NJ Pharmacy Act: Regulations and Enforcement

• These are study notes for the state law of the New Jersey Pharmacy Act.

New Jersey Pharmacy Act: Drug Utilization Review

• Drug utilization review involves checking for allergies, class, dose, and directions.
• It also includes checks for duplicates, interactions (DFI, DDI, ADE), and proper medication use.

NJ Board of Pharmacy: Enforcement and Membership

• The board enforces all aspects of the pharmacy act.
• It consists of 11 members appointed by the governor, including registered pharmacists with 5+ years of experience in NJ, two public members, and one state executive member.
• Eight members are pharmacists – one from retail, one from a hospital, and one who owns a pharmacy.
• Members serve staggered 5-year terms, and no more than three can leave in the same year, with a limit of two consecutive terms.
• The NJPhA or other entities can suggest pharmacist candidates to the governor.
• The board annually elects a president, vice president, and executive director (who must be a pharmacist).
• The executive director earns $150 per working day.
• The board meets monthly and can convene more frequently if necessary.

NJ Board of Pharmacy: Duties and Regulations

• The board is responsible for licensing, renewal, and registration of pharmacists.
• It establishes professional standards and rules, including requirements for collaborative practice and direct drug administration.
• The board regulates technological pharmacies and devices.
• It can seize drugs that pose a danger to the public.
• The board establishes rules for recordkeeping and maintenance and inspects pharmacy sites.
• The board inspects prescriptions, can take them for review but must provide a copy, and returns the original after it has served its purpose.
• It sets requirements for counseling, patient profiles, DURs, and regulations to protect health and safety.
• The board sets fees for exams, certifications, licenses, and renewals.
• It recognizes and approves pharmacy schools and sets training regulations for interns, externs, preceptors, and technicians.
• The board collects professional demographic data and works with organizations to improve standards.
• It develops a bill of rights for patient services and education and sets standards for continuing education for pharmacists.
• The board creates regulations for emergent situations and pilot programs and ensures that pharmacist certification is not misleading.

NJ Board of Pharmacy: Disciplinary Actions and Oversight

• The board can seize drugs owned by a licensee if their license is suspended, revoked, or not renewed.
• Seized drugs cannot be disposed of until an appeal is decided.
• Courts can order the board to sell perishable drugs, with proceeds deposited with the court.
• Drugs suspected of being outdated, misbranded, or adulterated must be tagged and cannot be moved or sold without board or court approval.
• A judge decides if a drug is adulterated; if so, it is destroyed at the owner's expense unless corrected with fees paid.
• All actions are under the supervision of a board representative.

Scope of Practice and Restrictions

• Only individuals licensed under the New Jersey Pharmacy Act can practice pharmacy.
• The act does not apply to drug sales to another pharmacy, doctor, or to doctors giving medications directly to their patients, which is regulated by the medical board.
• A licensee must select an address of record, which is public, and can be a home or business address but not a P.O. box unless a street address is also given.
• Dispensing includes interpreting a prescription, selecting, labeling, packing the drug, and consulting with the patient.
• Interchangeable biologics are listed in the purple book.

Prescribers and Prescription Requirements

• Certified nurse midwives can prescribe with authorization and must include specific details on the prescription.
• Required prescription contents: CNM name, address, license number, degree or identification, patient name, address, age, date, drug name, strength, route, quantity, refills, instructions, and whether substitutions are allowed.
• For CII drugs: Quantity in words and numbers, signature, DEA number (if controlled), collaborating physician, and written on numbered NJ prescription blank, with only one controlled substance per prescription.
• Physician Assistants can prescribe in inpatient and outpatient settings, including controlled substances under specific conditions.
• PA prescriptions must include PA name, identification (PA-C), license, address, supervising doctor's full name and DEA if for controlled substances, along with "prt" (protocol) or "spd" (dr direction). All other requirements are as above.
• Optometrists can prescribe CIII-V drugs, but not CII drugs, and can administer hydrocodone.
• They are limited to treating eye conditions and can only do injections for anaphylaxis.
• Optometrists must be TPA certified by the board, complete CE credits, and can prescribe eye medications based on their license prefix (27TO for topical, 27OM for oral and topical).
• Advanced Practice Nurses can prescribe in inpatient settings if doctors and nurses decide a consult is needed for controlled substances in which order is based on protocols and signed to include credentials.
• Protocol review needs to be signed annually by the nurse and the doctor.

