North Dakota Board of Pharmacy Discusses Compounding at Meeting

on November 15, 2012.  To view agenda, click here  The minutes of this meeting show that:

At 11:15 AM Pharmacists Michael Riepl and Kevin Oberlander arrived to discuss the
compounding and sale of Over-the-Counter medications and the labeling required for that sale.
The discussion also included aspects of sterile compounding and consideration of what might
happen relative to the FDA’s increased scrutiny of compounding in light of the New England
Compounding issue.
Pharmacist Riepl distributed a label that he had prepared for one of the Over-the-Counter
products which he has been making and which are in clinical trials with the Mayo Clinic and his
pharmacy.
It was moved by Pharmacist Ziegler and seconded by Pharmacist Thom to table the Over-
The-Counter compounding issue until the January 2013 Board Meeting and invite nonsterile
compounding pharmacists interested in the preparation of Over-the-Counter
products to attend that meeting with specific suggestions for how the Board should regulate
this activity. All Board Members voted aye – the motion carried.

To view the entire minutes click here

New Compounding Rules Will Be Effective in January 2015 in North Dakota

Pharmacy Inspections
It is the time of the year for pharmacy inspections to occur. By the time this Newsletter gets to you, inspections for most pharmacies will be complete. For those of you still waiting, as a reminder, the emphasis of the inspections this year will include:
♦ Use and compliance of Prescription Drug Monitoring Program
♦ Counseling or offer to counsel on all prescriptions by the pharmacist
♦ CII controlled substance audit: one done before the inspector arrives
and one during inspection
♦ Information on new hospital first dose review rule effective June
2015
♦ Information on new compounding rules effective January 2015

Taken from the September 2012 Newsletter found here.
These are the rules that must be complied with by 2015 here.

North Dakota Proposed Rules for Nonsterile and Sterile Compounding

On March 12, 2012, the North Dakota State Board of Pharmacy posted the following letter:


Full Notice
NOTICE OF INTENT TO [ADOPT, AMEND, OR REPEAL] ADMINISTRATIVE RULES
TAKE NOTICE that the North Dakota State Board of Pharmacy will hold a public
hearing to address proposed N.D. Admin. Code Article 61; 61-02-01-03 Pharmaceutical
Compounding Standards.  The Hearing will be held at 10:00 AM on Thursday,
November 17, 2011, at the Board of Pharmacy Office – 1906 East Broadway  in
Bismarck  ND 58501.
The purpose of these proposed rule in 61-02-01-03 are to set standards for both nonsterile and sterile compounding [United States Pharmacopeia guidelines have been in
place since June 2008].   This rule, once adopted, will give specificity to those
individuals and entities in North Dakota wishing to compound pharmaceuticals, both
non-sterile and sterile.    This rule will give North Dakota entities a basis for coming into
compliance with professional standards and a timeline for doing so.
The proposed compounding rules may have an impact on the regulated community in
excess of $50,000. The regulatory analysis can be obtained at the location bellow.
The proposed rules may be reviewed at the office of the ND State Board of Pharmacy –
1906 E Broadway – Bismarck ND 58501 or Board website www.nodakpharmacy.com.
A Copy of the proposed rules and/or a regulatory analysis may be requested by writing
P O Box 1354 Bismarck ND 58502-1354; emailing ndboph2@btinet.net or calling 701-
328-9535.  Written or oral comments on the proposed rules sent to the above address
or email address and received by January 2, 2012 will be fully considered.
If you plan to attend the public hearing and will need special facilities or assistance
relating to a disability, please contact the ND State Board of Pharmacy at the above
telephone number or address at least two weeks (14 days) prior to the public hearing.
Dated this 11th day of  October  2011.