Showing posts with label importation. Show all posts
Showing posts with label importation. Show all posts

Wednesday, October 28, 2020

FDA Takes Actions to Help Lower U.S. Prescription Drug Prices

Read the full FDA press release:  FDA Takes Actions to Help Lower U.S. Prescription Drug Prices - FDA.gov

In summary, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule allows FDA-authorized programs to import certain prescription drugs from Canada under specified conditions designed to ensure that the imported drugs pose no additional risk to the public’s health and safety, as well as to provide a “significant reduction” in costs to American consumers.

View the FDA guidance document:  Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

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California Designated Representative (wholesaler, 3PL) Training by SkillsPlus Intl Inc.
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Saturday, December 21, 2019

Canadian drug distributors say no to Trump import plan - Reuters

Read the full article:  Canadian drug distributors say no to Trump import plan - Reuters

According to the article:
"Many of Canada’s drug suppliers cannot, or will not, agree to ship cheaper prescription medicines into the United States, a new challenge to the Trump administration’s push to reduce drug prices, companies and industry officials told Reuters."

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Friday, December 20, 2019

4 reasons Trump’s drug importation plan won’t work - Politico

Read the full article:  4 reasons Trump’s drug importation plan won’t work - Politico

Importers would need the cooperation of the Canadian government and the drug industry, both of which oppose it.

According to the article:
"President Donald Trump has promised that the plan his administration rolled out Wednesday to bring in cheaper prescription drugs from Canada will immediately lower medication costs. Experts say the plan won’t work — and many write it off as a political stunt. 
Under the proposal, importers would need the cooperation of the Canadian government and the drug industry, both of which oppose it. Importers would have to take many expensive and complicated steps to prove to the FDA that importation wouldn’t harm Americans, and to weave through complex regulations and the intricacies of the U.S. health delivery system."

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Board-approved California Designated Representative online training programs for wholesalers, 3PL, third-party logistics provider, reverse distributors. Earns a training affidavit.
Board-approved California Designated Representative online training programs for wholesalers, 3PL, third-party logistics provider, reverse distributors. Earns a training affidavit.

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
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For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

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Monday, August 5, 2019

Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace

Read the full article:  Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace.com


According to Dirk Rodgers:

"Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets?  Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost."

His analysis of the situation is a worthy read.

You might also be interested in his book, "The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances 2nd Edition:"




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California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.
California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, July 23, 2019

Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

Read the full text of the Op-Ed:  Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

From the Op-Ed:
"As we see it, there is no legal or operational way of transforming a drug packaged for a foreign market into a drug that meets the U.S. requirements of our in-progress track-and-trace system. What’s more, there is no way to alter the law to enable importation without undermining the law’s purpose and value.  ... 
Importation laws undermine the country’s progress in building a modern technology infrastructure to track and trace prescription drugs. Making exceptions to the in-progress track-and-trace system would ignore the many instances of drug diversion and counterfeiting that led to the creation and passage of the law in 2013."

The Op-Ed covers the following areas:
  • State drug importation laws undermine the process that keeps our supply chain safe
  • Why the U.S. is building a track-and-trace system 
  • How track-and-trace works 
  • Importation undermines the track-and-trace system
  • Importation enables counterfeits 
  • Forgetting the lessons 
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California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
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For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

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Tuesday, May 9, 2017

Drug importation will threaten supply chain security and the patients it protects | TheHill

Updated August 31, 2026

You might also like:

The Dangers of Drug Importation:
https://phrma.org/importation

---  the original post follows below  ---

Read the full article: Drug importation will threaten supply chain security and the patients it protects | TheHill:

"Such a proposal will dismantle the hard work supply chain stakeholders and regulators have undertaken since the passage of the groundbreaking Drug Supply Chain Security Act (DSCSA) nearly four years ago. "

'via Blog this'

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

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