Pharmacy Law Exam 2

Various statutes enacted by the legislature regulating the practice of pharmacy in New Jersey are listed in the New
Jersey Statutes Annotated ("N.J.S.A."). They include the following: "Pharmacy Act",
"New Jersey Controlled Dangerous Substances Act", and the
"Prescription Drug Price and Quality Stabilization Act"

1. Enforces the Pharmacy Act
2. Inspects for compliance
3. Promulgates Regulations/Rules
4. Investigates alleged violations
5. Causes violators to be prosecuted

The practice of pharmacy in this State is declared a health care professional practice affecting the public health, safety and welfare and is subject to regulation and control in the public interest. It is further declared to be a matter of
public interest and concern that the practice of pharmacy merits and receives the confidence of the public and that only qualified persons be permitted to engage in the practice of pharmacy in this State. This act shall be liberally
construed to carry out these objectives and purposes.

means the direct application of a drug to the body of a patient or research subject by subcutaneous,
intramusclar or intradermal injection, inhalation or ingestion by a pharmacist engaged in collaborative practice or in
accordance with regulations jointly promulgated by the board and the State Board of Medical Examiners.

means a written protocol directed on a voluntary basis by a patient's
physician, with the patient's consent, that is between a patient's physician who is treating the patient for a specific
disease and a pharmacist for cooperative management of a patient's drug, biological and device-related health care
needs, which shall be conducted in accordance with regulations jointly promulgated by the board and the State Board
of Medical Examiners and shall only include the collecting, analyzing and monitoring of patient data; ordering or
performing of laboratory tests based on the standing orders of a physician as set forth in the written protocol; ordering
of clinical tests based on the standing orders of a physician as set forth in the written protocol, provided those
laboratory tests are granted waived status in accordance with the provisions of the ''New Jersey Clinical Laboratory Improvement Act

means the preparation, mixing, assembling, packaging or labeling of a drug or device as the result
of a practitioner's prescription or initiative based on the relationship of the practitioner or patient with the pharmacist
in the course of professional practice or for the purpose of, or incident to, research, teaching or chemical analysis and
not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of
prescription drug orders based on routine, regularly observed prescribing patterns. Nothing in this act is meant to limit
a prescriber's ability under pre-existing law to order a compounded medication for use in the prescriber's practice, as
permitted by State and federal law.

includes, but is not limited to, the following activities: (1) Evaluation of prescription drug
orders and patient records for known allergies, rational therapy contraindications, appropriate dose and route of
administration and appropriate directions for use; (2) Evaluation of prescription drug orders and patient records for
duplication of therapy; (3) Evaluation of prescription drug orders and patient records for interactions between drug-
drug, drug food, drug-disease and adverse drug reactions; and (4) Evaluation of prescription drug orders and patient
records for proper utilization, including over-or under-utilization, and optimum therapeutic outcomes.

means a level of control which assures that the pharmacist is physically present at the
pharmacy practice site and has the responsibility for accuracy and safety with respect to the actions of pharmacy technicians, interns and externs.

means an individual registered with the Board working in a pharmacy practice site who is
under the immediate supervision of a pharmacist in compliance with N.J.A.C. 13:39-6.15 (N.J.A.C. 13:39-1.2).

The board shall enforce the provisions of this act. The board shall have all of the duties, powers, and authority specifically granted by or necessary for the enforcement of this act, as well as such other duties, powers and authority as it may be granted from time to time by applicable law.

Board consists of 11 members, all citizens and all appointed by the Governor:
2 public members

1 State Executive Department Member

8 Pharmacists-At least one pharmacist employed by a chain drug retailer who owns or operates at least 7 pharmacy practice sites, one who is employed by a health care system and one who owns a pharmacy practice site in this State. Five year term: Staggered terms for RPh. No more than 3 pharmacists terms to expire in 1 year. No member of the Board shall serve more than 2 consecutive full terms
NJPhA and other state professional organizations may suggest R.Phs. to Governor each year.

Governor may remove a Board member upon proven charges of: misconduct, incompetence, neglect of duty or for any
other sufficient cause.

be able and skilled registered pharmacists in N.J.:
Registered in N.J.> 5 years
Actively engaged in pharmacy
Must continue in pharmacy

The board shall meet at least once every month to transact its business. The board shall meet at those additional times
that it may determine. They will only meet twice a month when the workload warrants it. (NJBP News April 2009). Additional meetings may be called by the president of the board or by two thirds of the members of the board.

The board of pharmacy is responsible for various functions, including:
•Licensing and renewal of pharmacy practice
•Enforcement of professional standards and rules of conduct
•Regulation of pharmacy practice through technological means
•Inspection of pharmacy practice sites and prescription records (AT REASONABLE HOURS; also, should provide a certified copy of records they take and should return them once they have fulfilled their intended use)
•Establishment of minimum specifications for record keeping and patient counseling
•Protection of the health and safety of pharmacy patients
•Continuing education and certification of pharmacists.

a). Except as otherwise provided in this act, it shall be unlawful for any individual to engage in the practice of pharmacy unless currently licensed to practice under the provisions of this act.

means an address designated by licensee. May be home, business or mailing address. It shall not
be a PO box unless another street address is provided.

(1) interpretation of prescription
(2) proper selection, measuring, labeling and packing in proper container
(3) Consultation by the pharmacist

(a) USP/NF, Homeopathic Pharmacopoeia; (b) articles intended for use in diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals; (c) articles (other than food) intended to affect the
structure or any function of the body of human beings or animals; and (d) intended for use as a component of above (sugar, starch), but not including devices or their components.

For Biological products indicated as interchangeable by the FDA in the "List of Licensed Biological
Products with Reference

means that the pharmacist is physically present in the compounding/dispensing area
when interns, externs and pharmacy technicians are performing delegated duties, and the pharmacist conducts any
necessary in-process checks and the final check in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, the finished label and the accuracy and appropriateness of the actions of pharmacy technicians, interns and externs.

Certified Nurse Midwives registered with the Board of Medical Examiners may apply for authorization to prescribe drugs according to standing orders and practice protocols developed with a collaborative physician. If there is a formulary listing the categories of drugs established in the clinical guidelines, including controlled dangerous substances, CNMs may order, prescribe, administer, or dispense drugs.

All Rx blanks provided by a CNM must contain the patient's name, address, and age, the CNM's full name, address, telephone number, license number, and proper academic degree or identification of professional practice, the date of the Rx, the name, strength, route, and quantity of the drug, words to indicate the drug quantity authorized if the prescription is for a CII, the number of refills or time limit for refills, the signature of the prescriber, and the prescribing practitioner's DEA number, if the drug is a CS. Additionally, every Rx blank must have "substitution permissible" and "do not substitute" with a space for the CNM's initials next to the chosen option and a signature line. Each Rx must have no more than one CS, and be consecutively numbered NJPB.

In both in-patient and out-patient settings, Physician Assistants (PAs) can order or prescribe controlled dangerous substances with the authorization of a supervising physician, as long as certain conditions are met. PAs must include specific information on all prescription blanks, such as their full name, professional identification, license number (PA-C), and the supervising physician's full name (stamped) and DEA number (if for a controlled substance). The prescription must also include the patient's full name, age, and address, as well as the name, strength, route of administration, and quantity of the drug. Additionally, there must be adequate instructions, number of refills or time limit, and the PA's hand-written signature. Every prescription blank must have "substitution permissible" and "do not substitute" options, and the PA's DEA number if authorized to issue controlled substance prescriptions. Finally, all prescriptions must be written on consecutively numbered NJPB.

Optometrists can prescribe medication for the eye and adnexae, but with certain limits. They cannot prescribe CII drugs (except Hydrocodone) and cannot administer injections, except for emergencies. They must be certified by the Board of Optometry and take continuing education credits to obtain a TPA certification number. With a TPA certification number beginning with "27TO," they can prescribe topical agents only, while those with a TPA certification number beginning with "27OM" can prescribe oral medications and topical agents. All prescriptions must be consecutively numbered and include the prescriber's full name, address, phone number, license number, and academic degree, as well as the patient's full name, date of the prescription, and the prescriber's handwritten signature.

In the inpatient setting, an advanced practice nurse can order medications and devices if they follow these conditions:

Collaborating physician and the nurse should agree if prior consultation is needed to order a controlled dangerous substance.

The order should follow standing orders, joint protocols, or physician's direction.

The advanced practice nurse signs and authorizes the order, including their own name, certification number, and collaborating physician's name.

The physician should be present or available through electronic communications.

Charts and records of patients treated by the nurse should be reviewed by both parties within a specified time period.
Joint protocols should be reviewed, updated, and signed annually by both parties.

The advanced practice nurse should have completed six contact hours of continuing professional education in pharmacology related to controlled substances.

All prescriptions, except for licensed acute or long-term care facilities, must contain the prescriber's full name, designation, address, telephone number, and certification number. If it's for a controlled dangerous substance, the DEA number must be included. It should also include the patient's name, address, age, prescriber's signature, collaborating physician's full name and title, and date of the prescription. The collaborating physician's DEA number is no longer required.

May prescribe "for any disease, pain, deformity, deficiency, injury, or physical condition of the human tooth, teeth, alveolar process, gums, cheek, or jaws or oral cavity and associated tissue".

ambulance services, certified chiropractors, euthanasia technicians, homeopathic physicians, medical psychologists, and naturopathic physicians. Animal shelters may administer CII narcotics and dispense and procure Sodium Pentobarbital.

means a therapeutic equivalence rating of "A" has been listed in the FDA "Approved Drug Products with Therapeutic Equivalence Evaluations".

Must pay penalties within 15 business days of receipt of penalty letter or final order. Failure to pay will invoke
N.J.S.A. 45:1-24. Note: Do not just sign and send it back.

May request a hearing if you have a problem.

The rules of the Board may be relaxed on a showing of undue hardship, economic or otherwise. Waiver requests
should be submitted in writing to the Board.

The examination for licensure shall measure the competence of the applicant to engage in the practice of pharmacy. The board may employ, cooperate and contract with any organization or consultant in the preparation and grading of an examination, but shall retain the sole discretion and responsibility for determining which applicants have successfully passed the examination.

a). For initial licensure one must:
1. Be at least 18 years of age, submit a completed application (passport size photo) and fee set forth in
N.J.A.C. 13:39-1.3
2. Have graduated with a B.S. in pharmacy with a minimum 5 year course, or with a Doctor of Pharmacy from an American Council of Pharmaceutical Education (ACPE) or equivalent.
3. Passed the NAPLEX and MJPE
4. If applying >2 years post-graduation the applicant shall complete 1,440 hours of practical experience and register as an intern with the board of pharmacy pursuant to N.J.A.C. 13:39-2.6 within the two-year period preceding the date of application; and
5. Satisfy the good moral character and criminal history background check requirements in N.J.A.C. 13:39-2.3 and 2.4.

NAPLEX - score of not less than 75
Law Exam (MJPE) - score of not less than 75
Three Failures of either NAPLEX or MJPE (includes "no score" and "not passing") - applicant not eligible to
retake the exam until one year from date of last exam. The Board may require remedial course at an ACPE accredited school of Pharmacy.
Results of NAPLEX and MJPE are only valid for 5 years from the date the applicant receives a passing
score.

Before the exam, you must prove that you have good moral character, which requires evidence that:
You are not currently using drugs or alcohol that would impair your ability to practice pharmacy safely and skillfully. This applies to any time within the previous year.

You have not been convicted of violating laws related to controlled dangerous substances or drugs.

You have not been convicted of violating pharmacy practice laws, as specified by N.J.S.A 45:1-21(f).

You have not been convicted of a crime involving moral turpitude, such as murder, rape, child abuse, robbery, theft, or fraud, which is conduct that is inherently base, vile, or depraved and shocks the public conscience (like Ravi's appearance).

You are not currently suspended from or have been suspended from a pharmacy registration/permit in any jurisdiction.