Advanced Practice Nurses and Other Prescribers

• APNs must have 6 hours of CE in pharmacology in order to prescribe controls.
• The prescription needs to match above, identification APN, in CS needs collab agreement.
• Dentist can prescribe anything for teeth/gums/surrounding tissue and animal shelters can prescribe CIIs and sodium pentobarbital.
• The following cannot prescribe: ambulances, chiropractors, oriental medicine practitioners, euthanasia technicians, homeopathic doctors, psychologists, and naturopathic doctors.

Pharmaceutical Services and Professional Judgement

• Pharmaceutical services include interpreting prescriptions, selecting, preparing, packaging, labeling, dispensing.
• Also store drug, monitor therapy, record ADEs, give drug information and educating and counseling safe drug use.
• Professional judgement: Judiciousness and discretion based on knowledge and sound application of pharmacy along with appropriate dispensing.
• If a drug is therapeutically equivalent, it is rated "A" in the Orange Book (or AB).

Registration and Penalties

• The registration fee is $125, and the license fee is $140, with a biennial renewal fee of $70.
• Renewal cost is $140.
• Penalties need to be paid within 15 days to avoid further legal issues.
• Individuals can request a hearing or a waiver for rule relaxation if facing hardship.
• Applications must be completed within one year, or they will be closed.

Continuous Quality Improvement Program (CQIP)

• The CQIP is done by the pharmacy permit holder with pharmacist in charge overseeing: to detect, prevent prescription errors.
• It involves analyzing and investigating prescription data to find the causes and factors of errors to prevent.
• Must be in written policies, and must include: incident reports, resolutions, root cause analyses, meeting minutes, attendance, and corrective action plans.
• There must also be internal incident reporting system, response to error in pharmacy, meetings every 3 months.
• Make sure everyone gets meeting minutes and supervisors. Submitting to quality events allows board deems as CQIP.

Pharmacy Licensure Requirements

• The criteria for pharmacy licensure include a written application, being at least 18 years old, having good character, a degree from an approved program, completion of an internship program, passing the NAPLEX and MJPE, and paying required fees.
• If more than two years post-graduation, the applicant needs 1440 hours of experience and must register as an intern within two years before applying.
• Foreign graduates need: application, age 18+, BS 5 years/ PharmD, certification through FPGEC, 1440 intern hours (registers within 2 years), pass NAPLEX/MJPE, background check.
• To pass NAPLEX and MPJE require 75.
• Background check includes checking the applicant's name, address, and fingerprints.
• Extern preceptors are approved by the school, while intern preceptors are RPhs who are board approved.

Pharmacy Internship and Licensing for Out-of-State Pharmacists

• Students who have graduated and are employed have to apply for a license.
• Training sites must be licensed by the board, dispense drugs, and have an RPh presence.
• The experience required is 1440 hours between 34 to 104 weeks, for 15-45 hours a week.
• No credit is given for hours before registration.
• Preceptors must register and have two years of experience as an RPh and can supervise only one intern at a time.
• Students aren't externs if working out of regular school scope and are considered pharmacy techs.
• Pharmacists licensed in another state need application, 1500 hours in past 2 years, or requirements in NJ within 1 year before applying.
• License can be obtained by passing the exam, paying fees, and providing proof of degree.

Pharmacy License Display and Renewal

• The process includes passing the exam, authorization, and issuance of the license, which must be displayed at place of employment.
• Must display conspicuously at work.
• It must be renewed biennially.
• If changing name or address, you have to notify the board within 30 days.
• Verification of license is good if asked for.
• You are not allowed to reprint/duplicate license yourself.
• Renewal notice is given before 60 days of expiration date.
• You can renew within 30 days of expiration with a fee (license active in 30 days), or as inactive. If do inactive and dont have renewal, suspended, no pharmacy practice is allowed.
• To get license reactivated renewal app needs to be send.

