Pharmacy Permit/PIC Requirements Flashcards
1
Q
A pharmacy permit shall be submitted to the Board by every individual or business entity desiring to…
A
operate a new pharmacy
2
Q
If the area for which a pharmacy permit is sought is less than the total area of the premises, the area subject to permit shall be known as…
A
the “pharmacy department”
3
Q
The permit shall exact the intended location and plan of the proposed pharmacy or department area, including any drive-thru area, and shall indicate…
A
any area contiguous or adjacent to but not necessarily a part of the proposed permitted area, and any area where drugs will be stored and/or dispensed.
4
Q
The pharmacy permit shall include:
A
1) the exact trade name(s), if any
2) the corporate name(s), if any
3) the name and addresses of the owners and operators (if a sole proprietorship, partnership, limited liability partnership or limited liability company)
4) the names and addresses of all officers and stockholders
5) the names and addresses of all principals duly licensed to write prescriptions if the pharmacy is not a publicly traded corporation
6) the names and addresses of the officers, if a publicly traded corporation
5
Q
The permit application shall include the…
A
name of the pharmacist-in-charge (PIC)
6
Q
A person submitting the application may be…
A
interviewed by the Board to review his/her qualifications and eligibility
7
Q
The Board shall inspect and…
A
approve the premises, fixtures and equipment of the new pharmacy or pharmacy department to ensure compliance.
8
Q
Upon approval of the permit application, the Board shall…
A
issue a permit number that will allow the applicant to place Rx legend drugs in stock
9
Q
All permits shall be issued by the Board in…
A
the name of the pharmacy
10
Q
A permit holder shall submit to the Board, on an annual basis, within 30 days after the permit expiration….
A
a renewal application and the renewal fee
11
Q
The Board shall send a notice of renewal to each permit holder, at least…
A
60 days before the expiration of the permit
12
Q
The permit issued by the Board for the operation of a pharmacy shall be…
A
conspicuously displayed
13
Q
When there is a change in the ownership of the business entity…
A
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. The new owner(s) shall perform an inventory of the pharmacy’s controlled substances. A new permit number shall be issued upon request.
2) 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.
3) When the existing ownership is changed through the addition of a new owner(s) or the subtraction of an existing owner, the owners shall, prior to, or within 10 business days of, the addition of the new owner(s), submit to the Board a new permit application. A new pharmacy permit # shall be issued upon request.
14
Q
Upon a change in ownership, the new ownership of such entity shall take custodial ownership of the…
A
previous 5 years of prescription and profile
records of the previous pharmacy and shall ensure that the prescription and profile records are maintained
15
Q
Upon the sale, transfer or acquisition of the business assets of a pharmacy, the person
or entity acquiring such assets shall take…
A
custodial ownership of the pharmacy’s previous
5 years of prescription and profile records and shall ensure that the prescription and profile records are maintained
16
Q
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…
A
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
17
Q
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…
A
30 days prior to such change for a new pharmacy permit.
18
Q
The Board shall issue an amended pharmacy permit
reflecting…
A
the new location and address of the pharmacy
19
Q
Before an amended permit may be issued to the permit holder for the new location, the Board shall inspect and approve…
A
the premises, fixtures, equipment, and inventory of the new location to ensure compliance
20
Q
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…
A
notify the Board at least 30 days in advance on a form prescribed by the Board
21
Q
The pharmacy permit holder shall submit plans for the continuation of operations during the remodeling
process which…
A
the Board shall review and approve, and the anticipated date of completion.
22
Q
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…
A
inspect and approve the premises, fixtures, equipment and inventory of the remodeled pharmacy to ensure compliance
23
Q
When a pharmacy permit holder intends to change the name of the pharmacy, the permit holder shall…
A
apply to the Board, at least 30 days prior to such change, for an amended permit
24
Q
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…
A
the State Board of Pharmacy, the Office of Drug Control, and the DEA at least 15 days prior to the anticipated closing date
25
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 DEA, as soon as possible prior to the actual closing date
26
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
27
Within 30 days of closing a pharmacy, the permit holder or his/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
| 5 years of prescription and patient profile records
28
Within 30 days of the closing, the permit holder or his or her representative shall return...
the permit to the Board for cancellation
29
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 the 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) Social media platforms
30
All pharmacies shall be kept open for the transaction of business at least...
