No. 28310 (Amendment): R156-37. Utah Controlled Substances Act Rules

DAR File No.: 28310
Filed: 10/31/2005, 02:55
Received by: NL

 

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division needs to update this rule as a result of changes made to the Pharmacy Practice Act, Title 58, Chapter 17b, and the Pharmacy Practice Act Rules, R156-17b.

 

Summary of the rule or change:

In Sections R156-37-102 and R156-37-103, statute citations were updated. In Section R156-37-301, updates those pharmacy classifications that may hold dispensing controlled substances licenses. In Section R156-37-302, deletes the ambulance services requirement for a Utah controlled substance license. The federal Drug Enforcement Administration (DEA) has chosen to issue multiple location DEA registrations to Medical Directors of ambulance services instead of a state license. In Section R156-37-602, changes language regarding prescription records mirrors the Code of Federal Regulations and allows for storage of information regarding refilled controlled substance prescriptions in either a paper format or an electronic format that is immediately accessible to anyone who would require the information. In Subsection R156-37-603(4), changes the dispensing date of a second or third prescription from no less than 20 days to no less than 30 days from the dispensing date of the previous prescription. Adds Subsection R156-37-610(8) that will allow the Utah Department of Health to access information contained in the Controlled Substance Database for research purposes for one scientific investigator and identifies access protocols.

 

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:

The Division will incur minimal costs of approximately $75 to reprint this rule once the proposed amendments are made effective. Any costs involved will be absorbed in the Division's current budget. The Division will also experience a minimal loss of licensing fees (new application and renewal) as a result of ambulance services no longer needing to hold a controlled substance handler license in Utah. The Division estimates it will lose approximately $364 every 2 years in renewal fees not collected ($52 renewal fee x 7 currently licensed ambulance services). The Division is unable to determine how many new ambulance services would apply in the future and would not need to pay the new application fee of $90.

 

local governments:

Ambulance services run by local governments that currently hold a controlled substances handlers license will not be required to renew the license, but the Medical Director of an ambulance service will need to apply for additional federal DEA registrations. The federal DEA registration costs are unknown to the Division.

 

other persons:

Costs with respect to ambulance services will shift from state licensure fees (as noted above) to federal DEA registration. Regarding the additional amendments proposed to this rule, the Division does not anticipate any costs or savings to be associated with those amendments to either the regulated profession or the general public.

 

Compliance costs for affected persons:

Costs with respect to ambulance services will shift from state licensure fees (as noted above) to federal DEA registration. Regarding the additional amendments proposed to this rule, the Division does not anticipate any costs or savings to be associated with those amendments to either the regulated profession or the general public.

 

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

The amendments in this rule filing are clarifying provisions in accordance with amendments to the Utah Pharmacy Practice Act (such as pharmacy classifications and scientific investigations by the Department of Health) and with federal guidelines and regulations. No fiscal impact to businesses is anticipated as a result of these amendments. 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:

Diana Baker at the above address, by phone at 801-530-6179, 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:

12/15/2005

 

This rule may become effective on:

12/16/2005

 

Authorized by:

J. Craig Jackson, Director

 

 

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-37. Utah Controlled Substances Act Rules.

R156-37-102. Definitions.

In addition to the definitions in Title 58, Chapters 1 and 37, as used in Title 58, Chapters 1 and 37, or these rules:

(1) "DEA" means the Drug Enforcement Administration of the United States Department of Justice.

(2) "NABP" means the National Association of Boards of Pharmacy.

(3) "Principle place of business or professional practice", as used in Subsection 58-37-6(2)(e), means any location where controlled substances are received or stored.

(4) "Schedule II controlled stimulant" means any material, compound, mixture or preparation listed in Subsection 58-37-4(2)(b)(iii).

(5) "Unprofessional conduct", as defined in Title 58 is further defined in accordance with Subsections 58-1-203([5]1)(e) and 58-37-6(1)(a), in Section R156-37-502.

 

R156-37-103. Purpose - Authority.

These rules are adopted by the division under the authority of Subsections 58-1-106(1)(a) and 58-37-6(1)(a) to enable the division to administer Title 58, Chapter 37.

