reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 3A - CONTINUING EDUCATION › Section 13:39-3A.2 - Criteria for continuing education credit

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A licensee may obtain continuing education credit from the following categories:
1. Programs or courses offered by Accreditation Council for Pharmacy Education (ACPE)-approved providers;
2. Programs and courses that have received prior Board approval pursuant to 13:39-3A.6;
3. Graduate course work relevant to the practice of pharmacy, taken at an accredited college or university, beyond that required for professional licensure;
4. Participation in teaching and/or research appointments;
5. Participation as a preceptor in externship programs;
6. Participation as a preceptor in internship programs; and
7. Publication of an article related to the practice of pharmacy in a peer-reviewed professional journal.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 3A - CONTINUING EDUCATION › Section 13:39-3A.3 - Continuing education credit hour calculations

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Credit for continuing education shall be granted as follows for each biennial license period:
1. Attendance at approved programs or courses shall be granted one credit for each hour of attendance. Credit shall not be granted for programs or courses which are less than one contact hour in duration, which is defined as 50 minutes of actual attendance in a program or course of study. One half credit shall be granted for each 30 minute segment of a program or course that is more than one contact hour in duration. Completion of an entire program or course is required in order to receive any continuing education credit for the program or course.
2. Successful completion of graduate course work related to the practice of pharmacy at an accredited college or university beyond that which is required for professional licensure shall be granted three continuing education credits for each course credit awarded.
3. Teaching and research appointments related to the practice of pharmacy shall be granted three continuing education credits for each new program or course taught or subject matter researched by a licensee, to a maximum of six credits. "New," in this paragraph, means a program, course or subject matter which the licensee has never taught or researched before in any educational or practice setting. A licensee who is employed as a teacher and/or as a researcher on a full-time basis shall not be eligible to obtain continuing education credit for such activities.
4. Participation as a preceptor in an externship program, upon prior approval by a college of pharmacy, shall be granted three continuing education credits per student to a maximum of six credits.
5. Participation as a preceptor in an internship program shall be granted three continuing education credits per 160 hours of work performed by the intern(s) and supervised by the licensee, to a maximum of six credits.
6. Publication of an article related to the practice of pharmacy in a peer-reviewed professional journal shall be granted three continuing education credits per article to a maximum of six credits.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 3A - CONTINUING EDUCATION › Section 13:39-3A.4 - Continuing education credit hour reporting procedure

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A licensee shall specify on his or her application for biennial license renewal that the required number of continuing education credits has been completed. Falsification of any information contained in the renewal application may result in an appearance before the Board and the assessment of penalties and/or license suspension pursuant to 45:1-21 et seq.
(b) A licensee shall maintain all documentation concerning the completion of continuing education requirements for a period of five years from the completion of the credit hours and shall submit such documentation to the Board upon request. Such documentation shall consist of:
1. For programs offered by Accreditation Council for Pharmacy Education (ACPE)-approved providers, a certificate of completion from the course or program or a transcript from the National Association of Boards of Pharmacy CPE Monitor;
2. For programs and courses approved by the Board, the sponsors' written verification of attendance;
3. For teaching or research appointments in an academic setting, a statement from the chairperson of the department verifying completion of the assignment;
4. For research appointments in an industrial setting, a statement from the project coordinator verifying completion of the assignment;
5. For participation as a preceptor in an externship program, a certificate from the college of pharmacy;
6. For participation as a preceptor in an internship program, a certificate from the Board; and
7. For publications in a peer-reviewed professional journal, submission of the published article.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 3A - CONTINUING EDUCATION › Section 13:39-3A.5 - Waiver of continuing education requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Board may waive continuing education requirements on an individual basis for reasons of military service, hardship, illness or disability.
(b) A licensee seeking a waiver of continuing education requirements shall apply to the Board in writing and set forth with specificity the reasons for requesting the waiver. The licensee shall also provide the Board with such additional information as the Board may request in support of the application for waiver.
(c) A waiver of continuing education requirements granted pursuant to this section shall be effective only for the biennial period in which such waiver is granted. If the condition(s) which necessitated the waiver continues into the next biennial period, a licensee shall apply to the Board for a renewal of such waiver for the new biennial period.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 3A - CONTINUING EDUCATION › Section 13:39-3A.6 - Responsibilities of continuing education sponsors

