Rachael G. Pontikes

Rachael G. Pontikes

Duane Morris LLP

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Latest Publications


FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities

On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include...more

12/10/2014 - Drug Compounding FDA Fees New Guidance Outsourcing Facilities Registration Reporting Requirements

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FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and...

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act...more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

U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill"), which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal...more

9/20/2013 - Drug Compounding Drug Safety FDA Outsourcing Pharmacies Prescription Drugs Proposed Legislation

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

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

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

FDA Tightens Requirement for Patient-Specific Prescriptions in the Wake of the Meningitis Outbreak

In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription. In...more

2/26/2013 - Drug Compounding Electronic Barcoding FDA Fungal Meningitis Patient-Specific PharMEDium Prescription Drugs

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

1/7/2013 - DOJ Drug Compounding FDA FDCA Officers Park Doctrine Pharmacies

FDA and State Pharmacy Boards Discuss Regulating Compounding Pharmacies

On December 19, 2012, the U.S. Food and Drug Administration (FDA) and officials from all 50 states' boards of pharmacy met to discuss their views on state and federal roles in regulating compounding pharmacies. The meeting...more

12/21/2012 - Drug Compounding FDA Pharmacies

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