Searching Content indexed under Criminal Law by Frederick Ball ordered by Published Date Descending.
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U.S. Government’s Use Of The "Park Doctrine" To Police Pharmacies
Based on the current public scrutiny that compounding pharmacies are under due to the outbreak of fungal meningitis in Massachusetts, pharmacy executives may want to review their internal procedures for compliance with the FDCA to ensure they are robust.
United States
8 Jan 2013
FDA Issues "Non-Binding" Park Doctrine Criteria for Potential Referral of "Responsible Corporate Officials" for Prosecution for Alleged Violations of the Food, Drug and Cosmetic Act
The U.S. Food and Drug Administration ("FDA") recently set forth, in its "Regulatory Procedures Manual" for FDA personnel, criteria for when it would refer a matter for potential prosecution under the "Park" doctrine.
United States
17 Feb 2011
FDA To Increase Criminal Prosecution Of Corporate Officials In The Pharmaceutical Industry
In a recently released letter to U.S. Sen. Chuck Grassley (R-Iowa), the Government Accountability Office (GAO) reported the results of its study into the Food and Drug Administration's (FDA) criminal investigation of individuals and companies through the FDA's Office of Criminal Investigations (OCI).
United States
23 Mar 2010
Update On Medicaid Requirement For "Tamper-Resistant" Prescription Pads
As we discussed in our Alert of July 31, 2007, pharmacists and physicians should take note that on October 1, 2007, the Centers for Medicare and Medicaid Services ("CMS") will deny federal participation in Medicaid for prescriptions written on traditional prescription pads. Effective October 1, an amendment to 42 U.S.C. § 1396(b)(i) will require that all written, non-electronic prescriptions be issued on "tamper-resistant" prescription pads. The amendment applies to prescriptions for covered out
United States
24 Sep 2007
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