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A continuing education sponsor shall receive prior Board approval for a program or course if the sponsor provides, in writing on a form provided by the Board, information which demonstrates that the program or course meets the following requirements:
1. The program or course is offered in a subject matter relevant to the practice of pharmacy;
2. The program or course is at least one contact hour in length; and
3. The program or course is conducted by a qualified instructor or discussion leader who submits a curriculum vitae and who is:
i. A pharmacist with a B.S. in Pharmacy or a Pharm.D. with at least five years of experience;
ii. A pharmacist with a B.S. in Pharmacy or a Pharm.D. with expertise in the program or course subject area;
iii. A pharmacist with a B.S. in Pharmacy or a Pharm.D. who is certified by a nationally recognized board or association; or
iv. A licensed health care professional who demonstrates special expertise in the lecture subject area.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 3A - CONTINUING EDUCATION › Section 13:39-3A.7 - Monitoring of continuing education programs or courses

Current through Register Vol. 56, No. 14, July 15, 2024
A Board member or a Board representative may monitor an approved program or course without prior notification to the continuing education sponsor.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.2 - Issuance of permits; permit renewals

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All permits shall be issued by the Board in the name of the pharmacy 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 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 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.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.3 - Display of permits

Current through Register Vol. 56, No. 14, July 15, 2024
The current permit issued by the Board for the operation of a pharmacy shall be conspicuously displayed in view of the public.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.4 - Death of owner or partner

Current through Register Vol. 56, No. 14, July 15, 2024
In the case of death of an individual owner or a partner, the permit issued to the deceased owner or to the partnership is terminated and shall be returned to the Board pursuant to N.J.A.C. 13:39-4.10. If the operation of the pharmacy is to be continued, the estate or heirs of the deceased partner and/or the remaining partners shall comply with the requirements set forth at N.J.A.C. 13:39-4.5.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.5 - Change of ownership; asset acquisition

Current through Register Vol. 56, No. 14, July 15, 2024
(a) When there is a change in the ownership of a pharmacy or in the ownership of the business entity holding the pharmacy permit, the following requirements shall be satisfied, as applicable:
1. If there is a complete change in ownership, the new owner(s) shall, within 30 days after the change, submit to the Board a permit application for change of ownership pursuant to N.J.A.C. 13:39-4.1, the permit application fee set forth in N.J.A.C. 13:39-1.3, and documentation evidencing the change of ownership. The new owner(s) shall perform an inventory of the pharmacy's controlled substances consistent with the requirements of N.J.A.C. 13:45H-5.4 and 5.5, which shall be made available to the Board upon request. A new permit number shall be issued if a request is made at the time of the filing of the permit application;
2. If there is a change of registered agents or officers, the business entity shall, within 30 days after the change, submit to the Board an affidavit indicating the changes that have taken place and any other information requested by the Board;
3. If there is a change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation, the corporation shall, within 30 days after the change, submit to the Board an affidavit indicating the changes that have taken place and any other information requested by the Board; and
4. If a reallocation of ownership interests occurs among existing owners, the owners shall, within 30 days after the change, submit to the Board an affidavit explaining the asset reallocation.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.7 - Change of location and/or address of licensed premises

Current through Register Vol. 56, No. 14, July 15, 2024
(a) When a pharmacy permit holder intends to change the physical location and address of the permitted premises, the permit holder shall apply to the Board, at least 30 days prior to such change, for a new pharmacy permit. If the change in location and address will result in the temporary closing of the pharmacy, the permit holder shall comply with all requirements set forth at N.J.A.C. 13:39-4.12(c) and (d). The permit holder shall submit a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. The Board shall issue an amended pharmacy permit reflecting the new location and address of the pharmacy. Before an amended permit may be issued to the permit holder for the new location, the Board shall inspect and approve the premises, fixtures, equipment, and inventory of the new location to ensure compliance with this subchapter and all relevant statutes, regulations, and ordinances. The permit holder shall ensure that the prescription and profile records from the pharmacy's previous location and address are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the location and address change.
(b) Whenever there is a change in a pharmacy's address but no change in the physical location of the licensed premises, the permit holder shall, within 10 business days of the change in address, submit an affidavit to the Board explaining such change.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.8 - Remodeling of licensed premises

