Showing posts with label Minnesota. Show all posts
Showing posts with label Minnesota. Show all posts

Thursday, January 2, 2014

1099 compounding sales jobs in Colorado, Georgia, Iowa, Indiana, Kansas, New Mexico, New Jersey, Minnesota, Missouri, Nevada, New York, Oklahoma, Texas, Washington

1099 Pharmaceutical Representative


 

NVYDiA Medical - Pharmaceutical Compound SalesIf you are currently in Pharmaceutical or Medical Sales and have established relationships with physicians (Primary Care, Internal Medicine, Neuro's, Ortho's, Plastic's, Podiatrists, Chronic Pain, Spine, Radiation Oncology, Hospice, Urology, Hand Surgeons, Lower/upper Extremity, Sports Medicine, Rheumatology, Rehabilitation, etc.) this is a great opportunity for you.This is not a position you have to leave your current job for. This is an opportunity for you to supplement your income with an additional revenue stream added to your existing salary.  This opportunity can increase your yearly income without you going outside of your call pattern, if you have existing relationships.  If you have solid contacts in medical, pharmaceutical or other healthcare industries, send your resume and we will contact you.Below is a general description of what you will be offering your physicians:First, we offer everyday used injectable drugs that are administered with in the clinic, for example, B-12, steroid injections, Testosterone injections, antibiotic injections, etc.  Our business model has cut out the middle man to offer these products at a discounted price.  What makes this sale so easy, is that we are offering products that the doctors or clinics are purchasing, we are just helping them save money.Second, pharmaceutical compounding, (done in compounding pharmacies) is the creation of a particular pharmaceutical product to fit the unique needs of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose needed. More recently it has been suggested that some doctors and clinics have turned away from major drug manufacturers and turned to compounding pharmacies because they often provide a much higher quality of product and charge much lower prices than the major manufacturers.Positions available in:  Colorado, Georgia, Iowa, Indiana, Kansas, New Mexico, New Jersey, Minnesota, Missouri, Nevada, New York, Oklahoma, Texas, WashingtonFor those who meet the qualifications and are interested, send your resume to: resumes@nvydiamedical.com

Wednesday, January 16, 2013

MINNESOTA BOARD OF PHARMACY URGENT MEMORANDUM

MINNESOTA BOARD OF PHARMACY
URGENT MEMORANDUM
DATE: November 15, 2012
TO: Pharmacists and pharmacies licensed by the Minnesota Board of Pharmacy
FROM: Cody Wiberg, Executive Director, Minnesota Board of Pharmacy
RE: Compounding
Given the recent tragic events surrounding the distribution of contaminated products to
Minnesota health care providers, I am sending this reminder memo to all pharmacists and
pharmacies licensed by the Board. 
The Minnesota Board of Pharmacy frequently receives questions and complaints about the sale
of drug products to physicians and clinics for office-use. The most common question is whether
or not pharmacies can fill a prescription that is not written for a specific patient but is instead
written out for “office use”. The short answer is no, they can’t.
Minnesota Statutes §151.01, subd. 16 defines “prescription” as: “a signed written order, or an
oral order reduced to writing, given by a practitioner licensed to prescribe drugs for patients in
the course of the practitioner's practice, issued for an individual patient and containing the
following: the date of issue, name and address of the patient, name and quantity of the drug
prescribed, directions for use, and the name and address of the prescriber”.  (Emphasis added).
Clearly, by law, a practitioner cannot issue a prescription without specifying an individual
patient. Thus, if a physician writes out an order on a prescription pad (or as part of an electronic
prescription or chart order) that is “for office use”, the order is not a legally valid prescription. 
A pharmacy is allowed to sell prescription drugs to a physician or clinic pursuant to a wholesale
transaction, but only if it is licensed by the Minnesota Board of Pharmacy as a wholesaler. In
such cases, the pharmacy must follow all applicable state and federal laws and rules concerning
the wholesaling of drug products. However, drugs prepared by a compounding pharmacy
cannot be supplied to a physician or clinic as part of a wholesale transaction unless certain
other conditions are met, as described below 

Thursday, January 10, 2013

Minnesota Board Implements Plan to Strengthen Regulation of Compounding Pharmacies

