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.
STATE OF NEW YORK
________________________________________________________________________
6182
2025-2026 Regular Sessions
IN ASSEMBLY
February 26, 2025
___________
Introduced by M. of A. DINOWITZ, BORES, SIMON -- read once and referred
to the Committee on Higher Education
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 31 to read as follows:
3 31. "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 6833 to read
12 as follows:
13 § 6833. 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 thirty-one 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
23 Enforcement Administration (DEA-ADD) registration number, and the appro-
24 priate New York state licensing.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD09313-01-5
A. 6182 2
1 3. The pharmacy shall maintain records on site at the pharmacy (hard
2 copy or electronic) for not less than ten years, including but not
3 limited to:
4 a. documentation of the approval for use and placement of the ADD
5 received from the department and/or the board of pharmacy;
6 b. delivery manifests or similar electronic documentation that moni-
7 tors the transport of controlled substances between the pharmacy and
8 ADD;
9 c. ADD cleaning and maintenance logs or similar documentation;
10 d. records and/or electronic data of all events involving the ADD
11 including but not limited to:
12 (i) identity of all personnel who access the contents;
13 (ii) location of the system accessed;
14 (iii) type of transaction with date/time stamp;
15 (iv) name, strength, dosage form, and quantity of the accessed medica-
16 tion;
17 (v) name or other identifier of the patient for whom the medication
18 was ordered;
19 (vi) reconciliation of all controlled substance inventories at least
20 monthly.
21 4. The prepackaged cartridges or containers may be sent to a remote
22 site to be loaded into such machine by personnel designated by the phar-
23 macist-in-charge provided:
24 a. the individual cartridges or containers are transported to such
25 remote site in a secure, tamper-evident container; and
26 b. the automated pharmacy system uses bar-coding, microchip, or other
27 technologies to ensure that the containers are accurately loaded in the
28 automated pharmacy system.
29 5. Access to an ADD shall be restricted to authorized pharmacy and
30 facility nursing licensed personnel, registered pharmacy technicians,
31 and pharmacy aides as established by the facility administration in
32 conjunction with the pharmacist-in-charge. A list of such authorized
33 personnel shall be maintained at all times within the system and shall
34 be reviewed and updated periodically.
35 6. All medications, including controlled substances shall be dispensed
36 from an automated dispensing device pursuant to a valid, patient-specif-
37 ic prescription or order.
38 7. The pharmacy and the facility shall implement and maintain
39 adequate and appropriate policies, procedures and quality assurance
40 programs to ensure safety, accuracy, security, accountability, patient
41 confidentiality, and functionality with respect to administration and
42 usage of ADD.
43 8. The ADD will be monitored at the facility continuously by video and
44 under visual supervision by a pharmacist during the loading process.
45 9. Any losses of medication shall be reported in accordance with the
46 requirements of the servicing pharmacy's licensing body.
47 § 3. This act shall take effect on the sixtieth day after it shall
48 have become a law.
