The Law of Compounding Medications And Drugs

Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues

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Thursday, March 23, 2017

GOP senator jokes about losing his mammograms under health care ...

McClatchy Washington Bureau-7 hours ago
Pat Roberts, R-KS., if he would support Essential Health Benefits, which are mandated types of care covered by insurance. Those include vaccines, pediatric ...
This Republican senator is A-OK with women's health care cuts ...
Mic-6 hours ago
Pat Roberts apologizes for mammogram joke amid health care debate
Kansas City Star-7 hours ago
House Republicans delay vote on American Health Care Act
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Essential Read!! Documents included--Linwood, Philadelphia men plead guilty in federal prescription drug fraud case ERIN SERPICO, NICHOLAS HUBA & CLAIRE LOWE Staff Writers 3 hrs ago

UPDATED: Linwood man pleads guilty in $28 million drug  compounding  scheme Press of Atlantic City In court, Tedesco admitted to orga...

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A blog dedicated to educating pharmacists, doctors, veterinarians, and the general public about the law in the United States relating to compounded medications for both humans and animals

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Popular Posts

  • MY MEDS Matter Claim Victory that Animal Drugs Not Covered by DQSA: Drug Quality and Security Act: new law doesn't affect compounded medications in veterinary use. Thursday, November 21, 2013 posted by: Anonymous (not verified)
  • 7/22/13 - Imprimis Pharmaceuticals, Inc. Receives Institutional Review Board (IRB) Approval for its Phase III Clinical Trial Protocol; Phase III Clinical Trial to Begin in 3Q 2013
  • (no title)
  • Health Care Fraud 101
  • Interesting!
  • Growth Hormone Schemes and Scams by Stephen Barrett M.D.
  • Nationwide Recalls From Two Compounding Pharmacies Medscape · 19 hours ago

Essential and Historical Documents Related to Compounding

  • November 14, 2012 – Written testimony of Dr. Margaret A. Hamburg, M.D. before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations hearing “The Fungal Meningitis Outbreak: Could It Have Been Prevented?”
  • November 14, 2012 – Video of the testimoney of Dr. Margaret A. Hamburg, M.D. before the House Committee on Energy and Commerce.
  • November 15, 2012 – Written testimony of Dr. Margaret A. Hamburg, M.D., before the Senate Committee on Health, Education, Labor and Pensions “Pharmacy Compounding: Implications ofthe 2012 Meningitis Outbreak”.
  • November 15, 2012 – Video of the Senate HELP Committee hearing.
  • December 2012 - Transcript of FDA Meeting – “Framework for Pharmacy Compounding – State and Federal Roles”
  • January 2013 – Comments Submitted to FDA Docket regarding “Framework for Pharmacy Compounding – State and Federal Roles”
  • April 16, 2013 - Written testimony of Dr. Margaret A. Hamburg before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations – “Continuing Investigation into the Fungal Meningitis Outbreak: Could It Have Been Prevented?”
  • April 16, 2013 – Video of testimony of Dr. Margaret A. Hamburg before the Energy and Commerce Committee.
  • April 16, 2013 - House Energy and Commerce, Preliminary Majority Staff Report – “FDA’s Oversight of NDCC and AmeriDose: A History of Missed Opportunities?”
  • April 26, 2013 – Senate HELP Committee posts Draft Compounding Legislation, asks for public input by 5/2/13.
  • May 23, 2013 – “Examining Drug Compounding” – Testimony given by Dr. Janet Woodcock, Director CDER before the House Subcommittee on Health , Committee of Energy and Commerce.
  • July 16, 2013 – “Reforming the Drug Compounding Regulatory Framework” – Statement given by Dr. Janet Woodcock, Director CDER before the House Subcommittee on Health, Committee of Energy and Commerce.
  • July 31, 2013 – GAO Report – “Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight“
  • November 18, 2013 - Drug Quality and Security Act passes Senate on voice vote – passed House in September – goes to President Obama for signature.
  • Bulk Drug Substances that May be Used to Compound Drug Products, etc., Concerning Outsourcing Facilities: Request for Nominations
  • Draft Guidance for Industry and Staff: Interim Product Reporting for Human Drug Compounding Outsourcing Facilities under the Federal Food, Drug, and Cosmetic Act
  • Draft Guidance for Industry and Staff: Pharmacy Compounding of Human Drug Products under the Federal Food, Drug, and Cosmetic Act; Availability; Withdrawal
  • Draft Guidance for Industry and Staff: Registration for Human Drug Compounding Outsourcing Facilities under the Federal Food, Drug, and Cosmetic Act
  • Drug Products that Present Demonstrable Difficulties for Compounding: Request for Nominations
  • List of Bulk Drug Substances that May be Used in Pharmacy Compounding; Withdrawal


Other Publications

Author, Joint Defense Agreements: Could It Help Your Client, Oklahoma Bar Journal, March 1998

Author, King for a Day, An Overview of Qui Tam Litigation Under State and Federal Law, Oklahoma Bar Journal, May 1999

Author, The Fifth Amendment Privilege Against Self-Incrimination: Walking the Tight Rope in Parallel Civil and Criminal Proceedings, Oklahoma Bar Association, October 2002

Tenth Circuit Standards of Review Manual, Western District of Oklahoma

Criminal Appeals Manual, Western District of Oklahoma

Creator, Author, and Presentor of Year in Review for Department of Justice United States Attorney's Office, Western District of Oklahoma

Other Blogs

www.thelawofveterinarymedicine.blogspot.com
www.oklahomapharmacylaw.blogspot.com

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