TLDR MPJE

worksheet

who are the board memebrs?

• the board shall be composed of not less than 9 pharmacists licensed in this state for at least 5 years and 2 registered pharmacy technicians

• the membership of the professional licensing boards created under sections 6523, 6804, 6903 and 7403 of this chapter shall be increased by 2 members, and each such board staff shall have at least 2 public representatives, who shall be selected by the board of regents from the general public

• minimum total membership: 13

• minimum public members: 2

• 9 licensed pharmacists

• 2 registered pharmacy technicians

is the board a separate entity or under another organization/depatment?

• the BOP falls under the board of regents

  • the board of regents oversees the licensing requirments of all professions in nYS

who chairs the board?

a chairman and vice-chairman are elected annually by the board of pharmacy members

how are board members selected? appointment/election?

• appointed by the regents based on the recommendation of the commissioner

• within these board members, they elect a chairman and vice-chairman

how long do board members serve?

members serve 5 year terms and can serve up to 2 terms

how often does the board convene?

no set law

who can attend meeting?

board meetings are open to the public except for “executive sessions”

who can apply to be a pharmacist?

• be of good moral character

• be at least 21 years of age

• meed education, examination and experience requirments

application fee for pharmacists?

$339

number of CE hours for renewal?

minimum 45hrs every 3 years, 23 live and 22 “self-study”

specific CE requirments

• a minimum of 45 contact hours (23 live)

• the 45 hours required must include at least 3 credits (home or live) of formal continuing education on strategies and techniques to reduce medication and rx errors, and at least 3 credits (home or live) of formal CE pertaining to compounding

• any licensee participating in CDTM shall complete at least 5 hours of formal continuing education acceptable to the department in the area or areas of practice generally related to any CTDM protocols to which the pharmacist may be subject, provided that such CE shall not be completed as self study

• maintain record for 6 (SIX!!) YEARS

minimum intern hours?

• no additional hours required for pharmD

• foreign grads do 12 months full time after taking NAPLEX

examinations required?

NAPLEX & MPJE

reinstatement process & pronation reasons / process

check misconduct & proceedings on law website

renewal period and fee?

$224 every 3 years

license/registration for pharmacy intern?

• a limited permit, identifying the holder as a pharmacy intern and authorizing the practice of pharmacy under the immediate and personal supervision of a registered pharmacist may be issued to

  • an applicant, enrolled in a program of pharmacy education registered or approved by the department, who has compleyed at least the third year of a 5 year program or its equivelent, provided that the applicant has completed the first year of professiona study or

  • a graduate of a nonregistered or nonaccredited pharmacy program, including a forgein pharmacy program, for the purpose of completeing the experience requirment

• a limited permit shall be displayed conspiculpisly in the pharmacy where the pharmacy intern is engaged for supervised practice

• a pharmacy intern may preform, under the supervision of a pharmacy, all of the functions delegated to pharmacists by law, rule or regulation except the administration of immunizations (only if they hold certificate the “I”)

who can apply for a pharmacy intern permit?

• enrolled in a program of pharmacy education and completed the first year of professional study

• graduate of non-accreditited pharmacy program (including forge in) to complete 2080 internship hours

application fee for pharmacy intern?

$70

hours required for intern permit?

no minimum hours

current enrollment/good standing required for pharmacy intern?

• enrolled in a program of pharmacy education registered or approved by the department, who has completed at least 3rd year of 5th year program or its equivalent, provided that the applicant has completed the first year of professional study

preceptor requirements?

• immediate and personal supervision of a registered pharmacist

• preceptor must have practiced for at least 1 year

renewal period for pharmacy intern?

initial permit lasts 5 years, can renew once for max 2 years

pharmacy technician

to qualify for licensure s a “registered pharmacy technician”, an applicantt shall fulfill the following requirments

• file an application with the department

• have high school education or its equivalent

• certification from a nationally accredited pharmacy technician certification program acceptable to the department

• at least 18y/o

• be of good moral character

• pay initial fee of $75 and a fee of $100 for first registration period and $100 every 3 years

specific requirments on who can access the pharmacy? without pharmacists? BOP? police?

• every pharmacy must be under immediate supervision and management of a licensed pharmacist at all hours when open

• state board of pharmacy, dept. of education and their employees designed by the commissioner shall have the right to enter any pharmacy at reasonable times for inspection

minimum sq footage for pharmacy?

