S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9729
 
                           I N  A S S E M B L Y
 
                               April 3, 2024
                                ___________
 
 Introduced  by  M. of A. McDONALD, FAHY -- read once and referred to the
   Committee on Higher Education
 
 AN ACT to amend the  education  law,  in  relation  to  shared  pharmacy
   services
 
   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)  "SHARED  PHARMACY  SERVICES" MEANS A SYSTEM THAT ALLOWS A REGIS-
 TERED PHARMACIST OR A REGISTERED PHARMACY, PURSUANT TO  A  REQUEST  FROM
 ANOTHER  REGISTERED  PHARMACIST  OR  PHARMACY,  TO  PROCESS  OR  FILL  A
 PRESCRIPTION OR  ORDER,  PURSUANT  TO  REGULATIONS  PROMULGATED  BY  THE
 COMMISSIONER.
   § 2. The education law is amended by adding a new section 6809 to read
 as follows:
   §  6809. SHARED PHARMACY SERVICES. 1. GENERAL REQUIREMENTS. NO PHARMA-
 CIST OR PHARMACY SHALL PROVIDE SHARED PHARMACY SERVICES UNLESS THEY  ARE
 REGISTERED  IN ACCORDANCE WITH SECTIONS SIXTY-EIGHT HUNDRED FIVE, SIXTY-
 EIGHT HUNDRED EIGHT, OR SIXTY-EIGHT HUNDRED EIGHT-B OF THIS ARTICLE, AND
 ARE IN COMPLIANCE WITH THE PROVISIONS OF THIS SECTION.
   2. QUALIFICATION. A PHARMACY MAY PROVIDE OR ENGAGE IN SHARED  PHARMACY
 SERVICES ONLY IF THE PHARMACIES INVOLVED:
   A. (I) HAVE THE SAME OWNER; OR
   (II)  HAVE  A WRITTEN CONTRACT OR AGREEMENT THAT OUTLINES THE SERVICES
 PROVIDED AND THE SHARED RESPONSIBILITIES OF EACH PHARMACY  IN  COMPLYING
 WITH  ALL APPLICABLE FEDERAL AND STATE STATUTORY AND REGULATORY REQUIRE-
 MENTS; AND
   B. SHARE A COMMON ELECTRONIC FILE OR TECHNOLOGY THAT ALLOWS ACCESS  TO
 INFORMATION NECESSARY OR REQUIRED TO PERFORM SHARED PHARMACY SERVICES IN
 COMPLIANCE WITH ALL APPLICABLE FEDERAL AND STATE STATUTORY AND REGULATO-
 RY REQUIREMENTS.
   3.  OPERATIONS.  A  PHARMACY  OR PHARMACIST ENGAGED IN SHARED PHARMACY
 SERVICES SHALL:
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD15019-01-4
              

