Minnesota Board of Pharmacy Outsourcing Compounded Sterile Products Statement as of Feb. 4, 2013

Minnesota Board of Pharmacy
Outsourcing Compounded Sterile Products
The Board strongly suggests that, on an ongoing basis, you review your policies and procedures regarding
outsourced compounded sterile preparations and revise them as necessary.
The Board suggests that you use the following as resources for this review:
 -American Society of Health-System Pharmacists (ASHP) “Guidelines on Outsourcing Sterile
Compounding Services” found at:
http://www.ashp.org/DocLibrary/Bestpractices/MgmtGdlOutsourcingSterileComp.aspx
 ASHP “Outsourcing Sterile Products Preparation: Contractor Assessment Tool” found at:
http://www.ashpfoundation.org/SterileProductsTool
 USP <1163> Quality Assurance in Pharmaceutical Compounding - outsourcing section
The Board suggests you include the following in your policy (if applicable):
 Proper regulatory compliance including licensure verification
 Validation of quality processes of the outsourced pharmacy focusing on the beyond-use date and
USP <797> compliance.
 Pharmacist-in-Charge oversight, to include documented approval of outsourced products and
vendors and assuming complete responsibility for patient outcomes from all medication-related
activities.
 P&T (or equivalent) and risk management committee review and approval of outsourced product
policy and allowed outsourced products.
 Collaboration with clinic prescribers to determine which products are truly needed or if a
commercially available manufactured product is available.
 Establish an ongoing communication process with prescribers to inform them of drug shortages
and discuss how to handle the shortages
 Do not allow prescribers to use their own supplies of compounded products while they are
providing services at your facility.
The Board reminds pharmacists to review the compounding memo found on the Boards website at:
http://www.phcybrd.state.mn.us/cmpdmemo.pdf. It is not legal to purchase drugs at wholesale from any
entity that is not licensed by the Board as a drug wholesaler. It is also not legal to purchase any
“compounded” products at wholesale from any company that is not also licensed as a manufacturer. Any
prescription dispensed for a specific patient would need documentation of a prescription which per M.S.
151.01 subd.16 must contain: 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. As the PIC it would be
wise to verify that all staff clearly understands these regulations.
Please do not hesitate to contact the Surveyors at the Board office at (651) 201-2839 if you have any
additional questions.
Source found here

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 

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

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