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Rachael G. Pontikes

Rachael G. Pontikes

Duane Morris LLP


Latest Publications

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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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