Here comes drug importation – Pharmaceutical Commerce

According to the article:

“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”

Read the source article:  Here comes drug importation – Pharmaceutical Commerce


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California HMDR Exemptee Online Training Certification Course

California HMDR Exemptee Online Training Certification Course

  • $525 per student
  • For home medical device retailers (HMDR)
  • Accepted by the California Department of Public Health (CDPH) – Food and Drug Branch
  • Earns a course completed training certificate accepted by the CDPH to include with your HMDR Exemptee license application

California HMDR Exemptee Online Training Certification Course

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How the Medicare CPAP Payment Prohibition Affects Your Business – HomeCare

According to the article:

“The increased demand for CPAPs and disposables creates opportunities for home medical equipment (HME) and durable medical equipment (DME) suppliers. But a word of caution: The supplier can have no involvement with a home sleep test (HST) administered to a patient covered by Medicare fee-for-service (FFS).”

“In short, Medicare will not pay ABC for the CPAP if ABC is the provider of the sleep test. That term is defined as “the individual or entity that directly or indirectly administers and/or interprets the sleep test and/or furnishes the sleep test device used to administer the sleep test.””

Read the full source article:  How the Medicare CPAP Payment Prohibition Affects Your Business – HomeCare


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Board-Approved! Three (3) California Designated Representative Online Training Programs

SkillsPlus International Inc. proudly offers the largest selection of Board-approved California Designated Representative online training courses. Earns a Board-recognized training affidavit. More than 6,000 students trained!

California Designated Representative Online Training for Drug/Device Wholesalers

California Designated Representative Online Training for 3PL (third-party logistics providers)

California Designated Representative Online Training for Reverse Distributors


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FDA Enforcement Delay of Wholesale Distributor Verification Requirement for Saleable Returns – LSPediA

“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.

If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”

Read the full source article:  FDA Enforcement Delay of Wholesale Distributor Verification Requirement for Saleable Returns – LSPediA

View the FDA final guidance document:  Wholesale Distributor Verification Requirement for Saleable Returned Drug Product — Compliance Policy – Guidance for Industry (PDF)


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Travel-Friendly CPAP Devices Side-by-Side Comparison Guide (August 2019) – Sleep Review Mag

“Sleep Review’s matrix compares features such as dimensions, weight, noise level, interface compatibility, operating pressure range, operating modes, features, warranty, and additional information for the following devices: Breas Medical Inc Z2 Auto, Drive Devilbiss Healthcare IntelliPAP2 CPAP System, Philips DreamStation Go, and ResMed AirMini.”

“View the full matrix at a legible size, download it, or print it:”  TravelCPAPGuide (PDF)

Read the full article:  Travel-Friendly CPAP Devices Side-by-Side Comparison Guide (August 2019) – Sleep Review Mag


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The Largest Selection Of Board-Approved California Designated Representative Training Programs

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California Designated Representative Training – Video Preview

California Designated Representative Online Training Programs. Largest selection of Board-approved training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.  More than 6,000 students have taken our state license-related training classes!

California Designated Representative Training by SkillsPlus International Inc.  –  Video Preview

You might also be interested in:  https://calidesreptraining.blogspot.com/


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DEA agent says recent indictments should be warning to drug distributors, pharmacists – WCPO

According to the article:

“A federal agent tells WCPO that others passing prescription drugs and adding to the opioid crisis should take it as warning.

“We’re going to come after you. If we can do it, we’re going to do it,” said Mauricio Jimenez, DEA assistant special agent in charge.

Jimenez said the Drug Enforcement Administration is cracking down on pharmaceuticals distributors and pharmacists it believes are breaking the law … “

Source article:  DEA agent says recent indictments should be warning to drug distributors, pharmacists – WCPO


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