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NEW JERSEY REGISTER
VOLUME 38, ISSUE 21
ISSUE DATE: NOVEMBER 6, 2006
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF PHARMACY
Fee Schedule; Waiver; Issuance of Permits; Permit Renewals; Procedures for Centralized
Prescription Handling; Out-of-State Pharmacy Registration

Proposed Amendments: N.J.A.C. 13:39-1.3, 4.2, and 4.18
Proposed New Rules: N.J.A.C. 13:39-1.6 and 4.19

Authorized By: Board of Pharmacy, Joanne Boyer, Executive Director.

Authority: N.J.S.A. 45:14-47 and 45:14-73.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2006-362.

Submit comments by January 5, 2007 to:
Joanne Boyer, Executive Director
Board of Pharmacy
P.O. Box 45013
Newark, NJ 07101

The agency proposal follows:

Summary

The New Jersey Board of Pharmacy (Board) is proposing a new rule at N.J.A.C. 13:39-4.19 that will require the registration of out-of-State pharmacies engaging in certain activities in New Jersey. The Pharmacy Practice Act, N.J.S.A. 45:14-73, requires any pharmacy that is located in another state but that sends prescription drugs or devices into New Jersey, by any manner, to be registered with the Board. Consistent with this statutory requirement, proposed new rule N.J.A.C. 13:39-4.19 requires any pharmacy that is located in a state other than New Jersey that ships, mails, distributes or delivers legend drugs, devices or controlled dangerous substances into the State pursuant to a prescription to be registered with the Board. In addition, any pharmacy that is located in a state other than New Jersey, but that performs any prescription processing functions in a central prescription handling arrangement approved under N.J.A.C. 13:39-4.18, must also be registered with the Board as an out-of-State pharmacy. As part of this proposal, the Board is amending N.J.A.C. 13:39-4.18 to reflect this requirement. The proposed new rule provides that it is unlawful for any out-of-State pharmacy not registered with the Board to engage in the activities set forth in the rule.

In order to become registered with the Board, an out-of-State pharmacy's license in its home state of licensure must be in good standing. If the pharmacy will be permanently closed, or if the licensing authority in the home state of licensure commences any action against the pharmacy, the pharmacy must notify the Board in New Jersey of such action. Upon a suspension or revocation of the pharmacy's license in its home state, the Board will immediately begin proceedings to suspend or revoke the pharmacy's registration in New Jersey. Out-of-State pharmacies will be required to pay a $ 175.00 application fee, and the registration will be renewable, on an annual basis, upon the payment of a $ 175.00 renewal fee.

The proposed new rule requires a registered out-of-State pharmacy to inform the Board, upon request, of the results of any inspections or investigations conducted by the regulatory or licensing agency of the pharmacy's home state of licensure or by a Federal agency. A registered out-of-State pharmacy is also required to notify the Board in New Jersey, within 30 days, of any change in the pharmacy's ownership, registered agents, locations, name, or registered pharmacist-in-charge. The out-of-State pharmacy must submit, as part of such notification, the applicable fees associated with changes in the pharmacy's ownership, name or location. The out-of-State pharmacy must also comply with any directions to the pharmacy and any requests for information issued by the Board in New Jersey. In addition, a registered out-of-State pharmacy must maintain its prescription records for patients in New Jersey for not less than five years, consistent with the recordkeeping requirements imposed upon pharmacies located in the State. A registered out-of-State pharmacy must also provide a toll-free telephone number for patients in New Jersey to call and speak to a pharmacist who has access to the patients' records. The number must appear on the prescription container label.

The new rule also authorizes the Board to forward any complaint it receives against a registered out-of-State pharmacy for violating any New Jersey or Federal law or regulation to the licensing agency in the pharmacy's home state of licensure. However, if the Board chooses, it may institute disciplinary proceedings in New Jersey to resolve the complaint or alleged violation. The Board is also proposing a new rule at N.J.A.C. 13:39-1.6, which sets forth the steps that licensees, permittees or registrants of the Board must follow in order to request a waiver of any of the Board rules. The new rule provides that the Board may waive its rules upon a written request from an applicant alleging undue hardship, provided the rule waiver would not unduly burden any affected parties and would not be inconsistent with the underlying purposes of the Pharmacy Practice Act. The new rule also authorizes the Board to waive its rules if full compliance with the rules would endanger the health, safety and welfare of the general public. As noted above, out-of-State pharmacies that wish to register with the Board must pay application and renewal fees. The Board is proposing to amend the fee schedule contained in N.J.A.C. 13:39-1.3 to reflect these new fees, as well as additional fees for such pharmacies for changes of pharmacy ownership, name, or location ($ 175.00), replacement permits ($ 25.00), late renewals ($ 100.00), and permit verifications ($ 25.00). The proposed fees are consistent with the fees charged by the Board for registered pharmacies located in New Jersey.