40 hours per week and at least 5 days per week
31
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
32
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...
any temporary changes in the opening or closing hours of the pharmacy, or indicating a temporary closing of the pharmacy whenever such changes occur
33
Any temporary closing of a pharmacy for more than 48 hours shall be...
reported to and approved by the Board
34
Notification to the Board shall include...
contingency plans for accessing patient records
35
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 special requirements
36
A replacement permit may be issued by the Board upon payment of a fee and submission of...
an affidavit describing the loss or destruction of the permit originally issued, or upon return of the damaged permit.
37
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.
38
The pharmacist(s) on duty in all pharmacies, including pharmacy departments, shall be responsible for:
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
39
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
40
The pharmacist(s) on duty shall be responsible for ensuring that the security of the prescription dispensing area and its contents are maintained at all times, including :
the restriction of persons unauthorized by the pharmacist on duty from being present in the prescription dispensing area
41
The pharmacist(s) on duty shall be responsible for reporting all thefts or diversions of:
prescription legend drugs and devices and
controlled substances, and any significant loss of prescription legend drugs and devices and controlled substances, to the PIC or the pharmacy permit holder upon discovery
42
The holder of a pharmacy or pharmacy department permit and the PIC of the pharmacy or pharmacy department shall ensure that..
All entrances to the pharmacy or pharmacy department are capable of being locked and are connected to a
monitored security system that transmits an audible, visual or electronic signal warning of intrusion. The security system shall be equipped with a back-up mechanism to ensure notification or continued operation if the security system is tampered with or is disabled. Only the pharmacist-in-charge shall be
responsible for the security of the keys and the security system access code to the pharmacy.
43
If theft or diversion of prescription legend drugs or devices or controlled substances, or a significant loss of prescription legend drugs or devices or CS, is reported to the PIC, then the PIC shall...
notify the holder of the pharmacy or pharmacy department permit of such report.
44
If theft or diversion occurs, the PIC and the holder of the pharmacy or pharmacy department permit shall ensure that...
i) A written report is filed with the Board upon discovery of the theft or diversion or the significant loss of prescription legend drugs or devices; and
ii) A written report is filed with the Federal DEA upon
discovery of the theft or diversion or any significant loss of CS, consistent with Federal requirements. A copy of such report shall be filed with the Office of Drug Control (ODC)
iii) There is a secure area for receiving packages known to contain Rx legend drugs and devices and CS.
45
No prescription drug shall be accepted
during the hours the pharmacy or pharmacy department is closed unless adequate
security for the storage of such shipments has been provided; and if...
a drop-off device is used for prescriptions, it must be of a one-way, irretrievable and secure design.
46
In addition to the requirements set forth in (b) above, the holder of a pharmacy department permit and the PIC of the pharmacy department shall also ensure that:
i) the department shall be separated from
the main store area by a secured barrier or partition extending from the floor or fixed counter to the ceiling of either the department or main store and attached thereto;
ii) all medications requiring supervision of a pharmacist, including dispensed medication, remain within the confines of the department when the pharmacist is not
in the pharmacy department
iii) if the pharmacy department has a published telephone number that is the same as
the one for the establishment in which the department is located, the caller is able to select the service or department to which he or she wants to be connected; and
iv) the telephone # of the PIC is available in the office of the manager of the establishment.
47
The holder of a pharmacy or pharmacy department permit shall comply with any law
and/or ordinance of the municipality in which the pharmacy or pharmacy department is
located requiring the placement of....
a security key box on the exterior of the pharmacy or
the premises in which the pharmacy department is located for purposes of permitting
emergency access to the premises.
48
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.
49
The four-component functions of handling a prescription are...
intake, processing, fulfillment and dispensing.
50
Central prescription handling entails...
two or more licensed pharmacies sharing
| responsibility for performing the 4 component functions of handling a Rx
51
The following pharmacies may engage in central prescription handling:
i) an intake or originating pharmacy
ii) a central processing pharmacy
iii) a central fill pharmacy
iv) a dispensing pharmacy
52
The 4 component functions of handling a prescription shall be performed by the following pharmacies:
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 may be
considered the intake or originating pharmacy if the prescription was transmitted by the prescribing practitioner directly to the centralized pharmacy or if the patient requested the refill from that pharmacy;
53
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;
54
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
55
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.