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Prior to the remodeling of a pharmacy or pharmacy department, where such remodeling entails a change within the premises of the location or size of the prescription area, or a change in the dimensions of the licensed premises, the permit holder shall notify the Board at least 30 days in advance on a form prescribed by the Board. The pharmacy permit holder shall submit plans for the continuation of operations during the remodeling process which the Board shall review and approve, and the anticipated date of completion. The permit holder shall ensure compliance with all requirements set forth in this chapter while services continue during the remodeling process, and if the remodeling will result in the temporary closing of the pharmacy, the permit holder shall comply with all requirements set forth at 13:39-4.12(c) and (d).
(b) The pharmacy permit holder shall notify the Board upon completion of the remodeling process. Within 60 days of the completion of the remodeling, the Board shall inspect and approve the premises, fixtures, equipment and inventory of the remodeled pharmacy to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.9 - Change of name

Current through Register Vol. 56, No. 14, July 15, 2024
(a) When a pharmacy permit holder intends to change the name of the pharmacy, the permit holder shall apply to the Board, at least 30 days prior to such change, for an amended permit. The permit holder shall submit a new permit application pursuant to 13:39-4.1 and the new permit application fee set forth in 13:39-1.3. The Board shall issue an amended pharmacy permit reflecting the new name of the pharmacy.
(b) The Board shall issue an amended permit bearing the new name upon return of the permit bearing the previous name to the Board for cancellation and payment of the permit fee as prescribed in 13:39-1.3.
(c) If a change in pharmacy name is associated with a change in ownership, the permit holder shall ensure that the requirements set forth in 13:39-4.5 are satisfied.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.10 - Discontinued pharmacies

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Whenever a pharmacy is to be discontinued and closed for any reason, including suspension or retirement of the permit holder, sale or insolvency, the permit holder shall immediately send written notification of the anticipated closing to the State Board of Pharmacy, the Office of Drug Control and the Drug Enforcement Administration at least 15 days prior to the anticipated closing date. Whenever a pharmacy is to be discontinued and closed as a result of an unanticipated occurrence, such as the death of the permit holder, the permit holder's representative shall send written notification to the Board, the Office of Drug Control and the Drug Enforcement Administration, as soon as possible prior to the actual closing date. All medications, including prescription legend and controlled drugs, should be transferred to the holder of a current pharmacy permit; a wholesaler; a reverse distributor; and/or a manufacturer. All medications not properly transferred shall remain on the pharmacy premises with all licenses and registrations in effect until such medications are disposed of in the manner prescribed by the Board, the Office of Drug Control and/or the Drug Enforcement Administration.
(b) Within 30 days of closing a pharmacy pursuant to (a) above, the permit holder or his or her representative shall remove all drug signs from both the inside and outside of the discontinued pharmacy and shall notify the Board in writing of the location of the previous five years of prescription and patient profile records, consistent with the requirements of 13:39-7.6 and 7.19. The permit holder or his or her representative shall return the permit to the Board for cancellation within 30 days of the closing. Prescription records and other information may be requested by the Board as outlined in 13:39-7.6 and 7.19.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.11 - Availability of records upon termination of business or change of ownership

Current through Register Vol. 56, No. 14, July 15, 2024
(a) When a pharmacy ceases operation as the result of a suspension, retirement, or death of the owner, sale, or other cause including insolvency, the permit holder, or the one responsible for supervising the disposition of the practice, shall make every effort to notify patrons that they have the right to obtain copies of currently valid prescriptions and/or copies of their patient profile and the location of the prescriptions and patient profile for a one-year period following notice, using all of the following methods:
1. Notification in writing to the Board;
2. Publication, once weekly for two successive weeks in a newspaper whose circulation encompasses the geographic area in which the pharmacy is located, of a notice advising patrons that they have the right to obtain copies of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile for a one-year period following publication;
3. A sign placed in the pharmacy location informing the patrons that they have the right to obtain copies of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile; and
4. For a permitted pharmacy that uses social media that is specific to individually identified locations, the pharmacy shall post notice on all social media platforms used by the pharmacy informing patrons of the pharmacy closure, that they have a right to obtain copies of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile. The pharmacy shall also discontinue and remove all commercial advertising from social media sites.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.12 - Business hours; unauthorized closing