300sq ft with at least 100sq dt of that educated for manufacturing, compounding and dispensing

minimum counter space for pharmacy?

non specified

counseling area requirements?

non specified

security system requirements?

a pharmacy operated as a department of a general merchandising established shall be enclosed permanently by a partition at least 9ft 6in in height, except where the ceiling is less than 9 ft 6in in which case the partition shall be from floor to ceiling

specification on alarms?

none specified

connectivity? (phone/fax/ etc)

none specified s

separate storage for prescription hard copies by control? drugs by control?

• file hard copy: c2 operate, c3-5 separate and non-controls separate

• drug storage: adequate heating and ventilation to safeguard purity and potency of drugs

• access to controlled substances stocks shall be limited to the minimum number of employees actually required to efficiently handle the manufacutre, distribution, custody, dispensing, administration or other handling of such substances

must storage area be locked for heard copies? drugs?

“system shall provide adequate safeguard against improper manipulation or alteration of stored records” so no??

must storage area be on side for heard copies? drugs?

must be kept on premises, readily available for 5 years

sign requirments for counseling?

none specified

sign requirments for hours?

none specified

sign requirments for PIC change?

none specified

sign requirement for closures?

none specified

other signage requirements (a lot)

• a sign bearing the full name of the registrant shall be displayed prominently on the exterior of the premises in which a registered establishment is located, or in the directory and on the immediate entrance to the registered establishment if it is located in a multi-tenanted structure

• pharmacies shall have a sign notifying people the variability of the drug retail price list and the availability of the DOH prescrption drug retail price list database and the web address of that database, conspicuously posted at or adjacent to the place in the pharmacy where rx are presented for compounding and dispensing, in the waiting area for customers, or in the area where prescribed drugs are delivered

• each covered pharmacy shall conspicuously post a notice to for LEP individuals of their rights to free, competent oral interpretation and translation services. such notice shall include the following statement in English and in each of the pharmacy primary language “point to ur language. language assistance will be provided at no cost to you”

• the statement in each of the pharmacy primary languages shall be in 20 point bold face. arial type in a color that sharply contrasts with the background color of the sign. each such statement shall be enclosed in a box and there shall be at least ¼ in clear space between adjacent boxes

• the statement in each of the pharmacy primary languages shall be printed on one sign that shall be conspicuously displayed at or adjacent to each counter where rx drug orders are dropped off and picked up, and near every cash register at which payment is received for rx drugs. such signs shall be positioned so that a consumer can easily point to the statement identifying the language in which such person is requesting assistance

time to notify board of changes to ownership?

within 30 days of change in ownership

• also applies to change in officers of corporation or in stockholders golding 10% or more of stock in the corporation

time to notify board of changes to PIC

owner must notify within 7 days of change

time to notify board of changes to address?

at least 30 days prior to expected relocation

time to notify board of changes to hours?

none specified

type of rx balance required

class A balance (6mg), and metric weights if needed for the operation of this balance

other equipment required?

• devices capable of measuring volumes from 0.1 to 500mL

• mortar and pestle

• refrigerator equipped with a thermometer and providing at times a storage temp of 2-8C (36-46F), limited to the storage of drugs

• a copy of laws, rules and regulations governing the practice of pharmacy in NY

• hot and cold running water in compounding and dispensing area

specific rules on automated dispensing cabinets?

none specified

must rph be on-site for access to pharmacy?

every pharmacy must be under the immediate supervision and management of a licensed pharmacist at all hours when open

after hours dispensing allowed? requirments?

none specified

emergency access to pharmacy procedures?

none specified

mail order allowed? (in state to out, out of state to in)

• yes, considered “ off-premises delivery”

• out of state must register as a nonresident establishment

• must be licensed and/or registered with their home set in order to see registration in NYS

• most provide a toll-free number during normal business hours and at least 40hr/wk for communication between the patient and pharmacist

• must resigned a resident agent in NYS (basically someone to reciveve notice of lawsuits)

exemptions:

• NYS may grant exceptions to registration requirements for nonresident establishments that restricts its sale or dispensing of drugs to residents on this state to “isolated transactions” (600 or fewer rx/yr for pharmacies or <10,000 in sale for manufactures or wholesales in NY; isolated transactions are transactions necessary to protect the public health by addressing emergency shortage of drug and/or device in NY

license required for mail to other states

no specific language, so likely subject to state which rx is delivered to

what are the fees for a pharmacy license

application: 345

renewal: $260 every 3 years

edorsement/relocation: $50

who can apply to own a pharmacy?

