No. 28530 (Amendment): R156-17b. Pharmacy Practice Act Rules

DAR File No.: 28530
Filed: 02/23/2006, 09:59
Received by: NL

 

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division and the Pharmacy Board have identified proposed changes that need to be made in the existing rule to correct cumbersome problems that have arise in the practice of pharmacy since the rule was made effective in May 2005.

 

Summary of the rule or change:

In Subsection R156-17b-102(20), updated United States Pharmacopeia-National Formulary (USP-NF) books to the most current edition. In Subsections R156-17b-304(3)(e)(i) through (iii), changes include adding additional provisions for a person obtaining the approved training for pharmacy technician but did not receive the license within the required year. The situations covered in the three changes being added seem to be occurring most and additional clarification is necessary. In Subsection R156-17b-304(4)(b), changes provide additional clarification for the out-of-state trained pharmacy technician who is endorsing that license into Utah. The language being added is similar to language in Title 58, Chapter 1, that requires the licensee to have worked hours in the state of licensure before transferring the license to Utah. In Subsection R156-17b-306(4), corrected a statute citation. In Subsection R156-17b-308(3)(c), this amendment being added further clarifies the extension of a pharmacy intern license after graduation and receipt of a degree from a pharmacy school or college. In Section R156-17b-402, additional statute citations were added that are relevant to administrative penalties. In Subsection R156-17b-402(40), removal of items in parentheses is done to encompass all operating standards. There has been some confusion that the items in parentheses are the only standards considered. In Subsection R156-17b-502(10), a rule citation is corrected. In Subsection R156-17b-603(18), added that the responsibility of ensuring that all appropriate personnel in the pharmacy are licensed falls on the pharmacist-in-charge. In Section R156-17b-605, amendments are made to decrease the number of required inventories of noncontrolled substances and to make the requirements of the section less laborious for the pharmacist. In Section R156-17b-612, the amendments proposed in this section are the most controversial of all changes in the rule. The amendments eliminate the "one time transfer" of medication between pharmacies. The entire section has been reformatted in order to better understand the changes. In Subsection R156-17b-613(9)(a), amendments identify what records are to be maintained on transferred prescriptions. In Subsections R156-17b-614c(2) and (5)(b), technical changes are made to identify individuals who can be responsible for destruction of medication and to update that administrative facilities have a consulting pharmacist and not a pharmacist-in-charge. Section R156-17b-618 is a new section outlining the requirements for change in ownership or location of a pharmacy. Sections R156-17b-619 through R156-17b-621 are renumbered because of adding the new section. In the new Subsection R156-17b-621(3), the addition identifies the number of required continuing education hours needed to update the knowledge of pharmacists who have achieved additional training for the administration of medications.

 

State statutory or constitutional authorization for this rule:

Sections 58-17b-101 and 58-37-1; and Subsections 58-17b-601(1), 58-1-106(1)(a), and 58-1-202(1)(a)

 

This rule or change incorporates by reference the following material:

Updates the United States Pharmacopeia/National Formulary (USP/NF) to the 2005 edition including Supplement 2 dated August 1, 2005, which is official from January 1, 2006, through Supplement 1, dated April 1, 2006

 

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $100 to reprint 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 do not affect local governments. The rule only affects licensed pharmacists, pharmacy interns, pharmacy technicians, and pharmacies. Therefore, there are no anticipated costs or savings to local governments.

 

other persons:

The Division anticipates there will be no significant costs or savings associated with these proposed amendments to either the general public or the regulated industry. Pharmacies may realize a saving in time and money due to the reduction in the inventory requirements.

 

Compliance costs for affected persons:

The Division anticipates there will be no significant costs or savings associated with these proposed amendments to either the general public or the regulated industry. Pharmacies may realize a saving in time and money due to the reduction in the inventory requirements.

 

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

This proposed rule makes clarifying amendments to address various concerns raised by the industry, including provisions about applying for or renewing a license after passage of time; requirements for out-of-state licensees applying for licensure by endorsement; pharmacy intern license extensions; placing the responsibility of ensuring licensure of personnel on pharmacist-in-charge; reducing the number of required inventories for drugs that are not controlled substances; and transfer of prescriptions and record keeping requirements. The rule filing also makes some technical changes to correct references and to make other clarifying amendments. No fiscal impact to businesses is foreseen as a result of this rule filing, other than the regulated industry could experience a cost-savings due to decreased inventory requirements. 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:

04/14/2006

 

Interested persons may attend a public hearing regarding this rule:

3/28/2006 at 9:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 4A, Salt Lake City, UT

 

This rule may become effective on:

04/15/2006

 

Authorized by:

J. Craig Jackson, Director

 

 

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-17b. Pharmacy Practice Act Rules.

R156-17b-102. Definitions.

In addition to the definitions in Title 58, Chapters 1 and 17b, as used in Title 58, Chapters 1 and 17b or these rules:

(1) "ACPE" means the American Council on Pharmaceutical Education or Accreditation Council for Pharmacy Education.

(2) "Drugs", as used in these rules, means drugs or devices.

(3) "Dispense", as defined in Subsection 58-17b-102(23), does not include transferring medications for a patient from a legally dispensed prescription for that particular patient into a daily or weekly drug container to facilitate the patient taking the correct medication.

(4) "Drug therapy management" means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

(5) "High-risk, medium-risk, and low-risk drugs" refers to the risk to a patient's health from compounding sterile preparations, as referred to in USP-NF Chapter 797, for details of determining risk level.

(6) "Hospice facility pharmacy" means a pharmacy that supplies drugs to patients in a licensed healthcare facility for terminal patients.

(7) "Hospital clinic pharmacy" means a pharmacy that is located in an outpatient treatment area where a pharmacist or pharmacy intern is compounding, admixing, or dispensing prescription drugs, and where:

(a) prescription drugs or devices are under the control of the pharmacist, or the facility for administration to patients of that facility;

(b) prescription drugs or devices are dispensed by the pharmacist or pharmacy intern; or

(c) prescription drugs are administered in accordance with the order of a practitioner by an employee or agent of the facility.

