! The Capitol Complex is closed to the public due to COVID-19. All meetings will be held virtually online. View procedures and guidelines (PDF) for remote public comment and virtual meeting instructions (PDF).

Download Zipped Enrolled WP 9 SB0100.ZIP 13,222 Bytes
[Introduced][Amended][Status][Bill Documents][Fiscal Note][Bills Directory]

S.B. 100 Enrolled

                 

PHARMACIST LICENSING AMENDMENTS

                 
2002 GENERAL SESSION

                 
STATE OF UTAH

                 
Sponsor: Peter C. Knudson

                  This act modifies the Pharmacy Practices Act. The act amends the definition of practice of
                  pharmacy to include counseling regarding drug interactions with food and nutrients. The
                  act includes violating a patient's right to privacy as unprofessional conduct. The act makes
                  technical amendments.
                  This act affects sections of Utah Code Annotated 1953 as follows:
                  AMENDS:
                      58-17a-102, as last amended by Chapter 162, Laws of Utah 1999
                      58-17a-502, as last amended by Chapter 162, Laws of Utah 1999
                  Be it enacted by the Legislature of the state of Utah:
                      Section 1. Section 58-17a-102 is amended to read:
                       58-17a-102. Definitions.
                      In addition to the definitions in Section 58-1-102 , as used in this chapter:
                      (1) "Administering" means:
                      (a) the direct application of a prescription drug or device, whether by injection, inhalation,
                  ingestion, or by any other means, to the body of a human patient or research subject by another
                  person; or
                      (b) the placement by a veterinarian with the owner or caretaker of an animal or group of
                  animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
                  means directed to the body of the animal by the owner or caretaker in accordance with written
                  directions of the veterinarian.
                      (2) "Analytical laboratory":
                      (a) means a facility in possession of prescription drugs for the purpose of analysis; and
                      (b) does not include a laboratory possessing prescription drugs used as standards and
                  controls in performing drug monitoring or drug screening analysis if the prescription drugs are
                  prediluted in a human or animal body fluid, human or animal body fluid components, organic


                  solvents, or inorganic buffers at a concentration not exceeding one milligram per milliliter when
                  labeled or otherwise designated as being for in-vitro diagnostic use.
                      (3) "Animal euthanasia agency" means an agency performing euthanasia on animals by the
                  use of prescription drugs.
                      (4) "Board" means the State Board of Pharmacy created in Section 58-17a-201 .
                      (5) "Branch pharmacy" means a drug outlet or other facility in a rural or medically
                  underserved area, used for the storage and dispensing of prescription drugs, which is dependent
                  upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
                  approved by the division as the parent pharmacy.
                      (6) "Compounding":
                      (a) means the preparation, mixing, assembling, packaging, or labeling of reasonable
                  quantities of a prescription drug or device by a licensed pharmacist or pharmacy intern upon receipt
                  of a valid prescription or medication order from a practitioner for an individually identified patient;
                      (b) includes preparation, mixing, assembling, packaging, or labeling of reasonable quantities
                  of a prescription drug for the purpose of, or incidental to research, teaching, or chemical analysis on
                  the condition the prescription drug is not offered for sale or dispensing;
                      (c) includes the preparation of a reasonable quantity of a prescription drug by a licensed
                  pharmacist or pharmacy intern in anticipation of a valid prescription or medication order to be
                  dispensed or administered to a patient based on routine, regularly observed prescribing patterns of
                  a practitioner; and
                      (d) does not include the preparation of prescription drugs by a pharmacist or pharmacy intern
                  for sale to another pharmacist, drug outlet, or the preparation by a pharmacist or pharmacy intern of
                  any prescription drug in a dosage form which is regularly and commonly available from a
                  manufacturer in quantities and strengths prescribed by a practitioner.
                      (7) "Controlled substance" has the same definition as in Section 58-37-2 .
                      (8) "Device" means an instrument, apparatus, implement, machine, contrivance, implant,
                  in-vitro reagent, or other similar or related article, including any component part or accessory, which
                  is required under federal or state law to be prescribed by a practitioner and dispensed by a pharmacist