• anyone of good moral character

• for corporate applications, all officers/directors/stockholders having 10% or greater interest in corporation all must be of good moral character

must be rph to own pharmacy?

no

additional requirments for pharmacy ownership?

if owner is not a rrph, must have licensed supervising pharmacist on the registration

• can only be PIC of one pharmacy

• PIC must be full time (30hr min) or majority of hours of operation

rules on sales/transfers of pharmacy

notify board within 30 days of change in ownership

• also applies to change in officers of corporation or in stockholders holding 10% or more of stock in the corporation

drugs can be sold at action, notify the board at least 7 days prior

application/fees required

$50 for location change

no fee for name change/ renovation/owner change

how long for notification period?

notify board within 30 days of change in ownership

• also applies to change in officers of corporation or in stockholders holding 10% or more of stock in the corporation

owner must notify board within 7 days of change of PIC

damage by fire/flood/disaster - must notify board within 48 hours

signage requirments?

• a sign bearing the full name of the registrant shall be displayed prominently on the exterior of the premises in which a registered establishment is located, or in the directory and on the immediate entrance to the registered establishment if it is located in a multi-tenanted structure

• the registration itself must be conspicuously displayed at all times inside the pharmacy

• if PIC changes, owner must applu for ammened registration and attach to rogiinal registration

rph-tech/clerk ratio?

no pharmacist shall obtain the assistance of more than 2 registered pharmacy technicians in the performance of licensed tasks within their scope of practice OR 4 unlicensed persons in the performance of the activities that do not require licensure, the total number of such persons shall not exceed 4 individuals at one time

rph-intern ratio?

• each preceptor pharmacist can supervise not more than 1 full time or 2 part time inters

• a pharmacy must dispense 5k rx annually per intern

• interns do not count towards the rph-tech ratio

is facility licensure required for general compounding? sterile compounding?

• no specific license for non-sterile compounding

• sterile compounding: any facility that compounds sterile drugs is considered an outsourcing facility

• any outsourcing facility that is engaged in the compounding of sterile drugs in this state shall be registered as an outsourcing facility under the FDC act and be registered as an outsourcing facility pursuant to this article

• the law also says the outsourcing facilities may not dispense or distribute drugs to any pursuant to a rx unless it is ALSO registered as a pharmacy. this means that not all outsourcing facilities are pharmacies

• outsourcing facility must submit a report every 6 months to the executive secretary of the state board identifying the drugs compounded in the 6 month period

  • API

  • source

  • NDC

  • strgenth of API

  • the dosage form and route of administration

  • package description

  • number of units produced

restrictions on compounding without a prescrption?

• must be pursuant to a patient specific order

• exception is compounding in limited quantities before the receipt of a valid prescription order for such individual patient is based on the hisory of the licensed pharmacist receiving valid rx orders for the compounding of the drug product, which orders have been generated solely with an established relationship

• if u have an established history of compounding this drug for a patient (refills), you can do small amounts before u get the actual rx

stability and BUD?

for nonsterile compounding:

• aqueous dosage forms (aw > 0.6)

  • non-preservative: 14 days fridge

  • w preservatives: 35 days room temp or fridge

• non-aqueous dosage forms (aw < 0.6)

  • oral liquids: 90 days room temp or fridge

  • other (non-oral liquids): 180 days room temp or fridge

for sterile compounding:

• category 1: must be prepared in a PEC that may be located in unclassifed segregated compounding area

  • BUD of <12 hr at controlled room temp or < 24 hr in fridge

• category 2: must be prepared in a cleanroom suite

  • may be assigned a BUD of > 12hr a controlled room temp or > 24hr in fridge

• category 3: have additional requriments that must be met at all times

  • may be assigned a BUD longer than BUDs established for CAT 2 CSPs, up to 120 days in the refridgerator or 180 days in the freezer

special volume requirments? manufacture license required?