56
Two or more pharmacies may engage in central prescription handling provided:
1) Any or all of the pharmacies participating in central prescription handling have a
contractual agreement to provide such services or have the same owner;
2) Prior to engaging in central prescription handling, all pharmacies that are parties to
the central prescription handling obtain Board approval.
3) An audit trail is maintained that records and documents the unique and secure use at the time the functions are performed, for each step of prescription handling that is required to be performed by each.
4) All entries to the audit trail made by a pharmacy
technician, intern or extern shall be reviewed and approved by the pharmacist.
57
When more than one pharmacist is involved in the component functions of prescription
handling, the...
unique and secure user identifier(s) of the pharmacist(s) responsible for the accuracy and appropriateness of each component function(s) shall be recorded in
the audit trail.
58
The audit trail and prescription information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for...
not less than 5 years from the date the Rx is filled or refilled. The oldest 4 years of information shall be maintained in such a manner so as to be retrievable and readable within 2 weeks. The most recent one year of information shall be retrievable and readable within 1 business day.
59
The dispensed prescription for any product bears a permanently affixed label with at
least the following information:
i) the brand name, or if a generic, the brand name, if still available in the marketplace, and the name of the generic in the following form, with the generic
name and brand name inserted as appropriate:
“----------- Generic for -------------"
*Note: if the brand name is not still available in the marketplace, the generic name.
60
In addition to drug name, the dispensed prescription for any product must bear a permanently affixed label with at least the following information:
ii) The strength of the medication, where applicable;
iii) The quantity dispensed;
iv) The date upon which Rx medication is dispensed;
v) A CDS cautionary label, where applicable and when permitted by law;
vi) The patient name;
vii) The practitioner name;
viii) The Rx number;
ix) Directions for use;
x) The phrase "use by" followed by the product's use by date, if dispensed in any
packaging other than the manufacturer's original packaging. For purposes of this
paragraph, "use by date" means the earlier of one year from the date of dispensing or the expiration date on the manufacturer's container;
xi) All auxiliary labeling as recommended by the manufacturer and/or as deemed
appropriate in the professional judgment of the dispensing pharmacist;
xii) The name, address, and telephone number of the pharmacy
xiii) For substituted biological products, the information required in N.J.A.C. 13:39- 7.23(d)
61
On the dispensed Rx label, "the patient name", the "brand/generic name", and the "directions for use" must appear...
in a different color type or in bolded type
62
If the patient is provided with written information, either on the prescription label or
with the prescription container, that indicates which pharmacy to contact if the patient
has any questions about the prescription or the medication, the written information
provided to the patient shall be in...
in bold print, easily read, and shall include the hours
a pharmacist is available and a telephone # where a pharmacist may be reached. The telephone service shall be available at no cost to the pharmacy's
primary patient population
63
All pharmacies that are to engage in central prescription handling maintain a...
common policies and procedures manual which designates who shall be responsible for each
of the component functions of handling the Rx. The policies and procedures manual shall also include maintenance of the audit trail.
64
All pharmacies that are to engage in central prescription handling share a common
electronic file; and are...
responsible for ensuring that the Rx has been properly filled.
65
A Rx for a CS may be filled or refilled by pharmacies engaging in central prescription handling when...
permitted by law
66
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 CS pursuant to a Rx into the State, or
which participates in a central prescription handling arrangement, shall be...
registered with the Board
67
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 PIC and his or her license # 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 2 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
68
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 # 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.
69
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 PIC
70
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 5 years. The oldest 4 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.
71
An out-of-State pharmacy registered with the Board shall, during its regular hours of operation, but not less than...
5 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 # shall be disclosed on a label affixed to each container of drugs dispensed to patients in the State of New Jersey.
72
Pharmacists are 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, under the following 3 circumstances:
1) Pursuant to a Rx by a NJ licensed physician for a vaccine, related emergency medications, and pharmacist administration of the vaccine that is patient
specific;
2) In immunization programs implemented pursuant to a NJ licensed physician'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.
