New Jersey MPJE Worksheet PDF

MPJE MPJE Worksheet Instructions: This is meant to be a guide that covers as many possible MPJE topics as possible. Each state has different laws, and you may find some boxes that are not addressed by...

MPJE MPJE Worksheet Instructions: This is meant to be a guide that covers as many possible MPJE topics as possible. Each state has different laws, and you may find some boxes that are not addressed by your state (in which case write n/a). Always check your state board for latest guidance. State New Jersey The Board of Pharmacy BOP consists of 11 members: 2 from general public, 1 state executive, and 8 pharmacists (RPh) Who are the Board Members? RPh shall have ≥ 5 years pharmacy experience in NJ, active license, and currently practicing pharmacy, with at least 1 RPh from a chain retailer and at least 1 from a health system. (45:14-43) Is the Board a Separate Entity or Under The BOP is a professional licensing board under the NJ Division of Consumer Affairs, which is a Another Organization/Department? division within the NJ Department of Law and Public Safety. (njoag.gov) A president and vice president are elected among the BOP members annually. Who Chairs the Board? The executive director of the BOP shall be a NJ licensed RPh. (45:14-44) NJ Governor shall appoint BOP members. How Are Board Members Selected? Every professional pharmacy association may send names of qualified RPh to the Governor. (45:14- Appointment/Election? 43) Term of five years serving no more than two consecutive full terms (45:14-43) How Long do Board Members Serve? Exception: Members appointed to fill vacancies prior to expiration of full term, shall serve unexpired part of the term. Members appointed for term less than five years are eligible to serve two more full terms. How Often Does the Board Convene? The Board shall meet at least once every month, but may meet additionally as needed. (45:14-46) Who Can Attend Meetings? Anyone may attend meetings, and submit comments in writing prior to the meeting. Licensure Requirements The Pharmacist New Transfer/Reciprocity Foreign Graduate At least 18 years of age At least 18 years of age At least 18 years of age Licensed in mutually reciprocating Valid certification from FPGEC Graduated from ACPE - state and in good standing of NABP Who Can Apply? accredited or -equivalent Engaged in at least 1500 hours Complete 1440 hours in pharmacy school (13:39-2.1) pharmacy practice before Board-approved internship application date (13:39-2A.1) (13:39-2.1) Application Fee? $125.00 $125.00 $125.00 # of CE Hours for Renewal? Minimum of 30 CE credits Note: Does not apply to initial license renewal For all RPh renewals (13:39-3A.1): At least 10 CE credits didactic, 3 CE credits pharmacy law, and 1 CE credit on opioids 10 CE credits CAN be carried over if earned in last six months of preceding biennial period Any CE credits on opioids CANNOT be carried over Special CE Requirements (e.g. Additional CE requirements (13:39-3A.1): live, compounding, preceptor, Complete at least 2 hours of CE in immunizations if administering vaccines (§ 13:39-4.21) HIV, MTM, vaccinations, Complete at least 10 CE in each disease covered by a collaborative practice agreement or total of 10 CE if opioid, medication safety)? treating patients with co-existing, related diseases/conditions (§ 13:39-13.3) Max 6 CE credits for teaching/research appointments (3 CE credits per “new” appointment) Max 6 CE credits as preceptor in an externship program (3 CE credits per student) Max 6 CE credits as preceptor in an internship program (3 CE credits per 160 hours worked by intern) Max 6 CE credits for articles on pharmacy published in peer-reviewed journal (3 CE credits per article) 1440 hours in Board-approved NO intern hours required if 1440 hours in Board-approved internship if without 1500 hours of graduated from ACPE pharmacy internship if graduated from pharmacy practice (13:39-2.6) Minimum Intern Hours? school and applying for license foreign pharmacy school NOT Note: NO intern hours required if within 2 years of graduating (13:39- ACPE -accredited or -equivalent engaged in 1500 hours of pharmacy 2.1) (13:39-2.6) practice prior to application date B.S. Pharmacy or Doctor of B.S. Pharmacy or Doctor of Pharmacy B.S. Pharmacy or Doctor of Degree/Education Required? Pharmacy from ACPE pharmacy from ACPE-accredited or -equivalent Pharmacy (13:39-2.1) school (13:39-2.1) pharmacy school (13:39-2.1) Pass NAPLEX minimum score 75 Pass NAPLEX minimum score 75 Examinations Required? Pass MPJE minimum score 75 Pass MPJE minimum score 75 Pass MPJE minimum score 75 Passport photo (13:39-2.1) Passport photo (13:39-2A.1) Passport photo (13:39-2.1) Documents (Transcript/Drug College transcript (13:39-2.1) Proof of character (13:39-2A.2) FPGEC certificate (13:39-2.1) Test/Background Check)? Proof of character (13:39-2.3) Background check (13:39-2A.4) Proof of character (13:39-2.3) © tl;dr pharmacy llc. All Rights Reserved  Background check (13:39-2.4) Background check (13:39-2.4) License reactivation (13:39-3.8) and License reinstatement (13:39-3.9) Submit reactivation or reinstatement application to NJ BOP Reinstatement Process? Pay required set of fees Submit certification of employment listing each job held during period of inactivation or suspension Submit evidence of CE credits completed during biennial period prior Probation Reasons/Process? NJ BOP does not specify anything regarding license probation. Renewal Period? Biennial Renewal Note: Renewal is April 30th of every odd year (e.g. April 30, 2021) Pharmacy Intern New Foreign Graduate FPGEC certificate and register License/Registration Required? Register with NJ BOP (13:39-2.7) (13:39-2.7) 1. Graduated from ACPE school and awaiting licensure 2. Seeking reciprocity but not engaged in at least 1500 Graduated from foreign pharmacy Who Can Apply? hours of pharmacy practice in preceding two years school not ACPE -accredited or - 3. Graduate participating in ASHP residency program equivalent (13:39-2.6) and awaiting initial licensure (13:39-2.6) Application Fee? $50.00 application fee + $70.00 initial registration fee Complete 1440 hours after registering with NJ BOP Complete between 15 - 45 hours of pharmacy practice each week Hours Required? Complete hours between 34 - 104 weeks under supervision of a Board-approved preceptor Accurate record of time must be kept and submitted to the Board for approval (13:39-2.6) Criminal background check, fingerprinting, and proof of good moral character (13:39-2.7) Current Enrollment/Good Standing Required? (refer to above “Who can apply?”) A Board-approved, licensed, full-time RPh who has been practicing for at least two years (13:39- Preceptor Required? 2.6) Intern registration is valid for two years from the date issued. One-time renewal is allowed on Renewal Period? individual basis for military service, hardship, illness or disability. (13:39-2.7) Pharmacy Technician New License/Registration Required? Register with NJ BOP (13:39-6.6) Who Can Apply? 18 years of age, diploma or equivalent, and proficient in written and spoken English (13:39-6.6) # of CE Hours for Renewal? NJ BOP does not specify CE for technicians. Note: CE credit hours are required for PTCB Special CE Requirements (e.g. compounding, Refer to the PTCB website for information on national CE requirements: live, HIV, opioid, medication safety)? https://www.ptcb.org/continuing-education Application Fee? $50.00 Requirements? Examination, PTCB, Education? Criminal background check, fingerprinting, and proof of good moral character (13:39-6.6) Drug Test? Background Check? Renewal Period? Biennial Renewal The Pharmacy The Physical Space Specific Requirements on Who Pharmacy permit holders shall comply with any law and/or ordinance that requires a security box be placed on Can Access the Pharmacy? the exterior of the pharmacy/premises for emergency access. Without Pharmacist? BOP? RPh shall comply with BOP visits, as long visits occur during normal business hours. (13:39-4.15) Police? Space requirements differ for pharmacies in operation prior to July 1, 1963 (13:39-5.4): Prescription area shall be 10% or more of the main floor area, and at least 50 sq.ft. Exception: If main area is more than 1200 sq.ft., then prescription area shall be at least 120 sq.ft. Minimum Square Footage? All other pharmacies in operation (13:39-5.4): Prescription area must be at least 150 sq.ft. The pharmacy shall have a secure barrier/partition extending from the floor or a fixed counter to the ceiling separating from non-pharmacy. (13:39-4.15) Minimum Counter Space? No less than 18 inches wide and no less than 12 feet long (13:39-5.5) Counseling Area NJ BOP does not specify requirements for the counseling area. Requirements? All entrances must be capable of being locked and connected to a monitored security system. Security System Requirements Security system shall have a back-up mechanism. Only the PIC shall be responsible for security of keys and access codes. (13:39-4.15) © tl;dr pharmacy llc. All Rights Reserved  Specifications on Alarms? Security system shall transit audible, visual, and electronic signal of unauthorized access. (13:39-4.15) Pharmacy required to include a phone number on each prescription label for contact. (13:39-11.21) Connectivity (Phone/Fax/Internet Note: Secure phone, fax and internet connectivity are required for sending/receiving prescriptions, as well as Required)? maintaining patient profiles and participating in prescription drug monitoring for CDS. Area for receiving/storing drugs/devices shall be secure (not accessible by public). (13:39-4.15) Maintain C-II prescriptions in a separate file. (13:39-7.9) Maintain C III - V prescriptions in a separate file or with non-controls that are readily retrievable. Separate Storage for o Either mark prescription face with “C” in the lower right corner with red ink at least one-inch high or Prescription Hard Copies by use an electronic record-keeping system for prescription retrievals). (13:39-7.9) Control? Drugs by Control? Store C-II in a safe/steel cabinet, which may be equipped with an alarm system. (§ 13:45H-2.2) Store C-III, IV, V, and other legend drugs/devices in a secure area inaccessible to unauthorized personnel or public, and which can be secured during non-working hours. (§ 13:45H-2.2) All prescription records shall be maintained and stored securely for a minimum of 5 years. Must Storage Area Be Locked The oldest 4 years of information shall be retrievable within 2 weeks for Hard Copies? Drugs? The most recent 1 year of information shall be retrievable within 1 business day. (13:39-7.6) Must Storage Area Be On Site Records not currently in use can be stored off-site, but shall be stored securely. (13:39-7.6) for Hard Copies? Drugs? Signage Sign Requirement for NJ BOP does not specify sign requirements for counseling. Counseling? Pharmacies shall post hours and the name of PIC in plain view of the public at all consumer entrances and Sign Requirement for Hours? access points to the pharmacy (including drive-thru and drop-off boxes). (13:39-5.3) Sign Requirement for PIC Name of the PIC (current, interim, change) shall be in plain view of the public. (13:39-5.3) Change? Sign Requirement for Display notice on exterior of pharmacy indicating temporary changes in hours or closing. (13:39-4.12) Closures? Post sign when RPh on break (restroom or 30-minute meal) in the prescription dispensing area stating Other Signage Requirements? “Pharmacist on break, but available for emergencies and counseling.” (13:39-6.4) Board Notification 1. Death of an owner/partner: Permit is terminated and shall be returned to BOP. The estate/heirs or remaining partners shall submit a new permit/affidavit as required. (13:39-4.4) 2. Complete ownership change: New owner shall submit permit to BOP within 30 days of ownership. The new Time to Notify Board of owner must perform inventory of controls, available to BOP upon request. (13:39-4.5) Changes to Ownership? 3. Change of agents/officers: Submit affidavit indicating change to BOP within 30 days. (13:39-4.5) 4. Change ≥ 10% stock owners: Submit affidavit indicating change to BOP within 30 days. (13:39-4.5) 5. Reallocation among owners: Submit affidavit indicating change to BOP within 30 days. (13:39-4.5) Note: The PIC shall be a full-time employee working minimum 35 hours per week, and cannot be PIC of more than one pharmacy at a time. (13:39-6.2) Time to Notify Board of Pharmacy permit holders shall notify BOP within 30 days of PIC change. Changes to PIC? Inventory of controls must be performed by BOTH outgoing and incoming PIC. No pharmacy shall operate without a PIC for more than 30 days. PIC and permit holder shall notify BOP naming interim PIC, if PIC to be absent more than 30 days. 1. Change in physical location/address of pharmacy: Apply for a new permit at least 30 days prior to change, Time to Notify Board of and BOP shall inspect and approve the new location. (13:39-4.7) Changes to Address? 2. Change in address but not physical location: Submit affidavit explaining change to BOP within 10 business days of change. (13:39-4.7) All pharmacies must be open for business at least 40 hours and at least 5 days per week. (13:39-4.12) Time to Notify Board of Notify BOP within 30 days of any permanent changes to pharmacy hours. Changes to Hours? Obtain BOP approval prior to any temporary closing lasting more than 48 hours. Equipment Class A prescription balance or equivalent electronic weighing device readily accessible in all prescription areas Type of Prescription Balance with non-sterile compounding. (13:39-5.8) Required? Pharmacies shall have balances, scales, weights and automatic counting devices inspected every 12 months by Department of Weights and Measures. (13:39-5.9) Most recent editions of reference texts in print or electronic. (13:39-5.8) Volumetric devices, steel and rubber/composition spatulas, counting trays or approved counting devices, labels, assorted stock of prescription containers and closures/caps. Other Equipment Required? Glass mortar and pestle, glass funnels, stirring rods, and ointment tile or parchment paper. Refrigerator (and/or freezer) for storage of pharmaceuticals only. (13:39-5.11) ○ Monitor temperature of pharmacy, fridge, and freezer at least 2 times daily (8 hours apart), and unless specified by manufacturer drugs shall be stored at 20 - 25℃ (68 - 77℉). © tl;dr pharmacy llc. All Rights Reserved  Drug-Dispensing Device (13:39-9.17): Dispenses meds pre-packaged or packaged/labelled by RPh or under RPh supervision. Use, access, maintenance, and review of devices is PIC responsibility. Device may be used in absence of RPh provided absence is less than 24 hours and/or proper review of device use can be ascertained. CDS may be stocked in devices with limited access, and use shall be checked every 24 hours. Automated Medication System (AMS) (13:39-10.2): Special Rules on Automated Any process that stores, packages, dispenses, and distributes meds while collecting, controlling, and Dispensing Cabinets? maintaining all transaction information. PIC responsible for at least the following regarding AMS (13:39-10.3): o Supervise its use and maintenance of stock o Write policies/procedures for use o Conduct annual self-inspection ensuring accurate dispensing and review policies/procedures o Inspect stock at least once every 2 months for expiration/BUD/misbranding/integrity, o Inspect security at least once every 2 months o Perform quality assurance at least every 6 months or when upgraded/changed o Report recurring errors (inaccuracy that occurs more than twice in 14 days) to BOP o Maintain records at least 2 years Access Must RPh Be On-Site for Generally, RPh should be on-site for access to pharmacy, except as permitted. (§ 13:39-4.15) Access to Pharmacy? (refer to below “After Hours dispensing”) After hours access to institutional pharmacy (13:39-9.21): Only RPh shall have access to pharmacy stock of CDS. PIC may designate RN to obtain meds from pharmacy PRN in emergencies if not in floor stock. PIC shall obtain a record of any drugs removed by designated RN with: Drug name, Dosage size, Amount, After Hours Dispensing Date, Patient’s name and location, and RN signature. Allowed? Requirements (i.e. After hours access with Dispensing Devices (13:39-9.17): Dispensing Cabinet? May be used when RPh not on duty, provided the absence does not exceed 24 hours and/or proper review of the use of the device can be ascertained, and records/use shall be reviewed every 24 hours. After hours access with Automated Medication Systems (13:39-10.4): Policies and procedures shall identify circumstances when meds may be removed by a licensed practitioner for distribution to a