No. 43333 (Amendment): Section R156-37-602. Records

(Amendment)

DAR File No.: 43333
Filed: 10/30/2018 09:37:17 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division of Occupational and Professional Licensing (Division) and the Utah State Board of Pharmacy recommend this amendment to clarify when a licensee must report the loss of controlled substances to the Drug Enforcement Agency (DEA), the Division, and local law enforcement.

Summary of the rule or change:

This proposed amendment provides guidance to licensees who experience a loss of controlled substance inventory. The amendment clarifies that a licensee shall report the loss to the DEA, the Division, and local law enforcement if the circumstances involve "any theft, including diversion, or significant loss". The new language clarifies that diversion is reportable as theft, and uses the term "significant loss" because this is the term used by the DEA and the DEA has issued guidance regarding what constitutes a significant loss.

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:

This amendment is not expected to impact state government revenues or expenditures because the amendment only updates this rule to provide guidance and encompass current standards in the profession. Accordingly, no fiscal impact to the state is expected beyond a minimal cost to the Division of approximately $75 to print and distribute this rule once the proposed amendment is made effective.

local governments:

This amendment is not expected to impact local governments' revenues or expenditures because the amendment only updates this rule to provide guidance and encompass current standards in the profession.

small businesses:

There are approximately 521 class A pharmacies, 274 class B pharmacies, 1,085 class C pharmacies, 723 class D pharmacies, and 573 class E pharmacies that are small businesses licensed in Utah, and if these small businesses are involved in the supply or dispensing of controlled substances they will be required to comply with this rule. (For a complete listing of the NAICS codes used in this analysis, please contact the Division). However, this amendment is not expected to impact revenues or expenditures for any of these small businesses because this amendment only updates this rule to provide guidance and encompass current standards in the profession.

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

This proposed amendment clarifies the requirements for reporting theft/diversion or significant loss of controlled substances in pharmacies to the DEA and local law enforcement. There are 3,941 pharmacists, 791 pharmacy interns, 5,774 pharmacy technicians, and 1,395 pharmacy technician trainees licensed in Utah who will be required to comply with this rule amendment if they are involved in the supply or dispensing of controlled substances and experience a loss. However, this amendment will not create a fiscal impact for these persons beyond the current requirements because this amendment only updates this rule to provide guidance and encompass current standards in the profession.

Compliance costs for affected persons:

This proposed amendment will affect a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee if they are involved in the supply or dispensing of controlled substances and experience a loss. However, this amendment will not create a fiscal impact for these affected persons beyond the current requirements because this amendment only updates this rule to provide guidance and encompass current standards in the profession.

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

The Division and the Utah Board of Pharmacy recommend this amendment to clarify when a licensee must report the loss of controlled substances to the Drug Enforcement Agency (DEA), the Division, and to local law enforcement. Section R156-37-602: This proposed amendment provides guidance to licensees who experience a loss of controlled substance inventory. This amendment clarifies that a licensee shall report the loss to the DEA, the Division, and local law enforcement, if the circumstances involve "any theft, including diversion, or significant loss". The new language clarifies that diversion is reportable as theft, and uses the term "significant loss" because this is the term used by the DEA and the DEA has issued guidance regarding what constitutes a significant loss. There are approximately 521 Class A pharmacies, 274 Class B pharmacies, 1,085 Class C pharmacies, 723 Class D pharmacies, and 573 Class E pharmacies that are small businesses licensed in Utah. If these small businesses are involved in the supply or dispensing of controlled substances, they will be required to comply with this rule. However, this amendment is not expected to have a fiscal impact on any of these small businesses because this amendment only updates this rule to provide guidance and encompass current standards in the profession. There are approximately 10 non-small business Class A retail pharmacies, 5 non-small Class B pharmacies, 22 non-small Class C pharmacies, 15 non-small Class D pharmacies, and 12 non-small Class E pharmacies licensed in Utah. If these non-small businesses are involved in the supply or dispensing of controlled substances, they will be required to comply with this rule. However, this amendment is not expected to have a fiscal impact on any of these non-small businesses because this amendment only updates this rule to provide guidance and encompass current standards in the profession.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office 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:

Larry Marx at the above address, by phone at 801-530-6254, by FAX at 801-530-6511, or by Internet E-mail at lmarx@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:

12/17/2018

Interested persons may attend a public hearing regarding this rule:

11/27/2018 08:30 AM, 160 East 300 South, North Conference Room (1st floor), Salt Lake City, Utah

This rule may become effective on:

12/24/2018

Authorized by:

Mark Steinagel, Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2019

FY 2020

FY 2021

State Government

Local Government

Small Businesses

Non-Small Businesses

Other Person

Total Fiscal Costs:

Fiscal Benefits

State Government

Local Government

Small Businesses

Non-Small Businesses

Other Persons

Total Fiscal Benefits:

Net Fiscal Benefits:

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described above. Inestimable impacts for Non-Small Businesses are described below.

Appendix 2: Regulatory Impact to Non-Small Businesses (50 or more employees)

There are approximately 10 non-small business Class A retail pharmacies, 5 non-small Class B pharmacies, 22 non-small Class C pharmacies, 15 non-small Class D pharmacies and 12 non-small Class E pharmacies licensed in Utah, and if these non-small businesses are involved in the supply or dispensing of controlled substances they will be required to comply with this rule. (For a complete listing of the NAICS codes used in this analysis, please contact the Division). However, this amendment is not expected to impact revenues or expenditures for any of these non-small businesses because the amendment only updates the rule to provide guidance and encompass current standards in the profession.

Agency sign off: The head of the Department of Commerce, Francine A. Giani, has reviewed and approved this fiscal analysis.

R156. Commerce, Occupational and Professional Licensing.

R156-37. Utah Controlled Substances Act Rule.

R156-37-602. Records.

(1) Records of purchase, distribution, dispensing, prescribing, and administration of controlled substances shall be kept according to state and federal law. Prescribing practitioners shall keep accurate records reflecting the examination, evaluation and treatment of all patients. Patient medical records shall accurately reflect the prescription or administration of controlled substances in the treatment of the patient, the purpose for which the controlled substance is utilized, and information upon which the diagnosis is based. Practitioners shall keep records apart from patient records of each controlled substance purchased, and with respect to each controlled substance, its disposition, whether by administration or any other means, date of disposition, to whom given, and the quantity given.

(2) Any licensee who experiences any [~~shortage or~~ ]theft, including diversion, or significant loss of controlled substances shall immediately:

(a) file the appropriate forms with the Drug Enforcement Administration, with a copy to the Division directed to the attention of the Investigation Bureau; and

(b) report the incident to the local law enforcement agency.

(3) All records required by federal and state laws or rules must be maintained by the licensee for a period of five years. If a licensee should sell or transfer ownership of records in any way, those records shall be maintained separately from other records of the new owner.

(4) Prescription records may be maintained electronically so long as:

(a) the original of each prescription, including telephone prescriptions, is maintained in a physical file and contains all of the information required by federal and state law; and

(b) an automated data processing system is used for the storage and immediate retrieval of refill information for prescription orders for controlled substances in Schedule III and IV, in accordance with federal guidelines.

(5) All records relating to Schedule II controlled substances received, purchased, administered, or dispensed by the practitioner shall be maintained separately from all other records of the pharmacy or practice.

(6) All records relating to Schedules III, IV, and V controlled substances received, purchased, administered, or dispensed by the practitioner shall be maintained separately from all other records of the pharmacy or practice.

KEY: controlled substances, licensing

Date of Enactment or Last Substantive Amendment: [~~December 11, 2017~~]2018

Notice of Continuation: February 6, 2017

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