NY State Senate Bill 2021-S58

Senate Bill S58

2021-2022 Legislative Session

Directs the commissioner of health to promulgate and implement rules authorizing the use of automated patient dispensing and storage systems

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Archive: Last Bill Status - In Senate Committee Higher Education Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 05, 2022	referred to higher education
Jan 06, 2021	referred to higher education

2021-S58 (ACTIVE) - Details

See Assembly Version of this Bill:: A5640
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6808, Ed L; add §280-d, Pub Health L
Versions Introduced in 2019-2020 Legislative Session:: S9047

2021-S58 (ACTIVE) - Summary

Directs the commissioner of health, in consultation with the commissioner of education, the commissioner of mental health, the state board of pharmacy and the commissioner of corrections and community supervision, to promulgate and implement rules and regulations authorizing the use of automated patient dispensing and storage systems for distribution of prescription and non-prescription drugs and medical devices.

2021-S58 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S58

SPONSOR: PERSAUD
 
TITLE OF BILL:

An act to amend the education law and the public health law, in relation
to directing the commissioner of health, in consultation with the
commissioner of education, the commissioner of mental health, the state
board of pharmacy and the commissioner of corrections and community
supervision, to promulgate and implement rules and regulations authoriz-
ing the use of automated patient dispensing and storage systems for
distribution of prescription and non-prescription drugs and medical
devices

 
PURPOSE OR GENERAL IDEA OF BILL:

The purpose of the bill is to direct the commissioner of health to
promulgate and implement rules authorizing the use of automated patient
dispensing and storage systems.

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1. Subdivision 1 of section 6808 of the education law, as
amended by section 2 of part D of chapter 60 of the laws of 2014, is
amended to read as follows: no person, firm, corporation or association
shall possess drugs prescriptions or poisons for the purpose of
compounding, dispensing, retailing, wholesaling, or manufacturing, or
shall offer drugs, prescriptions or poisons for sale at retail or whole-
sale unless registered by the department as a pharmacy, wholesaler,
manufacturer or outsourcing facility; provided, however, that the
provisions of this section shall not prohibit the dispensing and/or
storage of prescriptions, drugs or medical devices through the use of an
automated patient dispensing and storage system as provided in section
two hundred eighty-d of the public health law and rules and regulations
promulgated pursuant to such section.

 
JUSTIFICATION:

This bill is to facilitate patient safety, pharmacist commitment to
direct patient care, cost reduction, as well as incorporating rapid
innovation of technology into a safe medication process.  Recently,
Texas and South Carolina modified their pharmacy rules to allow for the
use of prescription pick-up kiosks, automated storage, dispensing, and
delivery systems amid the COVID-19 pandemic.  According to one of the
research that was done by the New York Times, on January 31, 2020, there
have been numerous life threatened errors made by overworked and burned-
out pharmacists who had to meet corporate unreasonable and unsafe
metrics. Pharmacists across the U.S. go through a great deal of struggle
to fill prescriptions, give flu shots, answer phones, work the regis-
ters, tend to patients and drive -through, call doctors and insurance
companies. The New York Times found out that many mistakes that are made
by overworked pharmacists were not accessible to the public because
companies often made the victims or; their families sign a confidential-
ity agreement before the settlements.

The automated dispenser makes it convenient for prescriptions to be sent
directly from a doctor's office to a pharmacist who can scan the
patient's file, refill the order, and put it into the dispenser for pick
up. The automated drug-dispensing machine can be efficient in reducing
the risk of medication contamination; the medications are kept in a safe
and sterile environment.

In 2001, Scott: Cybermedicine and Virtual Pharmacies reported the Army
has tested the automated drug dispensing systems and believes it can be
beneficial to an already sick soldier who is about to be deployed.
According to Health.mil the official website of the Military Health
System, the Air Force had its first automated patient dispensing and
storage system installed in June 2009. States such as California, Virgi-
nia, and Illinois are currently using the automated patient dispensing
system. The state of Florida allows Pharmaceutical kiosks in long-term-
care facilities, correctional institutions, hospices, and hospitals.
In-house pharmacists can focus on direct patient care while the kiosks
provide remote pharmacist consultation when needed.  Researchers have
done multiple studies regarding the importance of automated prescription
dispensers on school campuses, nursing home facilities, long-term care
facilities, hospitals, and in house pharmacies. A research that was done
by PubMed Central (PMC), which is a free full-text archive of biomedi-
cal, and life sciences journal literature, at the U.S. National Insti-
tutes of Health's National Library of Medicine concluded: "automated
dispensing machines eliminate the dispensing of unused "a s-needed" or
(PRN) doses, which in Latin means pro re nata, thereby decreasing the
potential for administration errors that can arise if more doses than
needed are dispensed and available for administration." The automated
dispensing machine is very helpful, and it improves customer service. It
allows pharmacists to devote more time to patient care services such as;
answering questions about prescriptions and provide basic preventive
care.  The automated dispenser will allow Pharmacists the ability to
track and monitor the drug usage pattern. Such data will be easily
accessible and can be shared with other healthcare professionals when
needed.

 
PRIOR LEGISLATIVE HISTORY:

2020: S9047 referred to rules

 
FISCAL IMPLICATIONS:

None

 
EFFECTIVE DATE:
This act shall take effect immediately.

2021-S58 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                    58
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                                (PREFILED)
 
                              January 6, 2021
                                ___________
 
 Introduced  by  Sen. PERSAUD -- read twice and ordered printed, and when
   printed to be committed to the Committee on Higher Education
 
 AN ACT to amend the education law and the public health law, in relation
   to directing the commissioner of  health,  in  consultation  with  the
   commissioner  of  education,  the  commissioner  of mental health, the
   state board of pharmacy and the commissioner of corrections and commu-
   nity supervision, to promulgate and implement  rules  and  regulations
   authorizing  the  use  of  automated  patient  dispensing  and storage
   systems for distribution of prescription  and  non-prescription  drugs
   and medical devices
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1.  Subdivision 1 of section 6808 of  the  education  law,  as
 amended  by  section  2  of part D of chapter 60 of the laws of 2014, is
 amended to read as follows:
   1. No person, firm, corporation or association  shall  possess  drugs,
 prescriptions  or  poisons  for  the purpose of compounding, dispensing,
 retailing,  wholesaling,  or  manufacturing,  or  shall   offer   drugs,
 prescriptions  or  poisons for sale at retail or wholesale unless regis-
 tered by the department  as  a  pharmacy,  wholesaler,  manufacturer  or
 outsourcing  facility;  PROVIDED,  HOWEVER,  THAT THE PROVISIONS OF THIS
 SECTION  SHALL  NOT  PROHIBIT   THE   DISPENSING   AND/OR   STORAGE   OF
 PRESCRIPTIONS,  DRUGS OR MEDICAL DEVICES THROUGH THE USE OF AN AUTOMATED
 PATIENT DISPENSING AND STORAGE SYSTEM AS PROVIDED IN SECTION TWO HUNDRED
 EIGHTY-D OF THE PUBLIC HEALTH LAW AND RULES AND REGULATIONS  PROMULGATED
 PURSUANT TO SUCH SECTION.
   § 2. The public health law is amended by adding a new section 280-d to
 read as follows:
   §  280-D.  AUTOMATED  PATIENT  DISPENSING  AND STORAGE SYSTEMS. 1. THE
 COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER  OF  EDUCATION,  THE
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets

                       [ ] is old law to be omitted.
                                                            LBD02912-01-1