January 9, 2013 6:30 pm

The Minnesota Board of Pharmacy, which already has strong compounding regulations and requirements in place, is in the process of considering additional requirements, some of which will require the passage of new legislation. If the Minnesota Legislature approves an increased appropriation, the Board plans to hire additional surveyors. The Board will also begin vetting third-party entities that provide certifications and other verification services for pharmacies engaging in sterile compounding. To further protect the public, the Board is considering additional requirements for nonresident compounding pharmacies, including requiring that copies of recent inspection reports be submitted as a requisite for licensure, and requiring documentation of how past violations were resolved. Facilities located in states in which regular inspections are not performed may be required to submit to an inspection by a Board-approved entity that is qualified to perform such inspections, with NABP being one possibility.
Currently, Minnesota law (PDF) clearly distinguishes compounding from manufacturing or wholesale distribution. By statute and rule, compounding in Minnesota is only allowed pursuant to a prescription for an individual patient, while compounding for wholesale distribution or office use is prohibited. A pharmacy may compound a limited amount of medication in anticipation of its own prescription needs, but must receive a prescription for a specific patient before dispensing the medication. All pharmacies located within Minnesota are inspected prior to being granted a new license. In addition to conducting opening inspections, the Board regularly inspects all pharmacies located within the state. Minnesota’s surveyors, most of whom are already knowledgeable in United States Pharmacopeia Chapter 797 standards, will be receiving additional training in this area.
Entities producing drug products for wholesale distribution within the state must be licensed by the Board as a manufacturer and must also register with Food and Drug Administration (FDA) as manufacturers, or submit to the Board a letter from FDA indicating why the entity does not need to register as a manufacturer. A nonresident entity seeking licensure for wholesale distribution of compounded drug products into Minnesota must also submit proof of appropriate licensure in its resident state, or documentation indicating why they are not required to be licensed.

Source located here

Sunday, December 16, 2012

Minnesota November 27th Special Ad Hoc Meeting Concerning Compounding


Minnesota Board of Pharmacy
Special Ad Hoc Meeting Concerning Compounding
At approximately 9:00 a.m., on November 27, 2012, the Minnesota Board of
Pharmacy met for an ad-hoc meeting in Conference Room A, at the University Park
Plaza Building, 2829 University Avenue Southeast, Minneapolis, Minnesota, for the
purpose of conducting a special business meeting regarding recent correspondence
from the National Association of Boards of Pharmacy concerning compounding, two
requests from Congressional Committees for data concerning compounding and a data
practices request from a reporter. All members of the Board were in attendance. Also
in attendance were the Board’s Executive Director, Dr. Cody Wiberg, Board’s Legal
Counsel, Mr. Bryan Huffman, and Board of Pharmacy staff, Ms. Candice Fleming, Mr.
Leslie Kotek, Ms. Karen Schreiner, Mr. Steven Huff, and Mr. Timothy Litsey. The
Board’s President, Mr. James Koppen, called the meeting to order.
Mr. Koppen then announced that Mr. Ikram-Ul-Huq submitted a resignation from
the Board on November 26, 2012. Mr. Koppen stated that Dr. Wiberg would be
advising the Governor's office of this resignation. Mr. Koppen thanked Huq for his many
years of service to the Board and the public.
Dr. Wiberg brought to the Board’s attention that when the situation involving New
England Compounding Center (NECC) began, he was contacted by numerous
members of the media, locally and nationally. One of the reporters, from Minnesota
Public Radio, submitted a data practices request under the provisions of the MN
Government Data Practices Act in Chapter 13 of state law and requested copies of
survey reports and communications about adverse findings regarding compounding
pharmacies (facilities along the lines of NECC or specialty compounding pharmacies).
Prior to giving the information to the reporter, Dr. Wiberg asked for an opinion from the
Attorney General’s Office (AGO) concerning the whether or not the reports were
classified as public data. After consulting with the AGO, Dr. Wiberg concluded that
survey reports are public documents due to the fact that they contain data that concerns
a business and not an individual. Investigative data may or may not be public
depending on whether it is on an individual or on a facility. Inactive investigative data
on individuals retains it privacy. Investigative data concerning pharmacies and other
businesses licensed by the Board becomes public as soon as the investigation is
complete.
There was much discussion about the possibility that members of the media or
the public might confuse citations for violations of statutes or rules with mere
recommendations that the Surveyors might make that do not involves citations.
Consequently, it was proposed that a working group be developed to revise the forms
used by the Surveyors during surveys so that they have separate sections for a
checklist, citations for violations of statutes and rules and for recommendations that do
not involve citations. Mr. Stuart Williams moved that the president appoint two board
members and Dr. Wiberg appoint three staff members to revise the inspection reports.
Ms. Laura Schwartzwald seconded. The mappointed Ms. Kay Hanson and Ms. Karen Bergrud to the working group. Dr. Cody
Wiberg appointed Ms. Candice Fleming, Mr. Steven Huff, and Ms. Karen Schreiner.
Ms. Karen Bergrud moved and Mr. Stuart Williams seconded to accept staff’s
recommendation concerning the interpretation of what is a public record. The
interpretation presented by staff is that the Board is obligated to disclose survey reports
and complaint data that are not maintained as part of an active investigation, provided
that the complaint involves a licensed facility and not an individual. However,
confidential/private information in the documents would be subject to redaction. (e.g. -
social security numbers or medical data concerning a patient). The motion passed.
The Board gave directions to the staff that the above interpretation be e-mailed to
all licensees and registrants of the Board and to be reported in the Board's newsletter.
Dr. Wiberg next reported that he has received letters from the U.S. House of
Representatives Committee on Energy and Commerce and the U.S. Senate Committee
on Health, Education, Labor, and Pensions. These Committees held hearings on the
compounding issue. As a result of these hearings they sent out letters to all boards of
pharmacy requesting information about compounding. After much discussion, the
Board directed Dr. Wiberg to prepare responses to the Committees and to have the
President of the Board review the letters prior to them being mailed out. It is the
consensus of the Board that the dichotomy between “non-traditional” compounding and
“traditional” compounding, as is being advanced by the U.S. Food and Drug
Administration and possibly the above-mentioned committees is not the appropriate way
to look at this issue. Instead, the real distinction is between compounding and
manufacturing that is being done under the guise of compounding.
Dr. Wiberg next presented the National Association of Boards of Pharmacy’s
(NABP) action plan. At an Executive Director’s meeting held in Chicago earlier in the
month, it was announced that the Iowa Board of Pharmacy has a contract with NABP to
do work for it and that the contract would be expanded. The Iowa Board of Pharmacy
has requested NABP to do inspections on its behalf of the non-resident pharmacies that
Iowa has licensed, focusing on the pharmacies that do compounding. The Iowa Board
of Pharmacy has licensed only about two dozen pharmacies that are located within
Minnesota, with just a few of them doing compounding. After discussion, it was the
consensus of the Board that neither NABP or the Iowa Board of Pharmacy should
contact pharmacies licensed in Minnesota to alert the pharmacies to the fact that NABP
would be doing unannounced inspections. Instead, Minnesota Board of Pharmacy
Surveyors will conduct all the compounding pharmacy inspections within this state and
then either share the inspection reports that have already been completed with NABP
and the Iowa Board of Pharmacy or allow the NABP inspectors to shadow the
Minnesota Surveyors when they conduct surveys of pharmacies on Iowa's list. It was
also the consensus of the Board that NABP should look into being a clearing house for
out-state pharmacies requesting licensure in other states.There being no further business requiring action by the Board, Mr. Bob Goetz
moved to adjourn the meeting. The motion occurred at approximately 10:45 am. Ms.
Laura Schwartzwald seconded the motion. The motion passed.
Source of minutes found here