The Board may refuse to issue a license to any applicant who has violated any law related to the practice of pharmacy
or for any of the reasons set forth in N.J.S.A. 45:1-21 et seq.

in 5th or 6th year of college (3rd or 4th professional year) - accredited - who is assigned to an
approved training site for purpose of acquiring accredited practical experience and under supervision of school in which enrolled.

graduate employed at approved training pharmacy for purpose of acquiring accredited
experience and has registered with Board

not deemed to be a pharmacy extern as defined in this section and shall register as a pharmacy technician in accordance with
N.J.A.C. 13:39-6.6. Such an individual may perform only the duties set forth in N.J.A.C. 13:39-6.15.

a) The Board sends a renewal notice to each licensee at least 60 days before the license expires. If the notice isn't sent on time, there won't be any fines for renewing within 60 days after the notice is sent or within 30 days after the expiration date.

b) Licensees must renew their license every two years before the expiration date by submitting an application and fee to the Board.

c) Licensees may renew their license as inactive, but can't practice pharmacy until the license is returned to active status.

d) If a license isn't renewed before the expiration date, it can still be renewed within 30 days by paying a late fee.

e) If a licensee doesn't renew the license within 30 days after it expires, the license will be suspended without a hearing.

f) Licensees who continue to practice with a suspended license may face legal action, even if they haven't been notified of the suspension.

If someone wants to reactivate their inactive license, they need to do the following:

Submit a renewal application

Provide a certification of employment for each job they had during the inactive period

Pay the biennial renewal fee

Show proof of completing all required continuing education credits during the previous biennial period.

If the Board thinks the person may have practice deficiencies, they might have to pass an examination or complete a refresher course before their license can be reactivated.

A pharmacist who has had his or her license administratively suspended pursuant to N.J.A.C. 13:39-3.7(e) may
apply to the Board for reinstatement.

It shall be unlawful for a pharmacist to enter into an arrangement with a health care practitioner who is licensed to
issue prescriptions for the purpose of directing or diverting patients to or from a specified pharmacy or restraining in any way a patient's freedom of choice. (Doctors cannot own pharmacies either; no shares)

Once pass exam, applicants receive a signed authorization to practice pharmacy from Board Secretary that is valid
until initial license is issued. Upon issuance of a license the current biennial renewal license shall be conspicuously displayed in the registered pharmacist's principle place of employment. If work at more than one store and license not displayed at that store, the pharmacist must carry the issued wallet-sized license.

Payment of a fee as per N.J.A.C. 13:39-1.3, proof of applicant's identity and reasonable proof of the loss or destruction of the original license is to be submitted to the Board.

The pharmacist shall notify the Board within 30 days of such change. Submit original or certified copy of court order
or marriage certificate showing change which the Board keeps. Once a replacement license is issued, the pharmacist
must return the initial license for cancellation, accompanied by the required fee as per N.J.A.C. 13:39-1.3.

Must notify Board in writing within 30 days, or may result in disciplinary action in accordance with N.J.S.A. 45:1-21(h) and N.J.A.C. 13:45C-1.3, and the imposition of penalties set forth in N.J.S.A. 45:1-25. Process is served on the
address of record.

is illegal

A certificate that the license of the RPh is in good standing may be obtained upon written request from the Board and
upon payment of the fee set forth in N.J.A.C. 13:39-1.3.

Out-of-state pharmacists can get a license in this state if they meet these requirements:

Submit a completed application with a photo and fee, and show they got their initial license by examination and it's in good standing and haven't had any other license suspended or revoked except for certain reasons.

Graduated from an accredited pharmacy school with a Bachelor of Science or Doctor of Pharmacy degree.

Have worked at least 1,500 hours in the past two years or completed internship requirements.

Passed the Multistate Jurisprudence Pharmacy Examination (MJPE) after receiving authorization to test.

Passed a criminal background check and shown good moral character.

To obtain a license by reciprocity, the applicant must demonstrate good moral character as an ongoing requirement for licensure. The Board will consider evidence to ensure the applicant is not currently engaged in drug or alcohol use that could impair their ability to practice pharmacy safely and skillfully, has not been convicted of violating any drug-related or pharmacy-related laws, has not been convicted of a crime involving moral turpitude, and has not had their license suspended or revoked due to violating any pharmacy-related laws, rules, or regulations.

To renew their registration as a pharmacist, individuals must complete continuing pharmacy education and provide proof to the board. The board will establish standards for this education, including the number of credits, subject matter, and selection of instructors. They will approve educational programs and other equivalent educational programs and establish procedures for the issuance of credit. The board may waive requirements for individual hardship reasons, and they do not require continuing education credits for initial renewal. If an individual completes more credits than required, they may carry them over for the next renewal period, but not beyond that. The board will not approve programs that discriminate or contain routine business or promotional presentations.

a) License renewal requires a minimum of 30 credits every two years, with at least 10 obtained through in-person instruction (not including video). At least 3 credits must be in pharmacy law, and one credit must be in opioid education starting May 1, 2017. This credit cannot be carried over. The Board may waive this credit on an individual basis.

b) Up to 10 credits earned in the last six months of the previous two-year period can be carried over to the next period if they were not previously reported.

c) Applicants for license renewal who are authorized to administer vaccines and related emergency medications must complete the continuing education requirements in N.J.A.C. 13:39-4.21, which will count towards the total number of credits required in (a) above.

d) Applicants for license renewal who are granted authorization to engage in collaborative drug therapy management must complete the continuing education requirements in N.J.A.C. 13:39-13.3, which will count towards the total number of credits required in (a) above.

Note: While not in the regulation many CE courses require an NABP profiler number to receive
credit.

To receive credit, approved programs or courses must be at least 1 contact hour (50 minutes). If a program or course is longer than 1 contact hour, 1/2 credit per 30-minute segment will be granted. Completing the entire program or course is necessary to receive credit.

Completion of graduate coursework related to pharmacy beyond what is required for licensure earns three credits per course credit awarded.

Teaching or researching a new program, course, or subject matter related to pharmacy earns three credits per activity, up to a maximum of six credits. Full-time teachers or researchers are not eligible for continuing education credit.

Participation as a preceptor in an externship program earns three credits per student, up to a maximum of six credits. Prior approval by a college of pharmacy is required.

Participation as a preceptor in an internship program earns three credits per 160 hours of supervised work performed by the intern(s), up to a maximum of six credits.

Publication of an article related to pharmacy in a peer-reviewed professional journal earns three credits per article, up to a maximum of six credits.

A licensee shall specify on application for license renewal the number of continuing education credits 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
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.
c). The Board shall audit licensees on a random basis at the end of each biennial period to determine compliance with continuing education requirements.

Applications for pre-approval of continuing education programs or courses shall be submitted by the continuing education sponsor on a form provided by the Board at least 45 days prior to the date the program or course is to be offered. Incomplete applications shall be returned to the sponsor.

The Board shall approve only such continuing education programs and courses as are available and advertised on a reasonable nondiscriminatory basis to all persons licensed to practice pharmacy in the State. The Board shall maintain a list of all approved programs and courses at the Board office and shall furnish the list to licensees upon request.

No person shall carry on, conduct or transact business under a name which contains as a part thereof the words ''pharmacist,'' '' pharmacy,'' ''apothecary,'' ''apothecary shop,'' ''druggist,'' '' drug'' or any word or words of
similar or like import, or in any manner by advertisement, circular, poster, sign or otherwise describe or refer to the place of business by the terms ''pharmacy,'' ''apothecary,'' ''apothecary shop,'' ''chemist's shop,'' ''drug store,''
''drugs'' or any word or words of similar or like import unless the place of business is a currently licensed pharmacy practice site operated or managed at all times by a pharmacist.

All pharmacy practice sites in this State, which engage in the practice of pharmacy in the State of New Jersey, shall be issued a permit by the board, and shall annually renew their permit with the board. If operations are conducted at
more than one location, each location shall be issued a permit by the board for the dispensing of medicine. Each pharmacy practice site shall have a pharmacist-in-charge. The pharmacist-in-charge and the owner of a pharmacy practice site shall be responsible for any violation of any laws or regulations pertaining to the practice of pharmacy.

Any pharmacy located in another state which ships, mails, distributes or delivers in any manner, legend drugs or devices pursuant to a prescription into this State, shall register with the board

All licensed pharmacy practice sites shall report to the board the occurrences of any of the following:
(1) Closing of the pharmacy practice site;
(2) Change of ownership, location, interior site design, permit classification or pharmacist-in-charge of the
pharmacy practice site;
(3) Any significant theft or loss of legend drugs or devices (See VII B5b4 above);
(4) Disasters, accidents, any theft, destruction or loss of records required to be maintained by State or federal law;
(5) Any pharmacy malpractice liability insurance claim settlement, judgment or arbitration award in excess of \$10,000 to which an owner, an employee of, or the pharmacy practice site itself is a party; and
(6) Any and all other matters and occurrences as the board may require by rule or regulation.
b). The manner, time and content of the notification shall be prescribed by rule or regulation by the board.

No pharmacy can operate unless it has been given permission by the board. The board has the power to stop or revoke the permission of any pharmacy for a variety of reasons, including breaking laws related to pharmacy practices, being convicted of a crime that relates to pharmacy, providing false information, losing other related licenses or permits, committing fraud, dealing with stolen drugs or devices, purchasing from unlicensed sources, not providing enough personnel or technology for the licensed pharmacist to do their job properly, violating drug laws or violating laws related to pharmacy practices.

Pharmacists and pharmacies shall comply with the provisions of the federal standard of Practice of Individually Identifiable Health Information, 45 C.F.R. Parts 160 and 164.

An individual or business entity must submit an application to the Board, indicating the proposed pharmacy area's location, physical arrangement, and the area where drugs will be stored and dispensed. The application must include the names and addresses of the owners, operators, officers, and principal stockholders, as well as the name of the pharmacist-in-charge. The applicant must be of high moral character, and the Board may interview the person submitting the application. The Board must inspect and approve the premises before issuing a permit, which is required before stocking drugs. Finally, within 90 days of the Board's approval, the pharmacy must notify the Board in writing that it has opened for business. If additional time is needed, a written request for an extension of time must be submitted no less than 30 days before the 90-day period expires.

A permit for a pharmacy is issued by the Board in the name of the pharmacy. The permit holder must submit a renewal application and fee within 30 days after the permit expiration. If they fail to do so, they must also submit a late renewal fee. If they continue to practice with an expired permit, they may face penalties. The Board will send a notice of renewal at least 60 days prior to the expiration of the permit. If this notice is not sent on time, no monetary penalty or fines will apply for any unauthorized practice during that period.

The current permit must be conspicuously displayed.

Death of individual owner or partner: permit is void and shall be returned to the Board pursuant to N.J.A.C. 13:39-4.10. Heirs or remaining partners must apply immediately to continue operations as set forth in N.J.A.C. 13:39-4.5.

When there is a change in the ownership of a business entity holding a permit to operate a pharmacy, certain requirements must be met. These include submitting a new permit application and fee within 30 days if there is a complete change in ownership, submitting an affidavit to the Board within 30 days if there is a change of registered agents or officers or stock ownership involving 10% or more of outstanding stock of a publicly traded corporation or reallocation of ownership interests among existing owners. The new ownership must also take custodial ownership of the previous five years of prescription and profile records and ensure they are maintained properly

a). If pharmacy changes location, must file for new permit on form provided by Board at least 30 days prior to such change. Board shall inspect and approve premises and inventory of new location. If location change will result in a
temporary closing must comply with N.J.A.C. 13-39-4.10 (c) and (d). Also, must assure records are maintained in any move as per N.J.A.C. 13:39-7.6 and 7.19.
(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.

(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 N.J.A.C. 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.

· Apply 30 days prior for permit
Return the old permit

· Notify DEA, DCU, and NJBP 15 days prior
· If unanticipated closing, write ASAP
· All meds to transfer to wholesaler, reverse distributor, or manufacturer
· Within 30 days of closing, remove drug signs and notify board in writing

Notify Patrons and Board:
o Notify board in WRITING
o PUBLICATION of rights once a week for 2 weeks in local paper
o SIGN in pharmacy detailing rights
o Social media platforms used by specific pharmacy

One year

· Kept open for 40 hours/week; 5 days per week (sign conspicuously displayed on exterior of building)
· If permanent changes to hours of operation, notify board in writing within 30 days

· Temporary closing for more than 48 hours: Reported to and approved by board with contingency plan for patient records
· If >48 hour closing, without board approval = trouble

A replacement permit may be issued by the Board upon payment of a fee pursuant to N.J.A.C. 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.

Any permit issued by the Board for the operation of a pharmacy or other board-licensed establishment may only be
photocopied for State agencies and other business entities with whom the permit holder does pharmacy related
business.