 S. 58                               2
 
 COMMISSIONER  OF  MENTAL  HEALTH,  THE  STATE  BOARD OF PHARMACY AND THE
 COMMISSIONER OF CORRECTIONS AND COMMUNITY SUPERVISION, SHALL  PROMULGATE
 RULES  AND  REGULATIONS  TO AUTHORIZE THE LICENSING AND USE OF AUTOMATED
 PATIENT DISPENSING AND STORAGE SYSTEMS AS PROVIDED IN THIS SECTION WHICH
 SHALL  INCLUDE, BUT NOT BE LIMITED TO, REQUIRING THAT THE OPERATOR OF AN
 AUTOMATED PATIENT DISPENSING AND STORAGE  SYSTEM  HOLDS  A  REGISTRATION
 FROM  THE  FEDERAL  DRUG  ENFORCEMENT  AGENCY  FOR  THE  DISTRIBUTION OF
 CONTROLLED SUBSTANCES.
   2. DEFINITIONS. AS USED IN THIS SECTION:
   (A) "AUTOMATED DRUG DELIVERY SYSTEM"  OR  "ADDS"  MEANS  A  MECHANICAL
 SYSTEM THAT PERFORMS OPERATIONS OR ACTIVITIES, OTHER THAN COMPOUNDING OR
 ADMINISTRATION,  RELATIVE TO THE STORAGE, DISPENSING, OR DISTRIBUTION OF
 DRUGS. AN ADDS SHALL COLLECT,  CONTROL,  AND  MAINTAIN  ALL  TRANSACTION
 INFORMATION  TO  ACCURATELY  TRACK THE MOVEMENT OF DRUGS INTO AND OUT OF
 THE SYSTEM FOR SECURITY, ACCURACY, AND ACCOUNTABILITY.
   (B) "AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM" OR "APDSS" MEANS
 AN ADDS FOR STORAGE AND DISPENSING OF DRUGS DIRECTLY TO PATIENTS  OR  TO
 MEDICAL  PERSONNEL  FOR  PROMPT  ADMINISTRATION  TO PATIENTS PURSUANT TO
 PRIOR AUTHORIZATION BY A PHARMACIST.
   (C) "COVERED ENTITY" MEANS:
   (I) A "COVERED ENTITY" AS DEFINED IN SECTION 256B OF TITLE 42  OF  THE
 UNITED STATES CODE; AND
   (II)  A  CORRECTIONAL  FACILITY  AS  DEFINED  IN  SECTION  TWO  OF THE
 CORRECTION LAW.
   (D) "DRUG" MEANS A CONTROLLED SUBSTANCE AS DEFINED IN SECTION  THIRTY-
 THREE  HUNDRED SIX OF THIS CHAPTER, A NON-PRESCRIPTION DRUG OR OVER-THE-
 COUNTER MEDICATION OR SUPPLY, AND/OR A MEDICAL DEVICE.
   (E) "PATIENT"  MEANS  AN  INDIVIDUAL  FOR  WHOM  MEDICATION  HAS  BEEN
