Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com

SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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Monday, November 18, 2013

Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

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HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204 - FDA Law Blog

FDA Law Blog: HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204:

"With fingers crossed, attendees looked ahead to the future of track-and-trace. Panelists expressed that the national system will hopefully make it harder for bad actors to corrupt the integrity of the supply chain, as the current patchwork of state pedigree laws allows bad actors to shop around for more lenient states. It is hoped that this bill will put everyone on a level playing field and reduce loopholes."

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All Eyes On The U.S. Senate Tonight - RxTrace

Hold your breath. Let's see if the U.S. Senate will pass this bill, H.R. 3204 (An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws."

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Friday, November 15, 2013

Florida Certified Designated Representative Exam - Locate a Pearson Vue Test Center

Florida Certified Designated Representative candidates must take an examination that's administered at a Pearson Vue Test Center.

Here's how to find a Pearson Vue Test Center near you:
  1. Follow the "Locate a Test Center" link below
  2. Choose category. Click on "Government / State Regulated / Federal Government"
  3. Choose testing program. Click on "Florida Certified Designated Representative - Drugs, Devices and Cosmetics"
  4. Test Center Search. Enter your search information to run a search
Locate a Test Center: Locate a Test Center

"Pearson VUE delivers certification and licensure tests through the world’s largest network of test centers in 175 countries across the world."

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Monday, November 11, 2013

Fingerprint Card Request - CA Board of Pharmacy

The CA Designated Representative application process includes fingerprint requirements. The Board will only accept fingerprint cards from residents outside of California (... in contrast, the board will only accept Live Scan Service Forms from California residents. Live Scan will be accepted from residents of other states if the Live Scan service is performed in California.).

Follow the link below to request fingerprint cards from the California Board of Pharmacy . . .

Publications, Brochures and Fingerprint Card Request - Pharmacy Board:

"To request publications, brochures and fingerprint cards, please select the desired forms and complete your name and address. When the information is complete, please click on the submit button"

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Saturday, November 9, 2013

End game for US medicines traceability bill? - SecuringIndustry.com

Updated Oct 28, 2015:  It passed, and is now enacted. Here's the full text:
Text of the Drug Quality and Security Act (govtrack.us)

= = = original post follows = = =

Prospects for the Drug Quality and Security Act (H.R. 3204) are not so promising . . .

SecuringIndustry.com - End game for US medicines traceability bill?:

"Govtrack.us is currently putting the chances of the bill being enacted at 42 per cent. The Congressional Budget Office (CBO) estimates that H.R. 3204 will authorise the collection of $27m in user fees for fiscal years 2014-2018."

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Thursday, November 7, 2013

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg:

"One lawmaker’s effort to alter Obamacare is holding up final action by Congress on legislation that would expand U.S. regulation of compounding pharmacies linked to meningitis deaths last year.

The Senate is poised to approve the measure to broaden the U.S. Food and Drug Administration’s oversight of compounding pharmacies. Ninety-nine senators have agreed to pass the legislation that the House passed without a roll call vote, Democratic and Republican lawmakers said.

Republican Senator David Vitter of Louisiana wants the vote on compounding pharmacies coupled with consideration of his proposal to deny lawmakers and their staffs employer contributions when they buy medical insurance on the exchanges set up under the new health-care law. As a result, senators may have to spend a week on work that could be done in minutes."

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Drug Supplier Will Acquire Pharmaceutical Wholesaler - CEMag

Drug Supplier Will Acquire Pharmaceutical Wholesaler - CEMag:

"ScripsAmerica Inc. has signed an agreement to acquire PIMD International, LLC, a wholesale distributor of prescription drugs as well as medical supplies and devices.

Based in Miami, PIMD International LLC serves as a pharmaceutical wholesaler to pharmacies, hospitals, and physician's offices in the US. The company also sells medical supplies in all health care settings and online. PIMD, which will become part of ScripsAmerica, provides its customers with access to specific medications for their end users."

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