The Board is also proposing an amendment to N.J.A.C. 13:39-4.2, which concerns the issuance of permits to in-State pharmacies, in order to codify current Board procedures as they relate to the renewal of such permits. The procedures currently utilized by the Board had been inadvertently omitted from the rules.

The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board believes that proposed new rule N.J.A.C. 13:39-4.19, which will require the registration of all out-of-State pharmacies that dispense prescription legend drugs, devices or controlled dangerous substances to patients in New Jersey, or that wish to be part of a central prescription handling arrangement in which prescriptions are prepared for New Jersey patients, will have a positive impact upon New Jersey consumers by ensuring that only those pharmacies that are licensed in good standing in other states and, therefore, subject to appropriate oversight, will be authorized to provide such pharmaceutical services to patients in the State. In addition, the requirement that registered out-of-State pharmacies maintain a toll-free telephone number for use by New Jersey patients will ensure that consumers will be able to speak to a pharmacist who has access to their prescription file should they have any questions regarding their prescriptions. Proposed new rule N.J.A.C. 13:39-4.19 will also have an impact upon the out-of-State pharmacies that wish to provide pharmaceutical services to New Jersey patients by clarifying what these pharmacies must do in order to become registered in New Jersey and what standards they must comply with in order to retain their registration.

The Board also believes that proposed new rule N.J.A.C. 13:39-1.6, which authorizes the waiver of Board rules in limited circumstances, will have a positive impact upon licensed pharmacists and pharmacy permit holders to the extent that they will now know what procedures must be followed, including what type of information must submitted, in order to have a rule waiver request reviewed. The Board also believes that the waiver rule will have a positive impact upon the general public by ensuring that waivers of Board rules requested by members of the regulated community are granted only when the criteria set forth in the rule are satisfied, or when the Board believes that a waiver is necessary in order to ensure the health, safety and welfare of the general public.

Economic Impact

The registration of out-of-State pharmacies required under proposed new rule N.J.A.C. 13:39-4.19, and the corresponding fees being proposed in N.J.A.C. 13:39-1.3, will have an economic impact upon pharmacies located in other states that wish to provide pharmaceutical services to New Jersey patients. These out-of-State pharmacies will be required to pay a $ 175.00 application for registration fee, and a $ 175.00 annual registration renewal fee, as well as other fees associated with changes of ownership, name, or location, the replacement of a permit, late renewal, and/or registration verification as discussed in the Summary above. The Board notes that the imposition of such fees is necessary to offset the administrative expenses that will be borne by the Board as a result of the proposed registration scheme for out-of-State pharmacies servicing New Jersey patients.

The proposed amendments to N.J.A.C. 13:39-4.2, which set forth the renewal process for in-State pharmacy permit holders, will continue to have an economic impact upon in-State pharmacy permit holders to the extent that the fees associated with the renewal of such permits must be remitted on an annual basis.

The Board also believes that proposed new rule N.J.A.C. 13:39-1.6 may have an economic impact upon Board licensees and permit holders who seek the waiver of certain Board rules to the extent that an applicant for a waiver may incur administrative expenses associated with making such application.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments and new rules are governed by N.J.S.A. 45:14-40 et seq., and are not subject to any Federal requirements or standards.

Jobs Impact

The Board does not believe that the proposed amendments and new rules will result in the creation or loss of jobs in the State.

Agriculture Industry Impact

The proposed amendments and new rules will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

Currently, the Board licenses approximately 12,741 pharmacists and issues permits to approximately 1,984 pharmacies. If Board licensees and permit holders are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed amendments and new rules will not impose any reporting or recordkeeping requirements upon licensed pharmacists and permitted pharmacies in the State of New Jersey. Proposed new rule N.J.A.C. 13:39-1.6 will impose compliance requirements upon any Board licensee or permit holder who makes an application for the waiver of Board rules. In addition, the proposed amendment to N.J.A.C. 13:39-4.2 will impose compliance requirements upon permit holders of pharmacies in New Jersey. These requirements are discussed in the Summary above.