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All pharmacies shall be kept open for the transaction of business at least 40 hours per week and at least five days per week.
(b) If any permanent changes are made in the opening or closing hours of a pharmacy, the Board office shall be notified in writing of these changes within 30 days.
(c) A notice shall be conspicuously displayed on the exterior of any pharmacy indicating any temporary changes in the opening or closing hours of the pharmacy, or indicating a temporary closing of the pharmacy whenever such changes occur.
(d) Any temporary closing of a pharmacy for more than 48 hours shall be reported to and approved by the Board. Notification to the Board shall include contingency plans for accessing patient records. Any temporary closing of more than 48 hours without prior Board approval shall result in the pharmacy being deemed a discontinued pharmacy requiring compliance with the requirements of 13:39-4.10 and 4.11.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.13 - Replacement permit

Current through Register Vol. 56, No. 14, July 15, 2024
A replacement permit may be issued by the Board upon payment of a fee pursuant to 13:39-1.3 and submission of an affidavit describing the loss or destruction of the permit originally issued, or upon return of the damaged permit.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.14 - Reproduction of permits

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Any permit issued by the Board for the operation of a pharmacy may be copied only for State agencies and other business entities with whom the permit holder does pharmacy related business.
(b) Any reproduction of a pharmacy permit by a permit holder for any unlawful purpose shall subject a permit holder to disciplinary action pursuant to 45:1-21.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.15 - Security of pharmacies and pharmacy departments

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The pharmacist(s) on duty in all pharmacies, including pharmacy departments, shall be responsible for:
1. Keeping the pharmacy or pharmacy department closed and the security system turned on at all times when he or she is not present within the permitted premises in the case of a pharmacy, or, in the case of a pharmacy department, when he or she is not present within the department, except as provided in 13:39-6.4;
i. In the case of a pharmacy or pharmacy department that has been issued an institutional permit, pharmacy technicians may remain within the permitted premises when the pharmacy or pharmacy department is closed and secured, if the pharmacist determines, based on his or her professional judgment, that the security of prescription legend drugs, devices and controlled substances will be maintained in the pharmacist's absence;
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.16 - Permits; specialized permits

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Board may issue a special permit, wherein the type of service is of a limited nature. The permit so issued, being based on special conditions of use imposed by the Board, may necessitate the waiver of certain rule requirements.
(b) Specialized permits shall pertain to pharmacies providing specific services as may be necessary and proper to efficiently meet a limited public need for pharmaceutical services. An applicant for any specialized pharmacy permit shall provide the Board with an application and a policy and procedure manual which sets forth a detailed description of the type of specialized pharmacy services to be provided within the pharmacy practice. The policy and procedure manual shall also contain detailed provisions which ensure the protection of the public welfare as determined by the Board.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.17 - Steering prohibited

Current through Register Vol. 56, No. 14, July 15, 2024
It shall be unlawful for a pharmacy permit holder to enter into an arrangement with a practitioner, or any institution, facility, or entity that provides health care services, for the purpose of directing or diverting patients to or from a specified pharmacy for the filling of prescriptions or restraining in any way a patient's freedom of choice to select a pharmacy.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.18 - Responsibilities of permit holders

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All permit holders shall be responsible for compliance with all the rules, regulations and laws governing the practice of pharmacy.
(b) Any permit holder may be held liable for violations of the New Jersey Pharmacy Practice Act, 45:14-40 et seq., and the rules in this chapter and may be subject to disciplinary action.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.19 - Procedures for centralized prescription handling

