Commerce, Occupational and Professional Licensing

Rule R156-37

Utah Controlled Substances Act Rule

Five-Year Notice of Review and Statement of Continuation

DAR File No.: 35892
Filed: 02/21/2012 02:14:47 PM

NOTICE OF REVIEW AND STATEMENT OF CONTINUATION

Concise explanation of the particular statutory provisions under which the rule is enacted and how these provisions authorize or require the rule:

Title 58, Chapter 37, provides for the regulation of controlled substances and Title 58, Chapter 37f, provides statutory authority with respect to the Controlled Substance Database which is housed in the Division of Occupational and Professional Licensing. Subsection 58-1-106(1)(a) provides that the Division may adopt and enforce rules to administer Title 58. Subsection 58-37-6(1) provides the Division may adopt rules relating to the licensing and control of the manufacture, distribution, production, prescription, administration, dispensing, conducting of research with, and performing of laboratory analysis upon controlled substances within this state. Subsection 58-37f-203(3)(a) provides the Division shall make rules with respect to the Controlled Substance Database. This rule was enacted to clarify the provisions of Title 58, Chapter 37, with respect to controlled substances and Title 58, Chapter 37f, with respect to the Controlled Substance Database.

Summary of written comments received during and since the last five-year review of the rule from interested persons supporting or opposing the rule:

Since this rule was last reviewed in March 2007, it has been amended three times. The Division has received two written comments with respect to this rule. A 12/28/2007 written request was received from James V. Olsen, President of the Utah Food Industry Association, in which he requested the Division to conduct a public rule hearing on proposed amendments to the rule which had been filed by the Division in December 2007. The Division thus filed notice of a 01/22/2008 rule hearing with the Division of Administrative Rules and said notice was thus published in the 01/15/2008 edition of the Utah State Bulletin. Notice of the scheduled 01/22/2008 public rule hearing was also provided to Mr. Olsen. The Division also received a 06/23/2008 letter from David M. Davis representing the Utah Food Industry Association and Utah Retail Merchants Association. Mr. Davis' written comments addressed concerns with current proposed rule amendments with respect to real time reporting requirements to the Controlled Substance Database as proposed in Subsection R156-37-609a(2). Mr. Davis indicated that the proposed amendment would place an undue burden on pharmacy operations without providing a significant enhancement to the Controlled Substance Database. Mr. Davis suggested an additional change which would require pharmacies to report to the Controlled Substance Database on a daily basis rather than when data become available at the pharmacy. After further review of Mr. Davis' comments, the Division determined no additional change would be made beyond the change in proposed rule filing which delayed weekly reporting to the Controlled Substance Database to 10/01/2008. However, it should be noted that future amendments to Subsection R156-37-609a(2) were made in 2009 which addressed Mr. Davis' concerns in his June 2008 letter.

Reasoned justification for continuation of the rule, including reasons why the agency disagrees with comments in opposition to the rule, if any:

This rule should be continued as it provides a mechanism to inform potential licensees and licensees of the rules relating to controlled substances, as allowed under statutory authority provided in Title 58, Chapter 37. This rule is applicable to occupations and professions involved with controlled substances which are regulated by the Division. The rule should also be continued as it provides information to ensure applicants for licensure are knowledgeable about controlled substance requirements of the Division with respect to items that are not covered separately in each occupational/professional rule. This rule should also be continued as it provides information to affected and interested persons with respect to the Controlled Substance Database as required in Title 58, Chapter 37f.

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Direct questions regarding this rule to:

• Debra Hobbins at the above address, by phone at 801-530-6789, by FAX at 801-530-6511, or by Internet E-mail at dhobbins@utah.gov

Authorized by:

Mark Steinagel, Director

Effective:

02/21/2012