73
Pharmacists authorized to immunize must complete...
at least 2 hours of CE in immunizations in each biennial renewal period
74
Documentation that establishes that a licensed pharmacist has satisfied the education
and training requirements to immunize shall be maintained at...
the pharmacy practice site. If the immunization program is to take place somewhere other than the pharmacy practice site, the documentation shall be maintained in the licensed pharmacist's possession at the immunization location. Such documentation shall be made available for inspection by the Board.
75
Board approval for immunization privileges shall be renewed on a biennial basis. A pharmacist seeking such renewal shall...
submit documentation which establishes that he
| or she has satisfied the requirements
76
A physician's standing order shall specify the procedures that shall be followed for the
reporting of adverse events. The licensed pharmacist shall maintain and adhere to a
manual of policies and procedures for dealing with acute adverse events. The policies
and procedures manual shall require, at a minimum, that the pharmacist immediately
notify EMS and...
obtain assistance for the patient when an
adverse event requiring the administration of emergency medications occurs. The policies and procedures manual shall be reviewed annually by the licensed pharmacist
and such review shall be documented.
77
Physicians' standing orders shall be maintained in either hard copy or electronic form as provided in (l) below and shall be...
available for inspection by the Board at the pharmacy
| practice site and, if applicable, at the immunization location.
78
Before administration of a vaccine, the licensed pharmacist shall:
1) Screen the patient using CDC established criteria for each specific vaccine to be
administered;
2) Counsel the patient and/or the patient's representative about contraindications,
proper care of the injection site, and instructions to contact a physician or emergency
care facility in the event of any adverse reaction;
3) Inform the patient and/or the patient's representative in writing, in specific and readily understood terms, about the risks and benefits of the vaccine and provide the patient with a VIS published by the CDC; and
4) Obtain a signed informed consent form, which complies with the requirements of (h)
below, from the patient or the patient's representative which shall be maintained at the pharmacy practice site. The signed informed consent forms shall be maintained in either hard copy or electronic form.
79
The licensed pharmacist shall document all immunizations he or she performs and such
documentation shall be maintained at the pharmacy practice site. Such documentation shall include:
1) The patient's name, address, telephone number, date of birth, allergies and gender;
2) The vaccine administered, the manufacturer, expiration date, lot number, site of
administration, and dose administered;
3) The date of original order and the date of administration(s);
4) The name and address of the delegating physician, and the name and address of the
licensed pharmacist administering the dose, and the immunization location, if different from the pharmacy practice site; and
5) The name and address of the patient's primary care provider, if provided.
80
The informed consent form provided by a licensed pharmacist to a patient shall contain...
i) a check-off box that authorizes the pharmacist to send copies of the patient's vaccine documentation to the patient's PCP, and
iii) another check-off box that prohibits the pharmacist from sending copies of the patient's vaccine documentation to the patient's PCP.
81
The licensed pharmacist shall document in detail and immediately report all clinically significant adverse events to the delegating physician, and to the PCP,
if identified and if authorized on the informed consent form. The licensed pharmacist shall...
within 72 hours, report such events to the appropriate
| government reporting system.
82
All documentation and records required to be maintained by this section shall be
maintained in either hard copy or electronic form for a period of not less than...
7 years from the date of most recent entry and shall be supplied to any physician or health care provider upon receipt of a signed patient release of health information form. All records shall be made available to persons authorized to inspect them under State and Federal statutes and regulations. The oldest 6 years of information shall be maintained in such a manner so as to be retrievable and readable within 2 weeks. The most recent one year of information shall be retrievable and readable within one business day.
83
To immunize a patient who is under 18 years of age, a pharmacist must obtain the written consent...
of the patient’s parent or legal guardian
84
For a patient who is under 12 years of age, but is at least seven years of age, a pharmacist may administer the influenza vaccine only...
pursuant to a prescription by a licensed physician.
85
A pharmacist shall not administer an influenza vaccine to a patient who is younger than...
7 years of age
86
Pharmacies shall maintain entrances that 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.
87
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
88
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.
