the FDA to take certain actions on a particular schedule (see “Decoding The FDA’s DSCSA Timeline”).  Two of those actions are the publication of guidance on identification of suspect product and termination of notifications of illegitimate product, which is due by next Monday, and the publication of draft guidance establishing standards for interoperable exchange of TI, TH and TS in paper or electronic format, which is due on or before November 27 of this year.  Both of these are guidance, which means they will contain non-binding information that represents the current thinking of the FDA on those topics.”  via The Differences Between The DSCSA, FDA Rules and Guidance.


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FDA DSCSA Workshop – Meeting Materials

Follow the link below to the FDA webpage of all related meeting materials and notices:

“[This FDA public workshop, May 8-9, 2014, was] intended to gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of drug product in which a change of ownership occurs, in addition to the feasibility of establishing standardized documentation to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot level data.” – – – via News & Events > Public Workshop: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.

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Apply for a Designated Representative License – CA Board of Pharmacy

Follow the link below to find and download the application form that you need, including Designated Representative, and Wholesaler applications:

“Apply for a License – Please select the license type you wish to apply for to download the application and instructions.” – via CA Board of Pharmacy – Apply for a License.


 

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FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop

Follow the link below for a sobering report of the FDA’s first DSCSA public workshop, and the short implementation timeline that faces the supply chain:

“Without an issued guidance, however, what are supply chain members to do in the meantime?  Perhaps the most important thing to do is to try to understand the DSCSA, and how different sectors of the supply chain are expected to interact, or “interoperate,” with each other.  Several resources are available, including some from FDA, as well as a fairly comprehensive DSCSA implementation timeline recently released by The Pew Charitable Trusts.  This timeline illustrates the requirements for each supply chain member, as well as how that supply chain member must interact with others in the supply chain.  As the FDA workshop made clear, the better the supply chain members understand their own responsibilities and challenges, as well as the responsibilities and challenges faced by the parties they work with in the supply chain, the better and more interoperable this new system could be.”

via FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop.

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About The HMDR Licensing Program

Follow the link below to learn more about the California HMDR Licensing Program:

“Welcome to the home page for the Home Medical Device Retailer (HMDR) licensing program. The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws.” . . .

via HMDR Licensing Program Home Page.

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