 

R156-37-301. License Classifications - Restrictions.

(1) Consistent with the provisions of law, the division may issue a controlled substance license to manufacture, produce, distribute, dispense, prescribe, obtain, administer, analyze, or conduct research with controlled substances in Schedules I, II, III, IV, or V to qualified persons. Licenses shall be issued to qualified persons in the following categories:

(a) pharmacist;

(b) optometrist;

(c) podiatric physician;

(d) dentist;

(e) osteopathic physician and surgeon;

(f) physician and surgeon;

(g) physician assistant;

(h) veterinarian;

(i) advanced practice registered nurse;

(j) certified nurse midwife;

(k) certified registered nurse anesthetist;

(l) [pharmaceutical researcher]Class A pharmacy-retail operations located in Utah;

(m) [drug outlets located in the state of Utah licensed as a]Class B pharmacy located in Utah providing services to a target population unique to the needs of the healthcare services required by the patient, including:

(i) [retail pharmacy]closed door;

(ii) hospital clinic pharmacy;

(iii) [institutional pharmacy]methadone clinics;

(iv) [pharmaceutical manufacturer]nuclear;

(v) [pharmaceutical wholesaler/distributor]branch;

(vi) [branch pharmacy]hospice facility pharmacy;

(vii) [nuclear pharmacy; or]veterinarian pharmaceutical facility;

(viii) [veterinary pharmaceutical outlet;]pharmaceutical administration facility; and

(ix) sterile product preparation facility.

(n) [pharmaceutical dog trainer;]Class C pharmacy located in Utah engaged in:

(i) manufacturing;

(ii) producing;

(iii) wholesaling; and

(iv) distributing.

(o) [pharmaceutical teaching organization;]Class D Out-of-state mail order pharmacies.

(p) [analytical laboratory;]Class E pharmacy including:

(i) medical gases providers; and

(ii) analytical laboratories.

(q) [out-of-state mail order pharmacy;

(r) pharmaceutical administration facility;

(s) animal euthanasia agency; and

(t) ]Utah Department of Corrections for the conduct of execution by the administration of lethal injection under its statutory authority and in accordance with its policies and procedures.

(2) A license may be restricted to the extent determined by the division, in collaboration with appropriate licensing boards, that a restriction is necessary to protect the public health, safety or welfare, or the welfare of the licensee. A person receiving a restricted license shall manufacture, produce, obtain, distribute, dispense, prescribe, administer, analyze, or conduct research with controlled substances only to the extent of the terms and conditions under which the restricted license is issued by the division.

 

R156-37-302. Qualifications for Licensure - Application Requirements.

(1) An applicant for a controlled substance license shall:

(a) submit an application in a form as prescribed by the division; and

(b) shall pay the required fee as established by the division under the provisions of Section 63-38-3.2.

(2) Any person seeking a controlled substance license shall:

(a) be currently licensed by the state in the appropriate professional license classification as listed in R156-37-301 and shall maintain that license classification as current at all times while holding a controlled substance license; or

(b) be engaged in the following activities which require the administration of a controlled substance but do not require licensure under Subsection (a):

(i) animal capture for transport or relocation as an employee or under contract with a state or federal government agency; or

(ii) [providing emergency services to an injured or ill person by an ambulance service; or

(iii) ]other activity approved by the Division in collaboration with the appropriate board.

(3) The division and the reviewing board may request from the applicant information which is reasonable and necessary to permit an evaluation of the applicant's:

(a) qualifications to engage in practice with controlled substances; and

(b) the public interest in the issuance of a controlled substance license to the applicant.

(4) To determine if an applicant is qualified for licensure, the division may assign the application to a qualified and appropriate licensing board for review and recommendation to the division with respect to issuance of a license.

 

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 of controlled substances shall immediately file the appropriate forms with the Drug Enforcement Administration, with a copy to the division directed to the attention of the Investigation Bureau. He shall also 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 his files in any way, those files 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) [there is a physical printout of the controlled substances dispensed each day that details the prescription number, the quantity of each drug dispensed, the prescribing practitioner and the dispensing pharmacist. Each pharmacist that is documented on the printout as having dispensed a controlled substance shall sign his name to the printout, attesting to the accuracy of the data detailed, or shall make appropriate changes and then sign his name]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.

