N.Y. Education Law § 6808-b: Registration of nonresident establishments

§ 6808-b. Registration of nonresident establishments. 1. Definition.

The term "nonresident establishment" shall mean any pharmacy located

outside of the state that participates in shared pharmacy 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

prescribers, and/or patients into this state shall be registered with

the department; except that such registration shall not apply to

intra-company 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

establishments 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. Conditions of registration. As a condition of registration, a

nonresident establishment shall comply with the following requirements:

a. Be licensed and/or registered and in good standing with the state

of residence;

b. Maintain, in readily retrievable form, records of drugs and/or

devices shipped into this state;

c. Supply, upon request, all information needed by the department to

carry out the department's responsibilities under the laws and rules and

regulations pertaining to nonresident establishments;

d. Comply with all statutory and regulatory requirements of the state

where the nonresident establishment is located, for prescription drugs

or devices shipped, mailed or delivered into this state, except that for

controlled substances shipped, mailed or delivered into this state, the

nonresident pharmacy shall follow federal law and New York law relating

to controlled substances;

e. The application shall be made in the manner and form prescribed by

the department;

f. The application of establishments to be registered as a

manufacturer, wholesaler or outsourcing facility of drugs and/or devices

shall be accompanied by a fee as provided in section sixty-eight hundred

eight of this article; and

g. The application of establishments to be registered as a nonresident

pharmacy shall be accompanied by a fee of three hundred forty-five

dollars and shall be renewed triennially at a fee of two hundred sixty

dollars.

5. Additional requirements. Nonresident pharmacies registered pursuant

to this section shall:

a. Provide a toll-free telephone number that is available during

normal business hours and at least forty hours per week, to enable

communication between a patient in this state and a pharmacist at the

pharmacy who has access to the patient's records; and

b. Place such toll-free telephone number on a label affixed to each

drug or device container.

6. Disciplinary action. Except in emergencies that constitute an

immediate threat to public health, the department shall not prosecute a

complaint or otherwise take formal action against a nonresident

establishment based upon delivery of a drug into this state or a

violation of law, rule, or regulation of this state if the agency having

jurisdiction in the state where the nonresident establishment is based

commences action on the violation complained of within one hundred

twenty days from the date that the violation was reported; provided

however, that the department may prosecute a complaint or take formal

action against a nonresident establishment if it determines that the

agency having jurisdiction in the state where the nonresident

establishment is based has unreasonably delayed or otherwise failed to

take prompt and appropriate action on a reported violation.

7. Revocation or suspension. A nonresident establishment that fails to

comply with the requirements of this section shall be subject to

revocation or suspension of its registration and other applicable

penalties in accordance with the provisions of article one hundred

thirty of this chapter.

8. Exception. The department may grant an exception from the

registration requirements of this section on the application of a

nonresident establishment that restricts its sale or dispensing of drugs

and/or devices to residents of this state to isolated transactions.

9. Rules and regulations. The department shall promulgate rules and

regulations to implement the provisions of this section.