patient without prior order review by RPh. Emergency Access to NJ BOP does not specify a pharmacy procedure for emergency access. Pharmacy Procedures? (refer to above “After hours access to institutional pharmacy” for institutional emergency access) Mail Order Out-of-State pharmacies that ship/mail/distribute/deliver any legend drug, device or CDS to NJ shall be Mail Allowed? (In-State to Out, registered with BOP (renewed annually). They shall operate at least 5 days per week, 40 hours per week and Out-of-State to In) provide a toll-free number disclosed on labels dispensed to patients. (13:39-4.20) License Required for Mail to NJ BOP does not specify license requirements for mailing out of state. Other States? Ownership Requirements What Are the Fees for A In-State Pharmacy Permit: $275 application fee, $175 annual permit renewal Pharmacy License? Out-of-State Pharmacy Permit: $175 application fee, $175 annual permit renewal A permit application shall be submitted to BOP by every individual/business entity. Who Can Apply? The individual/business entity shall be of high moral character without indictment or alleged violation of local, State, or Federal laws in the practice of pharmacy or any drug. (13:39-4.1) Must be RPh to Own Permit application must include name of PIC who is a NJ licensed RPh in good standing (13:39-4.1) Pharmacy? Permit application shall include: Additional Requirements for Exact intended location and plan for the pharmacy Ownership? Trade name, corporate name, name and address of owners/operators/officers/stockholders Name of PIC who is a NJ licensed RPh in good standing (13:39-4.1) When a pharmacy ceases operation they must make every effort to notify pharmacy patrons that they have the right to obtain copies of currently valid prescriptions and/or copies of patient profiles for a one-year period by performing all of the following (13:39-4.10 to 4.11): 1. Notify BOP in writing Rules on Sales/Transfers 2. Publish notice once weekly for 2 consecutive weeks in newspaper within geographic area 3. Place a sign in the pharmacy location 4. Permitted pharmacies that use social media can post notice on social media platforms For sale/transfer of assets/ownership, both new and former permit holders shall ensure access to prescriptions and profiles within 24 hours of sale/transfer and forward calls to new pharmacy. Application/Fees Required? In-State Pharmacy: $275.00 & Out-of-State Pharmacy: $175.00 © tl;dr pharmacy llc. All Rights Reserved  Pharmacy shall notify BOP in writing that pharmacy has opened for business within 90 days of BOP’s permit How Long for Notification approval. If additional time is needed, then the pharmacy shall submit a written request to BOP for an extension Period? no less than 30 days BEFORE expiration of the 90-day period. (13:39-4.1) Signage Requirements? Current pharmacy permit issued by BOP shall be displayed in view of public. (13:39-4.3) Staffing Requirements Intern (45:14-41) Any person who graduated from an accredited pharmacy school (or foreign graduate who met the Board’s requirements), and is being trained by Board-approved preceptor for the purpose of acquiring practical experience. Extern (45:14-41) Any person who is in 5th/6th year or 3rd/4th professional year at an accredited school of pharmacy, and who is assigned to a training site for the purpose of acquiring accredited practical experience under the school’s Role Definitions supervision. Technician (45:14-41) An individual registered with the Board to work in a pharmacy practice site under the immediate supervision of an RPh and assists in activities that do not require an RPh’s professional judgement. Tech Applicant (13:39-6.6) An individual who is hired as a pharmacy technician, but is not registered with the Board. Within the first 10 days of employment, the applicant applies with the Board and can work as such for max 180/220 consecutive days. Intern/Extern may perform these under RPh supervision (13:39-6.5): Retrieve prescription file, patient files/profiles, other records Prescription data entry Collect patient demographic info including allergies, idiosyncrasies, and medical conditions related to DURs Transcribe scanned prescriptions/orders in patient records Prepare label Intern/Extern Duties Count, weigh, measure, pour, compound prescriptions Fill automated medication system (AMS) Accept refill renewal authorizations, provided prescription remains unchanged Accept new prescriptions (verbal or voicemail) Transfer prescriptions (send/receive) Counsel or consult patients/caregivers and prescribers Technicians/Technician Applicant may perform these (13:39-6.15): Retrieve prescription file, patient files/profiles, other records Prescription data entry Collect patient demographic info including allergies, idiosyncrasies, and medical conditions related to DURs Transcribe scanned prescriptions/orders in patient records Prepare label Count, weigh, measure, pour, compound prescriptions Fill automated medication system (AMS) Accept refill renewal authorizations, provided prescription remains unchanged and technician/technician applicant identifies themselves as such to the prescriber or prescriber’s authorized agent Technician/Applicant Duties Technicians/Technician Applicant shall NOT perform these (13:39-6.15) Receive new verbal prescriptions Interpret a prescription or medication order for therapeutic acceptability and appropriateness Verify dosage and directions Engage in prospective drug review Provide patient counseling Monitor prescription usage Override computer alerts without first notifying pharmacist Transfer prescriptions (send/receive) Violate patient confidentiality Generally, RPh to technicians ratio is 1:2. (13:39-6.15) Note: Technicians and technician applicants receiving in-service training may be excluded from the 1:2 ratio, but RPh shall NOT supervise more than 2 persons receiving in-service training at the same time. RPh to technician ratio CAN exceed 1:2 if following conditions are met (13:39-6.15): 1. Establish written job descriptions, protocols, and policies/procedures for technician duties. 2. Ensure all technicians who work when ratio exceeds 1:2 are either PTCB-certified, passed a BOP-approved RPh-Tech Ratio? Different by certification program, or completed a BOP-approved program with testing. Setting? 3. Ensure all technicians are knowledgeable in established duties. 4. Ensure assigned duties do not exceed established duties. 5. Ensure all technicians receive in-service training. 6. RPh provides immediate supervision of all technicians. 7. Provide BOP copy of written job description, protocols, and policies/procedures as required. 8. Maintain policy and procedure manual that is reviewed at least every 2 years by PIC. Note: RPh shall provide immediate supervision to all technicians, externs, and interns. (13:39-11.13) © tl;dr pharmacy llc. All Rights Reserved  RPh (BOP-approved intern preceptor) can supervise one intern at a time. (13:39-2.6) RPh-Intern Ratio? Different by Extern preceptor: Individual approved by ACPE pharmacy school to supervise/train pharmacy extern. Setting? Intern preceptor: BOP-approved, licensed RPh in NJ to supervise/train pharmacy intern. RPh-Staff (Clerk/Delivery Driver/Cashier) Ratio? NJ BOP does not specify ratio requirements for other pharmacy personnel. Different by Setting? Compounding A pharmacy wishing to perform sterile compounding shall satisfy all pharmacy permit application requirements (refer to above “Ownership Requirements”) with amended pharmacy permit application. The BOP shall conduct an inspection and approve pharmacy prior to allowing sterile compounding. Permit holders shall notify BOP at least 60 days BEFORE any remodel/change. (13:39-11.3) Is Facility Licensure Required for General Compounding? Sterile The following are some requirements for sterile compounding (13:39-11.4): Compounding? Have an area designated for sterile compounding known as “cleanroom” Cleanroom shall include buffer area (containing ISO class 5 or better PEC) and ante area Cleanroom shall only be accessible by designated personnel and only for sterile compounding Cleanroom air conditioner shall maintain temperature 59 - 77℉ (ideal temp 66℉) Buffer area shall maintain ISO class 7 air and be minimum 100 sq.ft. May compound batch in quantity supported by PRIOR valid prescriptions/orders (13:39-11.17): Documents