· All entrances must be locked + monitored security system + backup mechanism
o Must have something to signal warning of intrusion
· Only pharmacist in charge responsible for keys and security system
· Should NOT accept Rx drugs (generally only pharmacist but it is legal for techs to receive controls) when pharmacy is closed unless security is provided for shipment
· Secured barrier protecting will call bin

ANY Pharmacist on Duty needs to report theft or diversion to PIC or permit holder:
o Actual quantity missing in relation to type of business
o Specific prescription drug missing
o Whether the prescription drug can be associated with access to those drugs by specific people or to activities
o Pattern of loss over time

o Written report filed with board, DEA
o Written report to FDA (if necessary) and DCU

a). Board has power to issue permits for limited services which waive certain rule requirements
b). Applicant for specialized pharmacy permit must provide Board with application and policy and procedure manual
with a detailed description of the type of specialized pharmacy services to be provided within the pharmacy practice

intake, processing, fulfillment, dispensing

a licensed 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 directly to the centralized pharmacy)

a licensed 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

a licensed pharmacy engaging in central prescription handling by filling and/or refilling prescriptions which includes the preparation and packaging of the medication

a licensed pharmacy that receives the processed prescription for dispensing to the patient and that offers patient counseling regarding the dispensed medication.

5 years
o Oldest four years should be retrievable in 2 weeks
o Most recent 1 year retrievable within 1 day

This prescription dispensing regulation requires any product with a prescription to have a permanently affixed label that includes the brand name or generic name (in the form "Generic for ---"), the strength of medication, quantity dispensed, date of dispensing, a CDS cautionary label (if applicable and permitted by law), patient and practitioner names, prescription number, directions for use, "use by" date (if dispensed in different packaging than the manufacturer's), auxiliary labeling as recommended by the manufacturer or deemed appropriate by the pharmacist, and the name, address, and telephone number of any intake, central processing, central fill, or dispensing pharmacy.

Any pharmacy located in a state other than New Jersey that ships, mails, distributes or delivers prescription drugs or devices into New Jersey or participates in a central prescription handling arrangement must fill out the application and register with the Board. Unlawful if not registered.

A practitioner practicing in this State shall use non- reproducible, non-erasable safety paper New Jersey Prescription Blanks bearing that practitioner's license number whenever the practitioner issues prescriptions for controlled dangerous substances, prescription legend drugs or other prescription items. The prescription blanks shall
be secured from a vendor approved by the Division of Consumer Affairs in the Department of Law and Public Safety. As per N.J.A.C. 13:45A-27.8 the blanks must be serially numbered and contain the NPI number if one was obtained.

Firstly, a practitioner may transmit a prescription by telephone or electronic means if they provide their Drug Enforcement Administration registration number and license number or other relevant identification number. Secondly, prescriptions for Schedule II controlled dangerous substances must be given or transmitted in writing and signed by the practitioner, unless the prescription is transmitted or prepared in compliance with federal and state regulations, in which case electronic prescriptions are allowed.

Not required to have one per one, but not more than one scheduled drug per blank (can have one controlled and other non-control)

means pain which has been shown to be refractory or resistant to management with standard

means any licensee subject to the regulatory authority of the Board authorized to prescribe or dispense drugs, including physicians, podiatrists and, to the extent permitted by law and rule, registered residents, resident
permit holders, physician assistants and certified nurse midwives.

· Prescriber name, address, phone, DEA, degree, license number
· Full name, address age of patient; Date of issuance
· Drug, strength, quantity, frequency
· Words to supplement number of drug quantity for control II
· Refills allowed, Signature of prescriber
· Instructions for patient
· Computer-generated script that is printed or faxed must have practitioner MANUALLY SIGN
· Must be numbered consecutively and include NPI

means the pain, whether resulting from disease, accidental or intentional trauma, or other cause, that the practitioner reasonably expects to last only a short period of time. "Acute pain" does not include chronic pain, pain
being treated as part of cancer care, hospice or other end of life care, or pain being treated as part of palliative care.

means pain that persists for three or more consecutive months and after reasonable medical efforts
have been made to relieve the pain or its cause, it continues, either continuously or episodically.

A prescription is new if the patient has never used the drug or its equivalent before, or if it has been more than a year since they last used it.

means care provided to an individual suffering from an incurable progressive illness that is expected to end in death, which is designed to decrease the severity of pain, suffering, and other distressing symptoms, and the
expected outcome of which is to enable the individual to experience an improved quality of life.

A practitioner can prescribe more than 30 days of a Schedule II drug if the patient has an implantable pump for pain relief (and practitioner documents need at least every 30 days) or if the practitioner writes multiple prescriptions and follows certain rules (which I am not writing).

a five day supply with lowest effective dose

a prescription for a patient who is currently in active treatment for cancer, receiving hospice care from a licensed hospice, receiving palliative care, or is a resident of a long-term care facility, or to any medications that are being prescribed for use in the treatment of substance abuse or opioid dependence.

"detoxification" or "maintenance treatment."

weight management, dieting or any other anorectic purpose, or for the treatment of fatigue.

Unless an accepted medical necessity exists practitioners shall not prescribe anabolic steroids or human growth hormones.

A pharmacist in New Jersey can only fill prescriptions written on a New Jersey blank or out-of-state by a US licensed prescriber (including territories). Always fill in accordance with NJ laws. Prescriptions from other countries are not legal.

A pharmacist shall get any missing information from the practitioner or use generic directions. The pharmacist shall record all information on the prescription or in the pharmacy's records. Put use as directed if doctor cannot be contacted.

Prescription drugs need the practitioner's or their agent's approval for renewal. Renewals are not allowed after one year or beyond the original prescription limit (even if prn written for refills). Schedule II drugs have no renewals. Schedules III-V have up to five renewals within six months.
New prescriptions from a practitioner must be recorded in hard copy or electronic form.

A pharmacist can give a 72-hour supply of a chronic drug (not controlled) without a prescription if the patient needs it and has proof of previous use. The pharmacist must document the communication and the patient's ID.

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 practitioner as provided under Federal law

Pharmacies must maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing various component functions of prescription handling. All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. 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 and will be documented as the function is performed.

Pharmacies must keep documentation identifying all pharmacists, pharmacy technicians, interns and externs employed by the pharmacy for at least five years after their last date of employment. If a manual system is used, documentation must include handwritten initials with signatures and printed names. The oldest four years of records must be retrievable within two weeks and the most recent year within one business day. Records not in use can be stored off-site in secure facilities.

A patient can get a copy of their prescription from the pharmacy. The copy must say "COPY - FOR INFORMATION ONLY". The copy must be given within 24 hours for recent prescriptions and 72 hours for older ones (cannot exceed). Words must be underlined and equal size.

A copy or a labeled container is not a valid prescription. The pharmacist must contact the prescriber or the original pharmacy to get the information to dispense the drug.
Prescriptions; Dispensation of Lowest Cost Interchangeable Drug Product; Exceptions;

Prescription blanks must have "substitution permissible" and "do not substitute" options with space for prescriber's initials. Unless "do not substitute" is selected, a pharmacist can dispense a different brand or non-brand drug of the same name if it's on the list of interchangeable drugs and costs less. The prescriber can request notification before the substitution.

Same
Prescriptions; Dispensation of Substitute Drug for Drug Not on Latest List of Interchangeable

A pharmacist can dispense a different brand or non-brand drug if it costs less, there's no proof of efficacy for the prescribed drug, the patient has sensitivity/allergies/adverse reactions to the prescribed drug or if there's a more appropriate drug. The pharmacist must notify and receive approval from the prescriber before dispensing.
Violations; Penalties; Collection and Enforcement; Validity of Prescription on Unauthorized

Any violation not less than \$100 for first offense and not less than \$200 for each subsequent offense.

The FDA's Orange Book and Drugs@FDA website list interchangeable drugs with therapeutic equivalence code ratings of A. Drugs with a B rating aren't therapeutically equivalent and can't be substituted. Therapeutically equivalent drugs are designated AA, AN, AO, AP, AT or AB. (e.g. AB3 products can only be substituted with other AB3 products.) BC, BD, BE, BN, BP, BR, BS BT BX or B* are not therapeutically equivalent.

not interchange a less expensive equivalent drug unless the prescriber has been contacted and approved the interchange in each specific case

False (you do not, just whatever saves money compared to the brand)

True; the sign is enough

True; even though that's weird

Licensed pharmacists, interns, externs, and technicians can administer vaccines and related emergency medications (diphenhydramine and epinephrine) to patients 18 years and older.

This can be done under the following circumstances:
With a prescription from a NJ licensed physician for a specific patient.

In immunization programs with a standing order from a NJ licensed physician that is not patient specific.

In government-sponsored immunization programs that are not patient specific.

Screen the patient using CDC criteria for the specific vaccine.

Counsel the patient about contraindications, injection site care and adverse reaction instructions.

Inform the patient in writing about vaccine risks and benefits and provide a CDC vaccine information sheet.

Obtain a signed informed consent form from the patient or representative and maintain it at the pharmacy practice site or immunization location in hard copy or electronic form.

this shall result in the patient's vaccine documentation being sent to the patient's primary care
provider, if identified.

Documentation and records must be kept in hard copy or electronic form for at least seven years.

Records must be supplied to physicians or health care providers with a signed patient release form.

Records must be available to authorized inspectors under State and Federal laws.

The oldest six years of records must be retrievable within two weeks and the most recent year within one business day.

Records not in use can be stored off-site in secure facilities and must be kept confidential.

In New Jersey, a licensed pharmacist, intern, or extern must be authorized to administer vaccines and related emergency medications. For patients under 18 years old, written consent from a parent or legal guardian is required. For patients between 7 and 10 years old, a prescription from a licensed physician is required for the influenza vaccine. Pharmacists cannot administer the influenza vaccine to patients younger than 3 years old

In New Jersey, a licensed pharmacy may sell hypodermic syringes or needles to a person over 18 years old with valid photo identification. Quantities of 10 or fewer can be sold without a prescription while quantities over 10 require a prescription. The pharmacy must keep its supply behind the counter and provide information about safe disposal and substance abuse treatment

In New Jersey, a licensed pharmacist or other provider of oxygen must notify the fire department where the patient resides and obtain written informed consent from the patient or their authorized representative. If consent is declined, the pharmacist must still report and may still supply oxygen. The pharmacist must also notify the fire department if oxygen is terminated within 10 days of removal. Compliance with these requirements grants immunity from civil liability

In New Jersey, a facility must have a consultant pharmacist and either a provider pharmacist or a director of pharmaceutical services. The pharmacist must comply with Federal and State laws and standards of practice. The facility must also have an interdisciplinary pharmacy and therapeutics committee that meets at least quarterly. The consultant pharmacist cannot be affiliated with the director of pharmaceutical services or the pharmacist provider. If the facility keeps emergency-controlled substances, it must have current DEA and CDS registrations.

The consultant pharmacist must review the medication of each resident monthly and report any issues to the attending physician, director of nurses, and document it. They should report drug defects and adverse reactions, and document known allergies. Medications without a specified duration must have automatic stop orders and notify the attending physician. If medication is withheld, it should be documented. Any medication errors or adverse drug reactions should be reported immediately and documented. If there is a medication error, there should be an immediate report to the director of nursing or pharmacy (if originated in pharmacy) should be notified immediately, and any severe reactions resulting in death should be reported to the Department.

Medication containers or packages in a nursing home must be labeled with the resident's full name, prescriber's name, prescription number, drug name and strength, quantity dispensed, lot number, date of issue, expiration date, manufacturer's name if generic, cautionary and/or accessory labels, and the name, address, and telephone number of the pharmacy. If a unit dose distribution system is used, each resident shall have their own labeled medication tray and each medication shall be individually wrapped and labeled with specific information. Over-the-counter and prescription medications may be kept as stock, but must be approved by the pharmacy and therapeutics committee and labeled accordingly. The consultant pharmacist shall conduct regular inspections and document any problems. Emergency kits shall be stored securely, checked after each use and at least monthly by the consultant pharmacist, and not be accessible to residents. Repackaged medications must also be properly labeled. The pharmacy and therapeutics committee must establish and enforce procedures for removing expired or damaged drugs, and all medications must be stored in accordance with requirements and kept in locked storage areas.

The facility must have at least two people witness the destruction of medication and keep a record of it. They should also have a crediting mechanism for medications dispensed, monitor inventory of controlled substances, and obtain prescription medications from a permitted pharmacy. If the facility uses drug samples, they must develop a mechanism for control and limitation. Instructions for medication use should be provided to promote proper storage, secure handling, and safe administration, and documentation should be entered into the resident's medical record.

