2012 Utah Code
Title 58 - Occupations and Professions
Article 17b - Pharmacy Practice Act
Section 309.5 - Exemption for prescribing practitioner of cancer drug regimen -- Division study of dispensing practitioners.

(1) For purposes of this section, "cancer drug treatment regimen":

(a) means a prescription drug used to treat cancer, manage its symptoms, or provide continuity of care for a cancer patient;

(b) includes:

(i) a chemotherapy drug administered intravenously, orally, rectally, or by dermal methods; and

(ii) a drug used to support cancer treatment, including to treat, alleviate, or minimize physical and psychological symptoms or pain, or to improve patient tolerance of cancer treatments or prepare a patient for a subsequent course of therapy; and

(c) does not mean a drug listed under federal law as a Schedule I, II, or III drug.

(2) In addition to the exemption from licensure under Section 58-1-307, the following individuals are exempt from licensure under this chapter:

(a) an individual who:

(i) meets the requirements of Subsection (2)(b) or (c); and

(ii) notifies the division that the individual intends to dispense a cancer drug regimen under this section;

(b) a prescribing practitioner who:

(i) treats a patient who is currently undergoing chemotherapy in an outpatient clinic setting;

(ii) prescribes a cancer drug treatment regimen to the patient;

(iii) determines that providing the cancer drug treatment regimen to the patient in the outpatient clinic setting is in the best interest of the patient, or provides better access to care for the patient;

(iv) discloses to the patient that the cancer drug treatment regimen may be obtained from a pharmacy unaffiliated with the prescribing practitioner and offers to the patient the opportunity to consult with a pharmacist if the patient desires patient counseling;

(v) does not directly or indirectly mark up, charge a commission, or make a profit on providing the cancer drug regimen, but may obtain payment for expenses and services related to providing the cancer drug regimen;

(vi) provides the cancer drug treatment regimen to the patient, or directs another person under Subsection (2)(c) to provide the cancer drug treatment regimen to the patient;

(vii) is certified or eligible to be certified by the American Board of Internal Medicine in medical oncology;

(viii) reports to the Utah Controlled Substance Database in the same manner as required by Section 58-37f-203, and follows labeling, recordkeeping, patient counseling, purchasing and distribution, operating, treatment, quality of care, and storage requirements established by administrative rule adopted by the division in consultation with the board; and

(ix) follows the USP-NF 797 standards for sterile compounding if the drug dispensed to the patient is reconstituted or compounded; and

(c) a person who is not a prescribing practitioner who:

(i) is employed as a health care provider by a prescribing practitioner or the outpatient clinic setting in which the prescribing practitioner works and is acting within the individual's scope of practice;

(ii) is acting under the direction of a prescribing practitioner who is immediately available on site for any necessary consultation, and who has complied with Subsection (2)(b)(i);

(iii) prepares or provides the cancer drug treatment regimen to the patient at the outpatient clinic setting; and

(iv) follows Subsections (2)(b)(iv), (v), and (viii).

(3) (a) The division shall work with stakeholders to evaluate the exemptions to licensure under this title in Subsections 58-17b-309(2)(b), (d), and (e) and this section.

(b) The evaluation under this Subsection (3) shall include:

(i) practitioner compliance with the requirements of this section and Section 58-17b-309;

(ii) current research on dispensing and patient safety;

(iii) survey of other state dispensing laws; and

(iv) recommendations for future action concerning practitioner dispensing.

(c) The division shall report to the Legislature's Health and Human Services Interim Committee by November 30, 2012, and by November 30, 2013, with the results and recommendations from the evaluation required by this Subsection (3).

(4) This section sunsets in accordance with Section 63I-1-258.

Enacted by Chapter 234, 2012 General Session