(8) "Legend drug" means any drug or device that has been determined to be unsafe for self-medication or any drug or device that bears or is required to bear the legend:

(a) "Caution: federal law prohibits dispensing without prescription";

(b) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian"; or

(c) "Rx only".

(9) "Maintenance medications" means medications the patient takes on an ongoing basis.

(10) "MPJE" means the Multistate Jurisprudence Examination.

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

(12) "NAPLEX" means North American Pharmacy Licensing Examination.

(13) "Parenteral" means a method of drug delivery injected into body tissues but not via the gastrointestinal tract.

(14) "PTCB" means the Pharmacy Technician Certification Board.

(15) "Qualified continuing education", as used in these rules, means continuing education that meets the standards set forth in Section R156-17b-309.

(16) "Sterile products preparation facility" means any facility, or portion of the facility, that compounds sterile products using aseptic technique.

(17) "Unauthorized personnel" means any person who is not participating in the operational processes of the pharmacy who in some way would interrupt the natural flow of pharmaceutical care.

(18) "Unit dose" means the ordered amount of a drug in a dosage form prepared for a one-time administration to an individual and indicates the name, strength, lot number and expiration date for the drug.

(19) "Unprofessional conduct", as defined in Title 58, Chapters 1 and 17b, is further defined, in accordance with Subsection 58-1-203(1)(e), in Section R156-17b-502.

(20) "USP-NF" means the United States Pharmacopeia-National Formulary (USP [28]29-NF [23]24), 200[4]5 edition, which is official from January 1, 200[5]6 through Supplement 1, dated April 1, 200[5]6, which is hereby adopted and incorporated by reference.

 

R156-17b-304. Licensure - Education Requirements.

(1) In accordance with Subsections 58-17b-303(2) and 58-17b-304(7)(c), the credentialing agency recognized to provide certification and evaluate equivalency of a foreign educated pharmacy graduate is the Foreign Pharmacy Graduate Examination Committee of the National Association of Boards of Pharmacy Foundation, or an equivalent credentialing agency as approved by the Division.

(2) In accordance with Subsection 58-17b-304(6), the preliminary education qualification for licensure as a pharmacy intern include:

(a) a current pharmacy student who has completed at least 15 semester hours of pharmacy course work in a college or school of pharmacy accredited by the ACPE;

(b) a graduate who has received a degree from a school or college of pharmacy which is accredited by the ACPE; or

(c) a graduate of a foreign pharmacy school who has received a certificate of equivalency from an approved credentialing agency defined in Subsection (1).

(3) In accordance with Subsection 58-17b-305(1)(f), a pharmacy technician must complete an approved program of education and training that meets the following standards:

(a) The didactic training program must be approved by the Division in collaboration with the Board and must address, at a minimum, the following topics:

(i) legal aspects of pharmacy practice including federal and state laws and rules governing practice;

(ii) hygiene and aseptic techniques;

(iii) terminology, abbreviations and symbols;

(iv) pharmaceutical calculations;

(v) identification of drugs by trade and generic names, and therapeutic classifications;

(vi) filling of orders and prescriptions including packaging and labeling;

(vii) ordering, restocking, and maintaining drug inventory;

(viii) computer applications in the pharmacy; and

(ix) non-prescription products including cough and cold, nutritional, analgesics, allergy, diabetic testing supplies, first aid, ophthalmic, family planning, foot, feminine hygiene, gastrointestinal preparations, and pharmacy care over-the-counter drugs, except those over-the-counter drugs that are prescribed by a practitioner.

(b) This training program's curriculum and a copy of the final examination shall be submitted to the Division for approval by the Board prior to starting any training session with a pharmacy technician in training. The final examination must include questions covering each of the topics listed in Subsection (3)(a) above.

(c) Approval must be granted by the Division in collaboration with the Board before a student may start a program of study. An individual who completes a non-approved program is not eligible for licensure.

(d) The training program must require at least 180 hours of practical training supervised by a licensed pharmacist in good standing with the Division and must include written protocols and guidelines for the teaching pharmacist outlining the utilization and supervision of pharmacy technicians in training that includes:

(i) the specific manner in which supervision will be completed; and

(ii) an evaluative procedure to verify the accuracy and completeness of all acts, tasks and functions performed by the pharmacy technician in training.

(e) An individual must complete an approved training program and successfully pass the required examinations as listed in Subsection R156-17b-302(3) within one year from the date of the first day of the training program, unless otherwise approved by the Division in collaboration with the Board.

(i) An individual who has completed an approved program, but did not seek licensure within the one year time frame must complete a minimum of 180 hours of refresher practice in a pharmacy approved by the board if it has been more than six months since having exposure to pharmacy practice.

(ii) An individual who has been licensed as a pharmacy technician but allowed that license to expire for more than two years and wishes to renew that license must complete a minimum of 180 hours of refresher hours in an approved pharmacy under the direct supervision of a pharmacist.

(iii) An individual who has completed an approved program, but is awaiting the results of the required examinations may practice as a technician-in-training under the direct supervision of the pharmacist for a period not to exceed three months. If the individual fails the examinations, that individual can no longer work as at technician-in-training while waiting to retake the examinations. The individual shall work in the pharmacy only as supportive personnel.

(4) An applicant for licensure as a pharmacy technician is deemed to have met the qualification for licensure in Subsection 58-17b-305(f) if the applicant:

(a) is currently licensed and in good standing in another state and has not had any adverse action taken on that license;

(b) has engaged in the practice as a pharmacy technician for a minimum of 1,000 hours in that state within the past two years or equivalent experience as approved by the Division in collaboration with the Board; and

(c) has passed and maintained current the PTCB certification or a Board approved equivalent and passed the Utah law exam.

 

R156-17b-306. Licensure - Pharmacist - Pharmacy Internship Standards.

(1) In accordance with Subsection 58-17b-303(1)(g), the standards for the pharmacy internship required for licensure as a pharmacist include the following:

(a) At least 1500 hours of practice supervised by a pharmacy preceptor shall be obtained in Utah or another state or territory of the United States, or a combination of both.