 PRESCRIBED  BY ANY PERSON AUTHORIZED TO PRESCRIBE MEDICATION PURSUANT TO
 ARTICLE ONE HUNDRED THIRTY-ONE, ONE HUNDRED THIRTY-ONE-B OR ONE  HUNDRED
 FORTY-ONE OF THE EDUCATION LAW.
   3. PURSUANT TO THE RULES AND REGULATIONS AUTHORIZED BY SUBDIVISION ONE
 OF  THIS SECTION, IF ALL OF THE FOLLOWING CONDITIONS ARE MET, A PHARMACY
 LOCATED IN THE STATE MAY PROVIDE PHARMACY SERVICES THROUGH THE USE OF AN
 AUTOMATED PATIENT DISPENSING SYSTEM TO:  (I) THE PATIENTS OF  A  COVERED
 ENTITY THROUGH AN APDSS LOCATED ON THE PREMISES OF THE COVERED ENTITY OR
 ON  THE  PREMISES  OF  MEDICAL  PROFESSIONAL PRACTICES UNDER CONTRACT TO
 PROVIDE MEDICAL SERVICES TO COVERED ENTITY PATIENTS, WHICH NEED  NOT  BE
 THE  SAME  LOCATION  AS  THE  PHARMACY;  AND (II) INDIVIDUAL PATIENTS AS
 DESCRIBED IN SUBDIVISION FIVE OF THIS SECTION:
   (A) THE PHARMACY OBTAINS A LICENSE FROM THE STATE BOARD OF PHARMACY TO
 OPERATE THE APDSS AT THE COVERED ENTITY OR AN AFFILIATED SITE, OR AT  OR
 ADJACENT TO THE PHARMACY, AS APPLICABLE. AS PART OF THE APPLICATION, THE
 PHARMACY  SHALL  PROVIDE  THE ADDRESS AT WHICH THE APDSS SHALL BE PLACED
 AND, IF THE APDSS IS TO BE INSTALLED AT A COVERED ENTITY,  IDENTIFY  THE
 COVERED  ENTITY.  A SEPARATE LICENSE SHALL BE REQUIRED FOR EACH LOCATION
 AND SHALL BE RENEWED ANNUALLY CONCURRENT WITH THE PHARMACY LICENSE.  THE
 APPLICATION  AND  RENEWAL  FEE SHALL BE THREE HUNDRED DOLLARS AND MAY BE
 INCREASED TO FIVE HUNDRED DOLLARS.   THE  STATE  BOARD  OF  PHARMACY  IS
 AUTHORIZED TO LOWER THE RENEWAL FEE TO NOT LESS THAN TWO HUNDRED DOLLARS
 IF  A  LOWER  FEE LEVEL WILL PROVIDE SUFFICIENT RESOURCES TO SUPPORT THE
 REGULATORY ACTIVITIES.
   (B) THE PHARMACY PROVIDING THE PHARMACY SERVICES TO THE PATIENTS OF  A
 COVERED ENTITY, INCLUDING, UNLESS OTHERWISE PROHIBITED BY ANY OTHER LAW,
 PATIENTS  ENROLLED IN THE MEDICARE AND MEDICAID PROGRAMS, SHALL BE UNDER

 S. 58                               3
 
 CONTRACT WITH THAT COVERED ENTITY TO  PROVIDE  THOSE  PHARMACY  SERVICES
 THROUGH THE USE OF THE APDSS.
   (C)  DRUGS  STORED  IN  AN APDSS SHALL BE PART OF THE INVENTORY OF THE
 PHARMACY PROVIDING PHARMACY SERVICES TO THE PATIENTS AND DRUGS DISPENSED
 FROM THE APDSS SHALL BE CONSIDERED TO HAVE BEEN DISPENSED BY THAT  PHAR-
 MACY.
   (D)  THE PHARMACY SHALL MAINTAIN RECORDS OF THE ACQUISITION AND DISPO-
 SITION OF DRUGS  STORED  IN  THE  APDSS  SEPARATE  FROM  OTHER  PHARMACY
 RECORDS.
   (E)  THE PHARMACY SHALL BE SOLELY RESPONSIBLE FOR THE SECURITY, OPERA-
 TION, AND MAINTENANCE OF THE APDSS; PROVIDED,  HOWEVER,  THAT  AN  APDSS
 INSTALLED  AT  A  CORRECTIONAL  FACILITY SHALL BE DEEMED TO BE UNDER THE
 DUAL SECURITY AND CONTROL OF THE PHARMACY AND THE CORRECTIONAL FACILITY.
   (F) THE PHARMACY SHALL PROVIDE TRAINING REGARDING  THE  OPERATION  AND
 USE OF THE APDSS TO BOTH PHARMACY AND COVERED ENTITY PERSONNEL USING THE
 SYSTEM.
   (G)  THE  OPERATION  OF  THE APDSS SHALL BE UNDER THE SUPERVISION OF A
 PHARMACIST LICENSED PURSUANT TO ARTICLE ONE HUNDRED THIRTY-SEVEN OF  THE
 EDUCATION LAW ACTING ON BEHALF OF THE PHARMACY PROVIDING SERVICES TO THE
 PATIENTS  OF  THE  COVERED ENTITY. THE PHARMACIST NEED NOT BE PHYSICALLY
 PRESENT AT THE SITE OF THE APDSS AND MAY SUPERVISE THE SYSTEM  ELECTRON-
 ICALLY.
   (H)  THE STATE BOARD OF PHARMACY MAY ISSUE A LICENSE FOR THE OPERATION
 OF AN APDSS AT AN ADDRESS FOR WHICH IT HAS ISSUED ANOTHER SITE  LICENSE,
 INCLUDING  BUT  NOT  LIMITED  TO  DRIVE-THROUGH PHARMACY AREAS AND OTHER
 AREAS ADJACENT TO THE PHYSICAL LOCATION OCCUPIED BY A PHARMACY.
   (I) THE STATE BOARD OF PHARMACY, WITHIN THIRTY DAYS AFTER  RECEIPT  OF
 AN  APPLICATION  FOR  AN  APDSS  LICENSE,  SHALL CONDUCT A PRE-LICENSURE
 INSPECTION AT THE PROPOSED LOCATION OF  THE  APDSS.  RELOCATION  OF  THE
 APDSS  SHALL REQUIRE A NEW APPLICATION FOR LICENSURE.  REPLACEMENT OF AN
 APDSS SHALL REQUIRE NOTICE TO SUCH BOARD WITHIN THIRTY DAYS.
   (J) THE APDSS LICENSE SHALL BE CANCELED BY OPERATION  OF  LAW  IF  THE
 UNDERLYING  PHARMACY  LICENSE  IS  NOT  CURRENT, VALID, AND ACTIVE. UPON
 REISSUANCE OR REINSTATEMENT OF THE UNDERLYING PHARMACY  LICENSE,  A  NEW
 APPLICATION  FOR  AN APDSS LICENSE SHALL BE SUBMITTED TO THE STATE BOARD
 OF PHARMACY, IF SO REQUIRED BY SUCH BOARD.
   (K) A PHARMACY THAT HOLDS AN APDSS  LICENSE  SHALL  ADVISE  THE  STATE
 BOARD  OF  PHARMACY IN WRITING WITHIN THIRTY DAYS IF USE OF THE APDSS IS
 DISCONTINUED.
   4. (A) AN  AUTOMATED  PATIENT  DISPENSING  AND  STORAGE  SYSTEM  SHALL
 COLLECT, CONTROL, AND MAINTAIN ALL TRANSACTION INFORMATION TO ACCURATELY
 TRACK  THE  MOVEMENT  OF  DRUGS INTO AND OUT OF THE SYSTEM FOR SECURITY,
 ACCURACY, AND ACCOUNTABILITY.
   (B) TRANSACTION INFORMATION SHALL BE MADE READILY AVAILABLE IN A DOWN-
 LOADABLE FORMAT FOR REVIEW AND INSPECTION BY INDIVIDUALS  AUTHORIZED  BY
 LAW TO REVIEW SUCH INFORMATION. THESE RECORDS SHALL BE MAINTAINED BY THE
 PHARMACY FOR A MINIMUM OF THREE YEARS.
   5.  DRUGS  FROM AN AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM MAY
 BE DISPENSED DIRECTLY TO A PATIENT FROM A DRIVE-THROUGH  PHARMACY  AISLE
 OR  OTHER  LOCATION  ADJACENT  TO  THE PHYSICAL LOCATION OCCUPIED BY THE
 PHARMACY, IF ALL OF THE FOLLOWING REQUIREMENTS ARE MET:
   (A) THE PHARMACY DEVELOPS, IMPLEMENTS, AND  ANNUALLY  REVIEWS  WRITTEN
 POLICIES AND PROCEDURES WITH RESPECT TO ALL OF THE FOLLOWING:
   (I)  THE  PHARMACY  MAINTAINS  THE SECURITY OF THE APDSS AND THE DRUGS
 WITHIN THAT APDSS;