 A. 9729                             2
 
   A. MAINTAIN RECORDS THAT IDENTIFY, INDIVIDUALLY FOR EACH  PRESCRIPTION
 OR ORDER FILLED OR PROCESSED, THE NAME AND IF APPLICABLE, THE LICENSE OR
 REGISTRATION NUMBER OF EACH PHARMACY AND INDIVIDUAL WHO TOOK PART IN THE
 PROCESSING  OR  FILLING OF THE PRESCRIPTION OR ORDER. SUCH RECORDS SHALL
 BE MAINTAINED IN ACCORDANCE WITH SUBDIVISION FIVE OF SECTION SIXTY-EIGHT
 HUNDRED  TEN  OF  THIS ARTICLE AND MADE AVAILABLE TO THE DEPARTMENT UPON
 REQUEST. RECORDS OF PRESCRIPTIONS FOR  CONTROLLED  SUBSTANCES  SHALL  BE
 MAINTAINED  PURSUANT  TO THE REQUIREMENTS OF ARTICLE THIRTY-THREE OF THE
 PUBLIC HEALTH LAW;
   B. MAINTAIN A SYSTEM FOR THE TRACKING OF EACH  PRESCRIPTION  OR  ORDER
 DURING  EACH STEP OF THE PROCESS INCLUDING, BUT NOT LIMITED TO, THE NAME
 AND IF APPLICABLE, THE LICENSE AND REGISTRATION NUMBER OF EACH  PHARMACY
 AND  INDIVIDUAL  TAKING  PART  IN  THE  PROCESSING  OR  FILLING  OF  THE
 PRESCRIPTION OR ORDER;
   C. NOTIFY THE DEPARTMENT, IN WRITING, WITHIN THIRTY DAYS OF ANY DISCI-
 PLINARY ACTION TAKEN BY  ANOTHER  STATE'S  REGULATORY  AGENCY  INVOLVING
 SHARED PHARMACY SERVICES AS DEFINED IN THIS ARTICLE;
   D.  ENSURE  THAT  THE  LABELS  FOR  ALL PRESCRIPTIONS FILLED UTILIZING
 SHARED PHARMACY SERVICES IDENTIFY THE NAMES AND REGISTRATION NUMBERS  OF
 THE   PHARMACIES   INVOLVED   IN  THE  DISPENSING  AND  FILLING  OF  THE
 PRESCRIPTIONS.  ALL LABELS SHALL CONFORM TO SECTIONS SIXTY-EIGHT HUNDRED
 TWENTY-NINE AND SIXTY-EIGHT HUNDRED THIRTY OF THIS ARTICLE AND THE REGU-
 LATIONS  PROMULGATED  THEREUNDER.  THE  LABELING  OF  PRESCRIPTIONS  FOR
 CONTROLLED  SUBSTANCES  SHALL  BE  SUBJECT  TO  ADDITIONAL  REQUIREMENTS
 PROVIDED  IN  ARTICLE  THIRTY-THREE  OF  THE  PUBLIC  HEALTH  LAW.   THE
 PROVISIONS  OF THIS PARAGRAPH SHALL NOT APPLY TO HOSPITALS AS DEFINED IN
 ARTICLE TWENTY-EIGHT OF THE PUBLIC HEALTH LAW WHEN FURNISHING  DRUGS  TO
 PATIENTS REGISTERED FOR TREATMENT BY THE HOSPITAL;
   E.  MAINTAIN A SYSTEM THAT ADEQUATELY PROTECTS THE CONFIDENTIALITY AND
 INTEGRITY OF PROTECTED PATIENT INFORMATION; AND
   F. MAINTAIN PROCESSES FOR THE STORAGE, PROCESSING  AND  DISPENSING  OF
 CONTROLLED  SUBSTANCES  IN  ACCORDANCE  WITH ARTICLE THIRTY-THREE OF THE
 PUBLIC HEALTH LAW.
   4. NOTIFICATION TO PATIENTS. A.  PHARMACIES  PARTICIPATING  IN  SHARED
 PHARMACY SERVICES SHALL:
   (I)  NOTIFY  PATIENTS  OR THE PATIENTS' AUTHORIZED REPRESENTATIVE THAT
 PENDING THEIR CONSENT, A PORTION OR ALL OF THEIR  PRESCRIPTIONS  MAY  BE
 PROCESSED  OR  FILLED  OFF PREMISES. SUCH NOTIFICATION SHALL BE CONVEYED
 USING CONSPICUOUSLY POSTED SIGNAGE AT OR ADJACENT TO THE  PLACE  IN  THE
 PHARMACY  WHERE PRESCRIPTIONS ARE PRESENTED FOR COMPOUNDING AND DISPENS-
 ING, IN THE WAITING AREA FOR CUSTOMERS, OR  THE  AREA  WHERE  PRESCRIBED
 DRUGS  ARE  DISPENSED. PHARMACIES THAT TRANSACT BUSINESS THROUGH THE USE
 OF THE INTERNET SHALL CONSPICUOUSLY PROVIDE SUCH NOTIFICATION  ON  THEIR
 WEBSITE; AND
   (II)  OBTAIN  AN  INITIAL  ONETIME  CONSENT TO FILL CURRENT AND FUTURE
 PRESCRIPTIONS THROUGH SHARED  PHARMACY  SERVICES  FROM  THE  PATIENT  OR
 PATIENT'S  AUTHORIZED  REPRESENTATIVE  PRIOR TO THE DISPENSING OF ONE OR
 MORE PRESCRIPTIONS FOR THE PATIENT. FOR THE PURPOSES  OF  THIS  SECTION,
 SUCH  CONSENT  SHALL  BE OBTAINED IN WRITING OR ELECTRONICALLY AND NOTED
 WITHIN THE PATIENT'S MEDICATION PROFILE.
   B. NOTHING IN  THIS  SUBDIVISION  SHALL  PROHIBIT  A  PATIENT  OR  THE
 PATIENTS'  AUTHORIZED  REPRESENTATIVE  FROM  OPTING  OUT  OF  HAVING THE
 PATIENTS' PRESCRIPTION PROCESSED OR FILLED VIA SHARED PHARMACY  SERVICES
 AT ANY TIME.
 A. 9729                             3
 