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The four component functions of handling a prescription are intake, processing, fulfillment and dispensing.
(b) Central prescription handling entails two or more licensed pharmacies sharing responsibility for performing the four component functions of handling a prescription. For purposes of this section, the term "prescription" shall include medication orders when a healthcare facility is involved in any of the component functions of central prescription handling.
(c) The following pharmacies may engage in central prescription handling: an intake or originating pharmacy; a central processing pharmacy; a central fill pharmacy; and a dispensing pharmacy. The four component functions of handling a prescription shall be performed by the following pharmacies:
1. An intake or originating pharmacy, which is a pharmacy that received the patient's or prescribing practitioner's request to fill or refill a prescription. A central processing pharmacy or a central fill pharmacy, as delineated in (c)2 and 3 below, may be considered the intake or originating pharmacy if the prescription was transmitted by the prescribing practitioner directly to the centralized pharmacy as provided in 13:39-7.10 and 7.11 or if the patient requested the refill from that pharmacy;
2. A central processing pharmacy, which is a pharmacy that engages in prescription review by performing functions that may include, but are not limited to, data entry, prospective drug review, refill authorizations, interventions, patient counseling, claims submission, claims resolution and adjudication;
3. A central fill pharmacy, which is a pharmacy engaging in central prescription handling by filling and/or refilling prescriptions, which includes the preparation and packaging of the medication; and
4. A dispensing pharmacy, which is a pharmacy that receives the processed prescription and/or the filled or refilled prescription for dispensing to the patient or to the patient's authorized representative and that offers patient counseling regarding the dispensed medication.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.20 - Out-of-State pharmacy registration

Current through Register Vol. 56, No. 14, July 15, 2024
(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.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.21 - Procedures for authorized prescriber ordered or government sponsored immunizations performed by pharmacists, pharmacy interns, or pharmacy externs

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.
"Direct supervision" shall have the same meaning as "immediate supervision" as set forth at N.J.S.A. 45:14-41.
"Supervising pharmacist" means a licensed pharmacist authorized to administer vaccines and related emergency medications pursuant to the requirements of this section, and who is responsible for the direct supervision of a registered pharmacy intern or pharmacy extern administering immunizations to patients pursuant to this section.
(b) The provisions of this section set forth the requirements for licensed pharmacists, registered pharmacy interns, and pharmacy externs authorized to administer vaccines and related emergency medications, which shall be limited to diphenhydramine and epinephrine, to eligible patients who are 18 years of age and older, consistent with the requirements at N.J.S.A. 45:14-63, under the following circumstances:
1. Pursuant to a prescription by a New Jersey authorized prescriber for a vaccine, related emergency medications, and pharmacist, pharmacy intern, or pharmacy extern administration of the vaccine that is patient specific;
2. In immunization programs implemented pursuant to a New Jersey authorized prescriber's standing order for the vaccine, related emergency medications, and administration instructions that are not patient specific; and/or
3. In immunization programs sponsored by government agencies that are not patient specific.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4 - PHARMACY PERMIT REQUIREMENTS › Section 13:39-4.21A - Requirements for pharmacists, pharmacy interns, and pharmacy externs to administer influenza vaccine to patients under 18 years of age

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A licensed pharmacist, registered pharmacy intern, and pharmacy extern must be authorized to administer vaccines and related emergency medications pursuant to and to comply with the requirements at N.J.A.C. 13:39-4.21.
(b) For a patient who is under 18 years of age, a licensed pharmacist, registered pharmacy intern, or pharmacy extern, as applicable, shall obtain the written consent of the patient's parent or legal guardian.
(c) For a patient who is under 10 years of age, but is at least seven years of age, a licensed pharmacist, registered pharmacy intern, or pharmacy extern may administer the influenza vaccine only pursuant to a prescription by an authorized prescriber.
(d) A licensed pharmacist, registered pharmacy intern, or pharmacy extern shall not administer an influenza vaccine to a patient who is younger than seven years of age.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4A - REMOTE PROCESSING OF PRESCRIPTIONS › Section 13:39-4A.1 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) For purposes of this subchapter, the following words shall have the following meanings, unless the context clearly indicates otherwise:
"Remote location" means a location where the pharmaceutical functions specified in this subchapter are performed, other than on the premises of a pharmacy. The remote location must be located in New Jersey or in another state, territory, or possession of the United States whose regulatory body overseeing the practice of pharmacy is a member of the National Association of Boards of Pharmacy (NABP).
"Remote processing of prescriptions" means the performance of pharmaceutical functions specified in this subchapter at a remote location as defined in this section. "Remote processing of prescriptions" does not:
1. Include the storing or dispensing of any medication; or
2. Involve more than one licensed pharmacy.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4A - REMOTE PROCESSING OF PRESCRIPTIONS › Section 13:39-4A.2 - Remote processing of prescriptions by a New Jersey pharmacy

