N.J. Admin. Code § 13:39-4.20

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:39-4.20 - Out-of-State pharmacy registration

(a) Any pharmacy located in a state other than New Jersey (hereinafter "out-of-State pharmacy") that ships, mails, distributes or delivers in any manner, legend drugs or devices or controlled dangerous substances pursuant to a prescription into the State, or which participates in a central prescription handling arrangement pursuant to 13:39-4.19, shall be registered with the Board pursuant to this section.

(b) It shall be unlawful for any out-of-State pharmacy not registered with the Board pursuant to this section to ship, mail, distribute or deliver in any manner, legend drugs or devices or controlled dangerous substances pursuant to a prescription into the State of New Jersey. Such conduct shall be deemed a violation of 45:14-73 and this section.

(c) An out-of-State pharmacy seeking to register with the Board shall submit a completed application for registration to the Board, which shall include the following:

1. The name under which the pharmacy is to be operated, the type of practice in which the pharmacy will be engaging, the weekly hours of operation for the pharmacy, and a copy of the prescription label to be used by the pharmacy;

2. The location, names and titles of all principal corporate officers, if the applicant is a corporation, or the location, names and titles of any individuals in whom ownership is or will be vested, if the applicant is not a corporation;

3. The name of the pharmacist-in-charge and his or her license number in the state in which the pharmacy is located, and his or her weekly hours of employment;

4. A dated copy of the most recent inspection report resulting from an inspection within the past two years of the out-of-State pharmacy conducted by the regulatory or licensing agency in the state in which the pharmacy is located;

5. A letter of good standing from the state licensing authority in the state in which the licensed, permitted or registered out-of-State pharmacy is located; and

6. The application fee specified in N.J.A.C. 13:39-1.3.

(d) An out-of-State pharmacy registered with the Board shall maintain, at all times, a valid unexpired license, permit, or registration to conduct the pharmacy in compliance with the laws and regulations of the state in which it is located. The pharmacy shall notify the Board immediately upon the permanent closing of the pharmacy or upon the commencement of any action by the licensing authority in the state in which it is located concerning its license, permit or registration to conduct the pharmacy. Suspension or revocation of a pharmacy's license, permit or registration in the state in which it is located shall result in the immediate commencement of proceedings by the Board to suspend or revoke the out-of-State pharmacy's registration in New Jersey.

(e) An out-of-State pharmacy registered with the Board shall submit on an annual basis, prior to the expiration of the registration, a renewal application which shall contain the information set forth in (c)1 through 5 above, and the renewal fee set forth in N.J.A.C. 13:39-1.3. A registered out-of-State pharmacy that fails to submit the renewal application within 30 days after the registration expiration shall submit the late renewal fee set forth in N.J.A.C. 13:39-1.3 in addition to the renewal fee. An out-of-State pharmacy that continues to ship, mail, distribute, or deliver legend drugs or devices or controlled dangerous substances into the State, or continues to participate in a central prescription handling arrangement pursuant to N.J.A.C. 13:39-4.19, with an expired registration shall be deemed to be engaging in the unauthorized practice of pharmacy and shall be subject to the penalties set forth in N.J.S.A. 45:1-25 et seq.

(f) An out-of-State pharmacy registered with the Board shall submit an application for registration pursuant to (c) above and the fee set forth in N.J.A.C. 13:39-1.3, within 30 days after the following:

1. A complete change in ownership. The new owner(s) shall also submit documentation evidencing the change of ownership. A new registration number shall be issued if a request is made at the time of the filing of the application;

2. A change in the location of the licensed, permitted, or registered pharmacy; or

3. A change in the name of the licensed, permitted, or registered pharmacy.

(g) An out-of-State pharmacy registered with the Board shall submit to the Board an affidavit indicating the changes that have taken place and any other information requested by the Board within 30 days after the following, as applicable:

1. A change of registered agents or officers;

2. A change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation;

3. A reallocation of ownership interests among existing owners; or

4. A change in the pharmacist-in-charge. When there is a change in the pharmacist-in-charge, the affidavit shall contain the information set forth in (c)3 above.

(h) An out-of-State pharmacy may obtain a replacement registration upon payment of the fee specified in N.J.A.C. 13:39-1.3 and upon submission of an affidavit describing the loss or destruction of the registration originally issued, or upon return of the damaged permit.

(i) An out-of-State pharmacy registered with the Board shall:

1. Inform the Board, upon request, of the results of any inspections or investigations conducted by the regulatory or licensing agency of the state in which the pharmacy is licensed, permitted or registered or by a Federal agency, including the filing of any action against the pharmacy by the agency;

2. Inform the Board, upon request, of any directions to, and requests for information from, the pharmacy issued by the regulatory or licensing agency of the state in which the pharmacy is licensed, permitted or registered or by a Federal agency; and

3. Comply with directions concerning compliance with this section and any requests for information issued by the Board.

(j) An out-of-State pharmacy registered with the Board shall maintain its record of prescriptions for patients in the State of New Jersey for a period of not less than five years. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of record information shall be retrievable and readable within one business day.

(k) An out-of-State pharmacy registered with the Board shall, during its regular hours of operation, but not less than five days per week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in the State of New Jersey and a pharmacist who has access to the patients' records. This toll-free number shall be disclosed on a label affixed to each container of drugs dispensed to patients in the State of New Jersey or the out-of-State pharmacy shall meet the requirements set forth in N.J.A.C. 13:39-4.19 (d)6.

(l) The Board may forward a complaint against any out-of-State pharmacy registered with the Board for alleged violations of any New Jersey or Federal law or regulation, or any information concerning alleged violations of New Jersey or Federal law by the pharmacy, to the regulatory or licensing agency in the state in which the pharmacy is located, or the Board may institute disciplinary proceedings in New Jersey pursuant to 45:1-21 et seq., to resolve the complaint or alleged violation.

N.J. Admin. Code § 13:39-4.20

Amended by 49 N.J.R. 3761(a), effective 12/4/2017