- 2 -


                  or pharmacy intern.
                      (9) "Dispense" means to prepare and deliver a prescription drug or device or nonprescription
                  drug or device under a lawful order of a practitioner in a suitable container appropriately labeled for
                  subsequent administration to or use by a patient, research subject, an animal, or other individual
                  entitled to receive the prescription drug or device.
                      (10) "Distribute" means to deliver a drug or device other than by administering or
                  dispensing.
                      (11) "Drug" or "drugs" means a prescription drug as defined in this chapter.
                      (12) "Drug outlet" means any person, other than an individual licensed as a pharmacist,
                  pharmacy technician, or pharmacy intern, who engages in dispensing, delivering, distributing,
                  manufacturing, or wholesaling prescription drugs or devices within or into this state.
                      (13) "Drug product equivalent" means a drug product that is designated the therapeutic
                  equivalent of another drug product in the Approved Drug Products with Therapeutic Equivalence
                  Evaluations prepared by the Center for Drug Evaluation and Research of the Federal Food and Drug
                  Administration.
                      (14) "Drug sample" means a prescription drug packaged in small quantities consistent with
                  limited dosage therapy of the particular drug, which is marked "sample," is not intended to be sold,
                  and is intended to be provided to practitioners for the immediate needs of patients for trial purposes
                  or to provide the drug to the patient until a prescription can be filled by the patient.
                      (15) "Extern" means a college of pharmacy student enrolled in a college coordinated
                  practical experience program in a licensed pharmacy under the supervision of a preceptor, as defined
                  in Subsection (45), and approved by the college of pharmacy.
                      (16) "Filling" or "refilling" have same meaning as dispense.
                      (17) "General supervision" means the supervising pharmacist is in the pharmacy or the
                  facility in which the pharmacy is located and is available for immediate oral contact with the
                  supervised pharmacy technician or pharmacy intern.
                      (18) "Hospital pharmacy" means a drug outlet providing pharmaceutical service to inpatients
                  of a general acute hospital or specialty hospital licensed by the Department of Health under Title 26,

- 3 -


                  Chapter 21, Health Care Facility Licensing and Inspection Act.
                      (19) "Institutional pharmacy":
                      (a) means a drug outlet providing pharmaceutical service to a defined and exclusive group
                  of patients who have access to the services of the pharmacy because they are treated by or have an
                  affiliation with a specific entity including health maintenance organizations and infusion companies;
                  and
                      (b) does not include hospital pharmacies, drug outlets engaged in retail sales of prescription
                  drugs and devices to the general public, or the offices of practitioners.
                      (20) "Labeling" means the process of preparing and affixing a label to the container of any
                  drug or device, exclusive of the labeling by a manufacturer, packer, or distributor of a
                  nonprescription drug or commercially packaged legend drug or device. Any label shall include all
                  information required by federal and state law or rule.
                      (21) "Licensee" means any person to whom a license has been granted under this chapter.
                      (22) "Manufacture":
                      (a) means the production, preparation, propagation, compounding, conversion, or processing
                  of a prescription drug or a device, either directly or indirectly by extraction from substances of
                  natural origin or independently by means of chemical synthesis or by a combination of extraction
                  and chemical synthesis and includes any packaging or repackaging of a substance or labeling or
                  relabeling of its container; and
                      (b) does not include the preparation or compounding of a noncontrolled substance drug by
                  an individual for that individual's own use or the preparation, compounding, packaging, or labeling
                  of a drug:
                      (i) by a pharmacist, pharmacy intern, or practitioner incident to administering or dispensing
                  of a drug in the course of professional practice; or
                      (ii) by a practitioner or by that practitioner's authorization under supervision for the purpose
                  of or incident to research, teaching, or chemical analysis and not for sale.
                      (23) "Medication profile" or "profile" means a record system maintained as to drugs or
                  devices prescribed for a pharmacy patient to enable a pharmacist, or pharmacy intern to analyze for

- 4 -


                  potential harmful or dangerous interactions, or other factors, or other drugs or devices prescribed for
                  the patient.
                      (24) "Nonprescription drugs" means medicines or drugs which may be sold without a
                  prescription and which are prepackaged for use by the consumer and labeled in accordance with the
                  requirements of the statutes and rules of this state and of the federal government.
                      (25) "Nuclear pharmacy" means a drug outlet providing radiopharmaceutical service.
                      (26) "Out-of-state mail service pharmacy" means a drug outlet located outside the state that:
                      (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a resident in this
                  state pursuant to a legally issued prescription;
                      (b) provides information to a resident of this state on drugs or devices which may include,
                  but is not limited to, advice relating to therapeutic values, potential hazards, and uses; or
                      (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
                  effects of drugs.
                      (27) "Person" means an individual, corporation, partnership, association, or any other legal
                  entity.
                      (28) "Pharmaceutical administration facility" means a health care facility or agency,
                  including birthing centers, ambulatory surgical facilities, abortion clinics, home health agencies,
                  hospices, nursing care facilities, end stage renal disease facilities, and penal institutions in which:
                      (a) a licensed drug outlet is not located;
                      (b) prescription drugs are held, stored, or are otherwise under the control of the facility or
                  agency for administration to patients of that facility or agency;
                      (c) prescription drugs are dispensed to the facility or agency by a licensed pharmacist or
                  pharmacy intern with whom the facility has established a prescription drug supervising relationship
                  under which the pharmacist or pharmacy intern provides counseling to the facility or agency staff
                  as required, and oversees drug control, accounting, and destruction; and
                      (d) prescription drugs are professionally administered in accordance with the order of a
                  practitioner by an employee or agent of the facility or agency.
                      (29) (a) "Pharmaceutical care" means carrying out the following in collaboration with a