Reactivating a Pharmacy License and Disciplinary Actions

• To reactivate an inactive license, a renewal application and employment certification are required, along with a fee and evidence of continuing education (CE) credits.
• The board can require remediation based on time inactivated, employment, professional and disciplinary history, and any license or civil litigation issues.
• If a license is suspended, the applicant must submit an application, employment history, fees (including reinstatement and prior biennial period fees), and all CE credits to apply for reinstatement.
• A pharmacist cannot steer patients to a specific pharmacy or collude with a doctor.

Reciprocal Licensure

• Pharmacists that are licensed in states with reciprocity can apply. They need: active license in reciprocating states, degree, background check, 1500 hours experience (or internship) in the past two years, pass MJPE.
• If foreign need certification from FPGEC license, degree, 1500h experience (or internship) over 2 years.
• Good moral character can be refused.

Grandfather Clause

• If already licensed when the act was implemented, a pharmacist can practice until their license expires.
• The pharmacist does not need to take an exam after paying the fee.

Continuing Education (CE) Credits

• Pharmacists need to complete CE credits for biennial renewal.
• The board sets standards for subjects and number of credits and approves educational programs.
• CE programs must be non-discriminatory, can have different fees for memberships, in or out of state.
• Business or promotional meetings do not count.
• The board can waive CE requirements for hardship or disability but are not needed for initial renewal.
• Credits may be carried over (max 10) to next period within 6mo of completing CE.
• 30 credits are required (10 in person), as well as 3 hours law, 1 for opioid abuse and 1 in vaccines.

Earning Continuing Education Credits

• 1 credit per class, 3 for university class, max 6 of articles / teaching / preceptor.
• Need to verify that you did your credits.
• The following are satisfactory compliance to verify teaching / published studies and certifications related to being a board preceptor.
• Need to include documentation on renewal of verified participation/completion of the above courses and other credits.
• CE can be waived for disability applied, random audits can occur.
• Application with the board needs to be sent at least 45 days before starting course. Pharmacy and etc are regulated by RPH and need PIC if they are without it.
• Each location needs to renew permits. No transferring permits of out-of-state pharmacies shipping drugs to NJ for register.

Pharmacy Permits and Out-of-State Pharmacies

• Cannot open pharmacy if being licensed. Must comply with states rule and request from NJ.
• They must give inspection reports, cap annual fee in each prescription. They must also have toll-free number.
• Everything has to be reported, including settlement.
• Can't lie or open without help. New permit for less than total area, must provide all information.

Pharmacy Application and Inspection

• Exact trade name and other names including officers needs to be included with PIC.
• Need to follow what board says and write if need more time.
• Have to have permits. Notify about change in officers and how change is occuring.

Discontinued Pharmacy and Business Hours / Security

• To discontinue must tell all office control units. The business for closure must remove all signs and tell location for RX reports, all records,
• You have to provide new pharmacy as well. Needs to follow all business hours of 40/5. All must be secured, and no access for non-pharmacists. If all these actions dont occur you must shut doors.

Centralized Prescription Handling and Out-of-State Pharmacies

• Have all the pharmacy names. 2 or more pharmacies share things, must have all policies available.
• Board can registered other states must need application in 30d, affidavit for who stock goes to as well. Needs to give number for pharmacist.

Remote Processing Center / Prescriptions

• Must give board and name, secure location, policy, and tech registered. Only pharmacist store not dispense.
• Serial numbers of drugs, have to have number of DR with NPI. Must have number of DR for all controlled substances, must be in writing.

CII and Prescriptions: Quantity limits and Dispensing

• CII need word + number for all quantities. Can only have one controller on the prescription.
• Initial prescription is patient who has never had it before. Pal care, only can give for death.
• 30-day limit doesn't occur if infusion installed and start low and then move forward. Cancer patients do not follow those limits.

Controlled Substances and Other Regulations

• Cant give depression medications (needs to be registered).
• Can give if in US state. Do not have to contact if has use as directed. Expired medication has one year limit after expires.
• Can refill CIII - CV for within 6 months. You cannot give an amphetamine or stimulant if weight loss. The exceptions are Idiopathic or other CNS issues.
• Must need medical needs to provide anabolic meds for short kinds, growh tumurs, HIV. The exceptions is burns or accidents that need a documentation. Cannot use for normal procedures.