 

R156-37-603. Restrictions Upon the Prescription, Dispensing and Administration of Controlled Substances.

(1) A practitioner may prescribe or administer the Schedule II controlled substance cocaine hydrochloride only as a topical anesthetic for mucous membranes in surgical situations in which it is properly indicated and as local anesthetic for the repair of facial and pediatric lacerations when the controlled substance is mixed and dispensed by a registered pharmacist in the proper formulation and dosage.

(2) A practitioner shall not prescribe or administer a controlled substance without taking into account the drug's potential for abuse, the possibility the drug may lead to dependence, the possibility the patient will obtain the drug for a nontherapeutic use or to distribute to others, and the possibility of an illicit market for the drug.

(3) When writing a prescription for a controlled substance, each prescription shall contain only one controlled substance per prescription form and no other legend drug or prescription item shall be included on that form.

(4) In accordance with Subsection 58-37-6(7)(f)(v)(D), the dispensing date of a second or third prescription shall be no less than [20]30 days from the dispensing date of the previous prescription, to allow for receipt of the subsequent prescription before the previous prescription runs out.

(5) If a practitioner fails to document his intentions relative to refills of controlled substances in Schedules III through V on a prescription form, it shall mean no refills are authorized. No refill is permitted on a prescription for a Schedule II controlled substance.

(6) Refills of controlled substance prescriptions shall be permitted for the period from the original date of the prescription as follows:

(a) Schedules III and IV for six months from the original date of the prescription; and

(b) Schedule V for one year from the original date of the prescription.

(7) No refill may be dispensed until such time has passed since the date of the last dispensing that 80% of the medication in the previous dispensing should have been consumed if taken according to the prescriber's instruction.

(8) No prescription for a controlled substance shall be issued or dispensed without specific instructions from the prescriber on how and when the drug is to be used.

(9) Refills after expiration of the original prescription term require the issuance of a new prescription by the prescribing practitioner.

(10) Each prescription for a controlled substance and the number of refills authorized shall be documented in the patient records by the prescribing practitioner.

(11) A practitioner shall not prescribe or administer a Schedule II controlled stimulant for any purpose except:

(a) the treatment of narcolepsy as confirmed by neurological evaluation;

(b) the treatment of abnormal behavioral syndrome, attention deficit disorder, hyperkinetic syndrome, or related disorders;

(c) the treatment of drug-induced brain dysfunction;

(d) the differential diagnostic psychiatric evaluation of depression;

(e) the treatment of depression shown to be refractory to other therapeutic modalities, including pharmacologic approaches, such as tricyclic antidepressants or MAO inhibitors;

(f) in the terminal stages of disease, as adjunctive therapy in the treatment of chronic severe pain or chronic severe pain accompanied by depression;

(g) the clinical investigation of the effects of the drugs, in which case the practitioner shall submit to the division a written investigative protocol for its review and approval before the investigation has begun. The investigation shall be conducted in strict compliance with the investigative protocol, and the practitioner shall, within 60 days following the conclusion of the investigation, submit to the division a written report detailing the findings and conclusions of the investigation; or

(h) in treatment of depression associated with medical illness after due consideration of other therapeutic modalities.

(12) A practitioner may prescribe, dispense or administer a Schedule II controlled stimulant when properly indicated for any purpose listed in Subsection (11), provided that all of the following conditions are met:

(a) before initiating treatment utilizing a Schedule II controlled stimulant, the practitioner obtains an appropriate history and physical examination, and rules out the existence of any recognized contraindications to the use of the controlled substance to be utilized;

(b) the practitioner shall not prescribe, dispense or administer any Schedule II controlled stimulant when he knows or has reason to believe that a recognized contraindication to its use exists;

(c) the practitioner shall not prescribe, dispense or administer any Schedule II controlled stimulant in the treatment of a patient who he knows or should know is pregnant; and

(d) the practitioner shall not initiate or shall discontinue prescribing, dispensing or administering all Schedule II controlled stimulants immediately upon ascertaining or having reason to believe that the patient has consumed or disposed of any controlled stimulant other than in compliance with the treating practitioner's directions.

