Pharmacies

News & Analysis as of

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more

FDA Issues Three Draft Guidance Documents For Drug Compounders

On April 15, 2016, the U.S. Food and Drug Administration (“FDA”) issued three new draft guidance documents related to human drug compounding under the Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Title I of the...more

FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding

If you read one thing... - FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before...more

Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals

The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act...more

Fighting Prescription Drug Abuse Gets a Little Easier for Florida Providers, Pharmacists

Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements. Florida established its Prescription Drug Monitoring...more

CMS Pitches Controversial Payment Model for Medicare Part B Drugs

CMS recently announced a proposed rule that would potentially create a new Medicare Part B prescription drug payment model. The proposed model is intended to improve quality of care and deliver better value for Medicare Part...more

Pharmaceutical Diversion – Risks and Steps to Address a Major DEA Focus

The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more

Massachusetts Adopts Comprehensive Legislation To Curb Opioid Abuse

On March 14, 2016, Massachusetts Governor Charlie Baker signed comprehensive legislation designed to curb opioid addiction. The legislation reflects growing concern for the “dangers in the medicine cabinet” (i.e., risks...more

Massachusetts Legislature Reaches Compromise on Opioid Legislation

On March 10, the Senate voted unanimously to pass a bill that offers long-awaited measures aimed at tackling the state’s growing opioid abuse crisis. After House approval the previous day and seven weeks of conference...more

What Does the Health Care Industry Do Now When Disposing "Hazardous Waste" Pharmaceuticals?

Potentially affected health care facilities should evaluate current management practices, evaluate best management practices for regulated facilities, and develop a plan to prepare for and manage a regulatory inspection....more

CMS Doubles Down on Targeting Part D Enrollee Prescription Drug Abuse, But Will Stakeholders Agree?

With the release of its 2017 draft call letter, CMS continues its push to curb opioid dependence, overdose and death among Medicare Part D enrollees. To that end, CMS proposes that Part D plan sponsors edit their benefit...more

Health Law Alert: Pharmacies and Prescription Drug Dispensers...Are You Ready for The March 1, 2016 DSCSA Compliance Deadline?

In order to improve drug security throughout the supply chain, and to facilitate drug recalls and to address drug importation, diversion, and counterfeiting, Congress passed the Drug Supply Chain Security Act (the "DSCSA")....more

CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take Note

Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and...more

King of Pain: FDA Plans to Re-Review Its Opioid Policies

The Food and Drug Administration announced recently that it intends to re-evaluate its policies on opioid medications, designed “at reversing the epidemic, while still providing patients in pain access to effective relief.”...more

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

Also In The News - Health Headlines - January 2016 #3

CMS Finalizes Medicaid Prescription Drug Rule – On January 21, 2016, CMS finalized a rule detailing reforms to the rebate and reimbursement systems for Medicaid prescription drugs, which the agency estimates “will save...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Legal Considerations for Retail Clinics

Retail clinics have grown substantially in number and popularity since their emergence in the early 2000s. Retail clinics are limited healthcare clinics that operate outside of physician offices and hospitals, typically in...more

Blame Flows Downhill: All the Way to Sales Clerks

What if a store clerk sells a product that, unbeknownst to him, is illegal? Can the clerk be convicted of a crime, despite not knowing the product was illegal and not intending to sell an illegal product? On January 14,...more

New York State Requires PBM Contracts to Include a Mechanism for Appealing Disputes Related to Generic Drug Pricing

On December 11, 2015, Senate Bill 3346-B[1] was signed into law by New York State Governor Andrew Cuomo. The new bill requires contracts between pharmacy benefit managers (“PBMs”) and pharmacies (or pharmacies’ contracting...more

Competition News January 2016

Record fine imposed on Orange by the French Competition Authority despite being reduced by the early application of the settlement procedure - By decision of December 17, 2015, the French Competition Authority imposed a...more

Final ACA Medicaid Drug Pricing Rule Published: Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to...

On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more

Morton Salt Presumption Of Injury Under Robinson-Patman Act

Plaintiffs and appellants, the disfavored purchasers in a Robinson-Patman Act case, were twenty-eight retail pharmacies who alleged that the pharmaceutical manufacturer defendants had charged them higher prices than those...more

The Department of Justice is Committed to Protecting Consumers from “Bad Medicine”

Last month, the Acting Associate Attorney General Stuart F. Delery, announced that the Department of Justice (DOJ) would continue to target illegitimate online pharmacies, which pose a threat to drug safety and undermine...more

Health Alert (Australia) - January 18, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: New South Wales 14 January 2016 - Health Care Complaints Commission v Athour [2016] NSWCATOD 5 The New South Wales...more

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