history of valid prescriptions/orders received within BUD of each product and within established prescriber-patient-RPh relationship Maintains prescription/order on file for all such products dispensed Documents each batch prep process with unique batch number Restrictions on Compounding Ensures labeling requirements are met (see below “Packaging”) Without Prescription? May NOT compound sterile or non-sterile prep for human use for a prescriber to use in their practice without a valid prescription, except to the extent permitted by Federal law. May compound sterile or non-sterile prep for non-human use for a prescriber to use in their practice without a valid prescription consistent with State and Federal laws for prescriber’s practice. (13:39-11.17, 13:39-11A.6) BUD in absence of sterility testing and stability information (13:39-11.19, 13:39-11A.11): RT (20 - 25℃) Fridge (2 - 8℃) Freezer (-20℃) Low-Risk Sterile Prep 48 hours 14 days 45 days Medium-Risk Sterile Prep 30 hours 9 days 45 days High-Risk Sterile Prep 24 hours 3 days 45 days Sterile product prepared in airflow workbench not located in a buffer area 12 hours (considered a low-risk level sterile product) Immediate use sterile prep 1 hour Opened/needle-punctured single-dose containers of sterile products used in 1 hour compounding prep for immediate use in less than ISO Class 5 air Single-dose vials used in compounding sterile prep exposed to ISO Class 5 6 hours or cleaner air quality Stability of Compounded Product? Opened/needle-punctured multiple-dose vials used in compounding sterile 28 days prep (unless specified by Manufacturer) Single-dose ampules used in compounding sterile prep Do not store Non-sterile, non-aqueous liquids/solids with 6 months or 25% of time remaining manufactured drug is source of active ingredient until expire date, whichever earlier Non-sterile, non-aqueous liquids/solids where USP-NF, 6 months or expire date of ingredient, AR, ACS, or FCC is source of active ingredient whichever earlier Non-sterile, non-aqueous liquids/solids where there is 6 months or the first expire date of more than one ingredient the ingredients Non-sterile, water-containing, liquid formulation stored 14 days at fridge temperature (2 - 8℃) All other non-sterile formulations 30 days Note: Review and know examples of the above compounded preparations for the MPJE. Pharmacies are exempt from registering as manufacturers as long as they (Section 503A): Special Volume Requirements? 1. Compound for sale in regular course of business and/or for prescriptions only, and Manufacturer License Required? 2. Compound with CDS NOT exceeding 20% of the completed compounded product © tl;dr pharmacy llc. All Rights Reserved  RPh, interns, externs, and technicians involved in sterile compounding must have didactic and practical Certifications/Licensure training (e.g. garbing, aseptic technique, use of equipment). The PIC is responsible for all personnel passing Required? annual written test demonstrating competency to perform sterile compounding. (13:39-11.16) RPh shall NOT compound commercially available products. (13:39-11A.4) Special Requirements for Patent Drugs? Controlled Drugs? OTC? Exceptions: Commercially available product modified to produce significant difference or product not available from normal distribution channel. RPh may compound pharmacy generated products (PGPS) for OTC without prescription. (13:39-11A.7) Product may not contain ingredients that exceed allowable strengths and doses for OTC drugs and does not require prescription/order Product is properly labelled: Product name; Names of all ingredients; Strength/quantity of all active Dispensing Without Prescription ingredients; Package size; Directions for use; Use by date; Pharmacy name, address, and telephone; Allowed? Which Drugs? Ancillary and cautionary instructions as needed; Storage details Product is sold directly to consumer after a professional interaction/consultation between RPh and consumer, and not sold for resale purposes Product is stored in manner inaccessible to the public Pharmacy maintains appropriate compounding record Behind the Counter Control drug substances not under FD&C Act may be dispensed without prescription if (13:45H-7.19): Product is dispensed only by RPh and uses professional judgement and care with sale Purchaser is at least 18 years of age with suitable identification Amount dispensed to same purchaser in any 48-hour period not to exceed: o 240 cc (8 oz) of any substance containing opium o 120 cc (4 oz) of any other control substance o 48 dosage units of any substance containing opium o 24 dosage units of any other control substance Record book is maintained with purchaser, control purchased, date, and name/initials of RPh C-V controlled substances that may be sold for approved medical purposes without a prescription under the FD&C Act (24:21-8.1): o Products with less than 200 mg codeine per 100 mL or per 100 g o Products with less than 100 mg dihydrocodeine per 100 mL or per 100 g Can Legend Drugs (e.g. Codeine, o Products with less than 100 mg opium per 100 mL or per 100 g Opium Tinctures) Be Dispensed o Products with less than 50 mg ethylmorphine per 100 mL or per 100 g Without Prescription? Which Ones? o Products with less than 2.5 mg diphenoxylate and less than 25 mcg atropine per dosage unit Logging Requirements? C-V products sold OTC require use of professional judgment for subsequent purchases (13:39-7.15): Upon 2nd request for C-V within 2-4 days following 1st purchase, RPh shall communicate with purchaser to determine correct use (how many people using, has condition improved) Upon 3rd request for C-V within 2-4 days following 2nd purchase, RPh shall communicate with purchaser about abuse potential and caution to consult physician if no improvement Upon 4th request for C-V within 2-4 days following 3rd purchase, RPh shall communicate with purchaser to determine correct use without abuse (people using, if continued use therapeutic, need for physician consultation, signs of abuse) Upon 5th request for C-V within 2-4 days following 4th purchase, RPh shall recommend purchaser consult physician and document justification for sale in record book For C-V substances dispensed to one individual more than 5 times within 12-month period, RPh shall obtain oral/written confirmation from physician for continued need for use Opioid antidote (naloxone) may be dispensed by RPh without prescription if there is a standing order from a prescriber, Commissioner of Health, or Deputy Commissioner of Health. (45:14-67.2) 1. Compounded pharmacy generated products (PGPS) for OTC (13:39-11A.7) Which Drugs Are Required to Be 2. Controlled substances that don’t require prescriptions under the FD&C Act (13:45H-7.19) Behind the Counter? 3. Ephedrine alkaloid products behind the counter and/or in locked cabinet (CMEA 2005) Max 240 cc (8 oz) of any substance containing opium in 48 hour period Dispensing Requirements Max 120 cc (4 oz) of any other control substance in 48 hour period (Maximum Allowed/Logging)? Max 48 dosage units of any substance containing opium in 48 hour period Max 24 dosage units of any other control substance in 48 hour period (13:45H-7.19) Can Syringes Be Dispensed Without RPh may sell 10 or less hypodermic syringes/needles to a person over 18 years of age who presents a Prescription? Logging Requirement? valid photo ID without a prescription. (NJSA 2C:36-6.2) Cannot sell/transfer product containing ephedrine alkaloids to minors under 18 years of age unless HCP is treating a minor with the consent of parent/guardian (N.J.S.A. 24:6H-1) What are the Rules Around Pseudoephedrine? Limits? Combat Methamphetamine Epidemic Act (CMEA 2005): Limit 3.6 grams ephedrine, pseudoephedrine, or phenylpropanolamine per purchaser per day No more than 9 grams per purchaser per 30-day period © tl;dr pharmacy llc. All Rights Reserved  No more than 7.5 grams via delivery per purchaser per 30-days Non-liquid forms must be in blister pack of no more than 2 dosage units Seller must maintain a written/electronic logbook for sales with: Product name; Quantity sold; Name and address of purchaser; Date and time of sale Exception: No logbook entry required for individual sales of package with 60 mg or less Drug Administration RPh must be authorized by BOP to vaccinate (13:39-4.21): 1. Complete an academic and practical curriculum with CDC guidelines for vaccines 2. Current certification from AHA BLS, Red Cross CPR, or ILCOR course 3. At least 2 CE hours in immunization in each biennial renewal period RPh, intern, extern administering vaccines to patients < 18 years of age (13:39-4.21A, 45:14-63) May administer flu vaccine to patients ≥ 7 years, BUT patients < 12 years old will require a prescription for an influenza vaccine. May NOT administer vaccines to patients < 18 years old without parent/guardian permission. May NOT administer vaccines to patients < 10 years old without prescription. Before vaccine administration, the RPh shall (13:39-4.21): 1. Screen each patient per CDC established criteria for each vaccine Can Pharmacists Administer 2. Counsel patient and/or patient representative about vaccine contraindications, injection site care, and Immunizations? Which Ones Can instructions to contact physician or 911 in event of adverse reaction They Administer? 