S T A T E O F N E W Y O R K
________________________________________________________________________
9051
I N S E N A T E
October 14, 2020
___________
Introduced by Sen. PERSAUD -- 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 directing the commissioner of corrections and community super-
vision, in consultation with the commissioner of health, the commis-
sioner of education, the commissioner of mental health, and the state
board of pharmacy, 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 in correctional facilities
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; USE IN
CORRECTIONAL FACILITIES. 1. THE COMMISSIONER OF CORRECTIONS AND COMMUNI-
TY SUPERVISION, IN CONSULTATION WITH THE COMMISSIONER OF HEALTH, THE
COMMISSIONER OF EDUCATION, THE COMMISSIONER OF MENTAL HEALTH, AND THE
STATE BOARD OF PHARMACY, SHALL PROMULGATE RULES AND REGULATIONS TO
AUTHORIZE THE LICENSING AND USE OF AUTOMATED PATIENT DISPENSING AND
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD17344-05-0
S. 9051 2
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 TO MEDICAL PERSONNEL FOR
PROMPT ADMINISTRATION TO PATIENTS PURSUANT TO PRIOR AUTHORIZATION BY A
PHARMACIST.
(C)"CORRECTIONAL FACILITY" MEANS A CORRECTIONAL FACILITY AS DEFINED IN
SECTION TWO OF THE CORRECTION LAW.
(D) "DRUG" MEANS A PRESCRIPTION DRUG, 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.
(F) "PHARMACY" MEANS A PHARMACY WHICH HOLDS A REGISTRATION FROM THE
FEDERAL DRUG ENFORCEMENT AGENCY FOR THE DISTRIBUTION OF CONTROLLED
SUBSTANCES.
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 FOR USE BY MEDICAL PERSONNEL FOR THE
ADMINISTRATION OF DRUGS TO PATIENTS CONFINED TO A CORRECTIONAL FACILITY
THROUGH AN APDSS LOCATED ON THE PREMISES OF THE CORRECTIONAL FACILITY:
(A) THE PHARMACY OBTAINS A LICENSE FROM THE STATE BOARD OF PHARMACY TO
OPERATE THE APDSS AT THE CORRECTIONAL FACILITY. AS PART OF THE APPLICA-
TION, THE PHARMACY SHALL PROVIDE THE ADDRESS AT WHICH THE APDSS SHALL BE
PLACED AND IDENTIFY THE CORRECTIONAL FACILITY. 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 SUFFI-
CIENT RESOURCES TO SUPPORT THE REGULATORY ACTIVITIES.
(B) THE PHARMACY PROVIDING THE PHARMACY SERVICES TO THE PATIENTS
CONFINED TO A CORRECTIONAL FACILITY, INCLUDING, UNLESS OTHERWISE PROHIB-
ITED BY ANY OTHER LAW, PATIENTS ENROLLED IN THE MEDICARE AND MEDICAID
PROGRAMS, SHALL BE UNDER CONTRACT WITH THAT CORRECTIONAL FACILITY 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.
S. 9051 3
(E) THE PHARMACY SHALL BE SOLELY RESPONSIBLE FOR THE OPERATION AND
MAINTENANCE OF THE APDSS. THE APDSS SHALL BE DEEMED TO BE UNDER THE DUAL
SECURITY 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 CORRECTIONAL FACILITY 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 CONFINED TO A CORRECTIONAL FACILITY. THE PHARMACIST NEED NOT BE
PHYSICALLY PRESENT AT THE SITE OF THE APDSS AND MAY SUPERVISE THE SYSTEM
ELECTRONICALLY.
(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.
(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. 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.
6. 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.
7. 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
CORRECTIONAL 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.
S. 9051 4
(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 CORRECTIONAL FACILITY, HAS
DEVELOPED 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.
8. 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 RULES AND REGULATIONS PROMULGATED PURSU-
ANT TO THIS SECTION AND SHALL BE THE RESPONSIBILITY OF THE PHARMACY.
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.
9. 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 AND ALL
APPLICABLE RULES AND REGULATIONS RELATING TO THE USE OF THE AUTOMATED
PATIENT DISPENSING AND STORAGE SYSTEM. ALL INFORMATION REGARDING OPERA-
TION, MAINTENANCE, COMPLIANCE, ERROR, OMISSIONS, OR COMPLAINTS PERTAIN-
ING TO THE APDSS SHALL BE INCLUDED IN THE SELF-ASSESSMENT.
10. 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 RULES AND REGULATIONS PROMULGATED
PURSUANT TO THIS SECTION, AND SHALL MAINTAIN THOSE RECORDS WITHIN THE
PHARMACY HOLDING THE APDSS LICENSE AND SEPARATELY FROM OTHER PHARMACY
RECORDS.
11. RULES AND REGULATIONS PROVIDING FOR THE IMPLEMENTATION OF THE
PROVISIONS OF THIS SECTION WITHIN CORRECTIONAL FACILITIES SHALL BE
IMPLEMENTED BY THE DEPARTMENT OF CORRECTIONS AND COMMUNITY SUPERVISION
WITHIN THREE HUNDRED SIXTY-FIVE DAYS OF THE EFFECTIVE DATE OF THIS
SECTION.
§ 3. This act shall take effect immediately.