Navigation Links
International Academy of Compounding Pharmacists (IACP) Responds to FDA's Appeal of the U.S. District Court Ruling on Pharmacy Compounding
Date:11/11/2011

HOUSTON, Nov. 11, 2011 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration (FDA) appealed the September 2011 U.S. District Court for the Middle District of Florida ruling in US vs. Franck's Lab, Inc., which had decided in favor of pharmacy compounding for veterinary patients.  This lawsuit, brought by the Food & Drug Administration against Paul Franck, R.Ph., FIACP of Franck's Lab in Ocala, Fla., alleged that the use of active pharmaceutical ingredients (APIs) in compounding veterinary preparations for non-food producing animals was illegal.  

(Logo: http://photos.prnewswire.com/prnh/20111111/DC05358LOGO)

In this landmark pharmacy compounding court decision, Judge Timothy Corrigan had ruled that:

  • The FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy so long as the pharmacy's activities are not manufacturing.  That rests with individual state Boards of Pharmacy.
  • Congress did not give FDA jurisdictional authority when it enacted the FDCA in 1938 to take enforcement action against a pharmacy that is engaged in the traditional practice of compounding.
  • The FDA cannot use its CPG for veterinary compounding issued in 2003 as the basis for enforcement action.
  • The regulations enacted by the FDA based upon AMDUCA are in error – AMDUCA did not give FDA authority to prohibit the use of bulk APIs in veterinary compounding.
  • Size and scope of compounding does not mean a pharmacy is a manufacturer.  
  • The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food producing animals is an illogical position for the FDA to take and contraindicated by its own actions over the past 50+ years.