89
For pharmacies in operation prior to July 1, 1963, the space devoted to the Rx 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
90
For all other pharmacies including pharmacies subject to the provisions of (a) above which are moving to a new location, the Rx area...
must occupy exclusively a minimum of 150 square feet
91
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.
92
An adequate sink with hot and cold running water shall be provided in the prescription area and be...
easily accessible to the prescription counter
93
There shall be sufficient shelf, drawer, or cabinet space within the prescription area for...
proper storage of prescription drugs and chemicals and the minimum equipment required
94
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
95
All prescription areas shall contain the following minimum equipment and supplies, which
shall be readily accessible:
1) The most recent edition of comprehensive pharmaceutical reference text(s) and
suitable current reference texts encompassing the pharmaceutical services provided
by the pharmacy, drug interactions, drug product composition and patient counseling.
Unabridged electronic versions of such reference texts shall be acceptable;
2) Over the counter Schedule V Record Book or an electronic recording system to maintain all
required information if Schedule V
controlled substances are sold without a prescription;
3) Permanent prescription filing device and patient profile record system
4) Storage place of substantial construction, which is capable of being securely locked
when the pharmacist is not present in the prescription dispensing area, for Schedule
II controlled substances, if not dispersed;
5) Suitable volumetric devices;
6) A steel spatula and a spatula of rubber or composition;
7) Refrigerator, as required by United States Pharmacopoeia Standards, to be used
only for the storage of pharmaceuticals;
8) Refrigerator thermometer and, if applicable, freezer thermometer, or temperature
monitoring device to enable control of temperature;
9) Suitable counting trays or approved counting device;
10) Labels;
11) Auxiliary labels;
12) The signage required pursuant to N.J.S.A. 24:6E-10, the 29th edition of the list of "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly
known as the "Orange Book"
13) Child safety caps
14) Copies of, or access to, current State statutes and rules relating to the practice of pharmacy.
96
All prescription areas where non-sterile compounding is performed shall contain the following minimum equipment and supplies, which shall be stored, so as to be readily accessible:
1) Class A prescription balance with a complete set of metric weights or equivalent electronic weighing device;
2) A glass mortar and pestle;
3) Glass funnels;
4) Stirring rods; and
5) Ointment tile or parchment paper;
97
The prescription area and all related equipment and supplies shall be kept...
in a clean, orderly, and sanitary condition at all times.
98
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.
99
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
100
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 N.J.A.C.
13:39-9.23.
101
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.
102
Appropriate manual, electromechanical, or electronic temperature recording equipment and/or logs shall be utilized to...
document proper storage of prescription drugs and chemicals.
103
A pharmacy shall maintain documentation of the recorded temperatures for...
2 years
104
The PIC shall develop and maintain written policies and procedures to ensure the proper storage in the pharmacy permitted area of all prescription drugs and
chemicals, and the proper storage when prescription drugs or chemicals are delivered
from the pharmacy to the patient, agent of the patient, or facility or healthcare provider
providing care. The written policies and procedures shall include, at a minimum, the
following:
1) Monitoring and recording the temperature of the pharmacy permitted area and refrigerator and, if applicable, freezer consistent with the requirements of this section;
2) Maintaining documentation of the recorded temperatures consistent with the requirements of this section;
3) Actions to be taken in the event of temperature excursions include, but are not limited to: notification of appropriate personnel, investigation of all temperature excursions, inspection and disposal, as applicable, of the stock in question, and corrective actions;
4) Calibrating thermometers or temperature monitoring devices consistent with the requirements of this section;
5) Actions to be taken in the event that the prescription drugs and chemicals do not arrive at their destination in a timely manner or when there is evidence that the integrity of a drug was compromised during shipment or delivery; and
6) Training of all personnel who handle, or are responsible for overseeing the handling
of, prescription drugs and chemicals to ensure the appropriate storage and delivery of all prescription drugs and chemicals, including refrigerated and frozen pharmaceuticals.
105
In the event of a temperature excursion, as defined in (d)3i above, at a permitted pharmacy practice site lasting 24 hours or more, the PIC shall immediately...
notify the Board. The notification shall be made in a manner such that notice is received by the Board within 48 hours of becoming aware of the temperature excursion.