(i) Internship hours completed in Utah shall include at least 360 hours but not more than 900 hours in a college coordinated practical experience program as an integral part of the curriculum which shall include a minimum of 120 hours in each of the following practices:

(A) community pharmacy;

(B) institutional pharmacy; and

(C) any clinical setting.

(ii) Internship hours completed in another state or territory of the United States shall be accepted based on the approval of the hours by the pharmacy board in the jurisdiction where the hours were obtained.

(b) Evidence of completed internship hours shall be documented to the Division by the pharmacy intern at the time application is made for a Utah pharmacist license.

(c) Pharmacy interns participating in internships may be credited no more than 50 hours per week of internship experience.

(d) No credit will be awarded for didactic experience.

(2) If a pharmacy intern is suspended or dismissed from an approved College of Pharmacy, the intern must notify the Division within 15 days of the suspension or dismissal.

(3) If a pharmacy intern ceases to meet all requirements for intern licensure, he shall surrender his pharmacy intern license to the Division within 60 days unless an extension is required and granted by the Division in collaboration with the Board.

(4) In accordance with Subsections 58-17b-102(5[1]0), to be an approved preceptor, a pharmacist must meet the following criteria:

(a) hold a Utah pharmacist license that is active and in good standing;

(b) have been engaged in active practice as a licensed pharmacist for not less than two years in any jurisdiction;

(c) is not currently under any sanction nor has been under any sanction at any time which when considered by the Division and the Board would be of such a nature that the best interests of the intern and the public would not be served.

(d) shall provide direct, on-site supervision to only one pharmacy intern during a working shift; and

(e) refer to the intern training guidelines as outlined in the Pharmacy Coordinating Council of Utah Internship Competencies, October 12, 2004, as information about a range of best practices for training interns.

 

R156-17b-308. Renewal Cycle - Procedures.

(1) In accordance with Subsection 58-1-308(1), the renewal date for the two-year renewal cycle applicable to licensees under Title 58, Chapter 17b is established by rule in Section R156-1-308.

(2) Renewal procedures shall be in accordance with Section R156-1-308.

(3) An intern license may be extended upon the request of the licensee and approval by the Division under the following conditions:

(a) have applied to the Division for a pharmacist license and to sit for the NAPLEX and MJPE examinations within three calendar months after obtaining full certification from the Foreign Pharmacy Graduate Equivalency Commission; or

(b) have passed the NAPLEX and MJPE examinations but lacks the required number of internship hours for licensure.

(c) An individual must pass the NAPLEX and MJPE examinations and seek licensure as a pharmacist within six months of graduation and receipt of a degree from a school or college of pharmacy which is accredited by the ACPE. An internship license will not be extended beyond the six month time frame from graduation and receipt of a degree.

(4) The extended internship hours shall be under the direct supervision of a preceptor who meets the criteria established in R156-17b-306(4).

 

R156-17b-402. Administrative Penalties.

In accordance with Subsection 58-17b-401(6) and Sections 58-17b-501 and 58-175-502, unless otherwise ordered by the presiding officer, the following fine and citation schedule shall apply.

(1) Preventing or refusing to permit any authorized agent of the Division to conduct an inspection:

initial offense: $500 - $2,000

subsequent offense(s): $5,000

(2) Failing to deliver the license or permit or certificate to the Division upon demand:

initial offense: $100 - $1,000

subsequent offense(s): $500 - $2,000

(3) Using the title pharmacist, druggist, pharmacy intern, pharmacy technician or any other term having a similar meaning or any term having similar meaning when not licensed to do so:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(4) Conducting or transacting business under a name which contains as part of that name the words drugstore, pharmacy, drugs, medicine store, medicines, drug shop, apothecary, prescriptions or any other term having a similar meaning or in any manner advertising otherwise describing or referring to the place of the conducted business or profession when not licensed to do so:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(5) Buying, selling, causing to be sold, or offering for sale any drug or device which bears the inscription sample, not for resale, investigational purposes, or experimental use only or other similar words:

initial offense: $1,000 - $5,000

subsequent offense(s): $10,000

(6) Using to the licensee's own advantage or revealing to anyone other than the Division, Board or its authorized representatives, any information acquired under the authority of this chapter concerning any method or process which is a trade secret:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(7) Illegally procuring or attempting to procure any drug for the licensee or to have someone else procure or attempt to procure a drug:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(8) Filling, refilling or advertising the filling or refilling of prescription drugs when not licensed do to so:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(9) Requiring any employed pharmacist, pharmacy intern, pharmacy technician or authorized supportive personnel to engage in any conduct in violation of this chapter:

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(10) Being in possession of a drug for an unlawful purpose:

initial offense: $500 - $1,000

subsequent offense(s): $1,500 - $5,000

(11) Dispensing a prescription drug to anyone who does not have a prescription from a practitioner or to anyone who is known or should be known as attempting to obtain drugs by fraud or misrepresentation:

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(12) Selling, dispensing or otherwise trafficking in prescription drugs when not licensed to do so or when not exempted from licensure:

initial offense: $1,000 - $5,000

subsequent offense(s): $10,000

(13) Using a prescription drug or controlled substance for the licensee that was not lawfully prescribed for the licensee by a practitioner:

initial offense: $100 - $500

subsequent offense(s): $1,000 - $2,5000

(14) Willfully deceiving or attempting to deceive the Division, the Board or its authorized agents as to any relevant matter regarding compliance under this chapter:

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(15) Paying rebates to practitioners or any other health care provider, or entering into any agreement with a medical practitioner or any other person for the payment or acceptance of compensation for recommending the professional services of either party:

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(16) Misbranding or adulteration of any drug or device or the sale, distribution or dispensing of any outdated, misbranded, or adulterated drugs or devices:

initial offense: $1,000 - $5,000

subsequent offense(s): $10,000

(17) Accepting back and redistributing any unused drugs, with the exception as provided in Section 58-17b-503:

initial offense: $1,000 - $5,000

subsequent offense(s): $10,000

(18) Violating Federal Title II, PL 91, Controlled Substances Act or Title 58, Chapter 37, Utah Controlled Substances Act, or rules and regulations adopted under either act:

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(19) Failure to follow USP-NF Chapter 797 guidelines:

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(20) Failure to follow USP-NF Chapter 795 guidelines:

initial offense: $250 - $500

subsequent offense(s): $500 - $750

(21) Administering without appropriate guidelines or lawful order:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(22) Disclosing confidential patient information in violation of the provision of the Health Insurance Portability and Accountability Act of 1996 or other applicable law:

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

(23) Engaging in the practice of pharmacy without a licensed pharmacist designated as the pharmacist in charge:

initial offense: $100 - $500

subsequent offense(s): $2,000 - $10,000

(24) Failing to report to the Division any adverse action taken by another licensing jurisdiction, government agency, law enforcement agency or court:

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

(25) Compounding a prescription drug for sale to another pharmaceutical facility:

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

(26) Preparing a prescription drug in a dosage form which is regularly and commonly available from a manufacturer in quantities and strengths prescribed by a practitioner:

initial offense: $500 - $1,000

subsequent offense(s): $2,500 - $5,000

(27) Violating any ethical code provision of the American Pharmaceutical Association Code of Ethics for Pharmacists, October 27, 1994:

initial offense: $250 - $500

subsequent offense(s): $2,000 - $10,000

(28) Failing to comply with the continuing education requirements set forth in these rules:

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

(29) Failing to provide the Division with a current mailing address within 10 days following any change of address:

initial offense: $50 - $100

subsequent offense(s): $200 - $300

(30) Defaulting on a student loan:

initial offense: $100 - $200

subsequent offense(s): $200 - $500

(31) Failing to abide by all applicable federal and state law regarding the practice of pharmacy:

initial offense: $500 - $1,000

subsequent offense(s): $2,000 - $10,000

(32) Failing to comply with administrative inspections:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(33) Abandoning a pharmacy and/or leaving drugs accessible to the public:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(34) Failure to return or providing false information on a self-inspection report:

initial offense: $100 - $250

subsequent offense(s): $300 - $500

(35) Failure to pay an administrative fine:

Double the original penalty amount up to $10,000

(36) Any other conduct which constitutes unprofessional or unlawful conduct:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(37) Failure to maintain an appropriate ratio of personnel:

Pharmacist initial offense: $100 - $250

Pharmacist subsequent offense(s): $500 - $2,500

Pharmacy initial offense: $250 - $1,000

Pharmacy subsequent offense(s): $500 - $5,000

(38) Unauthorized people in the pharmacy:

Pharmacist initial offense: $50 - $100

Pharmacist subsequent offense(s): $250 - $500

Pharmacy initial offense: $250 - $500

Pharmacy subsequent offense(s): $1,000 - $2,000

(39) Failure to offer to counsel:

Pharmacy personnel initial offense: $500 - $2,500

Pharmacy personnel subsequent offense(s): $5,000 - $10,000

Pharmacy: $2,000 per occurrence

(40) Violations of the laws and rules regulating operating standards [(security system, unkempt facility, no hot water, etc.) ]in a pharmacy discovered upon inspection by the Division:

initial violation: $50 - $100

failure to comply within determined time: $250 - $500

subsequent violations: $250 - $500

failure to comply within established time: $750 - $1,000

(41) Practicing or attempting to practice as a pharmacist, pharmacist intern, or pharmacy technician or operating a pharmacy without a license:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(42) Impersonating a licensee or practicing under a false name:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(43) Knowingly employing an unlicensed person:

initial offense: $500 - $1,000

subsequent offense(s): $1,000 - $5,000

(44) Knowingly permitting the use of a license by another person:

initial offense: $500 - $1,000

subsequent offense(s): $1,000 - $5,000

(45) Obtaining a passing score, applying for or obtaining a license or otherwise dealing with the Division or Board through the use of fraud, forgery, intentional deception, misrepresentation, misstatement, or omission:

initial offense: $100 - $2,000

subsequent offense(s): $2,000 - $10,000

(46) Violating or aiding or abetting any other person to violate any statute, rule or order regulating pharmacy:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(47) Violating or aiding or abetting any other person to violate any generally accepted professional or ethical standard:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(48) Engaging in conduct that results in conviction of, or a plea of nolo contendere, or a plea of guilty or nolo contendere held in abeyance to a crime:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(49) Engaging in conduct that results in disciplinary action by any other jurisdiction or regulatory authority:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(50) Engaging in conduct, including the use of intoxicants or drugs, to the extent that the conduct does or may impair the ability to safely engage in practice as a pharmacist, pharmacy intern or pharmacy technician:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(51) Practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician when physically or mentally unfit to do so:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(52) Practicing or attempting to practice as a pharmacist, pharmacy intern, or pharmacy technician through gross incompetence, gross negligence or a pattern of incompetency or negligence:

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(53) Practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician by any form of action or communication which is false, misleading, deceptive or fraudulent:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(54) Practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician beyond the individual's scope of competency, abilities or education:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(55) Practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician beyond the scope of licensure:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(56) Verbally, physically or mentally abusing or exploiting any person through conduct connected with the licensee's practice:

initial offense: $100 - $1,000

subsequent offense(s): $500 - $2,000

(57) Failure to comply with the pharmacist-in-charge standards:

initial offense: $500 - $2,000

subsequent offense(s) $2,000 - $10,000

(58) Failure to resolve identified drug therapy management problems:

initial offense: $500 - $2,500

subsequent offense: $5,000 - $10,000

 

R156-17b-502. Unprofessional Conduct.