IACP Response on FDA's Appeal Today

"Despite
'/>"/>

SOURCE International Academy of Compounding Pharmacists (IACP)
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
2. Paper in International Journal of Oncology Reports Alfacells ONCONASE(R) Suppresses Intracellular Oxidative Stress
3. Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale dUrologie
4. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
5. International Expert Group Initiates Largest Multi-center Phase III Trial to Evaluate NeuroAid(TM) in Stroke Recovery
6. Surface Logix Presents Positive Phase 1 Repeat-Dose Trial Data on SLx-4090 at The 16th International Symposium on Drugs Affecting Lipid Metabolism
7. Preclinical Data on Lead MEK Inhibitor, RDEA119, to be Presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
8. Tumor Growth Inhibition and Pharmacokinetic Profile of NKTR-102 (PEG-Irinotecan) in Multiple Solid Tumors To Be Presented at Upcoming AACR-NCI-EORTC International Conference
9. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
10. Survival Data for Avicenas Amyotrophic Lateral Sclerosis Drug Candidate, AL-02, to be Presented at 18th International Symposium on ALS/MND
11. CEL-SCI CEO to Present at the International Society for Pharmaceutical Engineering 2007 Chesapeake BioShowcase
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... , May 23, 2013  Every day, their baby ... air to his lungs. April and Bryan Gionfriddo ... predictions weren,t true. "Quite a few doctors said ... alive," says April Gionfriddo , about her ... Anything that would work, we would take it and run ...
(Date:5/23/2013)... , May 23, 2013   Direct to ... mastectomy is an appropriate option for many women ... surgically reduce their breast cancer risk, or with ... expansion process and a second surgery to insert ... the same surgery as mastectomy can be a ...
(Date:5/23/2013)... TEL AVIV, Israel , May 23, 2013 ... of BrainTech Israel 2013 , Israel,s ... take place on October 14 th -15 th in ... 2 nd most innovative city in the world by ... the "Start-up Nation." BrainTech Israel 2013 will showcase ...
Breaking Medicine Technology:Baby's life saved with groundbreaking 3D printed device from U-M that restored his breathing 2Baby's life saved with groundbreaking 3D printed device from U-M that restored his breathing 3Baby's life saved with groundbreaking 3D printed device from U-M that restored his breathing 4Direct to Implant ("One Step") Mastectomy Breast Reconstruction Reduces Number of Surgeries and Time to Final Cosmetic Results 2Direct to Implant ("One Step") Mastectomy Breast Reconstruction Reduces Number of Surgeries and Time to Final Cosmetic Results 3Israel Brain Technologies Announces Israel's 1st International Brain Technology Conference 2Israel Brain Technologies Announces Israel's 1st International Brain Technology Conference 3
(Date:5/23/2013)... of borderline personality disorder often mimic traits of ... researchers in Canada say they have identified a ... disorder: a tendency to misinterpret emotions expressed by ... facial emotions and will see a negative emotion ... clinical neuropsychologist and assistant professor at the University ...
(Date:5/23/2013)... (HealthDay News) -- A shortage of a critical tuberculosis ... the United States to contain the spread of the ... drug, isoniazid (INH), was first used in 1951 and ... core of any first-line treatment for tuberculosis (TB). Patients ... according to the U.S. Centers for Disease Control and ...
(Date:5/23/2013)... at Emory Vaccine Center have shown that an immune ... responses in mice against viral infections. , The results ... , "Our findings highlight how IL-21 could be important ... Ata Ur Rasheed Mohammed, PhD, the first author of ... director of the Emory Vaccine Center and a Georgia ...
(Date:5/23/2013)... Netsmart today announced it is ... healthcare information technology (HIT) providers for 2013. , The HCI ... Healthcare Informatics magazine. Netsmart’s ranking of #49 is ... continued growth is largely due to our commitment to helping ... healthcare where resources are scarce, the demand for care is ...
(Date:5/23/2013)... examining outcomes for advanced heart-failure patients over the ... the increased availability and use of new therapies, ... caused by the rapid onset of severe abnormal ... the team found that even today, with these ... than three years after being diagnosed with advanced ...
Breaking Medicine News(10 mins):Health News:People With Borderline Personality Disorder May Misinterpret Facial Emotions 2Health News:People With Borderline Personality Disorder May Misinterpret Facial Emotions 3Health News:Shortage of Key Drug Hampering U.S. Efforts to Control TB: Report 2Health News:Vaccine blackjack: IL-21 critical to fight against viral infections 2Health News:Netsmart Named to Healthcare Informatics Top 100 List 2Health News:Death rates decline for advanced heart failure patients, but outcomes are still not ideal 2Health News:Death rates decline for advanced heart failure patients, but outcomes are still not ideal 3
... how cocaine corrupts the brain and becomes addictive. These findingsthe ... cocaine rewardwere published in Science on October 15. ... treating those addicted to the drug. Led by ... Neuroscience at Mount Sinai School of Medicine and first author ...
... The US Department of Defense (DOD) has awarded a ... Research and the University of Cincinnati to further develop ... severe brain injury. Management of severe brain trauma ... critical first few hours and days after an injury. ...
... , MONDAY, Oct. 18 (HealthDay News) -- Canadian ... the so-called swine flu -- to be very severe this ... of 50, especially those with chronic health conditions, get immunized ... results of blood tests given to 1,127 people in the ...
... Institute has awarded a $4.37 million grant to Jeffrey ... to advance a recent scientific laboratory discovery into a ... under the American Recovery and Reinvestment Act, will help ... by Toretsky and his team a critical step ...
... Texas (October 18, 2010) The latest colorectal ... Gastroenterology,s (ACG) 75th Annual Scientific meeting in San ... evidence that suggests significant disparity in colorectal cancer ... the first in a series of studies investigating ...
... Antonio, Texas (October 18, 2010) Investment in screening ... 50 and 64, is needed to reduce the costs ... the results of a new study, "Cost-Savings to Medicare ... unveiled today at the American College of Gastroenterology,s (ACG) ...
Cached Medicine News:Health News:Mount Sinai researchers discover why cocaine is so addictive 2Health News:Feinstein Institute to share $5M US Department of Defense grant 2Health News:H1N1 Unlikely to Cause Flu Pandemic in 2010-11: Analysis 2Health News:$4.37 million NCI grant accelerates recent laboratory finding in Ewing's sarcoma 2Health News:$4.37 million NCI grant accelerates recent laboratory finding in Ewing's sarcoma 3Health News:Notable racial disparities in diagnosis, treatment and outcomes of colorectal cancer 2Health News:Notable racial disparities in diagnosis, treatment and outcomes of colorectal cancer 3Health News:Investment in CRC screening targeting pre-medicare population could cut medicare treatment costs 2
... The BD Macro-Vue RPR (Rapid ... and Tear-drop Tests are nontreponemal testing ... syphilis described in A Manual of ... in this manual are the most ...
Rapid Plasma Reagin (RPR) set is a non-treponemal flocculation test that is,used for the qualitative and semi-quantitative determination of reagin,antibodies in serum or plasma from persons with syph...
For use as a quality assurance reagent in assays detecting IgG antibody to mumps virus (mumps IgG), IgG antibody to measles (Rubeola) virus (measles IgG) and IgG antibody to varicella zoster virus (V...
... For use as a ... detecting IgG antibody to Toxoplasma ... to rubella virus (rubella IgG), ... IgG) and IgG antibody to ...
Medicine Products: