S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   10784
 
                           I N  A S S E M B L Y
 
                               July 10, 2020
                                ___________
 
 Introduced by COMMITTEE ON RULES -- (at request of M. of A. Dinowitz) --
   read once and referred to the Committee on Higher Education
 
 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:
 
   Section 1. Section 6802 of the education law is amended  by  adding  a
 new subdivision 29 to read as follows:
   29. "AUTOMATED DISPENSING DEVICE (ADD)" SHALL MEAN A MECHANICAL SYSTEM
 DESIGNED  FOR  USE IN HEALTH CARE FACILITIES ALLOWING FOR COMPUTER-CONT-
 ROLLED STORAGE,  PACKAGING  AND  DISPENSING  OF  DRUGS  AND  DEVICES  TO
 LICENSED HEALTH CARE PROFESSIONALS NEAR THE POINT OF CARE.
   § 2. The public health law is amended by adding a new section 280-d to
 read as follows:
   § 280-D. AUTOMATED STORAGE AND DISPENSING OF CONTROLLED SUBSTANCES. 1.
 FOR  PURPOSES OF THIS SECTION, "AUTOMATED DISPENSING DEVICE (ADD)" SHALL
 MEAN A MECHANICAL SYSTEM DESIGNED FOR  USE  IN  HEALTH  CARE  FACILITIES
 ALLOWING  FOR  COMPUTER-CONTROLLED  STORAGE, PACKAGING AND DISPENSING OF
 DRUGS AND DEVICES TO LICENSED HEALTH CARE PROFESSIONALS NEAR  THE  POINT
 OF CARE.
   2.  NOTWITHSTANDING  ANY  PROVISION  OF LAW, RULE OR REGULATION TO THE
 CONTRARY, LICENSED HEALTH CARE FACILITIES THROUGHOUT THE STATE SHALL  BE
 PERMITTED  TO  USE  AUTOMATED  DISPENSING  DEVICES TO STORE, PACKAGE AND
 DISPENSE MEDICATIONS, INCLUDING CONTROLLED SUBSTANCES, AS AUTHORIZED  BY
 SUCH FACILITY'S LICENSING BODY.
   3. THE ADD AND ITS CONTENTS SHALL REMAIN THE PROPERTY OF THE PHARMACY.
   4.  LICENSED  HEALTH  CARE  FACILITIES  SHALL  IMPLEMENT  AND MAINTAIN
 ADEQUATE AND APPROPRIATE  POLICIES,  PROCEDURES  AND  QUALITY  ASSURANCE
 PROGRAMS  TO  ENSURE SAFETY, ACCURACY, SECURITY, ACCOUNTABILITY, PATIENT
 CONFIDENTIALITY AND FUNCTIONALLY WITH RESPECT TO THE ADMINISTRATION  AND
 USAGE OF AUTOMATED DISPENSING DEVICES.
   5.  ACCESS  TO AN AUTOMATED DISPENSING DEVICE WITHIN A LICENSED HEALTH
 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

 A. 10784                            2
 
 A  LIST  OF  SUCH  AUTHORIZED PERSONNEL SHALL BE MAINTAINED AT ALL TIMES
 WITHIN THE SYSTEM AND SHALL BE REVIEWED AND UPDATED PERIODICALLY.
   6. ALL MEDICATIONS, INCLUDING CONTROLLED SUBSTANCES SHALL BE DISPENSED
 FROM AN AUTOMATED DISPENSING DEVICE PURSUANT TO A VALID, PATIENT-SPECIF-
 IC PRESCRIPTION OR ORDER.
   7.  THE SERVICING PHARMACY SHALL MAINTAIN RECORDS ON-SITE FOR A PERIOD
 OF NOT LESS THAN FIVE  YEARS  WITH  RESPECT  TO  THE  USE  OF  AUTOMATED
 DISPENSING DEVICES. SUCH RECORDS SHALL INCLUDE:
   (A)  DOCUMENTATION  OF  THE APPROVAL FOR USE AND PLACEMENT OF AN AUTO-
 MATED DISPENSING DEVICE BY SUCH LICENSED HEALTH CARE FACILITY FROM  SUCH
 FACILITY'S LICENSING BODY, IF APPLICABLE;
   (B)  THE  LOCATION  OF  ALL AUTOMATED DISPENSING DEVICES BEING USED AT
 SUCH FACILITY;
   (C) DELIVERY MANIFESTS OR SIMILAR ELECTRONIC DOCUMENTATION WHICH MONI-
 TORS THE TRANSPORT OF CONTROLLED SUBSTANCES BETWEEN THE SERVICING  PHAR-
 MACY AND THE AUTOMATED DISPENSING DEVICE;
   (D)  AUTOMATED  DISPENSING  DEVICE  MAINTENANCE  AND CLEANING LOGS, OR
 SIMILAR DOCUMENTATION;
   (E) DOCUMENTATION OR ELECTRONIC DATA OF ALL EVENTS INVOLVING AN  AUTO-
 MATED DISPENSING DEVICE, INCLUDING, BUT NOT LIMITED TO:
   (I)  THE  IDENTITY OF PERSONNEL WHO HAVE ACCESSED THE CONTENTS OF SUCH
 DEVICE;
   (II) THE LOCATION OF THE DEVICE ACCESSED;
   (III) THE TYPE OF TRANSACTION, INCLUDING A DATE AND TIME STAMP;
   (IV) THE NAME, STRENGTH, DOSAGE FORM AND QUANTITY OF AN ACCESSED PROD-
 UCT;
   (V) THE  NAME  OR  OTHER  IDENTIFIER  OF  THE  PATIENT  FOR  WHOM  THE
 CONTROLLED SUBSTANCE WAS ORDERED; AND
   (VI) RECONCILIATION OF ALL INVENTORY ACTIVITIES.
   8.  ANY  LOSSES OF MEDICATION SHALL BE REPORTED IN ACCORDANCE WITH THE
 REQUIREMENTS OF THE SERVICING PHARMACY'S LICENSING BODY.
   9. SERVICING PHARMACIES  UTILIZING  AUTOMATED  DISPENSING  DEVICES  IN
 LICENSED  HEALTH  CARE FACILITIES FOR ROUTINE MEDICATION DISPENSING, FOR
 EMERGENCY MEDICATION KITS OR OTHER SIMILAR APPROVED USE, SHALL BE LOADED
 BY EITHER A:
   (A) PHARMACY TECHNICIAN, PHARMACY INTERN, OR PHARMACIST; OR
   (B) LICENSED NURSE.
   10. SERVICING PHARMACIES UTILIZING  AUTOMATED  DISPENSING  DEVICES  IN
 LICENSED  HEALTH  CARE  FACILITIES  FOR ROUTINE MEDICATION DISPENSING OF
 CONTROLLED SUBSTANCES  SHALL  OBTAIN  A  MACHINE-SPECIFIC  FEDERAL  DRUG
 ENFORCEMENT  AGENCY  (DEA) REGISTRATION NUMBER, AND APPROPRIATE NEW YORK
 STATE LICENSING.
   11. SERVICING PHARMACIES UTILIZING  AUTOMATED  DISPENSING  DEVICES  IN
 LICENSED  HEALTH CARE FACILITIES FOR ROUTINE MEDICATION DISPENSING SHALL
 ENSURE THAT SUCH DEVICE IS CONTINUALLY MONITORED BY VIDEO.
   § 3. This act shall take effect immediately.