106
Every pharmacy shall name a PIC. No pharmacy shall operate without a PIC for longer than...
30 days
107
Whenever the PIC is absent from the pharmacy for more than 30 days, the PIC and the permit holder shall notify the Board of...
the name of the pharmacist who shall act as the interim PIC
108
A pharmacist shall not assume the responsibilities of a PIC of more than one pharmacy or pharmacy department simultaneously, except when...
1) If an area within a health care facility is permitted as both an institutional pharmacy and a retail pharmacy, the health care facility may employ one individual to act as the PIC for both the institutional pharmacy and the retail pharmacy.
109
Whenever there is a change of a PIC of a pharmacy, an inventory of all controlled dangerous substances shall be performed by...
both the outgoing and incoming PIC.
110
Whenever a pharmacist assumes or terminates the duties as a PIC of a pharmacy, both the outgoing and incoming PIC and the permit holder shall so advise the Board in writing within...
30 days by completing a form provided by the
| Board
111
A PIC shall be a full-time employee, employed for a minimum of...
35 hours per week and shall be physically present in the pharmacy or pharmacy department
112
The PIC is responsible for the accuracy and completeness of the biennial inventory of all controlled dangerous substances and shall...
sign and date the biennial inventory upon its completion. This requirement applies whether the inventory is conducted by the PIC or another licensed pharmacist.
113
All personnel working at any pharmacy practice site, except personnel engaging in the
compounding of sterile preparations, shall
wear an identification tag, which shall include...
at least the person's first name, first initial of their
last name, and job title. *Note: The identification tag of any employee in training shall reflect the status
of the employee as a trainee.
114
A sole pharmacist on duty may take restroom breaks and 30-minute meal breaks while working in a pharmacy consistent with the following requirements:
1) The pharmacist shall remain in the pharmacy or, in the case of a pharmacy
department, in the pharmacy department building, and shall be accessible for
emergencies or for counseling, if requested;
2) The pharmacy shall remain open during the restroom or meal breaks, provided a pharmacy employee remains present in the pharmacy, for patient-related services
3) A sign shall be posted in the prescription dispensing area stating "Pharmacist on break, but available for emergencies and counseling."
115
An applicant for registration as a pharmacy technician who has successfully satisfied all Board requirements for registration and has been approved by the Board to be registered shall, upon payment of the initial registration fee, receive an authorization signed by...
the Executive Director of the Board granting the applicant the right to practice as a pharmacy technician in the State of New Jersey until such time as
an initial registration may be issued. The registrant shall maintain such authorization on his or her person at all times while engaging in the practice of pharmacy as a pharmacy technician until the initial registration is issued
116
Upon issuance, the current biennial renewal registration shall be conspicuously displayed in view of the public in the registered pharmacy technician's....
principal place of employment
117
A registered pharmacy technician who is employed by more than one pharmacy in the State shall maintain...
the wallet-sized registration issued by the Board on his or her person when he or she is working at a location where his or her current biennial renewal registration is not on display
118
If a registered pharmacy technician legally changes the name under which he or she has been practicing as a pharmacy technician, the pharmacy technician shall...
notify the Board within 30 days of such change. The registered pharmacy technician shall submit original proof of the change of name or a certified copy of the court order or marriage certificate which shall be
retained by the Board. When a replacement registration is issued, the initial registration shall be
returned for cancellation and the pharmacy technician shall remit the required fee
119
A registered pharmacy technician shall notify the Board in writing of any change in his or her address of record within...
30 days of such change
120
The Board shall send a notice of renewal to each pharmacy technician registrant, at least 60 days prior to...
the expiration of the registration
121
A pharmacy technician shall renew his or her registration for a period of two years from
the last expiration date. The pharmacy technician shall submit a renewal application to
the Board, along with...
the renewal fee, prior to the date of registration expiration.
122
Pharmacy technicians and pharmacy technician applicants shall not:
1) Receive new verbal prescriptions;
2) Interpret a prescription or medication order for therapeutic acceptability and appropriateness;
3) Verify dosage and directions;
4) Engage in prospective drug review;
5) Provide patient counseling;
6) Monitor prescription usage;
7) Override computer alerts without first notifying the pharmacist;
8) Transfer prescriptions from one pharmacy to another pharmacy; or
9) Violate patient confidentiality.
