Pharmacies

News & Analysis as of

Health Alert (Australia) - July 14, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Commonwealth - 4 July 2014 - Angelos v Minister for Health [2014] FCA 706 - This was an application made to the...more

California Court Limits Liability for Loss of Certain Patient Information under CMIA

California appellate courts are clarifying potential liability under California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”) of health care providers, health plans, pharmaceutical...more

New Connecticut Pharmacy Rewards Disclosure Bill Took Effect July 1

On June 12th, Connecticut governor Dannel P. Malloy signed into law ”An Act Concerning Pharmacy Rewards Programs And Protected Health Information“. The law went into effect July 1st, and applies to pharmacy retailers in the...more

America's Largest Drug Store Chain to Pay $180,000 to Settle EEOC Disability Discrimination Suit

South San Francisco Walgreens Fired Longtime Employee With Diabetes Over a $1.39 Bag of Chips, Federal Agency Charged - SAN FRANCISCO - Drugstore giant Walgreens has agreed to pay $180,000 to a longtime employee with...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Health Care E-Note - June 19, 2014

In This Issue: - Report Ranks U.S. Last Out of 11 in Health Care System Quality - Analysis Identifies Un-Tracked Avoidable Hospital Complications - Number of Doctors Employed by Hospitals Grew 34% Over 10...more

CMS Announces Final Regulatory Changes to Medicare Advantage and Part D

- CMS issues final Medicare Advantage and Part D regulatory changes after a controversial proposed rule was announced earlier this year. - New requirements for the reporting and return of Medicare Advantage and Part D...more

FDA Regulatory Update: International Crack Down on Online Pharmacies Identifies Over 1,900 Websites Selling Unapproved or...

By participating in the organized, global action known as Operation Pangea VII, the U.S. Food and Drug Administration (“FDA”) made good on its promise to continue working with the international community to investigate online...more

CMS Changes to Medicare Advantage and Prescription Drug Benefit Programs for Contract Year 2015

On May 19, 2014, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule, published in the Federal Register on May 23, 2014, that sets forth changes to requirements for Medicare Advantage (“MA”) and...more

Compounded Drugs and Medicare Part B: OIG Report Recommends Payment and Oversight Changes

The Office of the Inspector General (OIG) for HHS recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (OIG Report) in which it recommended that CMS implement changes to the way...more

Pharmacy Manager Fails To Prove Kaiser Had Actual Or Constructive Notice That He Was Working Off-The-Clock

In an appeal from summary judgment, a non-exempt Outpatient Pharmacy Manager (“OPM”) for Kaiser contended that the trial court erroneously held his proffered evidence insufficient to create a triable issue as to whether...more

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance...more

Mississippi CON Report - May 2014

In this Report: - I. April 2014 – Mississippi Certificate of Need Meeting - II. Certificate of Need Program Report – Filings/Reports Since March 2014 - A. Letters of Intent to Change Ownership - B....more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases...more

$100 Million for Victims of Meningitis Outbreak

We’ve previously written about the 2012 meningitis outbreak caused by contaminated drugs originating from the New England Compounding Pharmacy (NECC). The meningitis outbreak from these tainted steroids was linked to 64...more

New Laws Regulating Pharmacy Benefit Managers In New Mexico, Utah And Washington

This past legislative session, several state legislatures enacted legislative regulating pharmacy benefit managers ("PBMs"). New Mexico, Utah, and Washington all adopted laws requiring licensure or registration of PBMs, in...more

Marijuana Dispensaries Should Be Put On Main Street

Medical marijuana is now legal in Connecticut, though still not legal under federal law. Control over the industry is in the hands of the Department of Consumer Protection (DCP), which has chosen four companies to operate...more

Florida Board Of Pharmacy Clarifies That Pharmacies Can't Compound Sterile Human Drugs For "Office Use"

The Florida Board of Pharmacy rules allow pharmacies to engage in office-use compounding. Rule 64B16-27.700, FAC. This allows pharmacies to compound drugs for physicians to use in treating their patients in the office without...more

Connecticut Pharmacy Rewards Program Disclosure Bill Could Cause Headaches

The Connecticut State Senate recently passed a bill that would impose additional disclosure and consent requirements on retailers offering pharmacy rewards programs to consumers. If the bill passes the Connecticut House and...more

FDA Regulation of Compounding Pharmacies: Unsolved Mysteries

The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the...more

Florida Acknowledges Exemption For Intracompany Sales Of Pharmaceuticals

A new declaratory statement from Florida regulators clarifies the restrictions on intracompany sales of pharmaceuticals. Previously, if one pharmacy in Florida wanted to send a bottle of prescription medicine to its sister...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

FDA Issuing Referral Letters To State Boards Of Pharmacy Against Traditional Pharmacies

FDA has recently issued several "referral letters" (RLs) to state boards of pharmacy based on year-old pre-Compounding Quality Act Form 483 Inspectional Observations. FDA counts RLs as new instruments of oversight designed to...more

Compounding Problems

In the production of pharmaceutical drugs there are large scale drug manufacturers which produce brand name and generic drugs, and there are compound pharmacies which are specialty pharmacies made to fill out unique orders...more

Breaking News: FDA Testifies Before Senate HELP Committee, Questioned On Recent Compounding Quality Act Enforcement

Today Senator Lamar Alexander (R-TN), member of the Senate HELP Committee asked FDA Commissioner Margaret Hamburg what FDA's policy was with regard to asserting jurisdiction over 503A traditional compounding pharmacies. He...more

83 Results
|
View per page
Page: of 4