only required to register as outsourcing facility if sterile compounding

certifications/licensure required

specific registration to register as an outsourcing facility, and it must also be overseen by a NYS licensed pharmacist

special requirements for patent drugs? controlled drugs? otc?

falls under FDC act and cannot be a copy of an FDA approved drug

can legend drugs be dispensed without prescrption? which ones? logging requirements?

not addressed in NYS law; see federal

which drugs are required to be behind the counter?

products containing ephedrine, pseudoephedrine, or phenylproppanolamine

dispensing requirements for BTC (max allowed/logging)

• must maintain a written or electronic list (logbook) that identifies the products by name, quantity sold, names and addresses of purchasers, and date and time of sales, and signature of purchaser

• must maintain records for at least 2 years

• limit of 3.6g per day and 9g per 30 days

• ID: state or cereal govt photographic identification card

• the logbook requirement does not apply to any purchase by an individual of a single sales package that contains not more than 60mg of pseudoephedrine

can syringes be dispensed without a prescription? logging requirement?

• without prescription, a registered provider can dispense syringes to a person 18y/o, with a safety insert containing information on proper use of syringes/needles, risk of blood-borne diseases from needle usage, methods for preventing transmissions of diseases, proper disposal practices, dangers of injection drug use, toll-free number for info on HIV, and statment that it is legal for persons to possess syringes obtained pursurants to article 33 of public health law

• pharmacies cannot advertise the avaliablity of synringes without rx, must be kept in a manner not avaliable to the public (behind the counter)

• authorized providers must register with the department in order to sell or furnish hypodermic needles and/or syringes without a prescritpion to this section

• prescrption syringes

  • oral rx are allowed for syringes

  • valid for 2 years in NYS, can be refilled up to the number of times specifically authorized by the prescriber

  • one authorized refill can be transffered to another pharmacy

what are the rules around pseudoephedrine? limits?

3.6g per day and 9g per 30 days

• if getting through mail order is 7.5g/30 days

ID: state or federal govt photographic identification card

can pharmacists administer immunizations? which ones can they administer?

• pharmacists must obtain a certificate of administration to give certain vacciens

• fee: $100

• authorized immunization agents. a certified pharmacist who meets the requirments of this section shall be authorized to adminsiyer to:

  • patients 18 years of age or older, immunizing agents to prvent influenza, pneumococcal, acute herpes zoster, menigococcal, teatnus, dipheria or pertusis disease, pursuant to a patient specific order or a non-patients specific order and

  • patients betweent eh ages of 2-18 years of age, immunizing agents to prvent influenza purusuat to a patient specifc order or a non-aptient specific order

• report such administration by electronic transmission or facsimile to the patient’s attending primary health care practioner or practioners, and to the statewide immunization registery or the citywide imunization registery

can pharmacists administer medications? which ones can they administer?

pharmacists who have an immunization cetification are allowed to authorize medications for the emergency treatment of anaphylaxis to patients 18 years or older (epi)

is a collaborative practice agreement/other required for immunizations?

can administer pursuant to either a patient speciiic order or non-patient specific order and protocol

• the protocol is by a licensed physician or nurse practioner

facility requirements? private space/parition?

when administering an immunization in a pharmacy, the licensed pharmacist shall provide an area for the immunization that provides for patient’s privacy. the privacy area should include:

• a clearly visable posting of the most currecnt “recommended adult immunization schedule” published by the advisory committee for immunization practies (ACIP)

• education materials on influenza vaccinations for children as dertmines by the commissioner and the commissioner of health

are there law/protections for emergencies? drugs covered?

• naloxone

• naloxone dispensing for pharmacists

• epinephrine

• prEP

• pharmacists are able to dispense up to a 7 day supply of HIV PEP drugs for the purpose of preventing HIV infection in persons who have potentially been exposed to HIV pursuant to a non-patient specific order and protocol

can pharmacists refuse to fill a valid rx? in what circumstances?

when a pharmacist begins practice in a professional setting, they should take steps that may include notifying the owner and supervising pharmacists if their beliefs will limit the drug products they will dispense. if a pharmacy employs a pharmacist that has identified circumstances that would preclude the filing of prescriptions for particular products, the owner and supervising pharmacist should devise, within reason, accommodations that will respect the pharmacist’s choice while assuring delivery of services to patients in need.