123
A pharmacy shall require all pharmacy technicians and pharmacy technician applicants employed by the pharmacy to sign a...
patient confidentiality statement. Such statements
| shall be maintained on-site by the pharmacy.
124
A pharmacist shall not supervise more than...
2 pharmacy technicians at any given time. Those personnel who do computer processing of prescriptions are to be included in the 1 to 2 ratio
125
The pharmacist shall provide immediate personal supervision of...
all pharmacy technicians he or she supervises.
126
A registered pharmacy technician or a pharmacy technician applicant who is receiving in-service training, which shall not exceed...
210 days, shall be excluded from the 1 to 2 ratio during such training. A pharmacist shall not supervise
more than 2 persons receiving in-service training at the same time.
127
A pharmacy that employs a pharmacist to pharmacy technician ratio greater than 1:2 shall:
1) Establish written job descriptions, task protocols, and policies and procedures that pertain to the duties performed by the pharmacy technicians;
2) Ensure and document that all pharmacy technicians who are working when the ratio exceeds 1:2 have:
i) Passed the Pharmacy Technician Certification Board's Pharmacy Technician Certification Examination and have fulfilled the requirements to maintain this
status;
ii) Passed a Board-approved certification program and have fulfilled the
requirements to maintain this status; or
iii) Completed a program that includes a testing component, which has been
approved by the Board as satisfying the criteria set forth in (f) below.
128
If the pharmacist to pharmacy technician ratio exceeds 1:2, the pharmacy shall maintain a policy and procedure manual with regard to pharmacy technicians, which shall include the following:
1) Supervision by a pharmacist;
2) Confidentiality safeguards of patient information;
3) Minimum qualifications;
4) Documentation of in-service education and/or ongoing training and demonstration of
competency, specific to practice site and job function;
5) General duties and responsibilities of pharmacy technicians;
6) Retrieval of prescription files, patient files, patient profile information and other records pertaining to the practice of pharmacy;
7) All functions related to prescription processing;
8) All functions related to prescription legend drug and controlled substance ordering
and inventory control;
9) Prescription refill and renewal authorization;
10) Procedures dealing with documentation and records required for controlled drug
substance and prescription legend drugs;
11) Procedures dealing with medication errors, including classification of medication
errors;
12) Pharmacy technician functions related to automated systems;
13) Functions that may not be performed by pharmacy technicians, including at a
minimum those functions listed in (b) above; and
14) A form signed by the pharmacy technician which verifies that the manual has been reviewed by the technician.
129
The PIC shall review at least every two years and, if necessary...
amend the policy and procedure manual. Documentation of the review shall be made available
to the Board upon request.
130
A pharmacist shall only fill a prescription issued by a practitioner licensed to issue prescriptions in NJ and practicing in NJ if the prescription is on a...
New Jersey Uniform Prescription Blank
131
A pharmacist shall fill a prescription issued by a practitioner authorized to issue prescriptions in another state, territory or possession of the United States, including prescriptions issued at facilities within or outside of NJ that are...
regulated by the United States Department of Veterans Affairs and/or the Department of Defense. Such
prescriptions shall be filled pursuant to NJ law. Such prescriptions shall not be required to be issued on a New Jersey Uniform Prescription Blank
132
If a practitioner fails to include on the original prescription any information that he or she
is required to include pursuant to rules governing the practitioner's professional practice, including New Jersey Uniform Prescription Blanks,
the pharmacist shall...
obtain such information.
133
If the practitioner has failed to include directions for use and the practitioner cannot be contacted, the pharmacist shall...
indicate on the prescription label the words "use
| as directed" or "as ordered by the physician" or similar words to the same effect.
134
A prescription for medication or devices, which pursuant to State or Federal law may be
sold, dispensed or furnished only upon prescription, shall not be renewed without specific
authorization of the practitioner or the practitioner's authorized agent, and the prescription may not be filled or refilled after...
one year from the date the original
prescription was issued. A pharmacist obtaining authorization from a practitioner's authorized agent shall document the name and title of the agent.