If the facility maintains a pharmacy in-house, the pharmacy shall be licensed by the New Jersey State
Board of Pharmacy, and shall possess a current Drug Enforcement Administration registration and a Controlled Dangerous Substance registration from the New Jersey State Department of Law and Public Safety.

The consultant pharmacist reviews drug records within 48 hours of admission via a facsimile or email service. All dated and signed comments and recommendations made by the consultant pharmacist shall be added to the resident's medical record and shall be distributed to the attending physician or advanced practice nurse and director of nurses for review and action.

means the delivery of a health care service using electronic communications, information technology, or other electronic or technological means to bridge the gap between a health care provider who is located at a distant site and a patient who is located at an originating site, either with or without the assistance of an intervening health care provider, and in accordance with the
provisions of the Act. It does not include the use, in isolation, of audio-only telephone conversation, electronic mail, instant messaging, phone text, or facsimile transmission.

Unless specifically prohibited or limited by federal or State law, a health care provider who
establishes a proper provider-patient relationship with a patient may remotely provide health care
services to a patient through the use of telemedicine. A health care provider may also engage in
telehealth as may be necessary to support and facilitate the provision of health care services to patients. In New Jersey, the prescription of Schedule II controlled substances through telemedicine or telehealth is only allowed after an initial in-person examination and subsequent in-person visits every three months. However, this requirement does not apply when prescribing a Schedule II stimulant for a minor patient under 18 years old using real-time audio and video technologies with written consent from the patient's parent or guardian .

Each telemedicine or telehealth organization operating in the State shall annually register with the
Department of Health.

New rule for opioids; need to have opioid risk of addiction and overdose sticker (must be red, orange, or yellow). Warning written in black size 10 font (print or block-based). Warning placed on side of the bottle

(CDS) means a drug, substance or immediate precursor in schedules I through V of this Act. The term shall not include spirits, wine, malt beverages or tobacco.

means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by combination of extraction and chemical synthesis:
a) Opium, coca leaves and opiates;
b) A compound, manufacture, salt, derivative or preparation of opium, coca leaves or opiates;
c) A substance which is chemically identical with any of the substances referred to in a and b above.

means any dangerous substance having addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability. It does not include dextromethorphan

Any person who manufactures, distributes or dispenses any CDS or proposes to engage in the foregoing shall obtain a registration by the division in accordance with rules and regulations promulgated by it. A separate registration will be required at each principle place of business.

These conditions include falsifying an application, being convicted of an indictable offense related to controlled dangerous substances (CDS), violating regulations in a way that reflects adversely on their reliability and integrity with regard to CDSs, having their federal registration suspended or revoked, or having their registration suspended or revoked by another state for violation of its CDS laws.

Manufacturers of CDSs must pay an annual fee of \$200, while distributors and reverse distributors must pay \$100. Dispensers or researchers must pay an annual fee of \$20. A separate fee is required for each place of business where registration is required. Certain individuals and organizations are exempt from these fees, including state-operated hospitals and clinics, other state agencies for which the state would be responsible for payment of the fee, and hospitals and facilities operated by any department of the U.S. However, exemption from fees does not relieve a person from registration requirements.

means administrative unit within the Department of Law and Public Safety, Division of Consumer Affairs, Enforcement Bureau, P.O. Box 45045, Newark, New Jersey, 07101.

means the administrator of the Drug Control Unit who may be contacted at (973) 504-6545.

means a person who receives CDS acquired from another person registered for the purpose of
1. Returning unwanted, unusable, or outdated CDS to the manufacturer or his agent.
2. Processing or arranging from processing CDS for disposal.

After an application for registration has been filed, the applicant's place of business will be inspected. However, at the discretion of the Commissioner of the Drug Control Unit, registration renewal may be issued prior to an inspection. The issuance of a registration does not guarantee continued registration if upon inspection it is determined that the registrant does not meet the requirements of applicable statutes or regulations. The registration certificate must be displayed conspicuously in the registered location.

Regulations promulgated pursuant to the United States Comprehensive Drug Abuse Prevention and Control Act of
1970 which designate, reschedule or delete a substance as a CDS under Federal Law shall be deemed to be effective
under the New Jersey Controlled Dangerous Substances Act 30 days after their effective date of the Federal Regulation unless the Commissioner objects within that 30 day period.

It is unlawful for any person to distribute or dispense CDSs in violation of Section 14, for a registrant to manufacture, distribute or dispense a CDS not authorized by their registration, to omit, remove or alter a symbol or mark required by federal or state laws, to fail to keep required records or provide required information under the Act, to refuse entry for inspection, or knowingly keep or maintain any place used for illegal use or sale of CDSs. Violations are subject to a fine of up to \$25,000. If the violation was committed knowingly or intentionally, the individual may also be guilty of a high misdemeanor and punished by imprisonment for up to three years and/or an additional fine of up to \$25,000.

It is the duty of the State Department of Health to enforce the act and cooperate with other agencies such as the Board of Pharmacy. The Commissioner of Health has the power to promulgate rules and regulations for enforcement of the act, including those promulgated by the Attorney General of the United States. The Commissioner may also issue an order relative to any CDS under the Act when delay would constitute an imminent danger to public health or safety. Such orders take effect immediately but expire after 120 days. Aggrieved parties may apply for a hearing with a decision made within 48 hours and a right to injunctive relief thereafter. In addition, designated officers or employees of the State Department of Health may execute warrants, subpoenas and summonses, seize property pursuant to provisions of the act, and perform other law enforcement duties designated by the Commissioner with approval from the Attorney General.

a) Administrative inspection warrants may be issued by a Judge upon proper oath or affirmation showing probable cause for the purpose of inspection and seizure of property. The warrant must identify the area to be inspected, the purpose of the inspection, and the appropriate type of property to be inspected, as well as the name of the individual who provided the facts for the warrant. The warrant must be served during normal business hours, executed and returned within ten days, and if a seizure is executed, a receipt and inventory shall be given to the individual executing the warrant.

b) The director can make administrative inspections of controlled premises, which are places where registrants must keep records and hold CDS's. The agent of the director can enter the premises upon presenting a warrant and appropriate credentials, and has the right to inspect and copy required records, inspect controlled premises and equipment, and inventory CDS substances and obtain samples. However, inspections may not extend to financial, sales, pricing, personal, or research data, unless the owner or operator consents in writing. Entry without a warrant may be made in exceptional or emergency circumstances, or if the owner or operator consents.

o Pharmacy should transfer script within 4 hours
o May transfer for 1 year from original date written if refills available
o CII CANNOT be transferred
o CIII, IV, V may transfer between pharmacies for one time only
o Not applicable to central-fill locations or pharmacies that share real-time database

o May transfer by fax, phone, electronic provided that
o Sending pharmacy invalidates script on file and records the order that:
§ Script was transferred/date of transfer
§ Name/address of pharmacy transferred to
§ Name of pharmacist, intern, extern who sent to/issuing transfer
o Receiving pharmacy records
§ Original number of script, name/address
§ Name of person sending script
§ All info on script
o Whoever made the transfer at original pharmacy must inform patient the original script is cancelled at sending pharmacy

The pharmacist must ensure that the facsimile prescription is transmitted by an authorized prescriber or their agent, and the transmission must contain specific information, including the identification number of the transmitting machine and the date and time of transmission. If the pharmacist questions the authenticity, accuracy, or appropriateness of the prescription, they must seek verbal verification from the prescriber. The pharmacist must retain a printed or electronic copy of the facsimile prescription for at least five years. The section also outlines specific requirements for filling facsimile prescriptions for Schedule II controlled substances, as well as Schedule III, IV, and V controlled substances. Finally, the section prohibits pharmacists from using technological devices to circumvent their responsibilities in verifying the validity of prescriptions or pharmacy practice standards.

Electronic prescriptions must be transmitted securely and can only be filled by a pharmacist if transmitted by an authorized practitioner or agent, and the prescription must contain all required information. Pharmacists may seek verification from the prescribing practitioner or authorized agent and must retain a copy of the prescription for five years. Schedule II controlled substances require the original signed prescription, while Schedule III, IV, and V controlled substances can be transmitted electronically if the pharmacist has obtained the original signed prescription, oral prescription, or facsimile prescription. Pharmacies cannot require electronic prescriptions be transmitted to a particular pharmacy, and technological devices cannot be used to circumvent regulations.

Pharmacist shall have the right to refuse to fill a prescription if in his/her professional judgment:
1. The prescription is outside the scope of practice of the practitioner; or
2. The pharmacist has sufficient reason to question the validity of the prescription; or
3. To protect the health and welfare of the patient

The dispensing container for any medication must have a label with the pharmacy's name, address, telephone number, brand or generic name, strength, quantity dispensed, date dispensed, CDS cautionary label (if applicable), patient name, practitioner's name, prescription number, directions for use, and "use by" date. For substituted biological products, additional information is required. Patient name, brand or generic name of medication, and directions for use must be in large or bolded typeface. Auxiliary labeling recommended by the manufacturer should also be included. If the pharmacist deems it necessary, additional cautionary messages or directions may be added to the label. The requirement for dispensing pharmacist's initials has been eliminated.

Provide the name of the animal (its species) and the owner's last name

a pharmacy practice site in New Jersey must fill lawful prescriptions for drugs or devices that it carries without delay. If the pharmacy does not have the drug or device in stock, it must offer to obtain it or locate a nearby pharmacy that has it in stock and transfer the prescription there. If the pharmacy does not carry the drug or device, it must offer to locate a nearby pharmacy that has it in stock. Violations of this section can be reported to the New Jersey State Board of Pharmacy.

means any attempt (directly or indirectly by publication, dissemination or circulation in print or electronic media) which induces or attempts to induce any person or entity to purchase goods or services from a Board
licensee (pharmacist/pharmacy).

for prescription drugs in ads shall stipulate strength and quantity required to be purchased for
offered price. Quotes shall include the usual and customary Rx cost. All services costing more (i.e., delivery) or adding to quoted price must be set forth in ad.

No References in ads to drug's quality or beneficial use.
d). Price quote must include effective date of that price.
Example: "Price effective now through 3/l/90."
e). Upon request pharmacist shall give price information over telephone and effective dates.
f). Ads shall be predominantly informational - not misleading, confusing or false. Cannot demean quality of professional services offered by other pharmacist/pharmacies.

a) Unprofessional conduct for a pharmacist to dispense a Schedule V over-the-counter controlled substance when:
• Knowing or reasonably should know that the requested substance will be used for unauthorized or illicit consumption or distribution.

• Knowing or reasonably should know that the person requesting the substance previously used it for unauthorized or illicit consumption or distribution.

b) Standard of professional judgment and care for sale of Schedule V over-the-counter controlled substance:

• Sales recorded in the over-the-counter Schedule V Record Book.

• Direct communication with purchaser for second to fourth requests within a short period of time to determine correct usage, improvement of condition, abuse potential, need for physician consultation, and similarity of requests to other pharmacies.

• Documentation of justification for fourth purchase in the Record Book, recommendation for medical evaluation, and obtaining oral or written confirmation from the purchaser's physician for dispensing more than five times within 12 months.

Correctly dispensed prescription medication may be accepted for return but cannot be reused for resale or stock, except in healthcare facilities where unit dose medication can be reused.
Incorrectly dispensed prescription medication must be accepted for return and cannot be reused for resale or stock.

Prescription medication prepared for a patient but not dispensed may be placed back in stock for reuse or resale within 2 weeks if it is eligible for re-dispensing.

Eligible medications can be consumed within their original stability and expiration time frame and have been stored correctly.

The medication cannot be placed in different lot numbers or expiration dates, and manufacturers' stock containers cannot be overfilled.

Medication not returned to original manufacturers' containers should be labeled and repackaged.

Medications without lot numbers and expiration dates should be used within one year from original preparation and marked with the same use-by date as the original preparation.

Unwanted drugs shall be disposed of in a manner that does not cause them to be a health hazard, and in accordance with Local, State, and Federal Codes.

No outdated, misbranded, deteriorated or adulterated drugs, or any drugs marked "sample", or like designation shall be placed or maintained in active stock for use or sale.