3. Inform patient and/or patient representative in writing about the risks and benefits of vaccine and provide a CDC Vaccine Information Sheet (VIS) 4. Obtain signed consent from patient and/or patient representative that contains check-off boxes that may authorize RPh to send copies to the patient’s PCP Additional requirements for vaccine administration by RPh (13:39-4.21): RPh shall document the following for all immunizations: Patient’s name, address, phone, DOB, allergies and gender; Vaccine name, manufacturer, expiration date, lot number, site of administration and dose administered; Date of original vaccine order and date of administration; Name and address of delegating physician; Name and address of RPh; Name and address of patient’s PCP if provided RPh shall report clinically significant vaccine-related adverse event to delegating physician, patient’s PCP if provided, and appropriate government reporting system within 72 hours Maintain all vaccine-related records for at least 7 years (oldest 6 years of records shall be retrievable within 2 weeks, and most recent year of records shall be retrievable within 1 day). Can Pharmacists Administer RPh authorized by BOP to administer vaccines and related emergency meds limited to diphenhydramine and Medications? Which Ones Can epinephrine in eligible patients 18 years or older. (13:39-4.21) They Administer? Is a Collaborative Practice RPh can administer meds directly to patients only for treatment of diseases for which RPh is nationally Agreement/Other Required? certified as BOP permits, and/or as collaborative practice agreement permits. (45:14-63) Facility Requirements? Private NJ BOP does not specify spatial/privacy requirements for administering vaccines. Space/Partition? Other Requirements? Patient (refer to above “Can Pharmacists Administer Immunizations? Which Ones Can They Administer?”) Age Limit? Are There Laws/Protections for Overdose Prevention Act (45:14-67.2) Emergencies (e.g. Anaphylaxis, Emergency administration of medication directly to patient, immunizations (45:14-63) Overdose)? Drugs Covered? Pharmacists’ Rights Pharmacy practice sites (and RPh) have duty to properly fill lawful prescriptions/orders without undue Can Pharmacists Refuse to Fill a delay, despite any conflicts due to sincerely held moral, philosophical, or religious beliefs. (45:14-67.1) Valid Prescription (e.g. Birth Control, Narcotics)? In What Circumstances? Note: Circumstances allow refusal based on professional judgment (see below requirements) RPh has right to refuse filling prescription if their professional judgement determines (§ 13:39-7.13): The prescription is outside the scope of the prescriber’s practice; or Requirements for Refusal? The RPh has sufficient reason to question the validity of the prescription; or To protect the health and welfare of the patient Religious Objection? No. If a prescription is valid, then it must be filled without undue delay. (45:14-67.1) RPh and permit holders responsible for compliance with all rules, regulations and laws governing practice What Actions Can Be Taken Against of pharmacy. Any violations may be reported to BOP and subject to disciplinary action. BOP may deny, RPh License for Refusal to Fill? suspend, revoke, restrict, or refuse license/permit for any violation. (13:39-3.11, 45:14-67.1) Appeals Process on Actions? If BOP seeks to impose disciplinary action, then a request can be made to be heard by BOP. (13:39-1.5) © tl;dr pharmacy llc. All Rights Reserved  Other Settings Long-Term Care Who Can Dispense/Administer A P&T committee shall establish/enforce procedures for drug administration. Self-administration shall be Medication? permitted to qualified residents or by authorized individuals. (§ 8:39-29.2) Who Can Access Dispensing A P&T committee and consultant RPh shall authorize access, administration, and disposal of medications Units? Special Requirements? with appropriate documentation and record-keeping. (§ 8:39-29.4) OTC and limited amounts of prescription meds may be kept as stock for administration of stat (emergency) doses, lost doses, or doses not sent by the provider pharmacy. These meds shall be approved by a P&T Who Can Access Medications committee, monitored for accountability, and labeled to include drug name and strength, manufacturer’s Without Pharmacy Staff? name, lot number, expiration date, recommended dosage for OTCs, and applicable cautionary/auxiliary labels. (§ 8:39-29.4) Label each resident’s medication container/package with the following (§ 8:39-29.4): Requirements on IV Labeling for Resident’s full name; Prescriber’s name; Prescription number; Drug name and strength; Quantity dispensed; Dispensing Unit Lot number; Date issued; Expiration date; Manufacturer’s name if generic; Cautionary/auxiliary labels; Name, address and phone number of the pharmacy Unit dose distribution shall meet the following requirements (§ 8:39-29.4): 1. Each resident shall have med tray labelled with their name and location Requirements on Unit Dose 2. Each med shall be individually wrapped and labelled with generic/brand name, strength, lot number, Labeling for Dispensing Unit expiration date, dose, and manufacturer 3. Cautionary instructions shall appear on resident’s med record Requirements on Multi- All medications re-packaged by the pharmacy shall be labeled with at least (§ 8:39-29.4): Dose/Repackaging Expiration date; Drug name and strength; Lot number; Date issued; Manufacturer if generic All meds shall be stored with manufacturer and USP requirements and be kept in locked storage. All med Requirements on Storage of destruction shall be witnessed by at least 2 persons (RPh, RN, or LPN). (§ 8:39-29.4) Controlled Medication? CDS shall be stored and records maintained per CDS Act and State, Federal laws. (§ 8:39-29.7) Who can Access Controlled P&T committee and PIC or consultant RPh shall establish and enforce procedures for access, inventory, Medications? management of controls. (§ 8:39-29.4) Emergency Dispensing Facility shall establish a plan for obtaining resident’s drugs on an emergency basis. (§ 8:39-29.6) Requirements? RPh shall review records within 48 hours of admission and perform DUR monthly. (§ 8:39-30.2) Consultant RPh shall make monthly inspections of all areas where meds are stored, dispensed and administered; Periodically determine quality assurance by observing medication pass and review Record Keeping Requirements? crediting system; Document problems and propose solutions. (§ 8:39-29.4) Destruction of meds shall be documented with 2 witnesses (RPh, RN, LPN). (§ 8:39-29.4) Maintain documentation of medication administration and release. (§ 8:39-29.4) Nuclear RPh licensed in NJ with training and experience in handling radioactive materials in accordance with U.S. RPh Special Requirements? Nuclear Regulatory Commission and State of NJ Bureau of Radiation Protection. (13:39-12.3) A specialized pharmacy permit application must be submitted and must have a nuclear RPh who shall provide immediate supervision of all personnel providing radiopharmaceutical services. (13:39-12.2) The nuclear pharmacy shall be separate from other areas and shall be inaccessible to unauthorized personnel. The environment handling radioactive materials must be properly ventilated. May be exempt from space requirements for pharmacies, but at least the following must be met (13:39-12.2 to -12.4): Area for storage, compounding, and dispensing