No. 31423: R156-37. Utah Controlled Substances Act Rules

DAR File No.: 31423
Filed: 07/14/2008, 10:01
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

Following a public rule hearing and additional review by the Division and the State Board of Pharmacy, one additional change is being proposed in Subsection R156-37-609(4) to delay implementation of the weekly reporting requirement to the Controlled Substance Database to 10/01/2008.

Summary of the rule or change:

In Subsection R156-37-609(4), the implementation date for weekly reporting to the Controlled Substance Database has been changed from 07/15/2008 to 10/01/2008. (DAR NOTE: This change in proposed rule has been filed to make additional changes to a proposed amendment that was published in the June 1, 2008, issue of the Utah State Bulletin, on page 62. Underlining in the rule below indicates text that has been added since the publication of the proposed rule mentioned above; strike out indicates text that has been deleted. You must view the change in proposed rule and the proposed amendment together to understand all of the changes that will be enforceable should the agency make this rule effective.)

State statutory or constitutional authorization for this rule:

Subsections 58-1-106(1)(a), 58-37-6(1)(a), and 58-37-7.5(7)

Anticipated cost or savings to:

the state budget:

No additional costs or savings are anticipated beyond those previously identified in the original rule filing.

local governments:

No additional costs or savings are anticipated beyond those previously identified in the original rule filing.

small businesses and persons other than businesses:

No additional costs or savings are anticipated beyond those previously identified in the original rule filing.

Compliance costs for affected persons:

No additional costs or savings are anticipated beyond those previously identified in the original rule filing.

Comments by the department head on the fiscal impact the rule may have on businesses:

No fiscal impact to businesses is anticipated from this change to proposed rule, which merely provides an effective date to the weekly reporting requirement. Francine A. Giani, Executive Director

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

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY UT 84111-2316

Direct questions regarding this rule to:

Laura Poe at the above address, by phone at 801-530-6789, by FAX at 801-530-6511, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

09/02/2008

This rule may become effective on:

09/09/2008

Authorized by:

F. David Stanley, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-37. Utah Controlled Substances Act Rules.

 

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R156-37-609. Controlled Substance Database - Procedure and Format for Submission to the Database.

(1) In accordance with Subsections 58-37-7.5(6)(a), the format in which the information required under Section 58-37-7.5 shall be submitted to the administrator of the database is:

(a) electronic data via telephone modem;

(b) electronic data stored on floppy disk or compact disc (CD);

(c) electronic data sent via electronic mail (e-mail) if encrypted and approved by the database manager;

(d) electronic data sent via a secured internet transfer method, including but not limited to, FTP site transfer and HyperSend; or

(e) any other electronic method preapproved by the database manager.

(2) The required information may be submitted on paper, if the pharmacy or pharmacy group submits a written request to the division and receives prior approval.

(3) The division will consider the following in granting the request:

(a) the pharmacy or pharmacy group has no computerized record keeping system upon which the data can be electronically recorded; or

(b) the pharmacy or pharmacy group is unable to conform its submissions to the format required by the database administrator without incurring undue financial hardship.

(4) As of [July 15, 2008]October 1, 2008, each pharmacy or pharmacy group shall submit all data collected during the preceding seven days at least once per week. If the data is submitted by a single pharmacy entity, the data shall be submitted in chronological order according to the date each prescription was filled. If the data is submitted by a pharmacy group, the data is required to be sorted by individual pharmacy within the group, and the data of each individual pharmacy within the group is required to be submitted in chronological order according to the date each prescription was filled.

(5) The format for submission to the database shall be in accordance with uniform formatting developed by the American Society for Automation in Pharmacy system (ASAP). The division may approve alternative formats or adjustments to be consistent with database collection instruments and contain all necessary data elements.

(6) The pharmacist-in-charge of each reporting pharmacy shall submit a report on a form approved by the division including:

(a) the pharmacy name;

(b) NABP number;

(c) the period of time covered by each submission of data;

(d) the number of prescriptions in the submission;

(e) the submitting pharmacist's signature attesting to the accuracy of the report; and

(f) the date the submission was prepared.

 

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KEY: controlled substances, licensing

Date of Enactment or Last Substantive Amendment: 2008

Notice of Continuation: March 15, 2007

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-37-6(1)(a); 58-37-7.5(7)