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A pharmacy may engage in the remote processing of prescriptions, provided that the pharmacy complies with the requirements of this subchapter.
(b) A pharmacy that engages in the remote processing of prescriptions shall notify the Board that it is engaging in the remote processing of prescriptions and shall provide the name of the pharmacist-in-charge who shall be responsible for ensuring and attesting to compliance with the requirements of this subchapter. Such notification shall be made on a form supplied by the Board.
(c) As part of the permit renewal process pursuant to N.J.A.C. 13:39-4.2, a pharmacy engaging in the remote processing of prescriptions, on an annual basis, shall have the permit holder and pharmacist-in-charge attest to compliance with the provisions of this subchapter.
(d) A pharmacy using remote processing of prescriptions shall ensure that:
1. A pharmacist performing pharmaceutical functions at the remote location holds an active New Jersey pharmacist license in good standing;
2. A pharmacy technician performing pharmaceutical functions at the remote location holds an active New Jersey pharmacy technician registration in good standing; and
3. All pharmaceutical functions performed by a pharmacy technician at a remote location are reviewed and approved by a licensed pharmacist.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 4A - REMOTE PROCESSING OF PRESCRIPTIONS › Section 13:39-4A.3 - Remote processing of prescriptions by out-of-State pharmacy

Current through Register Vol. 56, No. 14, July 15, 2024
An out-of-State pharmacy registered with the Board pursuant to N.J.A.C. 13:39-4.20 may engage in the remote processing of prescriptions that are to be shipped, mailed, distributed, or delivered to New Jersey, provided that the remote processing of prescriptions is authorized under the pharmacy laws and regulations in the jurisdiction where the out-of-State pharmacy is located, and provided that such functions are performed by a pharmacist or pharmacy technician who is licensed or registered and has been adequately trained, as required by the applicable law of the out-of-State jurisdiction(s).
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
The rules in this subchapter shall apply to all retail pharmacies, retail pharmacy departments and all institutional pharmacies filling prescriptions for outpatient use. For purposes of this subchapter, "pharmacy" means a retail pharmacy, retail pharmacy department or an institutional pharmacy filling prescriptions for outpatient use.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.2 - Pharmacy access and egress

Current through Register Vol. 56, No. 14, July 15, 2024
Pharmacies shall maintain entrances which are easily and safely accessible to the general public. Access to and egress from the pharmacy shall not be such that the public must traverse or traffic through any area in which prescriptions are prepared.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.3 - Pharmacy signs

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Pharmacies shall post a sign on the exterior of the building or a sign which is otherwise visible from a public roadway, conspicuously identifying the existence of a pharmacy on the premises, unless prohibited by lease agreement or municipal ordinance. In such case, a copy of the lease or ordinance shall be furnished to the Board.
(b) Pharmacies shall post the hours that the pharmacy is open and the name of the pharmacist-in-charge in plain view of the public at all consumer entrances and consumer access points to the pharmacy, including drive-thru windows and drop-off boxes.
(c) In the case of a pharmacy department, the hours that the department is open and the name of the pharmacist-in-charge shall be posted in plain view of the public at the entrance to the department and at all consumer entrances and consumer access points to the premises, including drive-thru windows and drop-off boxes. When the premises in which the pharmacy department is located maintains different hours of operation from the pharmacy department, all advertising, announcements, signs and statements indicating hours of operation and the presence of the pharmacy department shall clearly and distinctly indicate the hours that the pharmacy department is open.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.4 - Spatial requirement of pharmacy prescription area

Current through Register Vol. 56, No. 14, July 15, 2024
(a) For pharmacies in operation prior to July 1, 1963, the space devoted to the prescription area and laboratory shall not be less than 10 percent of the main floor area of the pharmacy, and in no instance shall it be less than 50 square feet. If the main floor area of such pharmacy exceeds 1,200 square feet, the 10 percent requirement does not apply and the minimum requirement for the prescription area shall not be less than 120 square feet.
(b) For all other pharmacies including pharmacies subject to the provisions of (a) above which are moving to a new location, the prescription area must occupy exclusively a minimum of 150 square feet.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.5 - Prescription counter

Current through Register Vol. 56, No. 14, July 15, 2024
Pharmacies shall contain a prescription counter or counters on which to work, including sufficient space for workstation equipment, and the free working space shall not be less than 18 inches in width and not less than 12 total feet in length. This minimum working surface shall be kept clear at all times for the processing and/or compounding of prescriptions.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.6 - Prescription area sink