"Unprofessional conduct" includes:

(1) violating any provision of the American Pharmaceutical Association (APhA) Code of Ethics for Pharmacists, October 27, 1994, which is hereby incorporated by reference;

(2) failing to comply with the USP-NF Chapters 795 and 797;

(3) failing to comply with the continuing education requirements set forth in these rules;

(4) failing to provide the Division with a current mailing address within a 10 business day period of time following any change of address;

(5) defaulting on a student loan;

(6) failing to abide by all applicable federal and state law regarding the practice of pharmacy;

(7) failing to comply with administrative inspections;

(8) abandoning a pharmacy or leaving prescription drugs accessible to the public;

(9) failing to identify licensure classification when communicating by any means;

(10) the practice of pharmacy with an inappropriate pharmacist to pharmacy intern ratio established by Subsection R156-17b-306(4)([b]d) or pharmacist to pharmacy technician ratio as established by Subsection R156-17b-601(3);

(11) allowing any unauthorized persons in the pharmacy;

(12) failing to offer to counsel any person receiving a prescription medication;

(13) failing to pay an administrative fine that has been assessed in the time designated by the Division;

(14) failing to comply with the pharmacist-in-charge standards as established in Section R156-17b-603; and

(15) failing to take appropriate steps to avoid or resolve identified drug therapy management problems as referenced in Subsection R156-17b-611(3).

 

R156-17b-603. Operating Standards - Pharmacist-in-charge.

The pharmacist-in-charge shall have the responsibility to oversee the implementation and adherence to pharmacy policies that address the following:

(1) assuring that pharmacists and pharmacy interns dispense drugs or devices, including:

(a) packaging, preparation, compounding and labeling; and

(b) ensuring that drugs are dispensed safely and accurately as prescribed;

(2) assuring that pharmacy personnel deliver drugs to the patient or the patient's agent, including ensuring that drugs are delivered safely and accurately as prescribed;

(3) assuring that a pharmacist, pharmacy intern or pharmacy technician communicates to the patient or the patient's agent information about the prescription drug or device or non-prescription products;

(4) assuring that a pharmacist or pharmacy intern communicates to the patient or the patient's agent, at their request, information concerning any prescription drugs dispensed to the patient by the pharmacist or pharmacy intern;

(5) assuring that a reasonable effort is made to obtain, record and maintain patient medication records;

(6) education and training of pharmacy technicians;

(7) establishment of policies for procurement of prescription drugs and devices and other products dispensed from the pharmacy;

(8) disposal and distribution of drugs from the pharmacy;

(9) bulk compounding of drugs;

(10) storage of all materials, including drugs, chemicals and biologicals;

(11) maintenance of records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials required by applicable state and federal laws and regulations;

(12) establishment and maintenance of effective controls against theft or diversion of prescription drugs and records for such drugs;

(13) if records are kept on a data processing system, the maintenance of records stored in that system shall be in compliance with pharmacy requirements;

(14) legal operation of the pharmacy including meeting all inspection and other requirements of all state and federal laws, rules and regulations governing the practice of pharmacy;

(15) assuring that any automated pharmacy system is in good working order and accurately dispenses the correct strength, dosage form and quantity of the drug prescribed while maintaining appropriate record keeping and security safeguards;

(16) implementation of an ongoing quality assurance program that monitors performance of the automated pharmacy system, which is evidenced by written policies and procedures developed for pharmaceutical care;[ and]

(17) assuring that all relevant information is submitted to the Controlled Substance Database in the appropriate format and in a timely manner;

(18) assuring that all personnel working in the pharmacy have the appropriate licensure.

 

R156-17b-605. Operating Standards - Inventory Requirements.

(1) General requirements for inventory of a pharmacy shall include the following:

(a) the pharmacist-in-charge shall be responsible for taking all required inventories, but may delegate the performance of the inventory to another person or persons;

(b) the inventory records must be maintained for a period of five years and be readily available for inspection;

(c) the inventory records shall be filed separately from all other records;

(d) the inventory records shall be in a typewritten or printed form and include all stocks of [legend drugs and ]controlled substances on hand on the date of the inventory including any that are out of date drugs and drugs in automated pharmacy systems. An inventory taken by use of a verbal recording device must be promptly transcribed;

(e) the inventory may be taken either as of the opening of the business or the close of business on the inventory date;

(f) the person taking the inventory and the pharmacist-in-charge shall indicate the time the inventory was taken and shall sign and date the inventory with the date the inventory was taken. The signature of the pharmacist-in-charge and the date of the inventory shall be documented within 72 hours or three working days of the completed initial, annual, change of ownership and closing inventory;

(g) the person taking the inventory shall make an exact count or measure all controlled substances listed in Schedule I or II;

(h) the person taking the inventory shall make an estimated count or measure all Schedule III, IV or V controlled substances[ and legend drugs], unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents must be made;

(i) the inventory of Schedule I and II controlled substances shall be listed separately from the inventory of Schedule III, IV and V controlled substances[ which shall be listed separately from the inventory of the legend drugs]; and

(j) if the pharmacy maintains a perpetual inventory of any of the drugs required to be inventoried, the perpetual inventory shall be reconciled on the date of the inventory.

(2) Requirement for taking the initial inventory shall include the following:

(a) all pharmacies having any stock of [legend drugs or ]controlled substances shall take an inventory on the opening day of business. Such inventory shall include all [stock of legend drugs and ]controlled substances including any out-of-date drugs and drugs in automated pharmacy systems;

(b) in the event a pharmacy commences business with none of the drugs specified in paragraph (2)(a) of this section on hand, the pharmacy shall record this fact as the initial inventory; and

(c) the initial inventory shall serve as the pharmacy's inventory until the next completed inventory as specified in Subsection (3) of this section.

(3) Requirement for annual inventory shall be within 12 months following the inventory date of each year and may be taken within four days of the specified inventory date and shall include all stocks including out-of-date drugs and drugs in automated pharmacy systems.

(4) Requirements for change of ownership shall include the following:

(a) a pharmacy that changes ownership shall take an inventory of all legend drugs and controlled substances including out-of-date drugs and drugs in automated pharmacy systems on the date of the change of ownership;

(b) such inventory shall constitute, for the purpose of this section, the closing inventory for the seller and the initial inventory for the buyer; and

(c) transfer of Schedule I and II controlled substances shall require the use of official DEA order forms (Form 222).

(5) Requirement for taking inventory when closing a pharmacy includes the pharmacist-in-charge, owner, or the legal representative of a pharmacy that ceases to operate as a pharmacy shall forward to the Division, within ten days of cessation of operation, a statement attesting that an inventory has been conducted, the date of closing and a statement attesting the manner by which legend drugs and controlled substances possessed by the pharmacy were transferred or disposed.

