STATE OF NEW YORK
________________________________________________________________________
8474
IN SENATE
June 3, 2020
___________
Introduced by Sen. SAVINO -- read twice and ordered printed, and when
printed to be committed to the Committee on Rules
AN ACT to amend the education law and the public health 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 designed for use in health care facilities allowing for computer-cont-
5 rolled storage, packaging and dispensing of drugs and devices to
6 licensed health care professionals near the point of care.
7 § 2. The public health law is amended by adding a new section 280-d to
8 read as follows:
9 § 280-d. Automated storage and dispensing of controlled substances. 1.
10 For purposes of this section, "automated dispensing device (ADD)" shall
11 mean a mechanical system designed for use in health care facilities
12 allowing for computer-controlled storage, packaging and dispensing of
13 drugs and devices to licensed health care professionals near the point
14 of care.
15 2. Notwithstanding any provision of law, rule or regulation to the
16 contrary, licensed health care facilities throughout the state shall be
17 permitted to use automated dispensing devices to store, package and
18 dispense medications, including controlled substances, as authorized by
19 such facility's licensing body.
20 3. The ADD and its contents shall remain the property of the pharmacy.
21 4. Licensed health care facilities shall implement and maintain
22 adequate and appropriate policies, procedures and quality assurance
23 programs to ensure safety, accuracy, security, accountability, patient
24 confidentiality and functionally with respect to the administration and
25 usage of automated dispensing devices.
26 5. Access to an automated dispensing device within a licensed health
27 care facility shall be restricted to authorized licensed personnel, and
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD16526-02-0
S. 8474 2
1 a list of such authorized personnel shall be maintained at all times
2 within the system and shall be reviewed and updated periodically.
3 6. All medications, including controlled substances shall be dispensed
4 from an automated dispensing device pursuant to a valid, patient-specif-
5 ic prescription or order.
6 7. The servicing pharmacy shall maintain records on-site for a period
7 of not less than five years with respect to the use of automated
8 dispensing devices. Such records shall include:
9 (a) documentation of the approval for use and placement of an auto-
10 mated dispensing device by such licensed health care facility from such
11 facility's licensing body, if applicable;
12 (b) the location of all automated dispensing devices being used at
13 such facility;
14 (c) delivery manifests or similar electronic documentation which moni-
15 tors the transport of controlled substances between the servicing phar-
16 macy and the automated dispensing device;
17 (d) automated dispensing device maintenance and cleaning logs, or
18 similar documentation;
19 (e) documentation or electronic data of all events involving an auto-
20 mated dispensing device, including, but not limited to:
21 (i) the identity of personnel who have accessed the contents of such
22 device;
23 (ii) the location of the device accessed;
24 (iii) the type of transaction, including a date and time stamp;
25 (iv) the name, strength, dosage form and quantity of an accessed prod-
26 uct;
27 (v) the name or other identifier of the patient for whom the
28 controlled substance was ordered; and
29 (vi) reconciliation of all inventory activities.
30 8. Any losses of medication shall be reported in accordance with the
31 requirements of the servicing pharmacy's licensing body.
32 9. Servicing pharmacies utilizing automated dispensing devices in
33 licensed health care facilities for routine medication dispensing, for
34 emergency medication kits or other similar approved use, shall be loaded
35 by either a:
36 (a) pharmacy technician, pharmacy intern, or pharmacist; or
37 (b) licensed nurse.
38 10. Servicing pharmacies utilizing automated dispensing devices in
39 licensed health care facilities for routine medication dispensing of
40 controlled substances shall obtain a machine-specific federal Drug
41 Enforcement Agency (DEA) registration number, and appropriate New York
42 state licensing.
43 11. Servicing pharmacies utilizing automated dispensing devices in
44 licensed health care facilities for routine medication dispensing shall
45 ensure that such device is continually monitored by video.
46 § 3. This act shall take effect immediately.