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 Judge Corrigan's clear ruling that the FDA once again attempted to exceed its jurisdictional authority, the agency seems determined to waste taxpayers' money with another lengthy and unnecessary legal case," said IACP President John Herr, R.Ph., FIACP.  "Given its track record with other cases affecting compounding pharmacists, the FDA again refuses to recognize that both the U.S. Constitution and the U.S. Congress limits its role in the state governed practice of medicine and pharmacy – a practice rightfully regulated by the state Boards of Pharmacy."

"For seven years, IACP and members of Congress continued to send a clear and simple message to the FDA… 'Fix the Veterinary Compounding Compliance Policy Guidance document.'  Had the FDA fulfilled its commitment to do so in 2004, this case would never have been brought to the courts in the first place.  Think of all the money wasted by the FDA prosecuting a case which they have now lost twice, all the money wasted by Community Pharmacist Paul Franck in defending his business, all the money that will be spent on appeals and defense of appeals… simply because a government agency refused to solve a problem of their own creation.  Despite rulings in other cases in addition to the recent US v. Franck Labs, Inc. and in language accompanying each of its own documents, the FDA appears unable to accept that its Compliance Policy Guidelines are not enforceable documents," says, IACP Executive Vice President & CEO David G. Miller, R.Ph. 

About IACP

The International Academy of Compounding Pharmacists (IACP) is a professional association founded in 1991 to protect, promote and advance personalized medication solutions. The association represents more than 2,100 pharmacists and pharmacist technicians located throughout North America, South America, Europe, Australia and Asia, who are committed to the safe and ethical practice of pharmacy compounding. In addition, IACP represents more than 159,527 patients, physicians, veterinarians and nurse practitioners through its ally grassroots organization, Patients & Professionals for Customized Care (P2C2). IACP is committed to ensuring the rights of practitioners to prescribe, of pharmacists to prepare, and of patients to take personalized medication solutions that meet their unique, individual health needs.   www.iacprx.org.  

IACP Contact:
Dagmar Climo,
IACP Director of Communications
dagmar@iacprx.org, 281/933-8400.

David G. Miller, R.Ph.
IACP Executive Vice President & CEO, davidmiller@iacprx.org, 215/778-5128


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

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:12/9/2016)... , Dec. 9, 2016 Department of Health ... regulations for medical marijuana dispensaries under Act 16 are ... , and are now available online . ... in the plan for operation; process for dispensing medical ... well as where the dispensary facilities can be located," ...
(Date:12/9/2016)... 9, 2016  Forge Therapeutics, Inc. today announced ... Exchange: EVT, TecDAX, ISIN: DE0005664809) to advance its ... treatment of bacterial infections including those caused by ... an attractive antibacterial target for more than the ... chemical starting points has hampered its progress. Forge ...
(Date:12/8/2016)... 8, 2016 Australia Ophthalmic Lasers Market Outlook ... Ophthalmic Lasers Market Outlook to 2022", provides key market ... provides value, in millions of US dollars, volume (in ... Excimer Lasers, Femtosecond Lasers and YAG Lasers. The ... for each of these market segements, and global corporate-level ...
Breaking Medicine Technology:
(Date:12/10/2016)... ... December 10, 2016 , ... "TransPanel Volume 2 is ... unique animations," said Christina Austin - CEO of Pixel Film Studios. , TransPanel ... FCPX . This set of versatile transitions features presets with up to ...
(Date:12/10/2016)... PITTSBURGH, PA (PRWEB) , ... December 10, 2016 , ... ... Jacksonville, Fla., worried about germs spreading from the seat to her body, and contamination ... but convenient and effective way to solve this problem that many people face. , ...
(Date:12/9/2016)... ... 2016 , ... Cellairis is a worldwide mobile device and computer repair franchise ... iPad and Samsung Galaxy devices with premium parts and accessories. Cellairis has recently ... and accessibility for customers. While customers do their shopping, Cellairis can accomplish a number ...
(Date:12/9/2016)... ... 2016 , ... The Justin Veatch Fund announced Thursday that ... film Whispering Spirits and its discussion guide for use by all of ... in the war against teen drug abuse. NCADD is the oldest anti-addiction advocacy ...
(Date:12/9/2016)... ... December 09, 2016 , ... Mediaplanet today announces distribution ... transplantation while encouraging readers to sign up as an organ donor for the 123,000 ... , An organ donor can save up to 8 saves through organ donation ...
Breaking Medicine News(10 mins):