(6) Requirements specific to taking inventory in a Class B pharmacy shall include the following:

(a) all Class B pharmacies shall maintain a perpetual inventory of all Schedule II controlled substances which shall be reconciled according to facility policy; and

(b) the inventory of the institution shall be maintained in the pharmacy; if an inventory is conducted in other departments within the institution, the inventory shall be listed separately as follows:

(i) the inventory of drugs on hand in the pharmacy shall be listed separately from the inventory of drugs on hand in the other areas of the institution; and

(ii) the inventory of the drugs on hand in all other departments shall be identified by department.

(7) All out of date legend drugs and controlled substances shall be removed from the inventory at regular intervals and in correlation to the date of expiration imprinted on the label.

 

R156-17b-612. Operating Standards - Prescriptions.

In accordance with Subsection 58-17b-601(1), the following shall apply to prescriptions:

(1) Prescription orders for controlled substances (including prescription transfers) shall be handled according to the rules of the Federal Drug Enforcement Administration.

(2) A prescription issued by an authorized licensed practitioner, if verbally communicated by an agent of that practitioner upon that practitioner's specific instruction and authorization, may be accepted by a pharmacist or pharmacy intern.

(3) A prescription issued by a licensed prescribing practitioner, if electronically communicated by an agent of that practitioner, upon that practitioner's specific instruction and authorization, may be accepted by a pharmacist, pharmacy intern and pharmacy technician.

(4) In accordance with Section 58-17b-609, prescription files, including refill information, shall be maintained for a minimum of five years and shall be immediately retrievable in written or electronic format.

(5) Prescriptions for legend drugs having a remaining authorization for refill may be transferred by the pharmacist or pharmacy intern at the pharmacy holding the prescription to a pharmacist at another pharmacy upon the authorization of the patient to whom the prescription was issued or electronically as authorized under Subsection R156-17b-613(9). The transferring pharmacist or pharmacy intern and receiving pharmacist or pharmacy intern shall act diligently to ensure that the total number of authorized refills is not exceeded. The following additional terms apply to such a transfer:

(a) the transfer shall be communicated directly between pharmacists or pharmacy interns or as authorized under Subsection R156-17b-613(9);

(b) both the original and the transferred prescription drug orders shall be maintained for a period of five years from the date of the last refill;

(c) the pharmacist or pharmacy intern transferring the prescription drug order shall void the prescription electronically or write void/transfer on the face of the invalidated prescription manually;

(d) the pharmacist or pharmacy intern receiving the transferred prescription drug order shall:

(i) indicate on the prescription record that the prescription was transferred electronically or manually; and

(ii) record on the transferred prescription drug order the following information:

(A) original date of issuance and date of dispensing or receipt, if different from date of issuance;

(B) original prescription number and the number of refills authorized on the original prescription drug order;

(C) number of valid refills remaining and the date of last refill, if applicable;

(D) the name and address of the pharmacy and the name of the pharmacist or pharmacy intern to which such prescription is transferred; and

(E) the name of the pharmacist or pharmacy intern transferring the prescription drug order information;

(e) the data processing system shall have a mechanism to prohibit the transfer or refilling of controlled substance prescription drug orders which have been previously transferred; and

(f) a pharmacist or pharmacy intern may not refuse to transfer original prescription information to another pharmacist or pharmacy intern who is acting on behalf of a patient and who is making a request for this information as specified in Subsection (12) of this section.

(6) Prescriptions for terminal patients in licensed hospices, home health agencies or nursing homes may be partially filled if the patient has a medical diagnosis documenting a terminal illness and may not need the full prescription amount.

(7) Refills may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order;

(8) If there are no refill instructions on the original prescription drug order, or if all refills authorized on the original prescription drug order have been dispensed, authorization from the prescribing practitioner must be obtained prior to dispensing any refills.

(9) Refills of prescription drug orders for legend drugs may not be refilled after one year from the date of issuance of the original prescription drug order without obtaining authorization from the prescribing practitioner prior to dispensing any additional quantities of the drug.

(10) Refills of prescription drug orders for controlled substances shall be done in accordance with Subsection 58-37-6(7)(f).

(11) A pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:

(a) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;

(b) either:

(i) a natural or manmade disaster has occurred which prohibits the pharmacist from being able to contact the practitioner; or

(ii) the pharmacist is unable to contact the practitioner after a reasonable effort, the effort should be documented and said documentation should be available to the Division;

(c) the quantity of prescription drug dispensed does not exceed a 72-hour supply, unless the packaging is in a greater quantity;

(d) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;

(e) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;

(f) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection; and

(g) the pharmacist affixes a label to the dispensing container as specified in Section 58-17b-602.

(12) If the prescription was originally filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:

(a) the patient has the prescription container label, receipt or other documentation from the other pharmacy which contains the essential information;

(b) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;

(c) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of (a) and (b) of this subsection; and

(d) the pharmacist complies with the requirements of Subsections (11)(c) through (g) of this section.[

(13) The transfer of original prescription drug order information for legend drugs and Schedule III through V controlled substances is permissible between pharmacies on a one time basis, except transfers back to the pharmacy making the original transfer and transfers within the same corporate pharmacy chain with a computer pharmacy system which accounts for the transfer to all sites, only for the valid remaining refills except as described in Subsection R156-17b-613(9).

(a) the transfer shall be communicated directly between pharmacists or pharmacy interns or as authorized under Subsection R156-17b-613(9):

(b) both the original and the transferred prescription drug orders shall be maintained for a period of five years from the date of the last refill;

(c) the pharmacist or pharmacy intern transferring the prescription drug order shall void the prescription electronically or write void on the face of the invalidated prescription manually;

(d) the pharmacist or pharmacy intern receiving the transferred prescription drug order shall:

(i) indicate on the prescription record that the prescription was transferred electronically or manually; and

(ii) record on the transferred prescription drug order the following information:

(A) original date of issuance and date of dispensing or receipt, if different from date of issuance;

(B) original prescription number and the number of refills authorized on the original prescription drug order;

(C) number of valid refills remaining and the date of last refill, if applicable;

(D) the name, address and, if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred; and

(E) the name of the pharmacist or pharmacy intern transferring the prescription drug order information;

(e) the data processing system shall have a mechanism to prohibit the transfer or refilling of legend or controlled substance prescription drug orders which have been previously transferred; and

(f) a pharmacist or pharmacy intern may not refuse to transfer original prescription information to another pharmacist or pharmacy intern who is acting on behalf of a patient and who is making a request for this information as specified in Subsections (12) and (13) of this section.]