- 5 -


                  prescribing practitioner, and in accordance with division rule:
                      (i) designing, implementing, and monitoring a therapeutic drug plan intended to achieve
                  favorable outcomes related to a specific patient for the purpose of curing or preventing the patient's
                  disease;
                      (ii) eliminating or reducing a patient's symptoms; or
                      (iii) arresting or slowing a disease process.
                      (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
                  prescribing practitioner.
                      (30) "Pharmaceutical dog trainer" means a person who is employed by or under contract to
                  a law enforcement agency who uses prescription drugs for the purpose of training dogs in the
                  detection of prescription drugs.
                      (31) "Pharmaceutical manufacturer" means a person engaged in the manufacture of
                  prescription drugs or devices.
                      (32) "Pharmaceutical researcher" means a person who is engaged in conducting scientific
                  research regarding drugs and their use in accordance with standard research protocols and
                  techniques, who maintains competent documentation with respect to the research, and who uses
                  prescription drugs in the conduct of the research.
                      (33) "Pharmaceutical teaching organization" means an accredited school of pharmacy within
                  the state, or a school or program meeting the requirements established in accordance with Subsection
                  58-17a-302 (4) providing education for pharmacy technicians within the state.
                      (34) "Pharmaceutical wholesaler/distributor":
                      (a) means a drug outlet engaged in the business of wholesale vending or selling of any
                  prescription drug or device to other than the consumer or user of the prescription drug or device,
                  which the drug outlet has not produced, manufactured, compounded, or dispensed; and
                      (b) does not include a drug outlet carrying out the following business activities:
                      (i) intracompany sales;
                      (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell, purchase, or
                  trade a prescription drug or device between hospitals or other health care facilities that are under

- 6 -


                  common ownership or control of the management and operation of the facilities;
                      (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell, purchase,
                  or trade a prescription drug or device for emergency medical reasons, or to supply another drug                   outlet
                  to alleviate a temporary shortage; or
                      (iv) the distribution of a prescription drug or device as a sample by representatives of a
                  manufacturer.
                      (35) "Pharmacist" means an individual licensed by this state to engage in the practice of
                  pharmacy.
                      (36) "Pharmacy" means a facility or location where the practice of pharmacy is carried out.
                      (37) "Pharmacy intern" means an individual licensed by this state to engage in practice as
                  a pharmacy intern.
                      (38) "Pharmacy patient" or "patient" means an individual for whom a practitioner has
                  prescribed a drug or device which is to be administered to or taken or used by that individual or an
                  animal.
                      (39) "Pharmacy technician" means an individual licensed by this state to engage in practice
                  as a pharmacy technician.
                      (40) "Physician" means an individual licensed by this state to engage in the practice of
                  medicine.
                      (41) "Practice as a pharmacy intern" means engaging in the practice of pharmacy under the
                  general supervision of a licensed pharmacist approved by the division in collaboration with the board
                  and in accordance with a scope of practice as defined by division rule made in collaboration with the
                  board.
                      (42) "Practice as a pharmacy technician":
                      (a) means engaging in practice as a pharmacy technician under the general supervision of
                  a licensed pharmacist and in accordance with a scope of practice as defined by division rule made
                  in collaboration with the board; and
                      (b) does not include performing a final review of the prescription and prescribed drug
                  prepared for dispensing, dispensing of the drug, or counseling a patient with respect to a prescription

- 7 -


                  drug or nonprescription drug.
                      (43) "Practice of pharmacy" includes any of the following:
                      (a) interpreting prescription orders;
                      (b) compounding, packaging, labeling, dispensing, administering, and the coincident
                  distribution of prescription drugs and devices, provided that the administration of a prescription drug
                  or device is:
                      (i) pursuant to a lawful order of a practitioner when one is required by law; and
                      (ii) in accordance with written guidelines or protocols:
                      (A) established by the licensed facility in which the prescription drug or device is to be
                  administered on an inpatient basis; or
                      (B) approved by the division, in collaboration with the board and the Physician's Licensing
                  Board, created in Section 58-67-201 , if the prescription drug or device is to be administered on an
                  outpatient basis solely by a licensed pharmacist;
                      (c) participating in drug utilization review;
                      (d) ensuring proper and safe storage of drugs and devices;
                      (e) maintaining records of drugs and devices in accordance with state and federal law and
                  the standards and ethics of the profession;
                      (f) providing information on drugs or devices, which may include advice relating to
                  therapeutic values, potential hazards, and uses;
                      (g) providing drug product equivalents;
                      (h) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
                  technicians;
                      (i) providing patient counseling, including:
                      (i) adverse and therapeutic effects of drugs; and
                      (ii) drug interactions with food, nutrients, and supplements; and
                      (j) providing pharmaceutical care.
                      (44) "Practitioner" means any person licensed by the state to prescribe drugs, medications,
                  or devices dispensed by prescription only.