   C. THE PROVISIONS OF THIS SUBDIVISION SHALL NOT APPLY TO A HOSPITAL AS
 DEFINED  IN  ARTICLE  TWENTY-EIGHT  OF  THE  PUBLIC  HEALTH LAW WHICH IS
 FURNISHING DRUGS TO PATIENTS REGISTERED FOR TREATMENT BY THE HOSPITAL.
   5. DRUG STORAGE AND SECURITY. A. DRUGS SHALL BE STORED AND TRANSPORTED
 IN  A  SECURE MANNER IN COMPLIANCE WITH ALL APPLICABLE FEDERAL AND STATE
 STATUTORY AND REGULATORY REQUIREMENTS.
   B. ACCESS TO THE AREA WHERE DRUGS  ARE  STORED  SHALL  BE  LIMITED  TO
 AUTHORIZED PERSONNEL.
   C.  PHARMACIES  PARTICIPATING  IN  SHARED PHARMACY SERVICES SHALL HAVE
 ADEQUATE SECURITY THAT COMPLIES WITH ALL APPLICABLE  FEDERAL  AND  STATE
 STATUTORY  AND  REGULATORY REQUIREMENTS AND PROTECTS THE CONFIDENTIALITY
 AND INTEGRITY OF PROTECTED PATIENT INFORMATION.
   6. POLICIES AND PROCEDURES. A. EACH PHARMACY PARTICIPATING  IN  SHARED
 PHARMACY  SERVICES SHALL JOINTLY DEVELOP, IMPLEMENT, REVIEW, REVISE, AND
 COMPLY WITH JOINT POLICIES AND PROCEDURES FOR SHARED PHARMACY  SERVICES.
 SUCH  POLICIES  AND PROCEDURES SHALL BE MADE AVAILABLE TO THE DEPARTMENT
 UPON REQUEST AND MAINTAINED PURSUANT TO REGULATIONS PROMULGATED  BY  THE
 COMMISSIONER.
   B. THE POLICIES AND PROCEDURES SHALL:
   (I) OUTLINE THE RESPONSIBILITIES OF EACH PHARMACY;
   (II)  INCLUDE  A  LIST OF THE NAMES, ADDRESSES, TELEPHONE NUMBERS, AND
 ALL REGISTRATION NUMBERS OF THE PHARMACIES INVOLVED IN  SHARED  PHARMACY
 SERVICES; AND
   (III) INCLUDE POLICIES AND PROCEDURES FOR:
   (A)  NOTIFYING THE PATIENTS OR THE PATIENTS' AUTHORIZED REPRESENTATIVE
 THAT THE PATIENTS' PRESCRIPTIONS MAY BE PROCESSED OR FILLED OFF PREMISES
 AND PROVIDING THE NAMES AND REGISTRATION NUMBERS OF THE OTHER PHARMACIES
 INVOLVED IN THE FILLING OR PROCESSING OF THE PRESCRIPTIONS;
   (B) PROTECTING THE CONFIDENTIALITY AND INTEGRITY OF PROTECTED  PATIENT
 INFORMATION;
   (C)  DISPENSING  A  PRESCRIPTION  WHEN A PRESCRIPTION FILLED UTILIZING
 SHARED PHARMACY SERVICES IS NOT RECEIVED OR THE PATIENT COMES IN  BEFORE
 SUCH PRESCRIPTION IS RECEIVED;
   (D)  MAINTAINING  A REQUIRED MANUAL OR ELECTRONIC RECORDS TO TRACK THE
 PRESCRIPTION OR ORDER THROUGH EACH STEP OF THE  PROCESS  INCLUDING,  BUT
 NOT  LIMITED  TO, THE NAMES AND, IF APPLICABLE, THE LICENSE OR REGISTRA-
 TION NUMBERS OF EACH INDIVIDUAL  WHO  PARTICIPATED  IN  SHARED  PHARMACY
 SERVICES; AND
   (E)  COMPLYING  WITH  ALL  APPLICABLE  FEDERAL AND STATE STATUTORY AND
 REGULATORY REQUIREMENTS; AND
   (IV) POLICIES AND PROCEDURES FOR HOSPITALS AS DEFINED  IN  THE  PUBLIC
 HEALTH  LAW  ARE  EXEMPT FROM THE REQUIREMENTS OF CLAUSES (A) AND (C) OF
 SUBPARAGRAPH (III) OF THIS PARAGRAPH, WHEN FURNISHING DRUGS TO  PATIENTS
 REGISTERED FOR TREATMENT BY THE HOSPITAL.
   7.  INDIVIDUAL  PRACTICE. FOR THE PURPOSE OF SHARED PHARMACY SERVICES,
 PERSONS LICENSED OR OTHERWISE AUTHORIZED UNDER THIS ARTICLE AND  ARTICLE
 ONE  HUNDRED THIRTY-SEVEN-A OF THIS TITLE, EMPLOYED BY OR UNDER CONTRACT
 WITH A PHARMACY, ACTING WITHIN THEIR RESPECTIVE SCOPES OF PRACTICE,  MAY
 ACCESS  THAT  PHARMACY'S  ELECTRONIC DATABASE FROM INSIDE OR OUTSIDE THE
 PHARMACY AND PERFORM PRESCRIPTION OR ORDER PROCESSING FUNCTIONS, IF BOTH
 OF THE FOLLOWING REQUIREMENTS ARE MET:
   A. THE PHARMACY ESTABLISHES CONTROLS TO  PROTECT  THE  CONFIDENTIALITY
 AND INTEGRITY OF PROTECTED PATIENT INFORMATION; AND
   B.  NO PART OF THE DATABASE IS DUPLICATED, DOWNLOADED, OR REMOVED FROM
 THE PHARMACY'S ELECTRONIC DATABASE.
 A. 9729                             4
 