The pharmacy must maintain patient profile records containing information such as patient details (family name, address, allergies [unknown put NKA], etc.) prescription number, prescriber's name, and drug details. The pharmacist must use professional judgment to review and monitor the patient's profile and make appropriate changes. The patient record must be stored for at least five years and be retrievable and readable within two weeks for records older than four years and one business day for records within the last year. The pharmacy must establish an auxiliary recordkeeping system when the electronic data processing system is inoperative, and the electronic data processing system must have safeguards to protect confidential information. The pharmacy must ensure that prescription and dispensing records remain complete even if their relationship with the supplier of data processing services or materials terminates.

before dispensing medication, a pharmacist must check the patient's record for potential drug interactions or misuse. If there is a potential issue, the pharmacist must take action to avoid it and consult with the patient and/or doctor if necessary. For refill prescriptions, the pharmacist must check if enough time has passed since the last refill and consult with the doctor and/or patient if needed. If a patient's record shows irregular use of medication, the pharmacist must consult with the patient and/or doctor to determine if continued use is appropriate.

before dispensing a new medication, a pharmacist shall make reasonable efforts
to counsel the patient or the patient's caregiver. The offer to counsel may be made by pharmacy personnel. However, counseling shall be performed only by a pharmacist, or by a pharmacy intern or pharmacy extern under the immediate personal supervision of a pharmacist

A pharmacist may dispense a prescription in a different dosage form than originally prescribed if the pharmacist notifies the prescriber no later than 48 hours following the dispensing of the prescription, provided the dosage form dispensed has the appropriate drug release rate.

a) Every pharmacy must have a registered pharmacist-in-charge licensed and in good standing in New Jersey. The pharmacy cannot operate without a registered pharmacist-in-charge for more than 30 days.

b) If the registered pharmacist-in-charge is absent from the pharmacy for more than 30 days, the Board and permit holder should be notified about the interim registered pharmacist-in-charge.

c) A registered pharmacist cannot be the registered pharmacist-in-charge of more than one pharmacy or pharmacy department at the same time.
d) If there is a change in the registered pharmacist-in-charge, an inventory of all controlled dangerous substances must be performed and reported to the Board.

e) If a registered pharmacist assumes or terminates the duties as a registered pharmacist-in-charge, the Board should be advised within 30 days.

f) The registered pharmacist-in-charge must be a full-time employee who is physically present in the pharmacy for at least 35 hours per week to supervise and ensure adequate staffing, accurate record-keeping, security, proper dispensing and labeling of prescriptions, professional consultation, and compliance with all Federal and State regulations.

g) The pharmacist-in-charge is responsible for the accuracy and completeness of the biennial inventory of all controlled dangerous substances and must sign and date the inventory upon completion.

All personnel working (except sterile compounding personnel) shall wear an identification tag which shall include at
least the person's first name, first initial of their last name and their job title in the pharmacy.

A sole pharmacist on duty may take restroom breaks and a 30-minute meal break while working in a pharmacy consistent with the following requirements:

Pharmacy technicians and pharmacy technician applicants can assist pharmacists in performing various tasks related to the practice of pharmacy, including retrieving prescription and patient files, data entry, demographic information collection, transcription, label preparation, medication compounding, and accepting authorization for prescription refills and renewals. However, they cannot perform certain tasks, such as receiving new verbal prescriptions, interpreting prescriptions, providing patient counseling, and violating patient confidentiality. A pharmacy that employs more than two pharmacy technicians must establish written job descriptions, task protocols, and policies and procedures, ensure that pharmacy technicians meet specific qualifications, and provide in-service training and documentation. Pharmacists cannot supervise more than two (2:1) pharmacy technicians, except for those who are receiving in-service training.

Any person who is hired as a pharmacy technician who is not registered with the Board shall be designated a pharmacy technician applicant. A person may only be considered a pharmacy technician applicant one time and only for a maximum of 180 consecutive days. During the first 10 days of employment, the pharmacy technician applicant
shall file an application with the Board to begin the pharmacy technician registration process

an applicant who has met all requirements and been approved by the Board to be registered as a pharmacy technician in New Jersey will receive an authorization to practice upon payment of the initial registration fee. This authorization must be kept on their person while working until their initial registration is issued. The current biennial renewal registration must be displayed at their principal place of employment. If they work at multiple pharmacies, they must carry their wallet-sized registration with them when working at a location where their registration is not on display.

"grossly unprofessional conduct" for licensed pharmacists. These include paying rebates for recommending services, providing prescription blanks with identifying information, claiming professional superiority, favoring one group of patients over another, distributing premiums or rebates in connection with drug sales (except for certain discounts for those over 60), advertising prescription drug prices in an inconsistent manner, and engaging in activities beyond the scope of a collaborative drug therapy management agreement. The state board may refuse to examine or suspend or revoke the license of a pharmacist who is found guilty of such conduct.

Any person to whom a certificate shall be denied by the
board or whose certificate shall be suspended or revoked by the board shall have the right to review that action by
appeal to the Appellate Division of the Superior Court in lieu of prerogative writ.

A pharmacist may dispense an opioid antidote to any patient regardless whether the patient holds an individual prescription pursuant to a standing order issued by a prescriber or pursuant to the standing order

Pharmacies shall contain a prescription counter or counters on which to work, 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.

An adequate sink with hot and cold running water shall be provided in the prescription area, easily accessible to the
prescription counter.

Sufficient shelf, drawer or cabinet space must be provided in the prescription area for proper storage of prescription drugs and chemicals and minimum equipment.

Prescription drugs and chemicals must be stored under adequate conditions including proper lighting, ventilation and temperature control as recommended by the drug manufacturer.

If storage conditions are not specified by the manufacturer, they must be maintained according to parameters set forth in the United States Pharmacopeia/National Formulary.

If no specifics are provided, temperature must be maintained between 20-25 degrees Celsius (68-77 degrees Fahrenheit) with protection from moisture and light.

all balances, scales, weights and automatic counting devices inspected every 12 months by
the Department of Weights and Measures

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.

In the event of a temperature excursion, as defined in (d)3i above, lasting 72 hours or more, a pharmacist shall not dispense any prescription drug or chemical unless the pharmacist verifies with the manufacturer of the prescription drug or chemical that as a result of the temperature excursion, the drug or chemical has not been adulterated, is safe
and efficacious, and its stability has not been adversely affected.

A pharmacy shall maintain a prescription drug retail price list containing the names of the 150 most frequently prescribed drugs in their most commonly prescribed dosage, made available to the pharmacy by the Director of the Division of Consumer Affairs. A pharmacy shall make a written prescription drug retail price list available to consumers for review upon request. The list shall be printed in at least 12-point type.

means a continually revised compilation of pharmaceuticals available in pharmacy developed by P&T committee.

means a facility licensed by the Department of Health and Senior Services pursuant to
N.J.S.A. 26:2H-1 et seq.

means one or more health care facilities which are owned or controlled by the same legal
entity

means the area in the health care facility licensed by the Board as a pharmacy that maintains an institutional permit. Area includes areas of health care facility where pharmaceuticals are stored, manufactured, compounded and dispensed.

means the active standing committee of the institution or health care facility which is the organizational line of communication & liaison between the medical and pharmacy staff and which acts to review and promote rational drug therapy & utilization in the facility.

means a single unit use medication with sealed packaging and contains the following
information: Product Name; Strength; Lot Number; "use by" followed by the use by date (earlier of one year from the
date of packaging or the manufacturer's expiration date); and manufacturer or re-packager.

The Pharmacist-in-Charge (PIC) is responsible for the specifications of drugs used in terms of quality, quantity and source. A purchasing agent can be used if approved by the PIC.

The PIC must develop written policies and procedures for the maintenance, content, control and accountability of drugs supplied and located throughout the facility. These must be approved by the P&T Committee.

The PIC and P&T committee must develop written policies and procedures for the control, use and accountability of Investigational New Drugs (INDs). INDs can be used with support from a principal investigator without violating pharmacy act.

Controlled dangerous substances must be handled in accordance with State and Federal laws. The PIC must develop written policies and procedures concerning their control, use and accountability.

a). Pharmacist shall review original drug orders (or direct copy or electronic facsimile) prior to dispensing initial dose.
b). If no instructions for end of order use automatic stop order procedure.
c). Can only use abbreviations or symbols if included on an approved standard list.
d). When appropriate, the pharmacist shall make necessary entries into the patient medical record relative to drug use in accordance with health care facility policies and, where applicable, pursuant to regulations of the Department of Health and Senior Services and/or Centers for Medicare and Medicaid Services.

It specifies that pharmacists (RPh) can only receive oral orders from the prescriber and that these orders must be reduced to writing and signed by the recipient. Oral orders for CII are only allowed in emergency situations. The text also mentions that oral orders must be countersigned by the prescriber and that pharmacists may dispense any remaining medication to the patient upon discharge in a multiple dose container if certain conditions are met. These conditions include labeling the medication for out-patient use, counseling the patient prior to discharge, and having discharge orders containing attending physician's authorizations to release the remaining medication.

a). Pharmacist shall monitor drug therapy including maintaining and reviewing patient medication profile (PMP)
prior to dispensing meds.
b). If STAT order, shall document on PMP immediately after dispensing.
c) If pharmacy closed, drugs shall be documented on PMP immediately after reopening.

a). Not allowed unless exception is in written procedures developed by PIC and approved by the P&T.
b). Use of patient's own medications should be discouraged. If used, written order shall be signed and dated by patient's MD. Medication shall be identified by the RPh as to contents and dispensing origin and noted on PMP.

If device is approved by PIC and P&T, can be used when RPh not on duty provided that absence is not greater than 24 hours or while on duty if proper review of device can be ascertained.

Controlled substances and other medications should be secured within a drug dispensing device and checked every 24 hours by a licensed professional/pharmacist. Only authorized individuals have access to the medication and all activity must be recorded and available to the pharmacist.

RPh. shall check record of withdrawals against prescribers order and document it within 24 hours from time of original order.

If no licensed pharmacy on the premise the device shall be controlled by the PIC. Maximum time between medication order checks is 24 hours.

Only pharmacists (RPh) have access to CDS and the pharmacy. In emergency situations when floor stock is not available, a registered nurse designated by the pharmacist-in-charge (PIC) may have access to the pharmacy. The PIC may also designate a registered nurse to remove certain drugs from the pharmacy stock. A record of any drug removed must be kept by the PIC and maintained for five years. The oldest four years of information must be retrievable within two weeks while the most recent year must be immediately retrievable within one business day.

a). Must make provisions for adequate safe storage of drugs and biologicals:
1. All drugs must be secure. CDS stored as per State and Federal laws and regulations.
2. External preparations must be separate from internal medications in patient care areas.
3. PIC responsible for all medications in facility.
4. Drugs throughout the facility must be stored adequately (lighting, temperature control) as per the drug manufacturer.
5. Pharmacy records shall have adequate storage. Records not currently used need not be kept in the pharmacy but the area must be readily accessible and secure (patient confidentiality).

b). Must check every 2 months for out of date drugs.

c). Must establish procedures to remove out of date drugs.

a) Pharmacists can accept prescriptions or medication orders transmitted by fax or other approved technological devices, subject to certain conditions.
b) Pharmacists with an institutional permit can dispense prescriptions for all substances consistent with state requirements.
c) Pharmacists in institutional pharmacies can accept all inpatient medication orders, including Schedule II substances, transmitted by technological devices.
d) If a pharmacist questions the accuracy or authenticity of a prescription, they must verify it with the prescribing practitioner.
e) Using technological devices to circumvent pharmacy practice standards is considered professional misconduct.
f) Pharmacists cannot provide or accept technological devices from prescribing practitioners.
g) Patients have the right to choose which pharmacy receives their prescription transmitted by technological device, and pharmacists cannot enter into agreements that deny this right.

means a health care facility or a distinct part of a health care facility in which preventive,
diagnostic, and treatment services are provided to persons who come to the facility to receive services and depart from
the facility on the same day.

If the facility has an institutional pharmacy, the pharmacy shall be licensed by the New Jersey State Board of Pharmacy and shall possess a current Drug Enforcement Administration registration and a Controlled Dangerous Substance registration from the Department in accordance with the Controlled Dangerous Substances Acts. The facility shall designate a pharmacist who shall be responsible for the direction, provision, and quality of pharmaceutical services.