Tuesday, October 30, 2012

2012 Minnesota Statute on Compounding Drugs: 151.5


2151.15 COMPOUNDING DRUGS UNLAWFUL UNDER CERTAIN CONDITIONS.

Subdivision 1.Location.

 
It shall be unlawful for any person to compound, dispense, vend, or sell drugs, medicines, chemicals, or poisons in any place other than a pharmacy, except as provided in this chapter.

Subd. 2.Proprietors of pharmacies.

 
No proprietor of a pharmacy shall permit the compounding or dispensing of prescriptions except by a pharmacist or by a pharmacist intern under the personal supervision of a pharmacist; or the vending or selling of drugs, medicines, chemicals, or poisons in the proprietor's pharmacy except under the personal supervision of a pharmacist.

Subd. 3.Unlicensed persons; veterinary legend drugs.

 
It shall be unlawful for any person other than a licensed veterinarian or pharmacist to compound or dispense veterinary legend drugs except as provided in this chapter.

Subd. 4.Unlicensed persons; legend drugs.

 
It shall be unlawful for any person other than a licensed practitioner or pharmacist to compound or dispense legend drugs except as provided in this chapter.

Wednesday, October 17, 2012

State: Hundreds of clinics bought drugs from suspect pharmacy


Worries about more meningitis cases in Minnesota grew Tuesday as health officials said 129 clinics in the state — far more than previously reported — bought drugs from the Massachusetts firm tied to a national outbreak that has killed 16 people.

The Star Tribune has a report on the latest news...

Sunday, September 2, 2012

Coverage of Compounded Medications in Minnesota

Compound Drugs

Revised: 01-23-2012

Compound Drugs
A compound drug consists of two or more ingredients. The quantity at the line level should reflect the way the NDC is normally billed.

Example: if the NDC is normally billed per milliliter, the quantity at the line should be the total number of milliliters dispensed for the entire prescription – not the number of containers of normal saline used.

Pharmacies will be paid only for the ingredients which are normally covered by DHS.

Commercially Available Products
If room stable commercially available products are compounded, reimbursement is limited to the rate of the commercially available product (WAC plus 2% or the SMAC plus dispensing fee).

Compounded Products, Preparations, and Oral Drugs
Compounded liquid oral drugs (e.g., solutions, suspensions, emulsions) are covered only for children and for aphagic adult recipients, and only when a commercial liquid version of the drug is not available.

Compounded capsules are covered only if a tablet or capsule commercial version of the drug is not available in the strength prescribed, and if the appropriate strength cannot be achieved using half or quarter tablets.

Compounded Topical Products
Compounded topical products are not covered when a product that contains the same combination of active ingredients in the same strengths is commercially available from a pharmaceutical manufacturer, regardless of the package size that is commercially available.

Example: If the prescription is for 15 grams of an ointment and the commercially available version is available only in 30 gram tubes, MHCP will not cover 15 grams of the compounded product.

Compounded Intravenous (IV) & Total Parenteral Nutritional (TPN) Drugs
Compounded IV and TPN drugs are covered according to FDA guidelines regarding approved indications and preparation.