| Chapter 320 |
| 2025 -- H 5353 SUBSTITUTE A Enacted 06/30/2025 |
| 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 |
| 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: |
| 5-19.1-375-19.1-38. Pharmacy technicians -- Scope of practice -- Pharmacy technician |
| dispensing process validation within institutional pharmacies. |
| (a) In accordance with this chapter 19.1 of title 5and 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 |
| (vi) 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 carehealthcare 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: |
| (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) The pharmacist-in-charge is responsible for ensuring that delegation of technology- |
| assisted dispensing process validation of medications by a licensed pharmacist under this section |
| does not lead to medication errors. |
| (f) 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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| LC000768/SUB A/2 |
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