S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8474
 
                             I N  S E N A T E
 
                               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:
 
   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

 S. 8474                             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.