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.