2025 -- H 5353

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LC000768

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2025

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES

     Introduced By: Representatives Casimiro, Noret, Spears, Donovan, Speakman, Morales,
Solomon, and Shanley

     Date Introduced: February 07, 2025

     Referred To: House Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby amended

by adding thereto the following section:

     5-19.1-37. Pharmacy technicians -- Scope of practice -- Pharmacy technician

dispensing process validation within institutional pharmacies.

     (a) In accordance with chapter 19.1 of title 5 and adopted by the state board of pharmacy,

a pharmacy technician or pharmacy intern may perform technology-assisted dispensing process

validation for medications prepared for distribution by another pharmacy technician or intern

within an institutional pharmacy.

     (b) Definitions. For purposes of this section, the following words and terms shall have the

following meanings:

     (1) “Automated storage and distribution devices” means a mechanical device that delivers

drugs other than by administration, and uses automated data processing technology to:

     (i) Provide effective storage and security of drugs contained in the device;

     (ii) Limit access to authorized individuals;

     (iii) Record the identity of all personnel who access the drugs stored within the device;

     (iv) Provide documentation of storage and removal of contents;

     (v) Provide ongoing documentation that monitors proper delivery of drugs to ensure patient

safety; and

     (iv) Comply with all relevant statutes, rules and regulations.

     (2) “Controlled substance" means a drug or substance, or an immediate precursor of such

drug or substance, so designated under or pursuant to the provisions of chapter 28 of title 21.

     (3) “Dispensing process validation” means the physical verification that ensures the drug,

drug dosage, and drug form selected is the correct drug, drug dosage, and drug form for the purpose

for which it was selected. When applicable, dispensing process validation is subject to, and occurs

after, licensed pharmacist drug utilization review and clinical conflict resolution.

     (4) “Institutional pharmacy” means any pharmacy that is located within or off-site, and

contracted with, any hospital, clinic or dispensary in which drugs are compounded or dispensed to

its patients or patients of another licensed in-patient healthcare facility with whom it has a contract.

     (5) “Supervision” means oversight and control by a licensed pharmacist who is responsible

for work performed by pharmacy technicians and pharmacy interns.

     (6) “Technology” means an electronic system designed to achieve accuracy in drug product

identity verification including, but not limited to, barcode scanning and radio frequency

identification (RFID).

     (c)(1) With regard to activities authorized, acting in compliance with this section, a licensed

pharmacist may delegate, and a pharmacy technician or pharmacy intern may perform under the

supervision of the pharmacist, technology-assisted dispensing process validation of medications

prepared for distribution by another pharmacy technician or pharmacy intern when such medication

will be administered to the patient by a licensed health care professional, including:

     (i) Patient-specific medication orders;

     (ii) Automated storage and distribution devices stock;

     (iii) Repackaged medication from bulk to unit-of-use doses; and

     (iv) Emergency kits.

     (2) Acting in compliance with this section, a licensed pharmacist shall not delegate

dispensing process validation for:

     (i) Controlled substances; or

     (ii) Compounded products (whether sterile or non-sterile) unless the compounded products

have been previously verified by a licensed pharmacist (e.g., previously batched compounded

product).

     (3) In delegating activities under this section, a licensed pharmacist shall use reasonable

professional judgment and shall ensure that authorized activities do not require the exercise of

discretion or clinical judgment by the pharmacy technician or pharmacy intern.

     (d) (1) With regard to quality and control, the institutional pharmacy where activities

authorized in this section are conducted shall:

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     (i) Document a pharmacy technician or pharmacy intern dispensing process validation

policy and procedure;

     (ii) Maintain an institutional pharmacy-specific training program including a record of

pharmacy technicians and/or pharmacy interns trained; and

     (iii) Maintain a continuous quality assessment system to periodically verify the accuracy

of the pharmacy technician or pharmacy intern dispensing process validation, including:

     (A) Recording any errors which reach the patient;

     (B) Recording any quality related events; and

     (C) Specific limits of acceptable quality related event levels before reassessment.

     (2) No pharmacy technician or pharmacy intern shall engage in authorized activities

without documentation of training.

     (e) With regards to rules and regulations, the board of pharmacy shall make, adopt, amend,

and repeal such rules and regulations as may be deemed necessary by the board from time to time

for the proper administration and enforcement of this section. Such rules and regulations shall be

promulgated in accordance with the procedures specified in chapter 35 of title 42 ("administrative

procedures").

     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES

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     This act would authorize a pharmacy technician or pharmacy intern to perform technology-

assisted dispensing process validation for medications prepared for distribution by another

pharmacy technician or intern within an institutional pharmacy.

     This act would take effect upon passage.

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