Elinor Hart

Elinor Hart

Duane Morris LLP

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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

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On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs.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

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