• if the rx is outside of the prescribers scope of practice and cannot legally order the rx, the pharmacist must NOT fill the rx

• if the pharmacist believes filing may cause hard to the patient, pharmacist can choose not to fill the rx

requirements for refusal?

moral/ethical/relgious: pharmacist have a professional obligation to take steps to avoid abandoning or neglecting a patient, including notifying the owner and supervising pharmacist of limitations

• if the rx is outside of the prescribers scope of practice and cannot legally order the rx, the pharmacist must NOT fill the rx

• if the pharmacist believes filing may cause hard to the patient, pharmacist can choose not to fill the rx

what actions can be taken against rph license for refusal to fill?

abandoning or neglecting a patient (practicing the profession with gross negligence on a particular occasion), is considered professional misconduct, and upon complaint the department will investigate the complaint and determine penalty as appropriate

appeals process on actions?

• rph may appear at the initial hearing and be represented by the counsel, as well as product witnesses and evidence, cross-examine witnesses and examine evidence produced against the rph

• decision of the board of regents can be reviewed by a court if the rph does not agree w the decision

who can dispense/administer medication in a long term care facility?

“appropriately licensed professionals with limited exceptions” and “unlicensed persons may assist self-directed individuals in taking the medications in community setting such as adult homes”

emergency medications;

• controlled substances contained in emergency medication kids may be administered by authorized personnel pursuant to an order of an authorized practioner to meet the immediate need of a resident. personnel authorized to administer controlled substances shall include registered professional nurses, licensed practical nurses or other practioners, licensed/registed under title VIII of the education law and authorized to administer controlled substances

controlled substances can be administered from a. sealed emergency kit upon the order of a prescriber. if this is an oral order, it must be reduced to writing afterwards and countersigned by the prescriber within 48 hours

must notify the pharmacy finishing the emergency medication kid anytime its unsealed

who can access dispensing units? special requirments?

the facility shall store all drugs and biologicals in locked compartments under proper temperature controls, and permit access only to authorized personnel

who can access medications without pharmacy staff?

bulk stocks of controlled substances may be distributed within the insutition to wards/floor stocks/or/er and carried as sub stocks of the hospital

• this would mean pharmacy staff is not required to be present when floor stock is accessed

requirements on IV labeling for dispensing unit

a drug which is dispensed for an inpatient health care facility by the pharmacy of that facility may be labeled in accordance with the policy adopted by the medical or other authorized board of the facility

requirments on unit dose labeling for dispensing unit

“facilities which use a unit dose drug distribution system shall develop and implement an appropriate method of providing accessory and cautionary instructions

requirments on multi-dose/repackaging in LTCF?

• labeling and recording requirements and records must be kept for 5 years

• controlled substances cannot be dispensed in customized medication packages

• medications are packaged in moisture proof containers that are either non-reclosable or are designed to show evidence of having been opened

• medications are dispensed in containers that bear a label affixed to the immediate container in which the medications. such label shall include:

  • all information requried by education law

  • the name, stength, and telephone number of the dispener

  • an experiation date for the customized patient medication package

  • a separate identifying serial number for each of the prescrioption orders for each of the drug products contained in the customized pedication package

  • any other information, inclusing storage and instructions or any statments, warnings requried for the medications contained in the package

• drugs repacked for in hours use only shall have an experiation date 12 months, or 50% of the time remaining to the manufacturer’s experation date, whichever is less, from the date of repackaging

• repacked drugs may be returned for redispensing is they meet certain criteria

requirments on storage of controlled medications in LTCF?

• “the faculty shall provide separately locked, permanently affixed, compartments for storage of controlled drugs and other drugs subject to abuse, except when faculty uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can readily be detected”

• insutitonal dispensers: C2 must be kept in either:

  • GSA calss 5 rated steel cabinet or equivelent safe approved by the BNE. if this safe weights less than 750 lbs it must be bolted or ceemented to the floor. the door of the cabinet must have a multiple position combination lock, a relocking device, a steel plate at least ½ in thick

  • a vault with mutliple position combination lock, relocking device, and ½ in thick steel door. for new construction, floor, walls, and ceiling should be no less than 8in of reinforced concrete