135
Prescriptions marked "PRN" or other letters or words meaning refill as needed shall not be...
renewed beyond one year past the date the original prescription was issued.
136
When the renewals listed on the original prescription have been depleted no additional renewals may be added to the original prescription. For additional dispensing...
a new prescription must be authorized by the practitioner.
137
Except in the case of Schedule II CS, in the absence of a current, valid prescription, a pharmacist may dispense an emergency supply of...
(no more than a 72-hour quantity) of a chronic maintenance drug or device if, in his or her professional judgment, refusal would endanger the health or welfare of the patient, provided the following conditions are satisfied:
1) The pharmacist first ascertains to the best of his or her ability, by direct communication with the patient or caregiver, that such a medication or device was
prescribed for that patient by order of a practitioner. The pharmacist shall require the patient or caregiver to provide suitable identification. Such communication shall be documented in the patient profile record system or in the pharmacy's other manual or electronic files; and
2) The pharmacist documents the dispensing of the emergency supply in the prescription record system.
138
A pharmacist may dispense an emergency supply of a Schedule II controlled dangerous substance in the absence of a current, valid prescription upon receipt of oral authorization from a prescribing practitioner...
provided under Federal law pursuant to 21 CFR
1306.11, consistent with the requirements of N.J.A.C. 13:45H-7.8:
1. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period not to exceed 72 hours (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner);
2. The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in 13:45H-7.5(a), except for the signature of the prescribing individual practitioner;
3. If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and
4. Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed (not to exceed the amount for a 72-hour period) to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of 13:45H-7.4, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the seven-day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription, which had earlier been reduced to writing. The pharmacist shall notify the Drug Control Unit and the nearest office of the DEA in his or her district if the prescribing individual practitioner fails to deliver a written prescription to him or her; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense with a written prescription of a prescribing individual practitioner.
139
No drug or medicine other than a compounded prescription order, consistent with (c) below, shall be...
sold or dispensed in any pharmacy within the State of New Jersey until such drug or medicine has received New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), Investigational New Drug Application (INDA) or other Federal Food
and Drug Administration (FDA) approval, where required.
140
Computer systems employed for audit trail documentation shall be designed to...
identify and document the unique and secure identifier for all pharmacists, pharmacy technicians, interns and externs who utilize the system. Computer systems that automatically generate the unique and secure user identifier of a pharmacist, pharmacy technician, intern or extern without requiring an entry by the responsible party are prohibited.
141
Appropriate documentation identifying the unique and secure user identifier of all pharmacists, pharmacy technicians, interns and externs employed by the pharmacy shall be maintained by the pharmacy for a period of not less than..
5 years after the last date of employment. If a pharmacy utilizes a manual system, appropriate documentation identifying the handwritten initials with the handwritten signature and printed name of all
pharmacists, pharmacy technicians, interns and externs employed by the pharmacy shall be maintained for a period of not less than 5 years after the last date of employment. The oldest 4 years of record information shall be maintained in such a manner so as
to be retrievable and readable within 2 weeks. The most recent one year of record information shall be retrievable and readable within one business day
142
Records not currently in use need not be stored in the pharmacy, but...
off-site facilities used to store such records shall be secure.
143
All audit trail and prescription information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of...
not less than 5 years. The oldest 4 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.
144
A pharmacy shall immediately comply with the patient's request for copies of prescriptions and/or patient profile. Copies of prescriptions issued directly to the patient shall state in letters at least equal in size to those describing the medication dispensed,
the underlined statement:
"COPY—FOR INFORMATION ONLY." For purposes of this section, for requests for prescriptions that are one year or less from the original date of filling, “immediately” shall not exceed 24 hours. For all other prescriptions, “immediately” shall not exceed 72 hours
145
Presentation of a prescription marked "COPY—FOR INFORMATION ONLY" or a labeled prescription container shall be for information purposes only and shall have no legal status as a valid prescription order. The pharmacist in receipt of such copy or labeled prescription container shall...
contact the prescribing practitioner for a new prescription or the last dispensing pharmacy to transfer the prescription pursuant to N.J.A.C. 13:39-7.8.
