Bill Text: NY A05512 | 2021-2022 | General Assembly | Amended
Bill Title: Relates to the automated storage and dispensing of controlled substances using an automated dispensing device at licensed nursing homes, residential health care facilities and hospices.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2022-01-05 - referred to higher education [A05512 Detail]
Download: New_York-2021-A05512-Amended.html
STATE OF NEW YORK ________________________________________________________________________ 5512--A 2021-2022 Regular Sessions IN ASSEMBLY February 19, 2021 ___________ Introduced by M. of A. DINOWITZ -- read once and referred to the Commit- tee on Higher Education -- again reported from said committee with amendments, ordered reprinted as amended and recommitted to said committee AN ACT to amend the education law, in relation to the automated storage and dispensing of controlled substances using an automated dispensing device 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 29 to read as follows: 3 29. "Automated dispensing device (ADD)" shall mean a mechanical system 4 used in nursing homes and residential health care facilities licensed 5 pursuant to article twenty-eight of the public health law and hospices 6 certified pursuant to article forty of the public health law, that pack- 7 ages and labels patient specific medication or multiple medications for 8 the purposes of administration by a health care professional licensed to 9 administer medications by the state of New York based on a prescription 10 or order that has completed final verification by a licensed pharmacist. 11 § 2. The education law is amended by adding a new section 6809 to read 12 as follows: 13 § 6809. Automated storage and dispensing of medications. 1. For 14 purposes of this section, "automated dispensing device (ADD)" shall have 15 the same meaning as subdivision twenty-nine of section sixty-eight 16 hundred two of this article. 17 2. The ADD and its contents shall remain the property of a pharmacy 18 registered under this article. The pharmacy shall maintain all 19 controls, record keeping as required by all laws, rules and regulations 20 of the state. Pharmacies utilizing automated dispensing devices as 21 permitted under this section for routine medication dispensing of 22 controlled substances shall obtain a machine-specific federal Drug EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD05766-06-1A. 5512--A 2 1 Enforcement Administration (DEA-ADD) registration number, and the appro- 2 priate New York state licensing. 3 3. The pharmacy shall maintain records on site at the pharmacy (hard 4 copy or electronic) for not less than five years as required by part 5 sixty-three of the regulations of the commissioner, including but not 6 limited to: 7 a. documentation of the approval for use and placement of the ADD 8 received from the department and/or the board of pharmacy; 9 b. delivery manifests or similar electronic documentation that moni- 10 tors the transport of controlled substances between the pharmacy and 11 ADD; 12 c. ADD cleaning and maintenance logs or similar documentation; 13 d. records and/or electronic data of all events involving the ADD 14 including but not limited to: 15 (i) identity of all personnel who access the contents; 16 (ii) location of the system accessed; 17 (iii) type of transaction with date/time stamp; 18 (iv) name, strength, dosage form, and quantity of the accessed medica- 19 tion; 20 (v) name or other identifier of the patient for whom the medication 21 was ordered; 22 (vi) reconciliation of all controlled substance inventories at least 23 monthly. 24 4. The prepackaged cartridges or containers may be sent to a remote 25 site to be loaded into such machine by personnel designated by the phar- 26 macist-in-charge provided: 27 a. the individual cartridges or containers are transported to such 28 remote site in a secure, tamper-evident container; and 29 b. the automated pharmacy system uses bar-coding, microchip, or other 30 technologies to ensure that the containers are accurately loaded in the 31 automated pharmacy system. 32 5. Access to an ADD shall be restricted to authorized pharmacy and 33 facility nursing licensed personnel, registered pharmacy technicians, 34 and pharmacy aides as established by the facility administration in 35 conjunction with the pharmacist-in-charge. A list of such authorized 36 personnel shall be maintained at all times within the system and shall 37 be reviewed and updated periodically. 38 6. All medications, including controlled substances shall be dispensed 39 from an automated dispensing device pursuant to a valid, patient-specif- 40 ic prescription or order. 41 7. The pharmacy and the facility shall implement and maintain 42 adequate and appropriate policies, procedures and quality assurance 43 programs to ensure safety, accuracy, security, accountability, patient 44 confidentiality, and functionality with respect to administration and 45 usage of ADD. 46 8. The ADD will be monitored at the facility continuously by video and 47 under visual supervision by a pharmacist during the loading process. 48 9. Any losses of medication shall be reported in accordance with the 49 requirements of the servicing pharmacy's licensing body. 50 § 3. This act shall take effect on the sixtieth day after it shall 51 have become a law.
