STATE OF NEW YORK ________________________________________________________________________ 9729 IN ASSEMBLY April 3, 2024 ___________ Introduced by M. of A. McDONALD, FAHY -- read once and referred to the Committee on Higher Education AN ACT to amend the education law, in relation to shared pharmacy services The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Section 6802 of the education law is amended by adding a 2 new subdivision 30 to read as follows: 3 (30) "Shared pharmacy services" means a system that allows a regis- 4 tered pharmacist or a registered pharmacy, pursuant to a request from 5 another registered pharmacist or pharmacy, to process or fill a 6 prescription or order, pursuant to regulations promulgated by the 7 commissioner. 8 § 2. The education law is amended by adding a new section 6809 to read 9 as follows: 10 § 6809. Shared pharmacy services. 1. General requirements. No pharma- 11 cist or pharmacy shall provide shared pharmacy services unless they are 12 registered in accordance with sections sixty-eight hundred five, sixty- 13 eight hundred eight, or sixty-eight hundred eight-b of this article, and 14 are in compliance with the provisions of this section. 15 2. Qualification. A pharmacy may provide or engage in shared pharmacy 16 services only if the pharmacies involved: 17 a. (i) have the same owner; or 18 (ii) have a written contract or agreement that outlines the services 19 provided and the shared responsibilities of each pharmacy in complying 20 with all applicable federal and state statutory and regulatory require- 21 ments; and 22 b. share a common electronic file or technology that allows access to 23 information necessary or required to perform shared pharmacy services in 24 compliance with all applicable federal and state statutory and regulato- 25 ry requirements. 26 3. Operations. A pharmacy or pharmacist engaged in shared pharmacy 27 services shall: EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD15019-01-4

A. 9729 2 1 a. maintain records that identify, individually for each prescription 2 or order filled or processed, the name and if applicable, the license or 3 registration number of each pharmacy and individual who took part in the 4 processing or filling of the prescription or order. Such records shall 5 be maintained in accordance with subdivision five of section sixty-eight 6 hundred ten of this article and made available to the department upon 7 request. Records of prescriptions for controlled substances shall be 8 maintained pursuant to the requirements of article thirty-three of the 9 public health law; 10 b. maintain a system for the tracking of each prescription or order 11 during each step of the process including, but not limited to, the name 12 and if applicable, the license and registration number of each pharmacy 13 and individual taking part in the processing or filling of the 14 prescription or order; 15 c. notify the department, in writing, within thirty days of any disci- 16 plinary action taken by another state's regulatory agency involving 17 shared pharmacy services as defined in this article; 18 d. ensure that the labels for all prescriptions filled utilizing 19 shared pharmacy services identify the names and registration numbers of 20 the pharmacies involved in the dispensing and filling of the 21 prescriptions. All labels shall conform to sections sixty-eight hundred 22 twenty-nine and sixty-eight hundred thirty of this article and the regu- 23 lations promulgated thereunder. The labeling of prescriptions for 24 controlled substances shall be subject to additional requirements 25 provided in article thirty-three of the public health law. The 26 provisions of this paragraph shall not apply to hospitals as defined in 27 article twenty-eight of the public health law when furnishing drugs to 28 patients registered for treatment by the hospital; 29 e. maintain a system that adequately protects the confidentiality and 30 integrity of protected patient information; and 31 f. maintain processes for the storage, processing and dispensing of 32 controlled substances in accordance with article thirty-three of the 33 public health law. 34 4. Notification to patients. a. Pharmacies participating in shared 35 pharmacy services shall: 36 (i) notify patients or the patients' authorized representative that 37 pending their consent, a portion or all of their prescriptions may be 38 processed or filled off premises. Such notification shall be conveyed 39 using conspicuously posted signage at or adjacent to the place in the 40 pharmacy where prescriptions are presented for compounding and dispens- 41 ing, in the waiting area for customers, or the area where prescribed 42 drugs are dispensed. Pharmacies that transact business through the use 43 of the internet shall conspicuously provide such notification on their 44 website; and 45 (ii) obtain an initial onetime consent to fill current and future 46 prescriptions through shared pharmacy services from the patient or 47 patient's authorized representative prior to the dispensing of one or 48 more prescriptions for the patient. For the purposes of this section, 49 such consent shall be obtained in writing or electronically and noted 50 within the patient's medication profile. 51 b. Nothing in this subdivision shall prohibit a patient or the 52 patients' authorized representative from opting out of having the 53 patients' prescription processed or filled via shared pharmacy services 54 at any time.