 S. 58                               4
 
   (II) THE PHARMACY DETERMINES AND APPLIES INCLUSION CRITERIA  REGARDING
 WHICH  DRUGS  ARE  APPROPRIATE  FOR PLACEMENT IN THE APDSS AND FOR WHICH
 PATIENTS;
   (III)  THE  PHARMACY ENSURES THAT PATIENTS ARE AWARE THAT CONSULTATION
 WITH A PHARMACIST IS AVAILABLE FOR ANY PRESCRIPTION MEDICATION,  INCLUD-
 ING THOSE DELIVERED VIA THE APDSS;
   (IV) THE PHARMACY DESCRIBES THE ASSIGNMENT OF RESPONSIBILITIES TO, AND
 TRAINING  OF, PHARMACY PERSONNEL, AND OTHER PERSONNEL USING THE APDSS AT
 THE LOCATION WHERE THE APDSS IS PLACED, REGARDING MAINTENANCE AND  FILL-
 ING PROCEDURES FOR THE APDSS;
   (V)  THE  PHARMACY  ORIENTS  PARTICIPATING  PATIENTS ON THE USE OF THE
 APDSS, NOTIFYING PATIENTS WHEN EXPECTED PRESCRIPTION MEDICATIONS ARE NOT
 AVAILABLE IN THE APDSS, AND ENSURING THAT PATIENT USE OF THE APDSS  DOES
 NOT INTERFERE WITH DELIVERY OF DRUGS; AND
   (VI)  THE  PHARMACY ENSURES DELIVERY OF DRUGS TO PATIENTS EXPECTING TO
 RECEIVE THEM FROM THE APDSS IN THE EVENT THE AUTOMATED PATIENT  DISPENS-
 ING AND STORAGE SYSTEM IS DISABLED OR MALFUNCTIONS.
   (B)  THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL ONLY BE
 USED FOR PATIENTS WHO HAVE SIGNED A WRITTEN CONSENT DEMONSTRATING  THEIR
 INFORMED CONSENT TO RECEIVE PRESCRIBED DRUGS FROM AN APDSS AND WHOSE USE
 OF  THE APDSS MEET THE CRITERIA PURSUANT TO PARAGRAPH (A) OF THIS SUBDI-
 VISION.
   (C) THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL  HAVE  A
 MEANS TO IDENTIFY EACH PATIENT AND ONLY RELEASE THE IDENTIFIED PATIENT'S
 DRUGS TO THE PATIENT OR THE PATIENT'S AGENT.
   (D) A PHARMACIST SHALL PERFORM ALL CLINICAL SERVICES CONDUCTED AS PART
 OF  THE DISPENSING PROCESS, INCLUDING, BUT NOT LIMITED TO, DRUG UTILIZA-
 TION REVIEW AND CONSULTATION.
   (E) DRUGS SHALL BE DISPENSED FROM THE AUTOMATED PATIENT DISPENSING AND
 STORAGE SYSTEM ONLY UPON AUTHORIZATION FROM A PHARMACIST AFTER THE PHAR-
 MACIST HAS REVIEWED THE  PRESCRIPTION  AND  THE  PATIENT'S  PROFILE  FOR
 POTENTIAL CONTRAINDICATED AND ADVERSE DRUG REACTIONS.
   (F)  ALL  DRUGS  DISPENSED  FROM  THE AUTOMATED PATIENT DISPENSING AND
 STORAGE SYSTEM FOR THE FIRST TIME SHALL BE ACCOMPANIED BY A CONSULTATION
 CONDUCTED BY A PHARMACIST LICENSED PURSUANT TO ARTICLE ONE HUNDRED THIR-
 TY-SEVEN OF THE EDUCATION LAW IN ONE OF THE FOLLOWING  MANNERS:  (I)  IN
 PERSON;  (II)  THROUGH  A  DRIVE-THROUGH PRESCRIPTION DISPENSING WINDOW;
 (III) VIA A TELECOMMUNICATIONS LINK THAT HAS TWO-WAY AUDIO AND VIDEO; OR
 (IV) THROUGH A TELEPHONE CALL BETWEEN THE PHARMACIST AND THE PATIENT  OR
 THE  PATIENT'S  APPOINTED  REPRESENTATIVE WITH THE PRESCRIBING PHYSICIAN
 PRESENT FOR THE DURATION OF THE CALL.
   (G) THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL  INCLUDE
 A  NOTICE,  PROMINENTLY  POSTED  ON THE AUTOMATED PATIENT DISPENSING AND
 STORAGE SYSTEM, THAT PROVIDES THE NAME, ADDRESS, AND TELEPHONE NUMBER OF
 THE PHARMACY THAT HOLDS THE AUTOMATED  PATIENT  DISPENSING  AND  STORAGE
 SYSTEM LICENSE FOR THAT APDSS.
   (H)  THE  LABELS  ON  ALL  DRUGS  DISPENSED  BY  THE AUTOMATED PATIENT
 DISPENSING AND STORAGE SYSTEM SHALL COMPLY WITH ALL NEW YORK  STATE  AND
 FEDERAL  REQUIREMENTS FOR LABELLING OF DRUGS PRESCRIBED AND DISPENSED IN
 THIS STATE.
   (I) ANY COMPLAINT, ERROR, OR OMISSION INVOLVING THE AUTOMATED  PATIENT
 DISPENSING  AND  STORAGE SYSTEM SHALL BE REVIEWED AS PART OF THE PHARMA-
 CY'S QUALITY ASSURANCE PROGRAM.
   (J) THE STATE BOARD OF PHARMACY SHALL NOT ISSUE A PHARMACY  MORE  THAN
 FIFTEEN  LICENSES  FOR  AUTOMATED  PATIENT DISPENSING AND STORAGE SYSTEM
 UNITS UNDER THIS SECTION. THE STATE BOARD OF PHARMACY  MAY  ADOPT  REGU-

