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--A
 
                        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 -- 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 29 to read as follows:
   29. "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  TWENTY-NINE  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
 PERMITTED  UNDER  THIS  SECTION  FOR  ROUTINE  MEDICATION  DISPENSING OF
 CONTROLLED SUBSTANCES  SHALL  OBTAIN  A  MACHINE-SPECIFIC  FEDERAL  DRUG
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00901-02-3
 A. 2132--A                          2
              

 
 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 FIVE YEARS  AS  REQUIRED  BY  PART
 SIXTY-THREE  OF  THE  REGULATIONS OF THE COMMISSIONER, 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.