 

R156-17b-613. Operating Standards - Issuing Prescription Orders by Electronic Means.

In accordance with Subsections 58-17b-102(3) and 58-17b-601(1), prescription orders may be issued by electronic means of communication according to the following:

(1) Prescription orders for Schedule II - V controlled substances received by electronic means of communication shall be handled according to Title 58, Chapter 37, Utah Controlled Substances Act and R156-37, Utah Controlled Substances Act Rules.

(2) Prescription orders for non-controlled substances received by electronic means of communication may be dispensed by a pharmacist or pharmacy intern only if all of the following conditions are satisfied:

(a) all electronically transmitted prescription orders shall include the following:

(i) all information that is required to be contained in a prescription order pursuant to Section 58-17b-602;

(ii) the time and date of the transmission, and if a facsimile transmission, the electronically encoded date, time and fax number of the sender; and

(iii) the name of the pharmacy intended to receive the transmission;

(b) the prescription order shall be transmitted under the direct supervision of the prescribing practitioner or his designated agent;

(c) the pharmacist shall exercise professional judgment regarding the accuracy and authenticity of the transmitted prescription. Practitioners or their agents transmitting medication orders using electronic equipment are to provide voice verification when requested by the pharmacist receiving the medication order. The pharmacist is responsible for assuring that each electronically transferred prescription order is valid and shall authenticate a prescription order issued by a prescribing practitioner which has been transmitted to the dispensing pharmacy before filling it, whenever there is a question;

(d) a practitioner may authorize an agent to electronically transmit a prescription provided that the identifying information of the transmitting agent is included on the transmission. The practitioner's electronic signature, or other secure method of validation, shall be provided with the electronic prescription; and

(e) an electronically transmitted prescription order that meets the requirements above shall be deemed to be the original prescription.

(3) This section does not apply to the use of electronic equipment to transmit prescription orders within inpatient medical facilities.

(4) No agreement between a prescribing practitioner and a pharmacy shall require that prescription orders be transmitted by electronic means from the prescribing practitioner to that pharmacy only.

(5) The pharmacist shall retain a printed copy of an electronic prescription, or a record of an electronic prescription that is readily retrievable and printable, for a minimum of five years. The printed copy shall be of non-fading legibility.

(6) Wholesalers, distributors, manufacturers, pharmacists and pharmacies shall not supply electronic equipment to any prescriber for transmitting prescription orders.

(7) An electronically transmitted prescription order shall be transmitted to the pharmacy of the patient's choice.

(8) Prescription orders electronically transmitted to the pharmacy by the patient shall not be filled or dispensed.

(9) A prescription order for a legend drug or controlled substance in Schedule III through V may be transferred up to the maximum refills permitted by law [with the prescriber's authorization ]by electronic transmission providing the pharmacies share a real-time, on-line database provided that:

(a) the information required to be on the transferred prescription has the same information as described in Subsection [R156-17b-6012(17)(b) and (i) through (v)]R156-17b-612(5)(a) through (f); and

(b) pharmacists, pharmacy interns or pharmacy technicians electronically accessing the same prescription drug order records may electronically transfer prescription information if the data processing system has a mechanism to send a message to the transferring pharmacy containing the following information:

(i) the fact that the prescription drug order was transferred;

(ii) the unique identification number of the prescription drug order transferred;

(iii) the name of the pharmacy to which it was transferred; and

(iv) the date and time of the transfer.

 

R156-17b-614c. Operating Standards - Class B - Pharmaceutical Administration Facility.

In accordance with Subsections 58-17b-102(44) and 58-17b-601(1), the following applies with respect to prescription drugs which are held, stored or otherwise under the control of a pharmaceutical administration facility for administration to patients:

(1) The licensed pharmacist shall provide consultation on all aspects of pharmacy services in the facility; establish a system of records of receipt and disposition of all controlled substances in sufficient detail to enable an accurate reconciliation; and determine that drug records are in order and that an account of all controlled substances is maintained and periodically reconciled.

(2) Authorized destruction of all prescription drugs shall be witnessed by the medical or nursing director or a designated physician, [or ]registered nurse or other licensed person employed in the facility and the supervising pharmacist or licensed pharmacy technician and must be in compliance with DEA regulations.

(3) Prescriptions for patients in the facility can be verbally requested by a licensed prescribing practitioner and may be entered as the prescribing practitioner's order; but the practitioner must personally sign the order in the facility record within 72 hours if a Schedule II controlled substance and within 30 days if any other prescription drug. The prescribing practitioner's verbal order may be copied and forwarded to a pharmacy for dispensing and may serve as the pharmacy's record of the prescription order.

(4) Prescriptions for controlled substances for patients in Class B pharmaceutical administration facilities shall be dispensed according to Title 58, Chapter 37, Utah Controlled Substances Act, and R156-37, Utah Controlled Substances Act Rules.

(5) Requirements for emergency drug kits shall include:

(a) an emergency drug kit may be used by pharmaceutical administration facilities. The emergency drug kit shall be considered to be a physical extension of the pharmacy supplying the emergency drug kit and shall at all times remain under the ownership of that pharmacy;

(b) the contents and quantity of drugs and supplies in the emergency drug kit shall be determined by the Medical Director or Director of Nursing of the pharmaceutical administration facility and the [pharmacist-in-charge]consulting pharmacist of the supplying pharmacy;

(c) a copy of the approved list of contents shall be conspicuously posted on or near the kit;

(d) the emergency kit shall be used only for bona fide emergencies and only when medications cannot be obtained from a pharmacy in a timely manner;

(e) records documenting the receipt and removal of drugs in the emergency kit shall be maintained by the facility and the pharmacy;

(f) the pharmacy shall be responsible for ensuring proper storage, security and accountability of the emergency kit and shall ensure that:

(i) the emergency kit is stored in a locked area and is locked itself; and

(ii) emergency kit drugs are accessible only to licensed physicians, physician assistants and nurses employed by the facility;

(g) the contents of the emergency kit, the approved list of contents and all related records shall be made freely available and open for inspection to appropriate representatives of the Division and the Utah Department of Health.

