Pharmacies

News & Analysis as of

FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more

Why does Big Pharma keep jacking up prices? EpiPen surfaces ugly factors

Mylan, the maker of the EpiPen, the hyper-allergy protection device, hasn’t gotten itself out of the public fire over its decision to jack up its product prices. Instead, the continuing revelations about this company, its...more

Compounding Pharmacy’s Group Boycott Claim Survives Motion to Dismiss

On August 23, 2016, the District Court for the Eastern District of Missouri allowed claims by a compounding pharmacy to proceed, denying a motion to dismiss filed by the defendant pharmacy benefit manager (“PBM”). In...more

Health Alert (Australia) August 29, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 23 August 2016 - Secretary, Department of Health (as successor to the Secretary, Department of Social Services) v DLW...more

The Board of Pharmacy’s 40 Hour Rule is Dead! Long live the 20 Hour Rule! Community Pharmacy Ownership Rule Change Creates new...

The Florida Board of Pharmacy (BOP) recently amended the rules regarding community pharmacy hours of operation to reduce required daily operating hours from 40 to 20 hours per week. As before, the hours have to be posted and...more

No Resuscitation of Hospital’s Exclusive Dealing Antitrust Suit against Competing Hospitals and Physicians

The Third Circuit reminds, “[i]n antitrust suits, definitions matter.” Last week, in applying that maxim, the court affirmed a lower court’s dismissal of a suit filed by a hospital against a competing hospital and physician...more

When It Absolutely, Positively Has to Be Indicted Overnight: How to Prevent Future Debacles Like the FedEx Prosecution

Against the backdrop of years of unprecedented monetary penalties imposed through DOJ civil settlements and deferred prosecution agreements with financial institutions embroiled in the 2008 financial meltdown, the DOJ came...more

FDA Releases Draft Guidances on Compounded Drugs, Helps to Answer “When are they Copies?”

Some of us remember the television commercial and poster, created by the then-audio cassette company, Memorex, asking “is it live, or is it Memorex?” Forty years later, the Food and Drug Administration could paraphrase the...more

DOJ dismisses last of the drug trafficking charges against FedEx: two key takeaways

Recently, four days into what had been scheduled to be a seven-week trial, the US Department of Justice voluntarily dismissed the last of the criminal charges it had brought in its money laundering and drug trafficking...more

NJ Project Medicine Drop

DCA Notice Regarding Drug Take Back Programs Must be Given When Dispensing CDS Prescriptions in NJ - New Jersey P.L. 2015, c.66, which became effective on January 1, 2016, requires prescribers and pharmacies to provide a...more

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

Arizona Passes Biosimilar Automatic Substitution Law

Last month, the governor of Arizona signed a bill into law allowing pharmacists to automatically substitute a biosimilar for a reference branded biologic. Arizona continues the recent trend of states enacting biosimilar...more

SC Public Policy Update - June 2016

What's New - SENATE - The Senate spent the final three days of the legislative session debating the remaining House bills on the calendar as well as bills returned from the House. Members worked late into the night...more

Recent New York Medicaid Settlement with Pharmacy Shows Importance of Checking Excluded Provider List Prior to Filling...

A New York pharmacy has agreed to pay approximately $500,000 to the State of New York for improperly billing New York Medicaid for prescriptions written by a physician who had been excluded from the Medicaid program. This...more

Seventh Circuit Finds that Pharmacy Discount Programs Are Not Exempt from the Definition of “Usual and Customary”

Created in 2006, Medicare Part D is a government program that subsidizes the cost of prescription drugs to Medicare beneficiaries. The program is run through “Plan Sponsors” – private entities that receive a fixed monthly...more

Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound...more

SC Public Policy Update - May 2016 #3

What's New - SENATE - It was another busy week in the Senate as members continued to work through various bills on the lengthy Senate Calendar. The Senate spent the day on Wednesday taking up the Governor’s veto on...more

Prohibition on Pharmacy Inducements Beyond College of Pharmacists’ Authority

In Sobeys West Inc v. Alberta College of Pharmacists, 2016 ABQB 232, the Alberta Court of Queen’s Bench held that amendments to the College of Pharmacists’ Codes of Ethics and Standards of Practice prohibiting inducements to...more

Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act)....more

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

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