A. 9729 3 1 c. The provisions of this subdivision shall not apply to a hospital as 2 defined in article twenty-eight of the public health law which is 3 furnishing drugs to patients registered for treatment by the hospital. 4 5. Drug storage and security. a. Drugs shall be stored and transported 5 in a secure manner in compliance with all applicable federal and state 6 statutory and regulatory requirements. 7 b. Access to the area where drugs are stored shall be limited to 8 authorized personnel. 9 c. Pharmacies participating in shared pharmacy services shall have 10 adequate security that complies with all applicable federal and state 11 statutory and regulatory requirements and protects the confidentiality 12 and integrity of protected patient information. 13 6. Policies and procedures. a. Each pharmacy participating in shared 14 pharmacy services shall jointly develop, implement, review, revise, and 15 comply with joint policies and procedures for shared pharmacy services. 16 Such policies and procedures shall be made available to the department 17 upon request and maintained pursuant to regulations promulgated by the 18 commissioner. 19 b. The policies and procedures shall: 20 (i) outline the responsibilities of each pharmacy; 21 (ii) include a list of the names, addresses, telephone numbers, and 22 all registration numbers of the pharmacies involved in shared pharmacy 23 services; and 24 (iii) include policies and procedures for: 25 (A) notifying the patients or the patients' authorized representative 26 that the patients' prescriptions may be processed or filled off premises 27 and providing the names and registration numbers of the other pharmacies 28 involved in the filling or processing of the prescriptions; 29 (B) protecting the confidentiality and integrity of protected patient 30 information; 31 (C) dispensing a prescription when a prescription filled utilizing 32 shared pharmacy services is not received or the patient comes in before 33 such prescription is received; 34 (D) maintaining a required manual or electronic records to track the 35 prescription or order through each step of the process including, but 36 not limited to, the names and, if applicable, the license or registra- 37 tion numbers of each individual who participated in shared pharmacy 38 services; and 39 (E) complying with all applicable federal and state statutory and 40 regulatory requirements; and 41 (iv) policies and procedures for hospitals as defined in the public 42 health law are exempt from the requirements of clauses (A) and (C) of 43 subparagraph (iii) of this paragraph, when furnishing drugs to patients 44 registered for treatment by the hospital. 45 7. Individual practice. For the purpose of shared pharmacy services, 46 persons licensed or otherwise authorized under this article and article 47 one hundred thirty-seven-a of this title, employed by or under contract 48 with a pharmacy, acting within their respective scopes of practice, may 49 access that pharmacy's electronic database from inside or outside the 50 pharmacy and perform prescription or order processing functions, if both 51 of the following requirements are met: 52 a. the pharmacy establishes controls to protect the confidentiality 53 and integrity of protected patient information; and 54 b. no part of the database is duplicated, downloaded, or removed from 55 the pharmacy's electronic database.

A. 9729 4 1 8. Effect. Failure to meet any or all of the requirements of this 2 section may result in a denial of renewal of registration. 3 § 3. Subdivisions 1, 2, and 3 of section 6808-b of the education law, 4 as amended by chapter 567 of the laws of 2002, subdivision 1 as amended 5 by section 5 of part D of chapter 60 of the laws of 2014, are amended to 6 read as follows: 7 1. Definition. The term "nonresident establishment" shall mean any 8 pharmacy located outside of the state that participates in shared phar- 9 macy services for registered pharmacies and/or patients residing in this 10 state or pharmacy, manufacturer, wholesaler, or outsourcing facility 11 located outside of the state that ships, mails or delivers prescription 12 drugs or devices to other establishments, authorized prescribers and/or 13 patients residing in this state. Such establishments shall include, but 14 not be limited to, pharmacies that transact business through the use of 15 the internet. 16 2. Registration. All nonresident establishments that participate in 17 shared pharmacy services for registered pharmacies and/or patients 18 residing in this state or that ship, mail, or deliver prescription drugs 19 and/or devices to other registered establishments, authorized prescri- 20 bers, and/or patients into this state shall be registered with the 21 department; except that such registration shall not apply to intra-com- 22 pany transfers between any division, affiliate, subsidiaries, parent or 23 other entities under complete common ownership and control. The 24 provisions of this subdivision shall apply solely to nonresident estab- 25 lishments and shall not affect any other provision of this article. 26 3. Agent of record. Each nonresident establishment that participates 27 in shared pharmacy services or ships, mails or delivers drugs and/or 28 devices into this state shall designate a resident agent in this state 29 for service of process pursuant to rule three hundred eighteen of the 30 civil practice law and rules. 31 § 4. This act shall take effect eighteen months after it shall have 32 become a law. Effective immediately, the addition, amendment and/or 33 repeal of any rule or regulation necessary for the implementation of 34 this act on its effective date are authorized to be made and completed 35 on or before such effective date.

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