- 8 -


                      (45) "Preceptor" means a licensed pharmacist approved by the division in collaboration with
                  the board to serve as a teacher, example of professional conduct, and supervisor of interns and
                  externs in the professional practice of pharmacy.
                      (46) "Prescription" means an order issued by a licensed practitioner, in the course of that
                  practitioner's professional practice, for a controlled substance, other prescription drug or device with
                  the intent the prescription drug or device will be used by a patient or an animal. The order may be
                  issued by word of mouth, written document, telephone, facsimile transmission, computer, or other
                  electronic means of communication as defined by division rule.
                      (47) "Prescription drug or device" or "legend drug or device" means:
                      (a) a drug or device which, under federal law, is required to be labeled with either of the
                  following statements or their equivalent:
                      (i) "CAUTION: Federal law prohibits dispensing without prescription"; or
                      (ii) "CAUTION: Federal law restricts this drug to use by or on the order of a licensed
                  veterinarian"; or
                      (b) a drug or device that is required by any applicable federal or state law or rule to be
                  dispensed on prescription only or is restricted to use by practitioners only.
                      (48) "Prescription drug or device order" means a lawful written or oral order of a practitioner
                  for a prescription drug or device for use in humans or animals.
                      (49) "Retail pharmacy" means a drug outlet dispensing prescription drugs and devices to the
                  general public.
                      (50) "Supportive personnel" means unlicensed individuals who:
                      (a) may assist a pharmacist, pharmacy intern, or pharmacy technician in nonjudgmental
                  duties not included in the definition of the practice of pharmacy, and as those duties may be further
                  defined by division rule made in collaboration with the board; and
                      (b) are supervised by a pharmacist in accordance with rules made by the division in
                  collaboration with the board.
                      (51) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17a-501 .
                      (52) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-17a-502 , and as

- 9 -


                  may be further defined by rule.
                      (53) "Veterinary pharmaceutical outlet" means a drug outlet dispensing veterinary
                  prescription drugs.
                      Section 2. Section 58-17a-502 is amended to read:
                       58-17a-502. Unprofessional conduct.
                      "Unprofessional conduct" includes:
                      (1) willfully deceiving or attempting to deceive the division, the board, or their agents as to
                  any relevant matter regarding compliance under this chapter;
                      (2) (a) paying rebates to practitioners or any other health care providers, or entering into any
                  agreement with a medical practitioner or any other person for the payment or acceptance of
                  compensation or its economic equivalent for recommending of the professional services of either
                  party, except as allowed under Subsection (2)(b); and
                      (b) price discounts conditional upon volume purchases are not prohibited under Subsection
                  (2)(a);
                      (3) misbranding or adulteration of any drug or device or the sale, distribution, or dispensing
                  of any misbranded or adulterated drug or device;
                      (4) engaging in the sale or purchase of drugs or devices that are samples or packages bearing
                  the inscription "sample" or "not for resale" or similar words or phrases;
                      (5) accepting back and redistributing of any unused drug, or a part of it, after it has left the
                  premises of any pharmacy, unless the drug is in the original sealed unit dose package or
                  manufacturer's sealed container;
                      (6) being employed as a pharmacist, pharmacy intern, or pharmacy technician, or sharing or
                  receiving compensation in any form arising out of an act incidental to professional activities in the
                  course of which any person requires him to engage in any aspects of the practice of pharmacy in
                  violation of this chapter;
                      (7) violation of Federal Title II, P.L. 91, Controlled Substances Act, or Title 58, Chapter 37,
                  Utah Controlled Substances Act, or rules and regulations adopted under either of them;
                      (8) requiring or permitting pharmacy interns or technicians to engage in activities outside

- 10 -


                  the scope of practice for their respective license classifications as defined in this chapter and division
                  rules made in collaboration with the board, or beyond an individual's scope of training and ability;
                  [and]
                      (9) administering without:
                      (a) appropriate training as defined by rule;
                      (b) written guidelines or protocols of a practitioner or in conflict with such guidelines or
                  protocols; or
                      (c) a lawful order, when one is required by law[.]; and
                      (10) disclosing confidential patient information in violation of the provisions of the Health
                  Insurance Portability and Accountability Act of 1996 or other applicable law.

- 11 -


[Bill Documents][Bills Directory]