 

R156-17b-618. Change in Ownership or Location.

(1) In accordance with Section 58-17b-614, except for changes in ownership caused by a change in the stockholders in corporations which are publicly listed and whose stock is publicly traded, a licensed pharmaceutical facility that proposes to change its name, location, or ownership shall make application for a new license and receive approval from the division prior to the proposed change. The application shall be on application forms provided by the division and shall include:

(a) the name and current address of the licensee;

(b) the pharmacy license number and the controlled substance license number of the facility;

(c) the DEA registration number of the facility; and

(d) other information required by the division in collaboration with the board.

(2) A new license shall be issued upon a change of ownership, name or a change in location only after an application for change has been submitted and approved.

(3) Upon completion of the change in ownership, name or location, the original licenses shall be surrendered to the division.

 

R156-17b-[618]619. Operating Standards - Third Party Payors.

Reserved.

 

R156-17b-[619]620. Operating Standards - Automated Pharmacy System.

In accordance with Section 58-17b-621, automated pharmacy systems can be utilized in licensed pharmacies, remote locations under the jurisdiction of the Division and licensed health care facilities where legally permissible and shall comply with the following provisions:

(1) Documentation as to type of equipment, serial numbers, content, policies and procedures and location shall be maintained on site in the pharmacy for review upon request of the Division. Such documentation shall include:

(a) name and address of the pharmacy or licensed health care facility where the automated pharmacy system is being used;

(b) manufacturer's name and model;

(c) description of how the device is used;

(d) quality assurance procedures to determine continued appropriate use of the automated device; and

(e) policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access and malfunction.

(2) Automated pharmacy systems should be used only in settings where there is an established program of pharmaceutical care that ensures that before dispensing, or removal from an automated storage and distribution device, a pharmacist reviews all prescription or medication orders unless a licensed independent practitioner controls the ordering, preparation and administration of the medication; or in urgent situations when the resulting delay would harm the patient including situations in which the patient experiences a sudden change in clinical status.

(3) All policies and procedures must be maintained in the pharmacy responsible for the system and, if the system is not located within the facility where the pharmacy is located, at the location where the system is being used.

(4) Automated pharmacy systems shall have:

(a) adequate security systems and procedures to:

(i) prevent unauthorized access;

(ii) comply with federal and state regulations; and

(iii) prevent the illegal use or disclosure of protected health information;

(b) written policies and procedures in place prior to installation to ensure safety, accuracy, security, training of personnel, and patient confidentiality and to define access and limits to access to equipment and medications.

(5) Records and electronic data kept by automated pharmacy systems shall meet the following requirements:

(a) all events involving the contents of the automated pharmacy system must be recorded electronically;

(b) records must be maintained by the pharmacy for a period of five years and must be readily available to the Division. Such records shall include:

(i) identity of system accessed;

(ii) identify of the individual accessing the system;

(iii) type of transaction;

(iv) name, strength, dosage form and quantity of the drug accessed;

(v) name of the patient for whom the drug was ordered; and

(vi) such additional information as the pharmacist-in-charge may deem necessary.

(6) Access to and limits on access to the automated pharmacy system must be defined by policy and procedures and must comply with state and federal regulations.

(7) The pharmacist-in-charge or pharmacist designee shall have the sole responsibility to:

(a) assign, discontinue or change access to the system;

(b) ensure that access to the medications comply with state and federal regulations; and

(c) ensure that the automated pharmacy system is filled and stocked accurately and in accordance with established written policies and procedures.

(8) The filling and stocking of all medications in the automated pharmacy system shall be accomplished by qualified licensed healthcare personnel under the supervision of a licensed pharmacist.

(9) A record of medications filled and stocked into an automated pharmacy system shall be maintained for a period of five years and shall include the identification of the persons filling, stocking and checking for accuracy.

(10) All containers of medications stored in the automated pharmacy system shall be packaged and labeled in accordance with federal and state laws and regulations.

(11) All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations.

(12) The automated pharmacy system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated pharmacy system, all in accordance with existing state and federal law. Written policies and procedures shall address situations in which medications removed from the system remain unused and must be secured and accounted for.

(13) The automated pharmacy system shall provide a mechanism for securing and accounting for wasted medications or discarded medications in accordance with existing state and federal law. Written policies and procedures shall address situations in which medications removed from the system are wasted or discarded and must be secured.

 

R156-17b-[620]621. Operating Standards - Pharmacist Administration - Training.

(1) In accordance with Subsection 58-17b-502(9), appropriate training for the administration of a prescription drug includes:

(a) current Basic Life Support (BLS) certification; and

(b) successful completion of a training program which includes at a minimum:

(i) didactic and practical training for administering injectable drugs;

(ii) the current Advisory Committee on Immunization Practices (ACIP) of the United States Center for Disease Control and Prevention guidelines for the administration of immunizations; and

(iii) the management of an anaphylactic reaction.

(2) Sources for the appropriate training include:

(a) ACPE approved programs; and

(b) curriculum-based programs from an ACPE accredited college of pharmacy, state or local health department programs and other board recognized providers.

(3) Training is to be supplemented by documentation of two hours of continuing education related to the area of practice in each preceding renewal period.

 

KEY: pharmacists, licensing, pharmacies

Date of Enactment or Last Substantive Amendment: [May 17, 2005]2006

Authorizing, and Implemented or Interpreted Law: 58-17b-101; 58-17b-601(1); 58-37-1; 58-1-106(1)(a); 58-1-202(1)(a)