 

R156-37-610. Controlled Substance Database - Limitations on Access to Database Information - Standards and Procedures for Identifying Individuals Requesting Information.

(1) In accordance with Subsections 58-37-7.5(8)(a) and (b), the division director shall designate in writing those individuals within the division who shall have access to the information in the database.

(2) Personnel from federal, state or local law enforcement agencies may obtain information from the database if the information relates to a current investigation being conducted by such agency. The manager of the database may also provide information from the database to such agencies on his own volition when the information may reasonably constitute a basis for investigation relative to violation of state or federal law.

(3) In accordance with Subsection 58-37-7.5(7)(b), persons may request information from the database either orally or in writing.

(4) The manager of the database may release information upon oral request only if the identity of the person is verified. Identity of a practitioner may be made by use of a DEA number or other verifiable, confidential numbers provided by the division or other government agencies to practitioners.

(5) Any individual may request information in the database relating to that individual's receipt of controlled substances. Upon request for database information on an individual who is the recipient of a controlled substance prescription entered in the database, the manager of the database shall make available database information exclusively relating to that particular individual under the following limitations and conditions:

(a) The requestor seeking database information personally appears before the manager of the database, or a designee, with picture identification confirming his identity as the same person on whom database information is sought.

(b) The requestor seeking database information submits a signed and notarized request executed under the penalty of perjury verifying his identity as the same person on whom database information is sought, and providing their full name, home and business address, date of birth, and social security number.

(c) The requestor seeking database information presents a power of attorney over the person on whom database information is sought and further complies with the following:

(i) submits a signed and notarized request executed by the requestor under the penalty of perjury verifying that the grantor of the power of attorney is the same person on whom database information is sought, including the grantor's full name, address, date of birth, and social security number; and

(ii) personally appears before the manager of the database with picture identification to verify personal identity, or otherwise submits a signed and notarized statement executed by the requestor under the penalty of perjury verifying his identity as that of the person holding the power of attorney.

(d) The requestor seeking database information presents verification that he is the legal guardian of an incapacitated person on whom database information is sought and further complies with the following:

(i) submits a signed and notarized request executed by the requestor under the penalty of perjury verifying that the incapacitated ward of the guardian is the same person on whom database information is sought, including the ward's full name, address, date of birth, and social security number; and

(ii) personally appears before the manager of the database with picture identification to verify personal identity, or otherwise submits a signed and notarized statement executed by the requestor under the penalty of perjury verifying his identity as that of the legal guardian of the incapacitated person.

(e) The requestor seeking database information shall present a release-of-records statement from the person on whom database information is sought and further complies with the following:

(i) submits a verification from the person on whom database information is sought consistent with the requirements set forth in paragraph (5)(b);

(ii) submits a signed and notarized release of records statement executed by the person on whom database information is sought authorizing the manager of the database to release the relevant database information to the requestor; and

(iii) personally appears before the manager of the database with picture identification to verify personal identity, or otherwise submits a signed and notarized statement executed by the requestor under the penalty of perjury verifying his identity as that of the requestor identified in the release of records;

(6) Before data is released upon oral request, a written request may be required and received.

(7) Database information may be disseminated either orally, by facsimile or by U.S. mail.

(8) The Utah Department of Health may access Database information for purposes of scientific study regarding public health. To access information, the scientific investigator must:

(a) show the research is an approved project of the Utah Department of Health;

(b) provide a description of the research to be conducted, protocols for the project and a description of the data needs from the Database;

(c) provide assurances and a plan that demonstrates all Database information will be maintained securely, with access only permitted by the scientific investigator;

(d) provide for electronic data to be stored on a stand alone database computer system with access only allowed by the scientific investigator; and

(e) pay all relevant expenses for data transfer and manipulation.

 

KEY: controlled substances, licensing

[August 19, 2002]2005

Notice of Continuation May 9, 2002

58-1-106(1)(a)

58-37-6(1)(a)

58-37-7.5(7)