Current through Register Vol. 56, No. 14, July 15, 2024
An adequate sink with hot and cold running water shall be provided in the prescription area, easily accessible to the prescription counter.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.7 - Adequate storage

Current through Register Vol. 56, No. 14, July 15, 2024
(a) There shall be sufficient shelf, drawer, or cabinet space within the prescription area for the proper storage of prescription drugs and chemicals and the minimum equipment required pursuant to N.J.A.C. 13:39-5.8.
(b) All prescription drugs and chemicals shall be maintained under adequate storage conditions, including proper lighting, ventilation, and temperature control, as recommended by the drug manufacturer.
1. If storage conditions are not specified by the drug manufacturer, the prescription drug or chemical shall be maintained according to the parameters set forth in the Drug Substance Monographs and Excipients of the United States Pharmacopeia/National Formulary, 2016 edition, incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia/National Formulary website at
www.usp.org
. Where no specific directions or limitations are provided in the packaging and storage section of individual monographs or in the manufacturer specifications, the conditions of storage shall include storage at a temperature maintained thermostatically between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit), protection from moisture, and, where necessary, protection from light.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.9 - Prescription balances, scales, weights and automatic counting devices

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All pharmacies shall have all balances, scales, weights and automatic counting devices inspected every 12 months by the Department of Weights and Measures of the municipality or county in which the pharmacy is located, and such balances, scales, weights and automatic counting devices shall be properly sealed by the applicable authority.
(b) Counting trays or counting devices that meet the requirements of (a) above shall be used to count oral, solid drugs or medications.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.10 - Restriction on storage of prescription legend drugs and controlled dangerous substances

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Prescription legend drugs, devices and controlled dangerous substances shall not be stored in the pharmacy or pharmacy department in such a manner as to be accessible to the public.
(b) Prescription legend drugs, devices and controlled dangerous substances shall be stored only in areas of the premises that are part of the pharmacy or pharmacy department, except that in a health care facility, prescription legend drugs, devices and controlled dangerous substances shall be stored consistent with the requirements of 13:39-9.23.
(c) Prescription legend drugs, devices and controlled dangerous substances that are received during hours the pharmacy or pharmacy department is closed shall be stored consistent with the requirements of 13:39-4.15(b)3.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.11 - Control and monitoring of temperature of prescription drugs and chemicals

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All prescription drugs and chemicals shall be stored, filled, dispensed, transported, and/or delivered to the patient, agent of the patient, or facility or healthcare provider providing care to the patient to assure and maintain the integrity and stability of the prescription drug or chemical at temperatures as specified by the drug manufacturer. If the drug manufacturer has not specified the appropriate temperature, the prescription drug or chemical shall be maintained at a temperature maintained thermostatically between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit).
1. A pharmacy shall monitor and record the temperature of the pharmacy permitted area and refrigerator and, if applicable, freezer, no less than twice daily with an interval of at least eight hours.
i. Appropriate manual, electromechanical, or electronic temperature recording equipment and/or logs shall be utilized to document proper storage of prescription drugs and chemicals.
ii. A pharmacy shall maintain documentation of the recorded temperatures for two years.
iii. A pharmacy shall calibrate thermometers or temperature monitoring devices at predetermined intervals according to the manufacturer specifications.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 5 - RETAIL FACILITY REQUIREMENTS › Section 13:39-5.13 - Prescription drug retail price list

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A pharmacy shall comply with all requirements imposed by, and all requests for information from, the Division of Consumer Affairs concerning prescription drug retail price lists as provided in 13:45A-32.1.
(b) Failure on the part of a pharmacy to comply with the requirements of 13:45A-32.1 may subject the permit holder and/or the pharmacist in charge to disciplinary action pursuant to 45:1-21 et seq.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 6 - PHARMACIST-IN-CHARGE; PHARMACY PERSONNEL › Section 13:39-6.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
The rules in this subchapter shall apply to all pharmacies and pharmacy departments in the State. For purposes of this subchapter, "pharmacy" means a retail pharmacy or a retail pharmacy department, an institutional pharmacy or a nuclear pharmacy.