The procurement, storage, use, and disposition of needles and syringes in accordance with all applicable Federal and State laws and rules, including those specified at N.J.A.C. 8:43A-14.6(b). All needles and syringes shall be kept in locked storage areas.

The security of the keys or codes to locked drug storage areas, including specification of the personnel who may retain the keys or security codes. Only licensed nursing or medical personnel shall retain the keys or security codes to storage areas in which drugs subject to the Controlled Dangerous Substances Acts and
amendments thereto are kept

All medications administered shall be prescribed in writing. Each written order shall specify the name of the drug, dose, frequency, and route of administration and shall be signed and dated by the prescriber. Medications must not be removed from their original containers until administration and each patient must be identified before administration. Drugs for one patient cannot be given to another. Drug allergies must be documented. Medication errors and adverse reactions must be reported immediately to the nurse in charge, prescriber, pharmacy, and documented in the patient's medical record according to facility procedures

All drugs, except intravenous infusion solutions, shall be kept in locked storage areas. Drug storage and preparation areas shall be kept locked when not in use.

Drugs for external use shall be kept separate from drugs for internal use.

All drugs in Schedule II of the Controlled Dangerous Substances Acts and amendments thereto shall be stored in
a separate, locked, permanently affixed compartment within the locked medication cabinet, medication room, refrigerator, or mobile medication cart.

The facility shall retain a consultant pharmacist who has no affiliation with the pharmacy that provides services to the facility, the facility in which services are provided, or any of their affiliates.

Establish standards applicable to all pharmacies that utilize automated medication systems (AMS) to store, package,
dispense, and distribute prescriptions or medication orders

Automated medication system means a process that performs activities (other than compounding) relative to the
storage, packaging, dispensing and distribution of medications, and which collects, controls and maintains all transaction information. "AMS" does not mean an automatic counting device operated as per N.J.A.C. 13:39-5.9 or a mechanical drug dispensing device operated as per N.J.A.C. 13:39-9.17

1. The pharmacy conducts an annual self-inspection
2. AMS is tested by pharmacy and is accurate.
3. AMS is made available to Board for inspection, and accuracy validated by the Board

Pharmacies using AMS must operate according to a written quality assurance program that requires continuous monitoring of the AMS, testing its accuracy at least every 6 months and after upgrades, establishing a protocol for measuring its effectiveness, reporting recurring errors to the Board and maintaining documentation for at least 2 years.

Must have a written plan for recovery from a disaster that interrupts service

means an ISO class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, labeling, and other high-particulate-generating activities are performed.

means a ventilated cabinet for compounded sterile preparations that has an open front with
inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for
product protection, and HEPA-filtered exhaust air for environmental protection.

means an ISO class 7 area where the primary engineering control is physically located and where the
preparation and staging of components and supplies used in compounding sterile preparations occurs. "Cleanroom" means a room in which the concentration of airborne particles is controlled to meet a specified airborne
particulate cleanliness (ISO) class. Microorganisms in the environment are monitored, so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class. A "cleanroom" includes a buffer area or room and ante area or room.

means preparations intended for emergency patient care and
involve only simple aseptic measuring and transfer manipulations of no more than three sterile non-hazardous
commercial drug and diagnostic radiopharmaceutical drug products, including an infusion or diluent solution. Unless
required for the preparation, the compounding process occurs continuously without delays or interruptions and does
not exceed one hour.

The compounding process involves only assembling, transferring, measuring, and mixing, using no more than three commercially manufactured sterile products, and not more than two entries into one sterile container or package to make the compounded sterile preparations. The compounding process is limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.

preparations compounded under low-risk level conditions but which require multiple individual or small doses of sterile products to be combined or pooled to prepare compounded sterile preparations that will be administered either to multiple patients or to one patient on multiple occasions. The
compounding process includes complex aseptic manipulations other than single volume transfer, and requires an unusually long duration, such as that required to complete dissolution or homogeneous mixing.

Preparations compounded from non-sterile ingredients or from ingredients that are incorporated using non-sterile equipment before terminal sterilization, or from commercially manufactured sterile products that lack effective antimicrobial preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality worse than ISO class 5 for more than one hour. Water containing preparations that are stored for more than six hours before terminal sterilization are also classified as high-risk level compounded sterile preparations.

An applicant for a pharmacy permit shall not dispense sterile preparations compounded at the site until receiving written approval from the Board to engage in such activities. A pharmacy permit holder who is approved to compound sterile preparations shall notify the Board at least 60 days in advance of any remodeling, change of location, or change in size of the pharmacy cleanroom. Such notification
shall include the pharmacy's remodeling or relocation plans, as appropriate, the pharmacy's interim plans for the
continuation of sterile compounding operations, which the Board shall review and approve, and the anticipated date of completion.

The buffer area shall
contain an ISO class 5 or better primary engineering control, such as a laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, and/or compounding aseptic containment isolator, unless the buffer area has ISO class 5 or better air quality.

All sterile compounding shall take place within the confines of the buffer area

A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room
pressurization or air velocity, respectively

1) Accessible only to designated personnel;
2) Used only for the compounding of sterile preparations or such other tasks that require a cleanroom;
3) Structurally isolated from other areas within the pharmacy by means of restricted entry or access; and
4) Air conditioned to maintain a temperature of 59 to 77 degrees Fahrenheit with an ideal temperature of 66
degrees Fahrenheit.

The surfaces in the cleanroom must be smooth, impervious and free from cracks and crevices to minimize spaces where contaminants may accumulate. Work surfaces must be made of smooth, impervious materials that can be easily cleaned and sanitized. Junctures where ceilings meet walls must be covered or sealed. Ceilings with inlaid panels must be impregnated with a polymer and caulked or weighted and clipped. Walls must be constructed of flexible material or epoxy-coated gypsum board. Floors must have seamless covering with coving to the sidewall and no floor drains. There should be no dust-collection overhangs or ledges. Ceiling lighting fixtures must have smooth exterior lens surfaces mounted flush and air tight. Carts must have good quality casters for mobility. Refrigerators must be within or accessible to the cleanroom.

The ante area shall have appropriate environmental control devices capable of maintaining ISO class 8 air quality
conditions for non-hazardous drug compounding activities and ISO class 7 air quality conditions for hazardous drug
compounding activities

1) A sink with hot and cold running water with an integrated and closed plumbing system;
2) Waste containers for all personal protective equipment;
3) An eyewash station; and
4) A hazardous waste spill kit

The buffer area must have environmental control devices to maintain ISO class 7 air quality conditions and contain only items required for tasks to be performed there. These items must be nonpermeable, nonshedding, cleanable and resistant to disinfectants and cleaned and disinfected before being placed in the buffer area. Equipment and other items used in the buffer area must not be taken from these areas except for maintenance purposes. This area shall be a minimum of 100 square feet

A pharmacy may utilize compounding aseptic isolators and compounding aseptic containment isolators not located in a cleanroom to prepare compounded sterile preparations, provided the compounding aseptic isolators and compounding aseptic containment isolators can provide isolation from the room and maintain ISO class 5 air quality during dynamic operating conditions, including transferring ingredients, components, and devices into and out of the isolator and during preparation of compounded sterile preparations.

A pharmacy with an institutional pharmacy permit may use ISO class 5 laminar airflow workbenches not located in a buffer area to prepare low-risk level compounded sterile preparations if administration commences within 12 hours or as recommended by the manufacturer. (whichever is less) These workbenches must be located in a sanitary area only traveled by persons engaged in compounding sterile preparations and not near unsealed windows or doors, high traffic flow or areas such as construction sites or food preparation. Sinks must not be adjacent to the workbench and personnel must follow cleansing and garbing procedures.

Pharmacists shall provide immediate personal supervision to pharmacy technicians, pharmacy interns, or pharmacy
externs who are performing sterile compounding. The ratio of pharmacists to pharmacy technicians shall not exceed
1:2 at any given time unless all of the requirements of N.J.A.C. 13:39-6.15 are met

Personnel protective equipment shall be donned in the following order:
i. Dedicated shoes or shoe covers;
ii. Head and facial hair covers (for example, beard covers in addition to face masks);
iii. Face masks; and
iv. Eye shields, if required

A hand and forearm cleansing procedure shall be performed. Personnel shall remove debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using either lint-free disposable towels or an electric hand dryer

hey make contact with non-sterile surfaces during compounding
activities. Disinfection of contaminated gloved hands may be accomplished by wiping or rubbing sterile 70 percent Isopropyl Alcohol (IPA) on all contact surface areas of the gloves and letting the gloved hands dry
thoroughly. Routine application of sterile 70 percent IPA shall occur throughout the compounding process and whenever non-sterile surfaces (for example, vials, counter tops, chairs, and carts) are touched.

All surfaces in laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators shall be cleaned and disinfected at the beginning of each work shift, before each batch preparation is started, after spills, and when surface contamination is known or suspected

Pharmacists and pharmacy staff involved in compounding sterile preparations must receive documented didactic and practical training in sterile preparation compounding, personnel cleansing and garbing, and cleaning and disinfecting sterile compounding areas. They must also pass a written test demonstrating competency and complete aseptic technique testing according to USP 797 standards. Gloved fingertip/thumb sampling is required annually for low- and medium-risk preparations and semi-annually for high-risk preparations. Individuals who fail the tests are prohibited from compounding sterile preparations. Test results must be maintained and made available to the Board upon request.

A pharmacy may compound sterile preparations in a quantity supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order if the pharmacist documents a history of valid prescriptions or medication orders subsequently received within the beyond-use dating time of each product generated within an established professional prescriber-patient-pharmacist relationship. The prescription or medication order must be maintained on file and the batch preparation process documented including selection of drugs, containers and diluents, lot numbers and expiration dates and verification that the compounded sterile preparation has been visually inspected for particulate matter, leakage and accuracy of labeling. Each batch must have a unique batch number.

A pharmacy may prepare compounded sterile preparations for a licensed prescriber for use in the prescriber's practice
without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.

The administration dates and times established shall not be exceeded or extended for compounded
sterile preparations without verifiable supporting valid scientific sterility and stability information that is directly
applicable to the specific preparation or compound.

Pharmacists are responsible for ensuring that compounded sterile preparations are properly prepared, labeled, controlled, stored, dispensed, and distributed according to the assigned risk level. The accuracy and appropriateness of the compounded prescription is also their responsibility, and their unique and secure user identifier(s) must be recorded in the audit trail. The pharmacy must maintain an audit trail and compounding record for each preparation, including information on the selection and verification of drugs, containers, and diluents, compliance with the prescription or medication order, labeling, visual inspection, and readiness for dispensing.

a) Compounded sterile preparations must have a labeled container with information including the date and time prepared, prescriber's name (in retail pharmacies only), patient's name, directions for use, active ingredients and diluents, pharmacy information, use by date and time, cautionary instructions, storage requirements, and prescription number (for medications not dispensed according to N.J.A.C. 13:39-9).

b) Compounded sterile preparations for immediate use must be labeled with the same requirements as (a) and include the name or identifier of the person who prepared it if it is not administered by or witnessed by them.

The policy and procedures manual shall include policies and procedures governing the
following:
1) A risk-management program, including, but not limited to, documentation of incidents, adverse drug
reactions, and product contamination.

i) The risk-management program shall require that the pharmacist-in-charge report all confirmed
incidents of product contamination to the New Jersey Board of Pharmacy within 48 hours of
becoming aware of such incidents

The policy and procedures manual shall be reviewed, at a minimum, once every 24 months and shall be updated, on a continuous basis, to reflect current practice. Documentation of the review shall be made available to the Board upon request.

Air and surface sampling for microbial organisms must be certified by an independent certification company every six months for ISO class 5 primary engineering controls and all other ISO classified areas, and whenever contamination is suspected. Cleanrooms must also be certified every six months and whenever there is relocation, alteration, or major service. The certifications must follow procedures outlined in the CETA Certification Guide for Sterile Compounding Facilities. If test results show non-compliance, the pharmacy must cease using the impacted cleanroom or primary engineering control and notify the Board in writing within 48 hours. The pharmacy must reevaluate all procedures associated with compounded sterile preparations produced in the impacted area and document the period of non-compliance.

a) Pharmacists are prohibited from compounding preparations that contain drug products listed on the FDA's List of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness.
b) Pharmacists are not allowed to compound commercially available drug products unless there is a significant difference between the compounded product and the comparable commercially available product, as determined by the prescriber, or if the commercially available product is not available in a timely manner to meet the patient's needs and has been approved by the prescriber and patient.

