S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2132
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 23, 2023
                                ___________
 
 Introduced by M. of A. DINOWITZ -- read once and referred to the Commit-
   tee 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
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00901-01-3
 A. 2132                             2
              

 
 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
 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.

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  2132--B
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 23, 2023
                                ___________
 
 Introduced  by M. of A. DINOWITZ, BORES, SIMON -- read once and referred
   to the Committee on Higher Education  --  committee  discharged,  bill
   amended,  ordered reprinted as amended and recommitted to said commit-
   tee -- recommitted to the Committee on Higher Education in  accordance
   with  Assembly  Rule  3, sec. 2 -- committee discharged, bill amended,
   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:
 
   Section  1.  Section  6802 of the education law is amended by adding a
 new subdivision 30 to read as follows:
   30. "AUTOMATED DISPENSING DEVICE (ADD)" SHALL MEAN A MECHANICAL SYSTEM
 USED IN NURSING HOMES AND RESIDENTIAL HEALTH  CARE  FACILITIES  LICENSED
 PURSUANT  TO  ARTICLE TWENTY-EIGHT OF THE PUBLIC HEALTH LAW AND HOSPICES
 CERTIFIED PURSUANT TO ARTICLE FORTY OF THE PUBLIC HEALTH LAW, THAT PACK-
 AGES AND LABELS PATIENT SPECIFIC MEDICATION OR MULTIPLE MEDICATIONS  FOR
 THE PURPOSES OF ADMINISTRATION BY A HEALTH CARE PROFESSIONAL LICENSED TO
 ADMINISTER  MEDICATIONS BY THE STATE OF NEW YORK BASED ON A PRESCRIPTION
 OR ORDER THAT HAS COMPLETED FINAL VERIFICATION BY A LICENSED PHARMACIST.
   § 2. The education law is amended by adding a new section 6809 to read
 as follows:
   § 6809. AUTOMATED  STORAGE  AND  DISPENSING  OF  MEDICATIONS.  1.  FOR
 PURPOSES OF THIS SECTION, "AUTOMATED DISPENSING DEVICE (ADD)" SHALL HAVE
 THE  SAME  MEANING  AS SUBDIVISION THIRTY OF SECTION SIXTY-EIGHT HUNDRED
 TWO OF THIS ARTICLE.
   2. THE ADD AND ITS CONTENTS SHALL REMAIN THE PROPERTY  OF  A  PHARMACY
 REGISTERED  UNDER  THIS  ARTICLE.    THE  PHARMACY  SHALL  MAINTAIN  ALL
 CONTROLS, RECORD KEEPING AS REQUIRED BY ALL LAWS, RULES AND  REGULATIONS
 OF  THE  STATE.  PHARMACIES  UTILIZING  AUTOMATED  DISPENSING DEVICES AS
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00901-05-3
              

 A. 2132--B                          2
 
 PERMITTED UNDER  THIS  SECTION  FOR  ROUTINE  MEDICATION  DISPENSING  OF
 CONTROLLED  SUBSTANCES  SHALL  OBTAIN  A  MACHINE-SPECIFIC  FEDERAL DRUG
 ENFORCEMENT ADMINISTRATION (DEA-ADD) REGISTRATION NUMBER, AND THE APPRO-
 PRIATE NEW YORK STATE LICENSING.
   3.   THE PHARMACY SHALL MAINTAIN RECORDS ON SITE AT THE PHARMACY (HARD
 COPY OR ELECTRONIC) FOR NOT LESS  THAN  TEN  YEARS,  INCLUDING  BUT  NOT
 LIMITED TO:
   A.  DOCUMENTATION  OF  THE  APPROVAL  FOR USE AND PLACEMENT OF THE ADD
 RECEIVED FROM THE DEPARTMENT AND/OR THE BOARD OF PHARMACY;
   B. DELIVERY MANIFESTS OR SIMILAR ELECTRONIC DOCUMENTATION  THAT  MONI-
 TORS  THE  TRANSPORT  OF  CONTROLLED SUBSTANCES BETWEEN THE PHARMACY AND
 ADD;
   C. ADD CLEANING AND MAINTENANCE LOGS OR SIMILAR DOCUMENTATION;
   D. RECORDS AND/OR ELECTRONIC DATA OF  ALL  EVENTS  INVOLVING  THE  ADD
 INCLUDING BUT NOT LIMITED TO:
   (I) IDENTITY OF ALL PERSONNEL WHO ACCESS THE CONTENTS;
   (II) LOCATION OF THE SYSTEM ACCESSED;
   (III) TYPE OF TRANSACTION WITH DATE/TIME STAMP;
   (IV) NAME, STRENGTH, DOSAGE FORM, AND QUANTITY OF THE ACCESSED MEDICA-
 TION;
   (V)  NAME  OR  OTHER IDENTIFIER OF THE PATIENT FOR WHOM THE MEDICATION
 WAS ORDERED;
   (VI) RECONCILIATION OF ALL CONTROLLED SUBSTANCE INVENTORIES  AT  LEAST
 MONTHLY.
   4.    THE PREPACKAGED CARTRIDGES OR CONTAINERS MAY BE SENT TO A REMOTE
 SITE TO BE LOADED INTO SUCH MACHINE BY PERSONNEL DESIGNATED BY THE PHAR-
 MACIST-IN-CHARGE PROVIDED:
   A. THE INDIVIDUAL CARTRIDGES OR CONTAINERS  ARE  TRANSPORTED  TO  SUCH
 REMOTE SITE IN A SECURE, TAMPER-EVIDENT CONTAINER; AND
   B.  THE AUTOMATED PHARMACY SYSTEM USES BAR-CODING, MICROCHIP, OR OTHER
 TECHNOLOGIES TO ENSURE THAT THE CONTAINERS ARE ACCURATELY LOADED IN  THE
 AUTOMATED PHARMACY SYSTEM.
   5.  ACCESS  TO  AN  ADD SHALL BE RESTRICTED TO AUTHORIZED PHARMACY AND
 FACILITY NURSING LICENSED PERSONNEL,  REGISTERED  PHARMACY  TECHNICIANS,
 AND  PHARMACY  AIDES  AS  ESTABLISHED  BY THE FACILITY ADMINISTRATION IN
 CONJUNCTION WITH THE PHARMACIST-IN-CHARGE.   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 PHARMACY  AND  THE  FACILITY  SHALL  IMPLEMENT  AND  MAINTAIN
 ADEQUATE  AND  APPROPRIATE  POLICIES,  PROCEDURES  AND QUALITY ASSURANCE
 PROGRAMS TO ENSURE SAFETY, ACCURACY, SECURITY,  ACCOUNTABILITY,  PATIENT
 CONFIDENTIALITY,  AND  FUNCTIONALITY  WITH RESPECT TO ADMINISTRATION AND
 USAGE OF ADD.
   8. THE ADD WILL BE MONITORED AT THE FACILITY CONTINUOUSLY BY VIDEO AND
 UNDER VISUAL SUPERVISION BY A PHARMACIST DURING THE LOADING PROCESS.
   9. ANY LOSSES OF MEDICATION SHALL BE REPORTED IN ACCORDANCE  WITH  THE
 REQUIREMENTS OF THE SERVICING PHARMACY'S LICENSING BODY.
   §  3.  This  act  shall take effect on the sixtieth day after it shall
 have become a law.