2025 -- H 5353 SUBSTITUTE A ======== LC000768/SUB A ======== S T A T E O F R H O D E I S L A N D IN GENERAL ASSEMBLY JANUARY SESSION, A.D. 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 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 1 by adding thereto the following section: 2 5-19.1-37. Pharmacy technicians -- Scope of practice -- Pharmacy technician 3 dispensing process validation within institutional pharmacies. 4 (a) In accordance with chapter 19.1 of title 5 and adopted by the state board of pharmacy, 5 a pharmacy technician or pharmacy intern may perform technology-assisted dispensing process 6 validation for medications prepared for distribution by another pharmacy technician or intern 7 within an institutional pharmacy. 8 (b) Definitions. For purposes of this section, the following words and terms shall have the 9 following meanings: 10 (1) “Automated storage and distribution devices” means a mechanical device that delivers 11 drugs other than by administration, and uses automated data processing technology to: 12 (i) Provide effective storage and security of drugs contained in the device; 13 (ii) Limit access to authorized individuals; 14 (iii) Record the identity of all personnel who access the drugs stored within the device; 15 (iv) Provide documentation of storage and removal of contents; 16 (v) Provide ongoing documentation that monitors proper delivery of drugs to ensure patient 17 safety; and 18 (iv) Comply with all relevant statutes, rules and regulations. 19 LC000768/SUB A - Page 2 of 4 (2) “Controlled substance" means a drug or substance, or an immediate precursor of such 1 drug or substance, so designated under or pursuant to the provisions of chapter 28 of title 21. 2 (3) “Dispensing process validation” means the physical verification that ensures the drug, 3 drug dosage, and drug form selected is the correct drug, drug dosage, and drug form for the purpose 4 for which it was selected. When applicable, dispensing process validation is subject to, and occurs 5 after, licensed pharmacist drug utilization review and clinical conflict resolution. 6 (4) “Institutional pharmacy” means any pharmacy that is located within or off-site, and 7 contracted with, any hospital, clinic or dispensary in which drugs are compounded or dispensed to 8 its patients or patients of another licensed in-patient healthcare facility with whom it has a contract. 9 (5) “Supervision” means oversight and control by a licensed pharmacist who is responsible 10 for work performed by pharmacy technicians and pharmacy interns. 11 (6) “Technology” means an electronic system designed to achieve accuracy in drug product 12 identity verification including, but not limited to, barcode scanning and radio frequency 13 identification (RFID). 14 (c)(1) With regard to activities authorized, acting in compliance with this section, a licensed 15 pharmacist may delegate, and a pharmacy technician or pharmacy intern may perform under the 16 supervision of the pharmacist, technology-assisted dispensing process validation of medications 17 prepared for distribution by another pharmacy technician or pharmacy intern when such medication 18 will be administered to the patient by a licensed health care professional, including: 19 (i) Patient-specific medication orders; 20 (ii) Automated storage and distribution devices stock; 21 (iii) Repackaged medication from bulk to unit-of-use doses; and 22 (iv) Emergency kits. 23 (2) Acting in compliance with this section, a licensed pharmacist shall not delegate 24 dispensing process validation for: 25 (i) Controlled substances; or 26 (ii) Compounded products (whether sterile or non-sterile) unless the compounded products 27 have been previously verified by a licensed pharmacist (e.g., previously batched compounded 28 product). 29 (3) In delegating activities under this section, a licensed pharmacist shall use reasonable 30 professional judgment and shall ensure that authorized activities do not require the exercise of 31 discretion or clinical judgment by the pharmacy technician or pharmacy intern. 32 (4) The pharmacist-in-charge of the pharmacy shall be held responsible for any medication 33 errors that take place as a result of the delegation of technology-assisted dispensing process 34 LC000768/SUB A - Page 3 of 4 validation of medications authorized under this section. 1 (d)(1) With regard to quality and control, the institutional pharmacy where activities 2 authorized in this section are conducted shall: 3 (i) Document a pharmacy technician or pharmacy intern dispensing process validation 4 policy and procedure; 5 (ii) Maintain an institutional pharmacy-specific training program including a record of 6 pharmacy technicians and/or pharmacy interns trained; and 7 (iii) Maintain a continuous quality assessment system to periodically verify the accuracy 8 of the pharmacy technician or pharmacy intern dispensing process validation, including: 9 (A) Recording any errors which reach the patient; 10 (B) Recording any quality related events; and 11 (C) Specific limits of acceptable quality related event levels before reassessment. 12 (2) No pharmacy technician or pharmacy intern shall engage in authorized activities 13 without documentation of training. 14 (e) With regards to rules and regulations, the board of pharmacy shall make, adopt, amend, 15 and repeal such rules and regulations as may be deemed necessary by the board from time to time 16 for the proper administration and enforcement of this section. Such rules and regulations shall be 17 promulgated in accordance with the procedures specified in chapter 35 of title 42 ("administrative 18 procedures"). 19 SECTION 2. This act shall take effect upon passage. 20 ======== LC000768/SUB A ======== LC000768/SUB A - Page 4 of 4 EXPLANATION BY THE LEGISLATIVE COUNCIL OF A N A C T RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES *** This act would authorize a pharmacy technician or pharmacy intern to perform technology-1 assisted dispensing process validation for medications prepared for distribution by another 2 pharmacy technician or intern within an institutional pharmacy. 3 This act would take effect upon passage. 4 ======== LC000768/SUB A ========