The United States Drug Enforcement Administration (DEA) is using its emergency scheduling authority to temporarily control three synthetic stimulants (Mephedrone , 3,4 methylenedioxypyrovalerone (MDPV) and Methylone).   This action was necessary to protect the public from the imminent hazard posed by these dangerous chemicals. Except as authorized by law, this action will make possessing and selling these chemicals or the products that contain them illegal in the U.S. for at least one year while the DEA and the United States Department of Health and Human Services (DHHS) further study whether these chemicals should be permanently controlled. 
A Notice of Intent to temporarily control was published in the Federal Register today to alert the public to this action. This alert is required by law as part of the Controlled Substances Act. In 30 days or more, DEA intends to publish in the Federal Register a Final Order to temporarily control these chemicals for at least 12 months, with the possibility of a six-month extension. The final order will be published in the Federal Register and will designate these chemicals as Schedule I substances, the most restrictive category, which is reserved for unsafe, highly abused substances with no currently accepted medical use in the United States.
“This imminent action by the DEA demonstrates that there is no tolerance for those who manufacture, distribute, or sell these drugs anywhere in the country, and that those who do will be shut down, arrested, and prosecuted to the fullest extent of the law,” said DEA Administrator Michele M. Leonhart.  “DEA has made it clear we will not hesitate to use our emergency scheduling authority to control these dangerous chemicals that pose a significant and growing threat to our nation.” 
Over the past few months, there has been a growing use of, and interest in, synthetic stimulants sold under the guise of “bath salts” or “plant food”. Marketed under names such as “Ivory Wave”, “Purple Wave”, “Vanilla Sky” or “Bliss”, these products are comprised of a class of chemicals perceived as mimics of cocaine, LSD, MDMA, and/or methamphetamine. Users have reported impaired perception, reduced motor control, disorientation, extreme paranoia, and violent episodes. The long-term physical and psychological effects of use are unknown but potentially severe. These products have become increasingly popular, particularly among teens and young adults, and are sold at a variety of retail outlets, in head shops and over the Internet.  However, they have not been approved by the FDA for human consumption or for medical use, and there is no oversight of the manufacturing process.

In the last six months, DEA has received an increasing number of reports from poison centers, hospitals and law enforcement regarding products containing one or more of these chemicals.  Thirty-three states have already taken action to control or ban these or other synthetic stimulants.  The Comprehensive Crime Control Act of 1984 amends the Controlled Substances Act (CSA) to allow the DEA Administrator to temporarily schedule an abused, harmful, non-medical substance in order to avoid an imminent hazard to public safety while the formal rule-making procedures described in the CSA are being conducted.

This morning on September 12, 2011, Judge Timothy Corrigan of the US District Court for the Middle District of Florida issued his ruling in US v. Franck’s Lab, Inc.  This lawsuit, brought by the Food & Drug Administration against IACP member Paul Franck and his pharmacy, alleged that the use of active pharmaceutical ingredients (APIs) in compounding veterinary preparations for non-food producing animals was illegal.  The FDA stated in its case that Franck’s Lab, Inc. – and all other pharmacists involved in compounding veterinary preparations with APIs – were in direct violation of AMDUCA, the FDA’s CPG, and the entire Food Drug and Cosmetic Act because those preparations are “new drugs” and subject to FDA review and approval.
The FDA lost.
Paul Franck and compounding pharmacy were victorious!
The ruling is a huge “win” for compounders.  Not only does it clearly refute the FDA’s attempts to exert unauthorized jurisdiction over compounding, it is sharply critical of the FDA’s approach towards veterinary compounding in particular.
“Not only did Judge Corrigan correctly rule that Congress never intended the FDA to prohibit the use of APIs in veterinary compounding, he also clearly stated what IACP has said for years – the FDA does not have jurisdiction over the traditional practice of pharmacy compounding.  That is the sole authority of the state Boards of Pharmacy,” said IACP President John Herr.  “Even more important to IACP members is Judge Corrigan’s outright dismissal of the FDA’s arguments that compounds prepared for an individual patient on the order of that patient’s prescriber are ‘new drugs’ and should be subject to FDA’s oversight.”
“For more than six years, IACP has worked with our supporters and allies in Congress to have the FDA address its ill-founded 2003 Compliance Policy Guideline on veterinary compounding,” explained David Miller, IACP Executive Vice President & CEO.  “Multiple Congressional inquiries, letters, phone calls… all of them ignored by a regulatory agency so sure of its ‘rightness’ in claiming that compounders were violating laws.  Well, today, they were proven wrong by the courts.  The tireless efforts of our members and our staff, the courage of Paul Franck to fight the FDA itself, and the commitment of IACP to its mission of the art and science of compounding has paid off.” 
Judge Corrigan’s ruling cites a number of landmark court cases and decisions affecting IACP members in addition to addressing the specific issue of APIs in veterinary compounding.  The document numbers more than 80 pages and provides an exceptional summary of the case as well as the FDA’s attempts to grant itself authority that Congress never intended it to have.  IACP will be providing additional information about the specific points in the ruling as part of our regular communications to members.