radioactive shall be separate Hot lab and storage area shall be minimum 120 sq.ft. Facility Special Requirements? Compounding and dispensing area shall be minimum 300 sq.ft. Equipped with: Dose calibrator; Fridge; Drawing station; Well scintillation counter; Microscope; Chromatographic or comparable device; Radiation survey equipment; Up-to-date references; Up-to-date State/Federal statutes and rules relating to pharmacy and radioactive materials Nuclear pharmacies shall maintain records at least 5 years, and maintain records of drug acquisition/disposition in accordance with the U.S. Nuclear Regulatory Commission. Radioactive drugs shall be dispensed with appropriate labels including standard radiation symbol and the words “CAUTION- RADIOACTIVE MATERIAL.” (13:39-12.2) Remote Special Licensure Requirements? Telemedicine/telehealth organizations in NJ register with Dept. of Health annually. (NJSA 45:1-64) Must Pharmacy Be Located at Not if part of a centralized prescription handling contract involving at least 2 pharmacies. (§ 13:39-4.19) Dispensing Site? (refer to below “Central Fill Allowed?”) HCP must establish a provider/patient relationship to provide telehealth/medicine. HCP shall be validly Telework? From Out of State? licensed/certified/registered in NJ and may be subject to NJ jurisdiction if either the patient or provider is located in NJ at any time of service. (NJSA 45:1-62) © tl;dr pharmacy llc. All Rights Reserved Must Pharmacist Have an In-State HCP shall be validly licensed/certified/registered in NJ and may be subject to NJ jurisdiction if either the License? patient or provider is located in NJ at any time of service. (NJSA 45:1-62) Central prescription handling entails 2 or more pharmacies sharing responsibilities (with contract) in performing 4 components of prescription/order handling, which can be the following (13:39-4.19): Intake or originating pharmacy: Receives patient or prescriber request to fill/refill Central Fill Allowed? Central processing pharmacy: Engages in prescription/order review Central fill pharmacy: Fill/refill prescription/order including prep and packaging Dispensing pharmacy: Dispenses filled/refill prescription Medical Offices Which Type of Providers Can NJ BOP does not specify which prescribers/providers can receive/store medications. Receive/Store Medications? NJ Board Medical Examiners does specify the following may be authorized to prescribe and dispense meds: Administer? physicians, podiatrists, residents, resident permit holders, PAs, and CNMs. (§ 13:35-7.1) No person may sell/purchase/trade or offer to sell/purchase/trade any drug sample. Manufacturers or authorized distributors may distribute drug samples by mail or common carrier to practitioner licensed to prescribe such drug or at the request of such a practitioner. (21 USC 353) Restrictions on Drug Samples? Drug samples may be provided to a patient in the following circumstances: 1. Practitioner licensed to prescribe such drug may provide drug sample to a patient 2. HCP under supervision/direction of a practitioner may provide drug sample to a patient 3. Hospital pharmacy at the direction of practitioner may provide drug sample to a patient Authorized prescribers may dispense 7 day supply or less of drugs (in scope of practice), but dispensed at/below the cost the prescriber paid plus administrative cost no more than 10% of the cost of the drug. Exceptions: Drugs dispensed in hospital ER, student health center, or public community health center/clinic; Prescriber more than 10 miles from licensed pharmacy; Prescriber dispenses allergenic extracts/injectables; Prescriber dispenses drugs per oncology or AIDS protocols; Prescriber dispenses slaves/ointments/drops; Prescriber dispenses drug to eye through contacts. (NJSA 45:9-22.11) Can Prescribers Prepare/Dispense Prescriptions? Additional info. on prescribing, administering, or dispensing from NJ Board of Medical Examiners: Controlled? Sterile Compounding? Requirements for prescribers who dispense drugs (§ 13:35-7.5) Treatment of obesity (§ 13:35-7.5A) CDS for acute and chronic pain (§ 13:35-7.6) CDS for detox/maintenance therapy (§ 13:35-7.7) Amphetamines and sympathomimetics (§ 13:35-7.8) Anabolic steroids, and HGH or similar analogs (§ 13:35-7.9) Drugs shall be kept in an orderly and sanitary area, in accordance with standard pharmaceutical practice and Requirements on manufacturer recommendations. The inventory shall not contain outdated, misbranded, deteriorated, Preparation/Storage/Logging? adulterated, recalled, unlabeled, damaged, discontinued or previously dispensed drugs. Practitioners shall maintain records of inventory, dispensing, and disposal. (§ 13:35-7.5) Drug Sources? Can Pharmacies Pharmacies can sell C-II for office dispensing if prescriber has DEA 222 order form. (21CFR1305.13) Supply Offices? Prescriber’s can obtain drug samples from manufacturers. (21CFR203) Miscellaneous Correctional facilities shall ensure each incarcerated person continues to receive any meds prescribed by Correctional Facilities Dispensing physician prior to incarceration for chronic conditions. Ensure all necessary meds are given in a timely Rules manner, including a method to maintain supply of most common meds at each facility or an on-call HCP available to prescribe and fill prescriptions. (NJSA 30:8-16.13) Veterinary/Animal Dispensing Guidance for Pharmacists Regarding The Labeling of Prescriptions Written for Animals Rules Emergency Room/Urgent Care Drugs dispensed in ER are exempt from the 7-day supply or less dispensing rules. (NJSA 45:9-22.11) Dispensing Rules Other Facilities & Dispensing NJ BOP does not specify rules on international drug sources. Rules International Drug Sources Rules NJ Dept. of Banking & Insurance has oversight over PBMs (NJ Statutes on PBMs: NJSA 17B:27f) Correctional facilities shall ensure each incarcerated person continues to receive any meds prescribed by physician prior to incarceration for chronic conditions. Ensure all necessary meds are given in a timely PBM Rules manner, including a method to maintain supply of most common meds at each facility or an on-call HCP available to prescribe and fill prescriptions. (NJSA 30:8-16.13) Records Patient Records Pharmacy shall maintain audit trail that records and documents unique and secure user identifier for all Can Records be Held Digitally? pharmacy personnel performing prescription/order intake, processing, fulfillment and dispensing. Requirements for Printed Copy? All audit trail and prescription information shall be maintained/stored in original hard copy form or in any other Other Requirements? media that facilitates reproduction of the original hard copy for 5 years or more. (13:39-7.6) © tl;dr pharmacy llc. All Rights Reserved  Pharmacy shall maintain/store CDS prescriptions for 5 years or more. (13:39-7.6) How Long do Controlled Prescriptions for C-II shall be maintained in a separate file. Prescriptions Need to Be Held? Prescriptions for C-III, IV, V shall be maintained in separate file or with non-controls that are readily CII? CIII to V? retrievable (mark prescription face with a “C” in lower right corner with red ink at least one-inch high or use an electronic record-keeping system for prescription retrievals). (13:39-7.9) 5 years or more. Prescriptions shall be maintained so the oldest 4 years of records are retrievable within 2 How Long do Legend weeks and most recent one year of records retrievable within one business day. (13:39-7.6) Prescriptions Need to Be Held? An electronic patient profile record system (PPRS) shall be maintained by all pharmacies. (13:39-7.19) Patients may request copies of prescriptions and patient profiles. Pharmacies shall provide copies with underlined statement, “COPY-FOR INFORMATION ONLY.” Copies of prescriptions one year or less from original Who Can Request or Receive date of fill shall be provided within 24 hours and all other copies within 72 hours. (13:39-7.7) Records (Family, Others)? Any Restrictions? POA? Records shall be made available to person’s authorized to inspect them under State and Federal statutes and regulations (e.g. during pharmacy audits). (13:39-7.6) CDS orders Audit trails & Inventory records Immunization Collaborative Policies and (invoices) prescription records including controls records practice records procedures Record Keeping Requirements ≥ 7 years from date ≥ 5 years ≥ 5 years ≥ 2 years ≥ 7 years ≥ 2 years of termination Reporting Any pharmacy filling CDS, HGH, or gabapentin in an outpatient setting shall collect and electronically submit to the Division’s PMP vendor the following daily for each prescription (13:45A-35.3): 1. Patient first name, surname and DOB 2. Patient address and phone number 3. Date of dispensing and written date of prescription 4. Number identifying the prescription and NDC of drug dispensed Requirements for Drug 5. Dispensing pharmacy permit number Monitoring Programs? 