Compounding on State House Legislature Agenda in Maine today

9:30 a.m.

Labor, Commerce, Research and Economic Development Committee; public hearings; room 208; Cross Building

L.D. 1288, "An Act Regarding Impairment of Health of a Correctional Employee Caused by Infectious Disease": provides that a condition of impairment of health caused by an infectious disease resulting in total or partial disability or death of an employee of a correctional facility must be presumed to have been received in the line of duty, unless the contrary is shown by competent evidence.

L.D. 1315, "An Act To Ensure the Safety of Compounded Drugs": defines "compounding pharmacy" and describes sterile and nonsterile compounding pharmacies; to the Maine Board of Pharmacy adds a physician and advanced practice registered nurse, decreases the number of pharmacists to three and requires that one public member has education and professional experience in the field of health care safety and quality assurance; requires compounding pharmacies to obtain a license as such and to specify if they are sterile or nonsterile; includes in the Maine Board of Pharmacy responsibilities licensing out-of-state compounding pharmacies, appoint and convene advisory committees, impose a fine on compounding pharmacies that violate the Maine Pharmacy Act, participate in data reporting and license pharmacy technicians in two categories: sterile and nonsterile; allows the board consultations with the Board of Licensure in Medicine, the Board of Osteopathic Licensure and the commissioner of Health and Human Services regarding the compounding of drugs; requires the Maine Board of Pharmacy to ensure standards for purity and quality are met by compounding pharmacies; adds documentation regarding compounding to the list of items that the board may remove from a premises being inspected; requires that licensing fees for pharmacies distinguish between compounding, sterile compounding and nonsterile compounding pharmacies; adds sterile and nonsterile compounding of drugs course work for continuing education for pharmacists; requires the Department of Health and Human Services to adopt rules regarding compounding pharmacies in hospitals and nursing facilities; and requires the director of Maine Center for Disease Control and Prevention to consult with the Maine Board of Pharmacy on issues related to epidemiology and public health.

Source found here

9:43 PM Tighter pharmacy regulation sought Rep. Anglin says Maine should learn from the 2012 meningitis outbreak linked to Massachusetts. By SUSAN M. COVER Kennebec Journal

AUGUSTA - The deaths of 53 people after a nationwide meningitis outbreak linked to a compounding pharmacy in Massachusetts has prompted a local lawmaker to submit a bill to strengthen regulations in Maine.
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Legislation to Allow Foreign Mail-Order Pharmacies to Dispense to Patients in Maine Poses Danger to Public Health, Warns NABP

March 20, 2013

Stressing the potential danger to patients, NABP expressed its opposition to legislation introduced in Maine that would allow the dispensing of drugs from mail-order pharmacies located around the world. Maine Legislative Document 449 proposes to amend the definition of the “practice of pharmacy” to allow mail-order pharmacies located in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and the European Union to dispense drugs to patients in Maine. In a letter (PDF) to Maine Senators John L. Patrick and Douglas Thomas, and Maine Representative Erin D. Herbig, NABP notes the concern that this action, by effectively circumventing the federally regulated United States medication supply chain, would open the door to unapproved, substandard, and counterfeit drugs and pose a significant risk to patient safety. The letter highlights the fact that medications dispensed by foreign mail-order pharmacies are not approved by the US FDA, or, in many cases, by any public health authority. Since such drugs are dispensed outside the tightly regulated US drug supply chain, there is no way of knowing whether the products are substandard, adulterated, contaminated, or even toxic. As indicated in the letter, the distribution of fake cancer medication purchased from foreign sources in February 2012 serves as a prime example. The Association also expressed its concern that the proposed legislation would condone and foster violation of federal law, placing residents of Maine who might use such mail-order pharmacies in jeopardy, both legally and from a public health standpoint. Organizations providing testimony in opposition to the proposed legislation included the Partnership for Safe Medicines and Rite Aid Corporation, and both entities presented NABP’s letter to Maine legislators.

Quoted from NABP located here

MAINE VETERINARY PRACTICE ACT Regarding Prescriptions

Title 32: PROFESSIONS AND OCCUPATIONS   Chapter 71-A: MAINE VETERINARY PRACTICE ACT OF 1975 HEADING: PL 1997, C. 246, §1 (RPR) §4876. Prescriptions of other veterinarians.  A licensed veterinarian may sell and dispense the written prescription of another licensed veterinarian with respect to any prescription or administration of a drug, medicine or nutritional substance on, for or to any animal in accordance with this chapter. [2011, c. 30, §1 (NEW).] SECTION HISTORY 2011, c. 30, §1 (NEW). 

Maine wants the Canadian drugs FDA is trying to stop

September 12, 2012 | By Eric Palmer

Read more: Maine wants the Canadian drugs FDA is trying to stop - FiercePharma http://www.fiercepharma.com/story/maine-wants-canadian-drugs-fda-trying-stop/2012-09-12?utm_source=rss&utm_medium=rss#ixzz26MQL9EBK
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FAME-backed loan for $150,000to help compounding pharmacy in Maine expand

FAME-backed loan to help pharmacy expand

A Portland-based pharmacy is set to receive a $150,000 loan backed by the Finance Authority of Maine to expand its operations in the city.

Apothecary by Design LLC, a locally owned pharmacy with headquarters on Marginal Way, will use the funds to relocate its speciality department to nearby Preble Street while expanding its headquarters, according to theBangor Daily News.

The loan is facilitated by FAME, which approved 90% loan insurance on the $150,000 loan being offered by Bangor Savings Bank at an Aug. 16 meeting. This is not the first financing collaboration between the three entities; since 2008, FAME has offered loan insurance to FAME on Bangor Savings Bank loans a number of times, according to the Bangor Daily News.

The expansion will see a doubling in the size of the pharmacy's compounding lab. The company currently employs 38 people.

FAME also approved the re-advancement of funds on an existing loan to the pharmacy, as well as the renewal of an existing line of credit.

Founded in 1983, FAME is charged with supporting the growth of the state's business community. FAME offers an array of business assistance programs, including loan insurance, tax credits and financing programs.

Maine Board of Pharmacy's Position on Office Use

The Maine Board of Pharmacy Minutes of the June 7, 2012 meeting contain the following information regarding office use of compounded preparations in that state:

E-Correspondence of May 18, 2012, David Kosar, regarding dispensing to a practitioner for office use

The Board concluded that compound products are only for a specific patient’s immediate need and anything outside of this would rise to the activity of manufacturing. A pharmacist cannot sell compounded product to a practitioner.

These minutes of the meeting can be found here.