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Prescription Drugs Recordkeeping Requirements

Husch Blackwell LLP

California Enacts First-in-Nation Pharmacy Medication Error Reporting Law

Husch Blackwell LLP on

On October 8, 2023, Governor Gavin Newsom signed Assembly Bill 1286 (AB 1286), a sweeping pharmacy measure with several components aimed at promoting patient safety. Chief among AB 1286’s mandates is a new law requiring that...more

Smith Gambrell Russell

Group Health Plan Fiduciaries May Now be a Target of Lawsuits for Excessive Fees

Smith Gambrell Russell on

History of 401(k) Plan Excessive Fee Cases. Once the Department of Labor’s participant fee disclosure rules for retirement plans became effective in 2012, the plaintiffs’ bar latched onto recordkeeping and investment fees...more

King & Spalding

DEA Proposes New Rules for Telemedicine Prescriptions

King & Spalding on

Would Require In-Person Examination In Many Prescribing Scenarios - Almost fifteen years ago, Congress amended the Controlled Substances Act (CSA) to reduce illegitimate, Internet-based access to controlled drugs while, at...more

Foley & Lardner LLP

DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends

Foley & Lardner LLP on

On February 24, 2023, the Drug Enforcement Agency announced proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The proposed rules are open for public...more

Mintz - Health Care Viewpoints

DEA Releases Long-Awaited Suspicious Orders Proposed Rule

It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more

Epstein Becker & Green

FDA PDMA Guidance in Response to COVID-19 Pandemic

Epstein Becker & Green on

The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.  The Prescription Drug Marketing Act of 1987 (PDMA)...more

Robinson+Cole Health Law Diagnosis

FDA Issues New Compounding Guidance

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

King & Spalding on

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

Foley & Lardner LLP

Telemedicine Practice and Remote Prescribing in Delaware

Foley & Lardner LLP on

Note: This is a companion piece to our parallel article discussing the various Delaware commercial insurance coverage requirements in the Act. Delaware Gov. Jack Merkell signed into law, on July 7, 2015, a bill...more

McDonnell Boehnen Hulbert & Berghoff LLP

GPhA Opposes California Biosimilar Bill; Points to Report on Savings from Biosimilars

Last week, the Generic Pharmaceutical Association (GPhA) released a statement regarding a California bill (SB-598) that the GPhA asserted would "introduce[] burdensome provisions that could raise costs and limit patient...more

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