Emergency Dispensing Regulations and Required records

• Can can get a documentation if need emergency medication. It is FDA approved so you can sell.
• Document and user need to identify employee, records 5 years. Copy records need to be complied in given timeframe.

Prescription Origin and Filing

• Write copy if need in request for copy. Need to immediately comply if needed . Transfers and CDS can be done via phone or fax with all the required signatures. All Clls stores in file.

Prescription by Fax Requirements and labeling

• Transmitting via Fax can be done if from from DR or employee. All documentation and records and verification should be kept.
• All labeling and information must be stored like the following pharmacy information with date.

Professional Judgement and Pharmacy Responsibility

• DR and RPH responsibility with judgement will take priority. Fill is based on morale issues. Needs all signatures.
• Can report issue to quality board if issues arise if they dont have medication.
• Drugs cannot reference drugs quality.

Sales restrictions and Patient Records

• OTC sales RPH knows issue. The sales are limited in sizes per unit. Third and 4th request needs documentation and justification and will allow for tracking system.
• If overmedicating and bad use its recorded in OTC and return the drugs. All records must be kept for 5 years.

Record Keeping requirements and Responsibilities

• RPH has to follow what profile states. RPH attempts, drug use, condition, and drugs all must be tracked. All records must be kept. Keep for 5 years

Drug Utilization Review and Collaboration

• The medical team must monitor medical needs in the system.
• If all are okay move to patient counselling. No interchange if doctor does not follow directions.
• DR must note issues on side in electronic report, inform dr with 48-hour informaiton. Must note the time etc to make a note on system.

Collaborative Practice and Consent

• Collaboration needs patient consent.
• Has to be apporved for 2 years. if 18 plus RPH and vaccine needs approval. if smaller 16 needs guardian permission and can give act if 3. They also need accreditation with min of 10 credits, keep for 7 years.
• The collaboration includes: Name and name and information with doctor notify in changes. All include name

Medication Records

• Medication order all original need kept and secured. Consultant needs to one there.

Pharmaceutical System / Compounding

• System for pharmacy to dispense etc will have automatic system. Clean space as all ISO space.

USP Standards and Compounding

• ISO rooms for all types of clean room. Must have air conditioned and filters so air is clear.
• High level all requirements, testing, monitoring must occur

Sterile Compounding Requirements and Procedure

• The compounds are for emergency and short for any contamination. All rooms and equipment must be sterile.
• Everything must include policy, test label for compound procedure. Documentation and test is needed after every product.

Compounded Audit and Safety Records for Manufacturing

• Has to all ingredients that are made need audit log. Can reject the drug.
• All must be certified by company, you must tell standard and give data to the test, FDA is bad cant make.

Non-Sterile Compounding and Nuclear pharmacy records / Labelling

• OTC compounds under follow rules. Need to follow labeling and cleaning requirements.
• Nuclear must state type and have name on bottle.

Labelling

• Name on bottle with how to handle. In case of emergency Every NJ black state if need substitute.

Product Brand Types and Drug Info

• The different product are labeled as follows. Drug need documentation with dr. If get a call needs all data with documentation and training. Dr gives orders in all of it.

Vaccine Administration and Documentation

• You can give drug if 18 plus, if had a previous doctor or if training by CDC with documentation of all the steps. Needs all the required steps
• If over 18 signing needs approval from dr. Needs be geographically in area.

Safety Compliance

• With certain drugs that compliance for 18 plus with oxygen.
• Long term if all followed. Dr cannot be working for drug.

Drug Control

• Emergency and medication and side effects on the unit. All errors must be document to the director.

Unit labelling and Protocols

• Units label all security emergency kit and sealed. Must do paperwork in review of facility.

Contraceptive

• They help avoid unwanted pregnancies. Must have training and certification.
• Also keep records for 7 year. Must have certification and training with certain test.

Drug and Substance Act

• Different drugs have certain risk.
• Injections and licensing can have risk etc , will need record.

Compliance

• Compliance and protocols need to be followed. Inventory will need to. The records if they followed or not.
• Always have documentation and training.