6. Prescriber’s name and DEA number 7. Name, strength, and quantity of medication 8. Number of refills and whether this is a refill/new prescription 9. Source of payment for medication 10. Identifying information for anyone other than the patient who picks up the prescription All persons authorized to access PMP information shall register with the Division. (13:45A-35.6) Health care-related fraud/abuse against NJ Medicaid and NJ FamilyCare programs, PAAD programs, and/or Work First NJ General Assistance programs shall be reported to the Division of Medical Assistance and Health Requirements for Reporting Services (DMAHS) with potential reward. (§ 10:49-13.4) Suspected Fraud/Abuse? Submit information regarding fraud/abuse to: DMAHS 1-888-9FRAUD-5 and Insurance Fraud 1-877-55FRAUD and Additional Information Pharmacy ADR Reporting (13:39-9.19): PIC is responsible for a system that records/reports ADRs and for submitting to appropriate agencies. Vaccine ADR Reporting (13:39-4.21): Requirements for Reporting Report vaccine ADR immediately to delegated physician, and to reporting system within 72 hours. ADRs? Reporting in LTC facilities with ASHP-USP-FDA Reporting Systems: Report ADRs and med errors to the director of nursing (or alternative). (§ 8:39-29.3) FDA MedWatch (FAERS, VAERS) and NJ Patient Safety Reporting System Requirements for Reporting Any complaints or violations may be reported to the Board. (45:14-67.1) Licensure Violations? Complaint form available requiring a detailed description of the complaint. Requirements for Reporting RPh and pharmacies shall comply with HIPAA. (45:14-76) Privacy Violations? Any breach/violation shall be reported. (HIPAA 1996) Patient Profile Upon receipt of prescription RPh shall examine patient’s profile before dispensing to determine potentially significant drug interaction, reaction or misutilization, and if substantial time has elapsed from last fill based on What Must RPh Review on RPh’s professional judgement. (13:39-7.20) Patient Profile Prior to RPh shall attempt to record patient allergies, idiosyncrasies, chronic conditions related to drug utilization. RPh Dispensing? REMS shall use professional judgement to review and monitor profiles. (§ 13:39-7.19) Requirements? Current REMS Note: RPh must follow REMS requirements, and it is considered “misbranding” if not followed. Specific Requirements for Pharmacy filling CDS, HGH, and gabapentin shall check PDMP with each prescription. (13:45A-35.3) Checking Drug interactions, indications, directions shall be checked using professional judgement. (13:39-7.20) PDMP/Interactions/Indication? © tl;dr pharmacy llc. All Rights Reserved  Notes on Laws & Requirements FD&C Federal Food, Drug, and Established FDA Cosmetic Act Durham-Humphrey OTC vs. Rx Amendment Kefauver Harris Thalidomide Amendment PPPA Poison Prevention Child-resistant packaging requirement Packaging Act (PPPA) HIPAA Health Insurance Portability and Privacy of identifiable health information and security of electronic PHI Accountability Act HITECH Health Information Technology for Economic Electronic health record implementation and Clinical Health Act Adulterated vs. Misbranded Food adulterations (NJSA 24:5-8) Drug or device adulterations (NJSA 24:5-10) Cosmetic adulterations (NJSA 24:5-11.1) Adulterated Exceptions to drug adulteration: Drugs that differ from standard strength, quality, or purity as long as the label states the difference plainly. (NJSA 24:5-11) Misbranded: Any food, drug, cosmetic or device packaged or labelled with false or misleading statements or design. (NJSA 24:5-16) Misbranded Food misbranding (NJSA 24:5-17) Drug or device misbranding (NJSA 24:5-18) Cosmetic misbranding (NJSA 24:5-18.1) Recalls Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative FDA Class I Recall product will cause serious adverse health consequences or death. Class II Recall is a situation in which use of, or exposure to, a violative product may cause temporary or FDA Class II Recall medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health FDA Class III Recall consequences. Other Recalls Additional Reading Definitions/References Red Book Drug Pricing Orange Book Therapeutic Equivalence Yellow Book International Travel Vaccines Green Book Animal Drug Products Pink Book Vaccine-Preventable Diseases Purple Book Biological Products USP 795 Nonsterile Compounding USP 797 Sterile Compounding USP 800 Hazardous Drug Handling The Prescription Required Fields What Are the Required Elements for a 1. Prescriber’s name, address, phone, license number, academic degree or professional practice Valid Prescription (ex. Name, DOB, 2. Patient’s full name, address, and DOB Address, Etc.)? 3. Date of issuance (or date written) © tl;dr pharmacy llc. All Rights Reserved  4. Name, strength, and quantity of drug prescribed 5. Drug quantity in words and numbers for any C-II substances 6. Adequate instructions/directions for use 7. Number of refills permitted or time limit for refills, or both 8. Handwritten signature of prescriber (or electronic signature for e-scripts) 9. Explicit indication with prescriber’s initials next to “do not substitute” for brand 10. Prescriber’s DEA number for control substances NJPB that contains 2 or more prescriptions for CDS shall be INVALID. NJPB that contains only one control and other non-control prescriptions shall be VALID. (§ 13:35-7.2) If prescriber fails to include required info. on original prescription, then RPh shall obtain and record such on the prescription including date, time, and name of prescriber or prescriber’s agent. If prescriber fails to include instructions for use and cannot be contacted, then RPh shall indicate on prescription label “use as directed” or similar words. (§ 13:39-7.2) Guidance for RPh on making changes to prescriptions (written, oral, fax, or electronic): May be changed UPON May be added WITHOUT May NEVER be changed What can RPh Correct/Change/Add to consultation with prescriber consultation with prescriber regardless of consultation Prescription (Legend/Controlled)? Patient address if incorrect Drug strength Drug quantity both numeric Patient address if missing Patient name if incorrect and alpha (for controls) Patient DOB Control prescribed except Drug dosage form Notation to correct patient when substituting generic Directions for use name if misspelled Prescriber’s signature Date issued DEA number if omitted What can non-RPh Pharmacy Staff Patient address if missing (can confirm with valid ID or patient profile) Correct/Change/Add to a Prescription Patient DOB if missing (Legend/Controlled)? Notation to correct patient name if misspelled NJ Generic Drug Substitution Act (Prescription Drug Price and Quality Stabilization Act): Unless prescriber states “do not substitute” with oral prescription or initials “do not substitute” on written prescription, then lower cost, interchangeable brand/generic may be dispensed. Substitutions What Type of Substitutions Are NOT on the list of interchangeable drugs shall be approved by prescriber. (NJSA 24:6E-7) Allowed? (Generic, Orange Book Note: Approved therapeutic equivalences (interchangeable) means rating of “A” in FDA Orange Book. Equivalence, Therapeutic Substitution, Etc.) RPh may substitute biological product provided (§ 13:39-7.23): 1. Prescriber has NOT indicated there shall be no substitution permissible; and 2. Substitution is interchangeable or therapeutically equivalent per the FDA Purple Book Non-controls may NOT be filled or refilled after one year from the written (issue) date. (13:39-7.3) Special Restrictions on Drugs/Refills? C-II (13:45H-7.9) and radiopharmaceuticals (13:39-12.2) may NOT be refilled at all. RPh shall only fill prescriptions issued by licensed prescriber in NJ on a NJ Uniform Prescription Blank Special Requirements for Prescription (NJPB), secured from an approved vendor, with the prescriber’s license number and DEA number for Pads? CDS or another state, territory or possession of the U.S. including facilities regulated by the U.S. Department of VA and/or Defense (which are not required to be on NJPB). (13:39-7.1) Fax Prescriptions Fax shall be able to send exact images and RPh shall retain a printed copy of fax prescription or an Requirements for Type of Fax electronic reproduction that is readily retrievable/printable for a minimum of 5 years. Machine? The fax shall be located within the pharmacy prescription area. (13:39-7.10) Can Patients Fax Their Prescription? RPh shall NOT fill any fax prescription transmitted by anyone other than an authorized prescriber or Prescribers from Outside Their their authorized agent. RPh shall seek verbal verification for any fax prescription they have reason to Practice? question the authenticity, accuracy, or appropriateness. (13:39-7.10) RPh may dispense prescriptions for C-III, IV, V transmitted by fax. RPh may fill prescription for C-II transmitted by fax provided the original, signed prescription is presented to RPh prior to dispensing except in 3 circumstances: What Controlled Schedules are 1. C-II for pain management to be compounded for direct administration to a patient by Allowed? parenteral, IV, IM, SC or intraspinal infusion. 2. C-II for pain management of a resident in an LTC facility. 3. C-II for pain management of hospice patient, where RPh shall note on fax patient is hospice. Note: The fax prescription shall serve as the original for the above 3 circumstances only. (13:39-7.10) Electronic Rx RPh may accept electronic prescriptions transmitted by computer devices in a secure manner for Requirements for Electronic dispensing, this includes computer to computer and computer to fax transmissions. Prescribing? RPh shall NOT fill any electronic prescription transmitted by anyone other than an authorized prescriber and their authorized agent (with their full name and title). (13:39-7.11) © tl;dr pharmacy llc. All Rights Reserved  The pharmacy shall ensure the electronic system utilized to receive prescriptions has adequate security Requirements for and system safeguards to prevent and detect unauthorized access, modifications, or manipulation of Certification/Technology? prescriptions. The computer/device shall be located within the prescription area. (13:39-7.11) Required Fields on Electronic Electronic prescription shall contain all information required for a written prescription, except that a Prescriptions? handwritten signature and NJPB shall not be required. (13:39-7.11) If permitted by Federal law, an electronic prescription shall serve as the original for all CDS. (13:39-7.11) What Control Schedules Are Allowed? Note: Federal law permits, and so NJ law permits. Can RPh Make Changes to Electronic RPh CAN make changes to valid prescriptions, ensuring changes are documented. (§ 13:39-7.2) Prescriptions? (refer to above “What can RPh Correct/Change/Add to Prescription (Legend/Controlled)?”) Can Electronic Prescriptions Be Yes. (13:39-7.1, 13:39-7.11) Transmitted Across State Lines? (refer to above “Requirements for Electronic Prescribing”) Phone Rx What Information Must Be Provided? (refer to above “What Are Required Elements for a valid prescription?)” Who Can Phone in Prescriptions Prescriber or authorized agent of prescriber (with their name and title) (13:39-7.3) (Prescriber, Staff, Receptionist)? Can Interns Receive New Prescriptions Interns and externs can accept new telephone (verbal or voicemail) prescriptions, and can accept refill Via Phone/Voicemail? Refills? renewals from practitioner or their agent, provided the prescription remains unchanged. (13:39-6.5) Can Technicians Receive New Technicians CAN accept renewal authorizations from practitioners or their agent provided the Prescriptions Via Phone/Voicemail? prescription remains unchanged and the technician identifies themselves as such. Refills? Technicians CANNOT receive new telephone (verbal or voicemail) prescriptions. (13:39-6.15) Can Clerks/Cashiers/Others Receive Technician applicants may receive renewal authorizations from practitioners or their agents provided New Prescriptions Via prescription remains unchanged and the technician applicant identifies themselves as such. Phone/Voicemail? Refills? Technician applicants CANNOT receive new telephone (verbal or voicemail) prescriptions. (13:39-6.15) Transfer Rx Transfers shall be made immediately (within 4 hours of request) by phone, fax or electronic means. Sending pharmacy invalidates (or voids) the prescription on file and records the following: 1. That the prescription has been transferred and date of transfer 2. Name and address/store identifier of receiving pharmacy 3. Name or personal identifier of RPh, intern, or extern receiving transfer 4. Initials or personal identifier of RPh, intern, or extern sending transfer Receiving pharmacy shall record the following upon receipt of transfer: What Information Must Be Provided? 1. Name and address/store identifier of sending pharmacy 2. Name or personal identifier of RPh, intern, or extern sending transfer 3. Original prescription number from sending pharmacy 4. Original prescription issue date 5. Original number of refills authorized 6. Number of remaining, valid refills 7. Last prescription fill date from sending pharmacy (13:39-7.8) Can Interns Transfer Prescriptions? Both interns and externs CAN send/receive transfers under direct supervision of RPh (13:39-7.8) Can Technicians Transfer No. Technicians and technician applicants can only obtain requests for transfer. (13:39-6.15) Prescriptions? Prescriptions may be transferred for one year from the date written as long as refills available. C-II CANNOT be transferred, and C-III, IV, or V may be transferred ONE TIME ONLY. (13:39-7.8) How Many Fills Can Be Transferred? Exception for C-III, IV, V: Central fill pharmacies or pharmacies that share real-time, on-line databases. Any Specific Rules for Out-Of-State? NJ BOP does not specify any specific rules for out-of-state transfers. Packaging Dispensed container label with at least the following (13:39-7.12): 1. Pharmacy name, address, and telephone number 2. Brand name (if available in marketplace) and generic as “------Generic for------” 3. Strength of medication, where applicable 4. Quantity dispensed 5. Directions for use 6. Date dispensed Information Required on Label? (List 7. Use by date (earlier of one year from dispensing or manufacturer expiration date) the Data Elements) 8. CDS cautionary label and other auxiliary labels, where applicable 9. Patient name 10. Practitioner’s name 11. Prescription number Brand and/or generic name, directions for use, patient name shall appear larger, in different color or bolded in comparison to other information on the label. Sterile compounding label (13:39-11.21) and non-sterile compounding label (13:39-11A.13) © tl;dr pharmacy llc. All Rights Reserved  1. Drug facts 2. Active ingredient(s) 3. Purpose(s) 4. Use(s) OTC Label Requirements 5. Warning(s) 6. Directions 7. Other information 8. Inactive ingredient(s) 9. Telephone number for consumer questions and/or comments (21CFR201.66) Child Safety Cap Requirements NJ BOP does not specify requirements for child safety caps. Use by date is the earlier of one year from dispensing or manufacturer expiration date. (13:39-7.12) Expiration/By-Use Date? (refer to above “Stability of Compounded Product?” for BUDs of compounded products) Prescriber Special Authority or Restrictions by Type of Provider? (Dentists, (refer to below chart “Prescribing Authority”) Optometrists, Etc.) Counseling Offer to counsel can be made by any pharmacy personnel, but only RPh and interns/externs under immediate supervision can provide consultation or counseling. Requirements for Counseling Reasonable efforts shall be made to counsel patients: If a patient/caregiver is not physically present, then an offer to counsel shall be made by phone or in writing. At time of dispensing RPh shall document if counseling was provided or refused by patient/caregiver. RPh is not required to counsel if a patient/caregiver refuses. (13:39-7.21) Counseling may include the following topics (13:39-7.21): 1. Name and description of the medication 2. Dosage form, dosage, route of administration, and duration of therapy 3. Special d