N.Y. Education Law § 6809: Shared pharmacy services

§ 6809. Shared pharmacy services. 1. General requirements. No

pharmacist 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

requirements; 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

regulatory requirements.

3. Operations. A pharmacy or pharmacist engaged in shared pharmacy

services shall:

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

disciplinary 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

regulations 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

dispensing, 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.

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

registration 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.

8. Effect. Failure to meet any or all of the requirements of this

section may result in a denial of renewal of registration.