No additional professional services will be needed to comply with the proposed amendments and new rules. The costs of compliance with the proposed amendments and new rules are discussed in the Economic Impact statement and Summary above. The Board believes that the proposed amendments and new rules should be uniformly applied to all licensees and permit holders in order to ensure the health, safety and welfare of the general public in the provision of pharmaceutical services. Therefore, no differing compliance requirements for any licensees or permit holders are provided based upon the size of the business.

Smart Growth Impact

The Board does not believe that the proposed amendments and new rules will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

13:39-1.3 Fee schedule

(a) The following fees shall be charged by the Board:

1. (No change.)
2. For in-State pharmacies as follows:
i.-iv. (No change.)
3. (RESERVED)
4. For out-of-State pharmacies as follows:
i. Pharmacy permits
(1) Application for permit.......................$ 175.00
(2) Annual permit renewal........................$ 175.00
(3) Change of ownership/name.....................$ 175.00
(4) Change of location...........................$ 175.00
ii. Replacement of annual permit.................$ 25.00
iii. Late renewal fee............................$ 100.00
iv. Verification of permit.......................$ 25.00

13:39-1.6 Waiver

(a) The rules in this chapter may be relaxed by the Board upon a showing of undue hardship, economic or otherwise, on an applicant; that the waiver of the rule would not unduly burden any affected parties: and that the waiver is consistent with the underlying purposes of the Pharmacy Practice Act, N.J.S.A. 45:14-40 et seq. and the implementing rules of this chapter.

(b) Waiver requests shall be submitted to the Board in writing and shall include the following:

1. The specific rule(s) or part(s) of the rule(s) for which the waiver is requested;

2. The reasons for requesting the waiver, including a statement detailing the hardship that would result to the applicant if the waiver is not approved; and

3. Documentation which supports the applicant's request for the waiver, if applicable.

(c) Absent a request for a waiver, the Board may waive the rules in this chapter if full compliance with the rules, or parts of the rules, would endanger the health, safety and welfare of the general public.

13:39-4.2 Issuance of permits; permit renewals

(a) All permits shall be issued by the Board in the name of the pharmacy or other licensed establishment for the operation of which the permit is issued.

(b) A permit holder shall submit to the Board, on an annual basis, within 30 days after the permit expiration, a renewal application and the renewal fee set forth in N.J.A.C. 13:39-1.3(a)2. A permit holder that fails to submit the renewal application within 30 days after the permit expiration shall submit the late renewal fee set forth in N.J.A.C. 13:39-1.3(a)2 in addition to the renewal fee. A permit holder that continues to engage in the practice of pharmacy with an expired permit 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.

(c) The Board shall send a notice of renewal to each permit holder, at least 60 days prior to the expiration of the permit. If the notice to renew is not sent 60 days prior to the expiration date, no monetary penalty or fines shall apply to the permit holder for any unauthorized practice during the period following the permit expiration, not to exceed the number of days short of 60 before the renewal was issued.

13:39-4.18 Procedures for centralized prescription handling

(a)-(c) (No change.).

(d) Two or more licensed pharmacies delineated in (c) above may engage in central prescription handling provided:

1. (No change.)

2. Prior to engaging in central prescription handling, all pharmacies that are parties to the central prescription handling obtain Board approval. If a participating pharmacy is located outside the State of New Jersey, the pharmacy shall have registered with the Board pursuant to N.J.A.C. 13:39-4.19. The pharmacies shall make a single application to the Board, delineating the scope of practice of each pharmacy and the specific rules in this chapter with which each pharmacy shall comply;

3.-9. (No change.)

(e) (No change.)

13:39-4.19 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 N.J.A.C. 13:39-4.18, 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 N.J.S.A. 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 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 out-of-State pharmacy is licensed, permitted or registered; and

6. The application fee specified in N.J.A.C. 13:39-1.3(a)4.

(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 6 above, and the renewal fee set forth in N.J.A.C. 13:39-l.3(a)4. 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(a)4 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. 13:39-4.18, 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 the information set forth in (c)1 through 6 above and the fee set forth in N.J.A.C. 13:39-1.3(a)4, if applicable, within 30 days of the following:

1. Any change in ownership of the individual equity holder(s) or business entity holding the license, permit or registration to operate the pharmacy;

2. A change of registered agents or officers or a change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation holding the license, permit or registration to operate the pharmacy;

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

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

5. A change in the registered pharmacist-in-charge.

(g) 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(a)4 and upon submission of an affidavit describing the loss or destruction of the registration originally issued, or upon return of the damaged permit.

(h) 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.

(i) 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.

(j) 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. 13:39-4.18(d)6.

(k) 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 N.J.S.A. 45:1-21 et seq., to resolve the complaint or alleged violation.



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