DAR File No. 40216

Commerce, Occupational and Professional Licensing

Rule R156-37

Utah Controlled Substances Act Rule

Notice of Proposed Rule

(Amendment)

DAR File No.: 40216
Filed: 02/22/2016 10:34:07 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division and Utah State Board of Pharmacy reviewed this rule and determined the following changes need to be made. The purpose of this filing is to: 1) establish a time frame within which an applicant for a controlled substance license must obtain a Drug Enforcement Administration (DEA) registration; 2) establish criteria that excludes particular applicants from having to obtain a DEA registration; and 3) add failing to obtain a DEA registration in the specified time period to unprofessional conduct.

Summary of the rule or change:

Subsection R156-37-305(1) is added to establish that an applicant for a controlled substance license must obtain a DEA registration within 120 days of the date the controlled substance license is issued unless the applicant is described in Subsection R156-37-305(2). Subsection R156-37-305(2) is added to establish that an applicant who obtains the prior written consent of their employer to use the employer's hospital or institution DEA registration to administer and/or prescribe controlled substances is not required to obtain an individual practitioner DEA registration. Section R156-37-306 is renumbered from Section R156-37-305 due to the addition of new Section R156-37-305. Subsection R156-37-502(9) is added to include failing to obtain a DEA registration within the time frame established in Section R156-37-305 to unprofessional conduct.

State statutory or constitutional authorization for this rule:

• Subsection 58-37-6(1)(a)
• Subsection 58-1-106(1)(a)
• Subsection 58-37f-301(1)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $75 to print and distribute the rule once the proposed amendments are made effective. Any costs incurred will be absorbed in the Division's current budget.

local governments:

The proposed amendments apply only to licensees provided in Title 58, Chapter 37. As a result, the proposed amendments do not apply to local governments.

small businesses:

The proposed amendments apply only to licensees provided in Title 58, Chapter 37. Licensees may work in a small business; however, the proposed amendments would not directly affect the business.

persons other than small businesses, businesses, or local governmental entities:

The proposed amendments apply only to licensees provided in Title 58, Chapter 37. It is anticipated the proposed amendments will have no increased compliance cost or impact for individuals that obtain a controlled substance license and the corresponding DEA registration. No fiscal impact to other persons is anticipated.

Compliance costs for affected persons:

The proposed amendments apply only to licensees provided in Title 58, Chapter 37. It is anticipated the proposed amendments should have no increased compliance cost or impact for individuals that obtain a controlled substance license.

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

This rule change establishes a time frame within which a controlled substance license applicant must obtain a DEA registration, establishes criteria that excludes certain applicants from having to obtain a DEA registration, and adds "failing to obtain a DEA registration within the specified time period" to the definition of unprofessional conduct. No fiscal impact to businesses is anticipated.

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:

• Dane Ishihara at the above address, by phone at 801-530-7632, by FAX at 801-530-6511, or by Internet E-mail at dishihara@utah.gov

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:

04/14/2016

Interested persons may attend a public hearing regarding this rule:

• 03/22/2016 08:30 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 474, Salt Lake City, UT

This rule may become effective on:

04/21/2016

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-37. Utah Controlled Substances Act Rule.

R156-37-305. Qualification for Licensure -- Drug Enforcement Administration (DEA) Registration.

(1) An individual who obtains a controlled substance license except those individuals described in Subsection (2) below, shall obtain a DEA registration within 120 days of the date the controlled substance license is issued.

(2) Any controlled substance licensee who obtains prior written consent of the licensee's employer to use the employer's hospital or institution DEA registration to administer and/or prescribe controlled substances, is not required to obtain an individual practitioner DEA registration.

 

R156-37-[305]306 . Exemption from Licensure -- Law Enforcement Personnel, University Research, Narcotic Detection Training of Animals, and Animal Control.

In accordance with Subsection 58-37-6(2)(d), the following persons are exempt from licensure under Title 58, Chapter 37:

(1) Law enforcement agencies and their sworn personnel are exempt from the licensing requirements of the Controlled Substance Act to the extent their official duties require them to possess controlled substances; they act within the scope of their enforcement responsibilities; they maintain accurate records of controlled substances that come into their possession; and they maintain an effective audit trail. Nothing herein shall authorize law enforcement personnel to purchase or possess controlled substances for administration to animals unless the purchase or possession is in accordance with a duly issued controlled substance license.

(2) Individuals and entities engaged in research using pharmaceuticals as defined in Subsection 58-17b-102(65) within a research facility as defined in Subsection R156-17b-102(49).

(3) Individuals employed by a facility engaged in the following activities if the facility employing that individual has a controlled substance license in Utah, a DEA registration number, and uses the controlled substances according to a written protocol:

(a) narcotic detection training of animals for law enforcement use; or

(b) animal control, including:

(i) animal euthanasia; or

(ii) animal immobilization.

 

R156-37-502. Unprofessional Conduct.

"Unprofessional conduct" includes:

(1) a licensee with authority to prescribe or administer controlled substances:

(a) prescribing or administering to himself any Schedule II or III controlled substance that is not lawfully prescribed by another licensed practitioner having authority to prescribe the drug;

(b) prescribing or administering a controlled substance for a condition he is not licensed or competent to treat;

(2) violating any federal or state law relating to controlled substances;

(3) failing to deliver to the Division all controlled substance license certificates issued by the Division to the Division upon an action that revokes, suspends or limits the license;

(4) failing to maintain controls over controlled substances that would be considered by a prudent practitioner to be effective against diversion, theft, or shortage of controlled substances;

(5) being unable to account for shortages of any controlled substance inventory for which the licensee has responsibility;

(6) knowingly prescribing, selling, giving away, or administering, directly or indirectly, or offering to prescribe, sell, furnish, give away, or administer any controlled substance to a drug dependent person, as defined in Subsection 58-37-2(1)(s), except for legitimate medical purposes as permitted by law;

(7) refusing to make available for inspection controlled substance stock, inventory, and records as required under this rule or other law regulating controlled substances and controlled substance records;

(8) failing to submit controlled substance prescription information to the database manager after being notified in writing to do so[.];

(9) failing to obtain a DEA registration within the time frame established in Section R156-37-305.

 

KEY: controlled substances, licensing

Date of Enactment or Last Substantive Amendment: [February 24, 2015]2016

Notice of Continuation: February 21, 2012

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-37-6(1)(a); 58-37f-301(1)