Drug Channels

NOVEMBER 23, 2021

Please join me for my upcoming live video webinar, Drug Channels Outlook 2022 , on December 17, 2021, from 12:00 p.m. Please join me for my upcoming live video webinar, Drug Channels Outlook 2022 , on December 17, 2021, from 12:00 p.m. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. Happy Thanksgiving, everyone!

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FDA Law Blog: Biosimilars

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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Drug Channels

NOVEMBER 22, 2021

In this issue: The State of Specialty Pharmacy 2021 How health plans profit—and patients lose—from insulin A fantastic new analysis of the gross-to-net bubble CVS acknowledges how its PBM profits from 340B Reconsidering Amazon Plus, the FDA preps you for Thursday with a regulatory soup review. Happy Thanksgiving, everyone! to 1:30 p.m.

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Drug Channels

SEPTEMBER 28, 2021

My recent social media topics have included: the ASPE report, biosimilar reimbursement, non-profit hospital shenanigans, HRSA’s reorganization, MTM in Part D, PBMs’ GPOs, pharmacy GPOs, channel strategy, white bagging, and the soothing sounds of pills being counted. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc.

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Drug Channels

APRIL 27, 2021

While we all roll up our sleeves for a full reopening, let’s spring into this month’s selection of noteworthy news: Thoughts on Cigna’s payments to patients for non-medical switching 340B’s explosive specialty pharmacy growth An excellent analysis of GoodRx Plus, my $0.02 Read more » Copyright © 2006-2021 Pembroke Consulting, Inc.

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Specialty Pharmacies Pharmacy Biosimilars Drugs 52

Drug Channels

NOVEMBER 23, 2021

Please join me for my upcoming live video webinar, Drug Channels Outlook 2022 , on December 17, 2021, from 12:00 p.m. Please join me for my upcoming live video webinar, Drug Channels Outlook 2022 , on December 17, 2021, from 12:00 p.m. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. Happy Thanksgiving, everyone!

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Specialty Pharmacies Pharmacy Biosimilars Drugs 52

Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. The notable new material in this 2021-22 edition includes three new sections: Section 4.2.5. Copyright © 2006-2021 Pembroke Consulting, Inc. Section 4.4.

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Drug Channels

NOVEMBER 24, 2020

In this issue: Rebate rule redux Most Favored Nation and healthcare benchmarking Amazon’s pharmacy customer opportunity Drug spending realities updated GPO consolidation Plus, I congratulate Dirk Rodgers of RxTrace on his retirement. Join me for an exclusive live webinar, Drug Channels Outlook 2021 , on December 18, 2020, from 12:00 p.m.

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Pharmacy Specialty Pharmacies Biosimilars Doctors 52

Drug Channels

NOVEMBER 8, 2021

Delivered as a Hybrid Event In-Person: December 13-14, 2021, Hilton Philadelphia at Penn’s Landing, Philadelphia, PA Virtual: December 16-17, 2021 [link]. Copyright © 2006-2021 Pembroke Consulting, Inc. Informa Connect’s Trade & Channel Strategies. Meet The Expert Faculty. Drug Channels, or any of its employees.

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Specialty Pharmacies Pharmacy Biosimilars Marketing 75

Drug Channels

NOVEMBER 15, 2021

Broadcast live on December 17, 2021. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. to 1:30 p.m. ET This page describes the event and explains how to purchase a registration. Read on for full details on pricing and registration.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec.

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FDA Law Blog: Biosimilars

MAY 16, 2024

In January 2021, MHCC agreed to pay $7,750,000 and comply with a comprehensive three-year MOA. Press Release – DEA alleged that Pikeville Medical Center (“PMC”) failed to maintain complete and accurate schedule II inventories and dispensing records that allowed a pharmacy tech to divert 62,780 schedule II doses.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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FDA Law Blog: Biosimilars

MAY 30, 2024

Initially, drug manufacturers were required to offer these discounts only to the in-house pharmacies of covered entities. In 2010, the Health Resources and Services Administration (HRSA) authorized covered entities to contract with an unlimited number of retail pharmacies to fill prescriptions for their patients.

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Drug Channels

DECEMBER 1, 2020

Pharmacy and healthcare provider markets experienced unprecedented volatility. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. Speaking of next year, Drug Channels Institute will host an exclusive live webinar, Drug Channels Outlook 2021 , on December 18, 2020, from 12:00 p.m.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), wholesale distributors) play before a finished product ever makes it to a patient. For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. Section I.C

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Drugs FDA Hospitals Government 59

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. of the total expenditures for all Part D drugs in 2021.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

The Transition from the Use of Legacy Identifiers on Device Labels to UDI The September 24, 2023, date is specific to the enforcement policy described in the May 2021 FDA Guidance , which applies to the requirement that legacy FDA identification numbers should no longer be used on a device label or device package.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023.

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Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. Circuit vacated the final rule in 2021.

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Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. Circuit vacated the final rule in 2021. What ever happened to that thing?

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FDA Law Blog: Biosimilars

JUNE 23, 2024

This information was widely publicized, and we are aware that industry practice evolved whereby pharmacies would deliver or dispense to practitioner’s office in certain cases including those discussed above. Then, President Biden revoked that Executive Order on his first day in office, January 20, 2021. the “ultimate user”).

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