In the absence of a valid
patient-specific prescription or medication order, pharmacists, pharmacy technicians, pharmacy interns, and pharmacy
externs shall not prepare compounded non-sterile preparations for human use for a licensed prescriber to use in his or
her practice, except to the extent permitted by Federal law. A pharmacy may prepare compounded nonsterile
preparations for a licensed prescriber for non-human use in the prescriber's practice without a prescription consistent
with State and Federal laws pertinent to the prescriber's health care practice.

The New Jersey regulations allow pharmacists to prepare and sell pharmacy generated products over-the-counter, provided that the product does not contain excessive ingredient strengths, does not require a prescription, is labeled correctly, sold directly to consumers only after consultation with a pharmacist, stored properly, not sold for resale, and documented in accordance with regulations.

For water-containing formulations prepared from solid ingredients, the beyond-use date is 14 days when stored at cold temperatures. For other formulations, the beyond-use date cannot exceed the intended duration of therapy or 30 days, whichever is earlier. These limits can only be exceeded if there is valid scientific stability information that is directly applicable to the specific preparation.

A manufactured drug product may be utilized as the source of an active ingredient. Only manufactured drug
products from containers labeled with a batch control number and an unexpired expiration date shall be utilized as sources of active ingredients. When compounding with manufactured drug products, the compounding pharmacist
shall consider all ingredients present in the drug product relative to the intended use of the compounded non-sterile
preparation.

The compounding pharmacist may delegate to pharmacy technicians, pharmacy interns, or pharmacy externs only the following tasks: recording of the prescription, selection of the drugs and container, typing of labels, and
compounding of preparations. The compounding pharmacist shall ensure that each task has been performed correctly.

Pharmacies must maintain a compounding record for each compounded non-sterile preparation, which includes information on ingredients such as source, lot numbers, and expiration dates, verification of compliance with the prescription or medication order, and the strength and date of preparation. It should also include the name or personal identifier of the person(s) who performed each step of the compounding process and the compounding pharmacist(s) who verified the preparation, formulation reference(s), total quantity, type of dispensing container used, beyond-use date, assigned internal identification number, and instructions for use, storage, and handling.

includes, but is not limited to, identifying the purchase source, the ultimate use
or disposition and any intermediate handling of any components of radiopharmaceuticals.

means a practitioner authorized by law to possess, use and administer
radiopharmaceuticals.

means individual under direct supervision of a practitioner authorized to communicate the
practitioners instructions to the nuclear pharmacy.

means the registered pharmacist is physically present in the
compounding/dispensing area when interns, externs, and technicians are performing delegated duties and conducts
any necessary in-process and final checks in preparation and compounding of medication.

includes conducting tests necessary to insure integrity of the test.

means any substance defined as a drug in FDCA Sec 201(g)(1) or FDA Nuclear Pharmacy
Guidelines and which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or
photons and includes any such drug which is intended to be made radioactive.

includes, but is not limited to, the performance of appropriate tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and
animals.

includes, but is not limited to, compounding, dispensing, labeling, delivery, participation in utilization reviews, proper and safe storage and distribution, quality assurance, and the offering of those acts, services, operations or transactions necessary in the conduct, operation, mgmt., and control of a nuclear pharmacy.

The oldest four years of record information shall be maintained in a manner so as to be sight-readable within 2 weeks while the
most recent one year record must be retrievable within 24 hours.

Proper procedures must be followed for handling radioactive materials, including ventilation and containment measures. Those compounding radiopharmaceuticals must comply with applicable regulations.

Records of acquisition and disposition of radioactive drugs must be maintained in accordance with USNRC regulations.

The outer and immediate containers of a radioactive drug must be labeled with specific information, including the radionuclide, amount, calibration time, and pharmacy information.

The immediate container must also be labeled with the radiation symbol and the phrase "CAUTION-RADIOACTIVE MATERIAL", as well as the name of the radiopharmaceutical.

Nuclear pharmacists may transfer to authorized persons and NRC licensed medical practitioners radioactive materials not intended for drug use, in accordance with NRC regulations. Can furnish to these practitioners for patient use.

Can only dispense radioactive drugs upon a non-refillable Rx order from a USNRC (United States Nuclear Regulatory Commission) licensed medical practitioner (or designated agent) authorized to possess, use and
administer.

Rx orders can be left on answering machine only if practitioner or designated agent is identified in a clearly recognizable manner.

Each nuclear pharmacy must have:
1. Area for storage, compounding and dispensing completely separate from pharmacy areas for non-radioactive
drugs;
2. Hot lab and storage area a min. of 120 sq.ft.; and
3. Compounding and dispensing area a min. of 300 sq.ft.

If there is theft or significant loss of any CS the registrant shall notify the New Jersey State Department of Health, Drug Control Unit upon discovery of the theft or loss. The registrant shall also complete form DDC-52.

Carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S.
Government Class V security container.

Individuals who legally possess CDS's may hold no more than a ten day supply in other than the original container, but must produce relevant information if so questioned. This includes the name and address of the prescriber or the pharmacist who dispensed it. If this is violated it is a disorderly person offense.

Practitioners, within 24 hours after determining that a person is a drug dependent person (CDS) for purposes other than treatment of sickness shall report this information verbally or by mail to the director. The director may treat
reports submitted under this Section as confidential. A practitioner who fails to make a report required by this Section
is a disorderly person.

Every inventory or record required to be kept under this sub-chapter shall be kept by the registrant and be available for at least two years from the date of such inventory of records for inspecting and copying. There are certain exceptions for financial and shipping records other than executed order forms which are set forth in the regulation

Inventory can be taken on a date that is within four days of his biennial inventory date pursuant to N.J.A.C. 13:45H-5.7 if he notifies in advance the Special Agent in charge of the DEA in his region and the Drug Control Unit
of the date on which he will take the inventory. A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date.

Every two years following the date on which the initial inventory was taken the registrant shall take a new inventory of all CS's on hand. The inventory may be taken on the day of the year in which the initial inventory was taken or on the registrants regular general physical inventory date which does not vary by more than six months from the biennial date that would otherwise apply. If the registrant elects to take the biennial inventory on his regular general physical inventory date or another fixed date he must notify the DEA and the Drug Control Unit.

Prescriptions for the substances shall be maintained either in a separate prescription file for CIII through CV only or in such form that they are readily retrievable from other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if when they are initially filed the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than one inch high and filed either in the prescription file for CI and II or in the usual consecutively numbered prescription file for non-controlled substances.

person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia and
required to keep records shall maintain a quarterly inventory (last day of March, June, September, and December)

a) A Prescription Monitoring Program is established to monitor controlled dangerous substances dispensed by a pharmacist in an outpatient setting.

b) Pharmacies must submit information about each prescription for a controlled dangerous substance dispensed, including patient information, drug details, and other necessary information to the division electronically at daily intervals specified by the director.

c) The division may grant a waiver for electronic submission for good cause, including financial hardship.

d) Direct administration of a controlled substance to an ultimate user or dispensing of an exempted controlled substance is exempted from these requirements.

(1) The division shall register a practitioner to access prescription monitoring information upon issuance or renewal of the practitioner's CDS registration.

(2) The division shall provide to a pharmacist who is employed by a current pharmacy permit holder online access to prescription monitoring information for the purpose of providing health care to a current patient or verifying information with respect to a patient or a prescriber.

The division shall offer an online tutorial to registered practitioners

A pharmacist shall not dispense a Schedule II controlled dangerous substance to any person
without first accessing the prescription monitoring information, as authorized pursuant to subsection h. of
this law, to determine if the person has received other prescriptions that indicate misuse, abuse, or diversion, if the pharmacist has a reasonable belief that the person may be seeking a controlled dangerous substance, in
whole or in part, for any purpose other than the treatment of an existing medical condition, such as for purposes of misuse, abuse, or diversion.

This regulation states that a pharmacist can only dispense a prescription to the intended patient, unless the person picking up the prescription provides personal identification to the pharmacist, and the pharmacist inputs that identifying information into the Prescription Monitoring Program. If the pharmacist believes that the person may be seeking a controlled dangerous substance for reasons other than treatment of an existing medical condition, they are not allowed to dispense the prescription. However, this provision will only come into effect after the director determines that the Prescription Monitoring Program has the technical capacity to accept such information.

The director has the authority to adopt a regulation to expand the Prescription Monitoring Program to include prescription drugs that are not controlled dangerous substances. The decision to include a prescription drug will be based on factors such as its potential for abuse, pharmacological effects, history of abuse, and risk to public health. The regulation will specify the monitoring period, and the director shall publish the decision to permanently include the prescription drug in the program at the end of the monitoring period. The chairpersons of the standing legislative reference committees on health of the Senate and General Assembly shall be provided with a copy of the notice of proposed rulemaking at the time the notice to expand the program is published in the New Jersey Register.

a) The division shall be immune from civil liability arising from inaccuracy of any of the information submitted to it
pursuant to the act.

b) A pharmacy permit holder, pharmacist or practitioner shall be immune from civil liability arising from compliance with the act.

The rules in this subchapter apply to pharmacies filling prescriptions for Schedule II, III, IV, or V controlled dangerous substances, human growth hormone, or gabapentin in an outpatient setting in New Jersey, as well as out-of-state pharmacies registered with the Board of Pharmacy that ship or deliver these substances into New Jersey. The rules also apply to persons authorized to receive PMP information, pharmacists, practitioners with a current State Controlled Dangerous Substance registration, and licensed healthcare professionals authorized by a practitioner to access prescription monitoring information. (Hospital pharmacies do not have to access the PMP to dispense to inpatient, only outpatient)

means any person who is the recipient of a professional service rendered by the practitioner for
purposes of diagnosis, treatment, or a consultation related to treatment. "Data Collection Manual" means the New
Jersey Prescription Monitoring Program Data Collection Manual, Version 2.1, incorporated herein by reference, as amended and supplemented, and available on the New Jersey Prescription Monitoring Program website at
www.njconsumeraffairs.gov.

means a coordinated program of interdisciplinary care and services furnished primarily in a patient's place of residence, and, in a hospice facility or hospital, if necessary, to terminally ill patients and their families

A pharmacy filling a prescription for a Schedule II, III, IV, or V controlled dangerous substance, for human growth hormone, as defined in N.J.A.C. 13:45A-35.1, or gabapentin, in an outpatient setting, shall collect and electronically transmit to the Division's PMP vendor on a daily basis information for each prescription, as specified in the New Jersey PMP Data Collection Manual.

A pharmacist who is employed by a current pharmacy permit holder and is authorized to dispense
controlled dangerous substances, human growth hormone, or gabapentin who certifies that the request is for the purpose of providing health care to or verifying information with respect to a new or current patient, or verifying information with respect to a prescriber.

All persons authorized to have online access to PMP information shall, in accordance with N.J.A.C. 13:45A-35.7, register with the Division and shall receive a login ID and password. Such persons shall complete all forms and
statements required by the Division.

Report unauthorized access within 5 days of discovering. Do not share passwords!

All persons granted access to PMP information, either through online access or by request, shall comply with all Federal and State laws, rules, and re ulations concerning the confidentiality of patient information, including the
Federal Health Insurance Portability and Accountability Act of 1996,

All individuals who are authorized to have online access to PMP information must register with the Division. To register, they must provide a unique individual email address, complete an online tutorial as required by the Director, and submit all required documentation to verify their identity and credentials. The Division will register a practitioner to have online access to PMP information when their CDS registration is issued or renewed, and practitioners may also register outside of their applicable CDS issuance or renewal time period.

if the pharmacist has a reasonable belief that the person may be seeking a controlled dangerous substance, in whole or in part, for any purpose other than the treatment of an existing medical condition, such as for purposes of misuse, abuse, or diversion, a pharmacist shall not dispense a Schedule II controlled dangerous substance to any person without first accessing the prescription monitoring information to determine if the person has received other prescriptions that indicate misuse, abuse, or diversion. (If there is a question on the exam that says you need to look up the RX everytime on the PMP and this is not an option, then go with that answer)

A situation in which it is not reasonably possible for the practitioner or pharmacist to access the PMP in a timely manner, no other individual authorized to access the PMP is reasonably available, and the quantity of
CDS prescribed or dispensed does not exceed a five-day supply of the substance.