 S. 58                               5
 
 LATIONS  TO  REDUCE THE NUMBER OF APDSS LICENSES THAT MAY BE ISSUED TO A
 PHARMACY.
   (K)  THE  PHARMACY  HOLDING  THE  LICENSE  FOR  THE  AUTOMATED PATIENT
 DISPENSING AND STORAGE SYSTEM SHALL MAINTAIN THE POLICIES AND PROCEDURES
 DEVELOPED PURSUANT TO PARAGRAPH (A) OF THIS SUBDIVISION FOR THREE  YEARS
 AFTER THE LAST DATE OF USE OF THAT APDSS.
   6. ACCESS TO THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL
 BE  CONTROLLED AND TRACKED USING AN IDENTIFICATION OR PASSWORD SYSTEM OR
 BIOSENSOR. A SYSTEM THAT IS ACCESSED VIA A PASSWORD SYSTEM SHALL INCLUDE
 A CAMERA THAT RECORDS A PICTURE OF THE INDIVIDUAL ACCESSING THE MACHINE.
 PICTURE RECORDS SHALL BE MAINTAINED FOR A MINIMUM OF ONE HUNDRED  EIGHTY
 DAYS.
   7.  THE  AUTOMATED  PATIENT DISPENSING AND STORAGE SYSTEM SHALL MAKE A
 COMPLETE AND ACCURATE RECORD OF ALL TRANSACTIONS THAT WILL  INCLUDE  ALL
 USERS  ACCESSING  THE APDSS AND ALL DRUGS ADDED TO, OR REMOVED FROM, THE
 APDSS.
   8. THE STOCKING OF AN AUTOMATED PATIENT DISPENSING AND STORAGE  SYSTEM
 SHALL  BE  PERFORMED  BY  A  PHARMACIST. IF THE APDSS UTILIZES REMOVABLE
 POCKETS, CARDS, DRAWERS, SIMILAR TECHNOLOGY, OR UNIT OF  USE  OR  SINGLE
 DOSE CONTAINERS AS DEFINED BY THE UNITED STATES PHARMACOPEIA, THE STOCK-
 ING  SYSTEM  MAY  BE  DONE  OUTSIDE OF THE APDSS AND BE DELIVERED TO THE
 FACILITY IF ALL OF THE FOLLOWING CONDITIONS ARE MET:
   (A) THE TASK OF PLACING DRUGS INTO THE REMOVABLE POCKETS, CARDS, DRAW-
 ERS, SIMILAR TECHNOLOGY, OR UNIT OF USE OR  SINGLE  DOSE  CONTAINERS  IS
 PERFORMED  BY  A  PHARMACIST,  OR  BY AN INTERN PHARMACIST OR A PHARMACY
 TECHNICIAN WORKING UNDER THE DIRECT SUPERVISION OF A PHARMACIST LICENSED
 PURSUANT TO ARTICLE ONE HUNDRED THIRTY-SEVEN OF THE EDUCATION LAW.
   (B) THE REMOVABLE POCKETS, CARDS, DRAWERS, SIMILAR TECHNOLOGY, OR UNIT
 OF USE OR SINGLE DOSE CONTAINERS ARE TRANSPORTED  BETWEEN  THE  PHARMACY
 AND THE APDSS IN A SECURE TAMPER-EVIDENCE CONTAINER.
   (C)  THE  PHARMACY, IN CONJUNCTION WITH THE COVERED ENTITY, HAS DEVEL-