The Maine Pharmacy Association (MPA), the oldest state pharmacy association in the country, is seeking an energetic, highly motivated individual to provide the office support for the organization. Initially this is a part-time, 20-hour per week position working out of the candidate’s home.

The Administrative Assistant will be responsible for providing all clerical support to the organization and directors. The position requires an ability to operate a variety of office machines and equipment; utilize proper grammar, spelling, punctuation, and arrangement of information on all correspondence; input, retrieve, download, merge, and output information from software programs and systems; create and maintain membership information; plan, organize, and make sound judgment and decisions; handle multiple tasks and priorities; communicate effectively; maintain the confidentiality of information; order and maintain supplies; prepare professional correspondence; maintain all necessary files and records; and assist in the organization and hosting of the annual MPA meetings. It is anticipated that for the first couple years the administrative assistant will perform the duties of the office primarily from his/her own home office.

Highly qualified applicants would be expected to have any equivalent combination of education, training, and experience that provides the required knowledge, skills and abilities and have a minimum of at least two years of full-time secretarial work experience. A working knowledge of Microsoft Office is required. Qualified applicants must be a high school graduate or equivalent. Previous experience with data base entry is desirable but not required. At least two years of full-time secretarial work experience is required.

A letter of application along with resume and the names and contact information of three references can be sent to:

Christopher Gauthier
Executive Director
Maine Pharmacy Association
PO Box 174
Turner, Maine 04282

Electronic submissions to cgauthierrph@gmail.com are encouraged. Evaluation of applications will begin immediately and applications will be accepted until the position is filled. Anticipated start date for this position is October 1, 2011.

Click below to read what you association had to say to Senator Susan Collins with regards to TRICARE. Your association is dedicated to a level playing field between mail order and community pharmacies.
Senator Collins Letter

On April 27,2011 Pharmacists from throughout the state, the Maine Pharmacy Association, and Student Pharmacists from both the University of New England and Husson University flocked to the State House to celebrate the profession of pharmacy and demonstrate our worth to the public health of our citizens!

Many thanks to Governor Paul LePage, Speaker of the House Robert Nutting, and all of the legislators that visited us in the Hall of Flags. The governing leaders of our state saw the true measure of our value to the healthcare system! With legislation for Medication Therapy Management, the expansion of the 340B program, Accountable Care Organizations, and the many new facets of the Affordable Care Act, it is good to know that our leaders are taking the time to get truly informed by the experts before making decisions that affect our careers.

Check out our photo gallery below for pictures from the event!

 
We monitored these bills and concurred with other interested parties that, if passed, vaccination rates would decline in Maine.
 
April 5th 1pm – Ought Not to Pass
(L.D. 694)            Bill “An Act To Encourage Transparency in Disclosing the Ingredients in Vaccinations for Children to Parents and Guardians” (HP0523) (Presented by Representative BOLAND of Sanford) (Cosponsored by Senator PLOWMAN of Penobscot, Senator PATRICK of Oxford, Representative DION of Portland, Representative ESPLING of New Gloucester, Representative GUERIN of Glenburn, Representative HARLOW of Portland, Representative MORRISON of South Portland, Representative O’CONNOR of Berwick)
                          
April 5th 1pm – Ought Not to Pass
(L.D. 941)            Bill “An Act To Prohibit Mandatory Immunizations” (SP0287) (Presented by Senator THOMAS of Somerset) (Cosponsored by Representative CEBRA of Naples, Representative JOHNSON of Greenville, Representative MALABY of Hancock, Representative O’CONNOR of Berwick, Representative SANDERSON of Chelsea, Representative SIROCKI of Scarborough)

Pseudoephedrine by Rx Only Bill Defeated

 
I enjoy having good news for Maine pharmacists/pharmacies. 
 
I am pleased to report that during the work session on LD774, an “Act to Allow Access to Pseudoephedrine
by Prescription Only”, the Health & Human Services Committee voted unanimously to kill this well-intended
but mis-guided legislation.
 
The legislative agenda continues to grow every day with our pharmacy legislative group monitoring upcoming
bills that would allow for reimbursement of Medication Therapy Management (MTM) practiced by Maine
pharmacists, Publishing of Healthcare prices, Hospital pharmacies to service their own nursing homes and 340B
program pharmaceuticals for Mainecare patients.
 
We will keep you updated and informed as these bills are heard (public hearings) and voted upon (work sessions).

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