A situation under which consultation of the PMP would result in a patient's inability to obtain a prescription in a timely manner, thereby, in the clinical judgment of the practitioner or pharmacist, adversely impacting the medical condition of the patient, and the quantity of CDS prescribed or dispensed does not exceed a five-day supply of the substance.

A situation in which the PMP is not operational as determined by the Division or where it cannot be
accessed by the practitioner or pharmacist due to a temporary technological or electrical failure and the quantity of CDS prescribed or dispensed does not exceed a five-day supply of the substance

A pharmacist who is employed by a pharmacy that, in accordance with N.J.A.C. 13:45A-35.4, has been
granted a waiver due to technological limitations that are not reasonably within the control of the pharmacist, or other exceptional circumstances demonstrated by the pharmacist (Cifaldi does not believe it's practical)

The State has facilitated the creation of a Suspicious Activity Report for pharmacists to
report a fraudulent or altered prescription or any other incident. Pharmacists may also report patterns of prescribing by doctors deemed to be suspicious in their experience and professional judgment

a) Only a registrant with an official written order form bearing the registrant's registration number is authorized to distribute CI and II controlled dangerous substances, and compliance with Federal laws respecting order forms shall comply with this section.

b) A pharmacist may sell aqueous or oleaginous solutions compounded with narcotic drugs or other CDS, not exceeding a proportion greater than 20 percent of the complete solution, upon an official written order from a practitioner in quantities not exceeding one ounce at any one time, to be used for medical purposes.

c) The person giving the order or their designated agent must sign an official written order form in triplicate for CI or II, with the original and triplicate presented to the person who sells the CDS. Each party must preserve their copy of the order for two years.

d) An electronic order must also comply with the above requirements.

An order for Schedule I and II controlled substances can only be filled by a person registered with DEA as a manufacturer or distributor of controlled substances listed in Schedule I or II. However, there are exceptions such as a person registered with DEA to dispense or export the substances, or to conduct chemical analysis or research with the substances, or a person registered as a compounder of narcotic substances for use at off-site locations in conjunction with a narcotic treatment program at the compounding location. In each case, the order must be made using a DEA Form 222 or an electronic order, and the distribution must comply with applicable regulations.

a) If a purchaser realizes that an unfilled order form is lost, they must follow the rules in 21 C.F.R. 1305.16 and also (b) and (c) below.

b) If any used or unused forms are stolen or lost (not during transmission) by a purchaser or supplier, they must follow the rules in 21 C.F.R. 1305.16 and report the theft or loss to the Drug Control Unit as soon as it is discovered.

c) If any unused order form that was reported stolen or lost is subsequently found or recovered, the Drug Control Unit must be notified immediately.

a) Except in emergency situations CII medication may only be dispensed upon written prescription of a
practitioner. No CII prescription may be refilled. (See other exceptions N.J.S.A. 45:14-14). (Electronic is now allowed)

b) CIII and IV substances may not be dispensed without a written or oral prescription. They may not be refilled more than six months after the initial filling nor refilled more than five times after the date of the prescription unless renewed.

c) CV may be distributed or dispensed only for a valid and accepted medical purpose.

a) A prescription for a CS must be for a legitimate medical purpose. Responsibility for proper prescribing and dispensing rests in the hands of the prescriber and the pharmacist. Filling prescriptions for non-legitimate medical purposes is a violation of the Act.

b) A prescription cannot be issued for an individual practitioner to obtain CS's for general dispensing to patients.

Prescriptions for controlled substances (CS) must be dated and signed on the day of issuance and include the full name and address of the patient, drug name, strength, dosage form, quantity prescribed, directions for use, and the full name, address, and registration number of the practitioner. All CS prescriptions (CIII-V) must be presented for filling within 30 days of issuance. If an oral order is not permitted, the prescription must be written in ink or indelible pencil or typewriter and manually signed by the practitioner.

A pharmacist may dispense a CII upon oral authorization for a prescribing practitioner in emergency situations (no more than 72 hour supply for NJ). Within 7 days after the emergency oral prescription the individual practitioner shall "create a written
prescription" for the emergency quantity prescribed and deliver it to the pharmacist. The maximum supply of a CII is a 30 day supply but there is an exception N.J.A.C. 13:35-7.6. This also does not apply to long term care facilities

The remaining portion may be filled within 72 hours of the first partial filling. If it cannot be filled within the 72 hour period, the pharmacist must notify the prescriber. After 72 hours no further quantity may be supplied without a new prescription.

a) A pharmacist may dispense a CIII to V pursuant to a written prescription of a registered practitioner.

b) A pharmacist may also dispense a CIII to V pursuant to an oral prescription of a prescriber promptly reduced to
writing by the pharmacist containing all the information required in N.J.A.C. 13:45H-7.5(a) (see above) except for the
prescriber's signature.

a) The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible,
provided that:
1) Each partial filling is recorded in the same manner as a refilling;
2) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and
3) No dispensing occurs after six months after the date on which the prescription was issued.

a) Pharmacists filling a prescription for a Schedule III, IV, or V controlled substance must attach a label conforming to N.J.S.A. 24:21-17.

b) The above requirements do not apply when a Schedule III, IV, or V controlled substance is prescribed for an institutionalized ultimate user, provided that the controlled substance is not in possession of the user before administration, the institution maintains appropriate safeguards and records, and not more than a 34-day supply or 100 dosage units are dispensed at one time. Additionally, the pharmacist must have a system to identify the supplier, the product, the patient, and the directions for use and cautionary statements.
Transfer Between Pharmacies of Prescription Information for Schedules III, IV and V

Pharmacies can transfer original prescription information for a Schedule III, IV, or V controlled substance for refill dispensing on a one-time basis. Pharmacies with a real-time online database can transfer up to the maximum refills permitted by law and prescriber's authorization. The transfer must be between two licensed pharmacists, and the transferring pharmacist must record the transfer information, including writing "VOID" on the invalidated prescription and recording the name, address, and DEA registration number of the pharmacy to which it was transferred, the name of the pharmacist receiving the prescription information, and the date of the transfer. For electronic prescriptions, the information must be added to the prescription record.

When taking a transferred prescription information for a controlled substance listed in Schedule III, IV, or V between pharmacies, pharmacists are required to record specific information such as the name, address, and DEA registration number of the receiving pharmacy and the name of the pharmacist receiving the prescription information. For paper prescriptions, the receiving pharmacist must write "TRANSFER" on the prescription and provide all required prescription information except for the prescribing practitioner's signature. This information includes the original prescription issuance date, original number of refills authorized, date of original dispensing, number of remaining valid refills, and the name of the transferor pharmacist.

The electronic transfer of prescription information for controlled substances listed in Schedule III, IV, or V is allowed between pharmacies, with some limitations and requirements. Pharmacists transferring the prescription information must record certain information, including the name, address, and DEA registration number of the receiving pharmacy, and the date and name of the transferring pharmacist. The receiving pharmacist must also record specific information, such as the date of original dispensing and number of refills remaining. Both the original and transferred prescription must be maintained for five years (from last refill). Pharmacies sharing a real-time, online database can transfer up to the maximum refills permitted by law and the prescriber's authorization. Pharmacies electronically accessing the same prescription record must satisfy all information requirements for manual mode for prescription transferal.

Pharmacists can dispense a controlled substance listed as a CV, CIII, or CIV without a prescription, as long as the sale is made only by a pharmacist, not a clerk, and not more than the maximum amount allowed for a purchaser within a 48-hour period. The purchaser must be at least 18 years old and provide suitable identification if unknown. A record book must be maintained containing the purchaser's name and address, name and quantity of the controlled substance purchased, date of purchase, and the name or initials of the dispensing pharmacist. The book must be maintained for 5 years.

The registrant must comply with the provisions of 21 C.F.R. 1301.52 and provide written notification to the Drug Control Unit at least 14 days before discontinuing or transferring the activities. The notification should include various information, such as the registrant's name and registration numbers, the name and registration numbers of the registrant receiving the controlled substances, and the date of the discontinuance or transfer. Additionally, the registrant must return their State Certification of Registration to the Drug Control Unit within 10 days of discontinuing or transferring their activities.

A pharmacy practice site in New Jersey that dispenses prescriptions drugs, other than a long-term care pharmacy, shall distribute, with each CDS prescription it dispenses a copy of the notice

The Division of Consumer Affairs shall prepare and post the notice to be used on its website that advises customers and patients about:
1) the availability of drug take-back programs sponsored by a local, State, or federal government agency, and
2) how to obtain information from the website for those programs concerning where unused prescription drugs may be dropped off for the purpose of ensuring their safe, secure, efficient, and environmentally sound disposal.

means dispensing for a period not in excess of 21 days of a narcotic in decreasing doses
to create a drug free state in a person dependent on narcotics.

means dispensing for a period in excess of 21 days of a narcotic in treatment of individual
for dependence upon heroin or other morphine like drug.

means an acute condition including, but not limited to, physical illness, coma, mania, hysteria, or
death resulting from the consumption or use of a controlled dangerous substance or another substance with which a
controlled dangerous substance was combined and that a layperson would reasonably believe to require medical
assistance.

means an organization, company, governmental entity, community-based program, or healthcare system that provides pre-hospital emergency medical services and assistance to opioid or heroin addicts or abusers in the event of an overdose. "Emergency medical response entity" includes, but is not limited to, a first aid, rescue and ambulance squad or other basic life support (BLS) ambulance provider; a mobile intensive care provider or other advanced life support (ALS) ambulance provider; an air medical service provider; or
a fire-fighting company or organization, which squad, provider, company, or organization is qualified to send paid or
volunteer emergency medical responders to the scene of an emergency.

In New Jersey, licensed pharmacists in good standing can request a standing order for opioid antidotes from the Department of Health by providing their name, license number, and contact information. The standing order can be requested via email or phone, and once verified, an approved standing order will be emailed to the pharmacist for signature. The signed order will be assigned a control number and returned as the final version. It is important to note that standing orders are issued to the pharmacist and not the pharmacy. Pharmacists can also dispense opioid antidotes with a prescription or a standing order from a physician. Pharmacies should maintain a copy of any standing orders from which the pharmacist is dispensing.

Pharmacists with a standing order from the Department of Health to dispense an opioid antidote must ask if the drug is for the person making the request or for someone else at risk. If it is for the latter, the pharmacist must set up a separate profile for the "caregiver" and provide information on the proper use and administration of opioid antidotes. The drug should not be included in any drug utilization review and should not be processed through insurance. The pharmacist may provide a link to the Department of Health's website with instructions and training videos on opioid antidote administration. Pharmacists may not dispense opioid antidotes to professionals or first responders without obtaining a standing order or prescription from a healthcare practitioner.

When a pharmacist dispenses naloxone pursuant to a standing order, they must provide the recipient with information on opioid overdose prevention and recognition, instructions on how to perform rescue breathing and resuscitation, information on opioid antidote dosage and administration, information on the importance of calling 911 for assistance with an opioid overdose, and instructions for appropriate care of an overdose victim after administering the opioid antidote.

A person who in good faith and without malice provides to the board any information concerning any act by a pharmacist licensed by the board which the person has reasonable cause to believe involves misconduct that may be
subject to disciplinary action by the board, or any information relating to such conduct requested by the board in the exercise of its statutory responsibilities or which may be required by statute, shall not be liable for civil damages in
any cause of action arising out of the provision of such information or services.

is a law that outlines the state's legal authority and procedures for responding to public health emergencies. It was enacted in 2005 in response to concerns over the spread of infectious diseases like SARS and avian flu. The law grants broad powers to state and local health officials to take actions necessary to protect public health during an emergency, including mandatory quarantine, isolation, and vaccination. The law also establishes procedures for the distribution and administration of vaccines and medical supplies during an emergency. The EHPA is designed to ensure that state and local officials have the tools and resources needed to respond quickly and effectively to public health emergencies while protecting the civil liberties of individuals.

Intentional use of any microorganism, virus, infectious substance, or biological product that may be engineered as a result of biotechnology, to cause death, disease, or other biological malfunction in a human,
an animal, a plant or other living organism in order to influence the conduct of government or to intimidate or coerce a civilian population.

Any person or entity who provides health care services including, but not limited to, hospitals, medical
clinics and offices, special care facilities, medical laboratories, physicians, pharmacists, dentists, physician assistants, nurse practitioners, registered and other nurses, paramedics, emergency medical or laboratory technicians, and ambulance and emergency medical workers.