 OPED POLICIES AND PROCEDURES  TO  ENSURE  THAT  THE  REMOVABLE  POCKETS,
 CARDS,  DRAWERS,  SIMILAR  TECHNOLOGY,  OR  UNIT  OF  USE OR SINGLE DOSE
 CONTAINERS ARE PROPERLY PLACED INTO THE AUTOMATED PATIENT DISPENSING AND
 STORAGE SYSTEM.
   9. REVIEW OF THE DRUGS CONTAINED WITHIN, AND THE OPERATION AND MAINTE-
 NANCE OF, THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM  SHALL  BE
 DONE IN ACCORDANCE WITH LAW AND SHALL BE THE RESPONSIBILITY OF THE PHAR-
 MACY.  THE  REVIEW SHALL BE CONDUCTED ON A MONTHLY BASIS BY A PHARMACIST
 AND SHALL INCLUDE A PHYSICAL INSPECTION OF THE DRUGS IN  THE  APDSS,  AN
 INSPECTION  OF  THE  APDSS  MACHINE FOR CLEANLINESS, AND A REVIEW OF ALL
 TRANSACTION RECORDS IN ORDER TO VERIFY THE SECURITY  AND  ACCOUNTABILITY
 OF THE APDSS.
   10.  A  PHARMACY  HOLDING  AN AUTOMATED PATIENT DISPENSING AND STORAGE
 SYSTEM LICENSE  SHALL  COMPLETE  AN  ANNUAL  SELF-ASSESSMENT,  PERFORMED
 PURSUANT  TO RULES AND REGULATIONS PROMULGATED PURSUANT TO THIS SECTION,
 EVALUATING THE PHARMACY'S COMPLIANCE WITH THE EDUCATION LAW RELATING  TO
 THE  USE  OF  THE  AUTOMATED  PATIENT DISPENSING AND STORAGE SYSTEM. ALL
 INFORMATION REGARDING OPERATION, MAINTENANCE, COMPLIANCE,  ERROR,  OMIS-
 SIONS,  OR  COMPLAINTS  PERTAINING TO THE APDSS SHALL BE INCLUDED IN THE
 SELF-ASSESSMENT.
   11. THE PHARMACY SHALL  COMPLY  WITH  ALL  RECORDKEEPING  AND  QUALITY
 ASSURANCE  REQUIREMENTS PURSUANT TO THIS SECTION AND ARTICLE ONE HUNDRED
 THIRTY-SEVEN OF THE EDUCATION LAW AND SHALL MAINTAIN THOSE RECORDS WITH-
 IN THE PHARMACY HOLDING THE APDSS  LICENSE  AND  SEPARATELY  FROM  OTHER
 PHARMACY RECORDS.

 S. 58                               6

   12.  RULES  AND  REGULATIONS  PROVIDING  FOR THE IMPLEMENTATION OF THE
 PROVISIONS OF THIS SECTION WITHIN THE FACILITIES OF ALL COVERED ENTITIES
 SHALL BE IMPLEMENTED WITHIN THREE HUNDRED SIXTY-FIVE DAYS OF THE  EFFEC-
 TIVE DATE OF THIS SECTION.
   § 3. This act shall take effect immediately.

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