• C3-5 must be stored in a securely locked cabinet

• working stocks of controlled substances can be dispersed through the stocks of non-controlled substances in a manner to obstruct theft or diversion provided the pharmacy is locked when not in operation

  • if not dispersed they should be kept stationary, securely locked cabinet

• patient specific controlled medications up to a 72 hour supply can be stored with patied other medications in a locked cart or storage unit

who can access controlled medications in long term care facilities?

no specific language on access

• the facility shall store all drugs and biologicals in locked compartments under proper temperature controls, and permit access to authorized personnel

emergency dispensing requirements for long term care facilities?

immediate administration must be necessary without alternate treatment available, and record maintained of use of emergency kit with notification to pharmacy

nuclear rph special requriemnts?

certified as a nuclear pharmacist by board of pharmaceutical specialties or have 200 contract hours of didactic instruction in nuclear pharmacy, and a minimum of 500 clinical hours of nuclear pharmacy training under the supervision of a certified nuclear pharmacist/nuclear pharmacy residency/ or some equivalent

nuclear facility special requirments?

basic requirements of a normal pharmacy and

• laminar flow hood, dose calibrator, exhaust hood anf filter system, chromatography apparatus, apparatus or materials for the determination of pH, a single channel and/or multichannel cintillation section system, microscope

• a pharmacy which dispenses both radioactive drugs and nonradioactive drugs shall maintain a separate area for the storage and dispensing of radioactive drugs, which area shall be secured from unauthorized personnel

remote special licensure requirments?

language does not indicate that remote services/telepharmacy are allowable

• hospitals “shall provide pharmaceutical services that are available at all times on the premsis to meet the needs of the patients”

• residental care facilities “shall provide pharmacettuical services and develop and implement polices and procedures that assure the accurate acquisition, receipt, dispensing and administering of all drugs and biologicals requured to meet the needs of each resident”

• out of state must be registered as a non-resident establishment

which type of providers can receive/store medications? administer?

• any prescriber who is allowed to prescribe medications is also allowed to dispense it.

• registered professional nurse may possess and administer drugs and devices pursuant to a non-patient specific regimen prescribed by a licensed physician or nurse practioner

restrictions on drug samples?

• falls under the prescription drug marketing act (PDMA)

• prescription drug samples may only be distributed to licensed practioners or to pharmacies of hospitals or other healthcare entities upon the written request of a licensed practioner. this does not include retail pharmacies. these are the only entities allowed to distribute drug samples to patients.

• controlled substances are not allowed to be distributed unless for research/intruction activities/chemical analysis

can prescribers prepare/dispense prescriptions? controlled? sterile compounding?

• prescribers are allowed to dispense prescriptions including controls up to a 72hr supply unless:

  • prescriber lives 10 miles or more from a pharmacy, dispense drugs at no charg to the patients, medical emergency, the drug is compounded by the prescriber, oncology/AIDS protocol

• a practioner may dispense up to a 3 month supply of a controlled substance, including chorionic gonadotroping, or up to a 6 month supply of an anabolic sertoid if used in accoradance with the directions for use, provided that such supply has been dispensed for the treatment of a condition specified in -"

• the practioner shall submit dispensing information, for all controlled substances dispensed, electronically to the department utilizing a transmission format acceptable to the department, not later than 24 hours after the substance was delivered

requirments on preparation/storage/logging?

• the drug dispensed must be labeled with the prescribers name, address, pt’s name, address, name of drug, strength, directions, date of delivery among other requriemtns

• in addition, the patients record should be annotated to reflect dispensing of drug w drug, quanitity, dose, directions and number of refills

drug sources? can pharmacies supply offices?

“no person, firm, corporation or association shall posses drugs, prescriptions or potions for the purpose of compounding, dispensing, retailing, wholesaling, or manufacturing or shall offer drugs, prescriptions or potions for sale at retail or wholesale unless registered by the department as a pharmacy, wholesales, manufacturer or outsourcing facility”

can records be held digitally? requirements for printed copy? other requirments?

• the law only required that records be maintained for at least 5 years and be readily available for inspection and copying

• paper prescriptions have to be filed in numerical/other form which provides for ready retrieval or prescriotions

• electronic prescriptions can be electronically stored and maintained

how long do controlled substance prescprtions need to be held? C2? C3-5?

5 years

how long do legend prescriptions need to be held?

5 years