   8. EFFECT. FAILURE TO MEET ANY OR ALL  OF  THE  REQUIREMENTS  OF  THIS
 SECTION MAY RESULT IN A DENIAL OF RENEWAL OF REGISTRATION.
   §  3. Subdivisions 1, 2, and 3 of section 6808-b of the education law,
 as amended by chapter 567 of the laws of 2002, subdivision 1 as  amended
 by section 5 of part D of chapter 60 of the laws of 2014, are amended to
 read as follows:
   1.  Definition.  The  term  "nonresident establishment" shall mean any
 PHARMACY LOCATED OUTSIDE OF THE STATE THAT PARTICIPATES IN SHARED  PHAR-
 MACY SERVICES FOR REGISTERED PHARMACIES AND/OR PATIENTS RESIDING IN THIS
 STATE  OR  pharmacy,  manufacturer,  wholesaler, or outsourcing facility
 located outside of the state that ships, mails or delivers  prescription
 drugs  or devices to other establishments, authorized prescribers and/or
 patients residing in this state. Such establishments shall include,  but
 not  be limited to, pharmacies that transact business through the use of
 the internet.
   2. Registration. All nonresident establishments  that  PARTICIPATE  IN
 SHARED  PHARMACY  SERVICES  FOR  REGISTERED  PHARMACIES  AND/OR PATIENTS
 RESIDING IN THIS STATE OR THAT ship, mail, or deliver prescription drugs
 and/or devices to other registered establishments,  authorized  prescri-
 bers,  and/or  patients  into  this  state  shall be registered with the
 department; except that such registration shall not apply to  intra-com-
 pany  transfers between any division, affiliate, subsidiaries, parent or
 other  entities  under  complete  common  ownership  and  control.   The
 provisions  of this subdivision shall apply solely to nonresident estab-
 lishments and shall not affect any other provision of this article.
   3. Agent of record. Each nonresident establishment  that  PARTICIPATES
 IN  SHARED  PHARMACY  SERVICES  OR ships, mails or delivers drugs and/or
 devices into this state shall designate a resident agent in  this  state
 for  service  of  process pursuant to rule three hundred eighteen of the
 civil practice law and rules.
   § 4. This act shall take effect eighteen months after  it  shall  have
 become  a  law.  Effective  immediately,  the addition, amendment and/or
 repeal of any rule or regulation necessary  for  the  implementation  of
 this  act  on its effective date are authorized to be made and completed
 on or before such effective date.