Elinor Hart

Elinor Hart

Duane Morris LLP

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DEA Releases Final Rule on Disposal of Controlled Substances

On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the Secure and Responsible...more

9/29/2014 - Controlled Substances Act DEA The Disposal Act

FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human...more

7/15/2014 - DQSA Drug Compounding FDA Pharmaceutical Prescription Drugs

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and...

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act...more

4/8/2014 - Drug Compounding FDA FDCA Fees Outsourcing Pharmaceutical Pharmaceutical Manufacturers

Compounding Pharmacies Now Subject to Federal Oversight

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act. Title I of this law—entitled the Compounding Quality Act (the "CQA")—allows the federal Food and Drug Administration (FDA) to oversee...more

12/3/2013 - Drug Compounding Drug Manufacturers FDA Pharmacies

Senate HELP Committee Releases Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies

Compounding Legislation Continues to See More Changes - The Senate HELP Committee has released a revised draft Senate Bill ("Revised Senate Bill"), updating the committee's first proposed compounding bill and signaling...more

7/30/2013 - Drug Compounding Drugs FDA FDCA Pharmaceutical

Governmental Agencies and Regulatory Boards Must Now Provide a Reasoned Explanation for Their Decisions in Illinois

The days of governmental agencies or regulatory boards issuing decisions without providing any reasoning may be nearing an end. The Illinois Appellate Court for the Fourth District recently clarified in Medina Nursing Center,...more

7/26/2013 - Administrative Boards Administrative Review Board Government Entities Regulatory Standards

Compounding Legislation Goes Through Another Change: New House Bill on Federal Oversight

U.S. Rep Griffith Releases Revised Draft Bill Providing Federal Oversight over Compounding Pharmacies - On July 11, 2013, U.S. Representative Morgan Griffith (R-Va.) released a revised draft House Bill ("Griffith...more

7/22/2013 - Drug Compounding Drug Manufacturers FDA FDAMA FDCA Memorandum of Understanding New Legislation Pharmacies

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the...more

7/18/2013 - Administrative Fines Detention Drugs FDA FDASIA Pharmaceutical

FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing

On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs. Specifically, the Guidance...more

6/19/2013 - CGMP Drug Manufacturers FDA FDCA Prescription Drugs Required Documentation

Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between...

In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on...more

4/30/2013 - Drug Compounding Drug Manufacturers FDCA Penalties Proposed Legislation

FDA Emphasizes Patient-Specific Prescriptions

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more

3/21/2013 - Drug Compounding FDA FDAMA FDCA Patient-Specific Prescriptions

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

3/6/2013 - Affordable Care Act CMS Healthcare Manufacturers Medical Devices Pharmaceutical Physicians Reporting Requirements Research Funding Sunshine Act

HIPAA Minimum Necessary Standard Should Be Key Component of Policies and Procedures, Now More Than Ever

On January 17, 2013, the U.S. Department of Health and Human Services ("HHS") announced the final omnibus rule amending the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") in accordance with the HITECH...more

2/11/2013 - Business Associates Covered Entities Data Breach Data Protection HHS HIPAA HIPAA Omnibus Rule HITECH Notifications PHI

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