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With who does a person seaking licensure have to file their application?
Executive director of the Board
How often does the board conduct examinations of applicants for licensure?
2 times a year
What are the requirements a person must meet to be considered for licensure as a pharmacist?
18 yo, good moral character, graduate of a board approved school, forgein school (pharmacy equivalency examination, written and oral English test), pass the exam, period of practical expierence no more than 12 months
What agency determines “approved pharmacy schools”?
The American Council on Pharmaceutical Education
What is licensure by endorsement?
Issuing a VA license to someone who already holds a state license from another state, VA may require applicants to pass a VA law exam
Display of license
Must be displayed at all times in their place of practice
Each renewal is annual list the months each type of license is due by: pharmacist active license, pharmacist inactive license, pharmacy technician license, pharmacy permit, non-resident pharmacy, controlled substances program
-pharmacist active, inactive, technician: due Dec 31
-pharmacy permit, non-resident pharmacy: due April 30
-controlled substances: due Feb 28
If a license has lapsed the person must apply for
-reinstatement
Reinstatement is at the discretion of…
the board except in instances of revocation or suspension (executive director of the board)
What is the minimum number of hours a person must have in practical expierence to obtain a license?
1500
Practical expiernce outside of an ACPE-accredited school can only be done after…
Credit cannot be given for the following min and max values
-2 semesters pharmacy school
-no more than 50 hours per week and no less than 20 hours per week
True or false: all practical expierence must be performed in the US?
True
Before performing practical expierence you must
register as a intern
What criteria has to be met to become an intern?
-the applicant is currently enrolled in pharmacy school and is working through thier courses (has an expiration date and is not valid if the person is no longer in school) or is a graduate of pharmacy school that needs to gain practical expiernce for licensure as a pharmacist and needs to provide proof of employment or the applicant has the required practial experience and is waiting for licensure (3 month expiration) or applicant for reactivation or reinstatement of a previsouly issued pharmacy license
What provides as evidence of practical expiernce as an intern?
-an affidavit filed prior to application
After the date of June 1 1964 what degree is required?
Bachelor of Science degree in pharmacy or Pharm D
In order to be licensed in VA what must apply to their pharmacy school?
the school which they obtained their first professional degree must adhere to teh school standards of VA
What happens when a person trying to obtain licensure fails the licensing exam (NAPLEX?) 3 times?
-must complete an additional 1,000 intern hours
If an applicant fails the law exam how long must they wait before they retake it?
-30 days
If an applicants requires special testing accomodations due to a disability what must the applicant provide?
-letter from applicant requesting the special testing accomodations
-written report of the disability from a medical professional that is 2 years current
-statement from a faculty/adminstrator from the pharamcy school that describes the needed testing accomodations
what must foregin trained students due before becoming an intern?
-obtain a FPGEC certificate
What is the 2nd step a foregin trained pharmacist must due?
-after receivieng FPGEC certificate they must apply for a pharamcy intern license and complete the required number of hours
What needs to be submitted to renew a pharmacist license?
-renewal fee, renewal form and statement of compliance with CE
If a newly licensed pharmacist is licensed on or after October 1st when do the need to renew?
-December 31 of the following year
If you are late to renew but are stil within one year of renewing what must you submit?
-renewal fee, renewal form, statement of compliance with CE and late fee
If you are late to renew and it has been more than one year what must you submit?
-apply for reinstatement, statement of compliance with CE, renewal fee, reinstatement fee
If your license has been deemed inactive what must you submit?
-must apply for reinstatment, documentation showing CE, pay the current year active fee
If you need to reactive or reinstate an active license what must you submit?
-pharmacist with an inactive license who has allowed their license to lapse/suspended/revoked must shwo CE hours equal to the number of years they allowed their license to lapse but not to exceed 60 hours
If you license has lapsed/inactive/suspended/revoked for more than 5 years what must you submit?
-60 hours of CE and recieve a passing score on law exam and one of the following: active license in another state or expiernce as an intern with 160 hours within 6 months of being reinstated
How many CE credit hours are required annually? Can excess CEUs be transferred to another year?
1.5 CEUs or 15 contact hours, no
What approval do CE’s have to have?
be approved bt the Accreditation Council for Pharmacy Education (ACPE), approved as a category I Continuing Medical Education (CME) course or appoved by the 18 VAC 110-20-100
How long must pharmacists keep a record of their CE’s showing the hours, date, provider?
2 years, can be audited for 2 years backwards following renewal
An approved CE is any program approved by
the board
If a pharmacist fails to have the required number of CE they can apply for an extension, how long is the extension for?
1 year
If you are a pharmacist licensed in additional states and have done a minimum of 15 hours how many more hours do you have to do?
none
If the board decides an amount of CE hours must be in a certain subject area how many hours would that be and when would htey notify pharmacists?
2 hours, no later than Jan 1st
What are acts that are restricted to pharmacists? (7)
-review prescription for accuracy and completeness
-the final check of a prescription
-recieve an oral prescription
-prospective drug reivew/cousneling
-info the public or provider about the therapeutic value of drug
-communication wtih prescriber/agent for modification excluding refill authorization
-surpervise interns and techs
Can pharmacy interns perfrom acts restricted to pharmacists if they are being supervised by a pharmacist?
yes
If a tech is making a compound who must supervise?
a pharmacist
What is the max number of techs/interns a pharmacist can supervise?
4
After the final check what must the pharmacist do?
Place their initals on the record of dispensing and keep this record for 2 years
if a pharmacist chooses not to fill a prescription for reasons other than unavailability of the drug what must they do?
1. write the word declined on the back of the prescription
2. name, address and telephone number of pharmacy
3. date was declined
4. pharmacist signature
If a pharamcist suspects a prescription is a forgery what must be done?
-do not return the prescription to the customer
-give Rx to law officer
-or keep for 30 days and then destroy
What must be submitted for a tech license?
-application fee and form
How does a tech become licensed?
-demonstrate completion of board certified training program and passing score on exam or provide evidence of PTCB certification
If a tech is newly registered on or after July 1st what occurs?
-they do not have to renew thier license until Dec 31 of the following year
if tech renews late but within one year of the date what must they submit?
-renewal fee, late fee, renewal form and proof of CE
if tech fails to renew for more than one year what must they submit?
-application for reinstatement, renewal fee, reinstatement fee, CE information
-reinstatment at the discretion fo the board
if it has been 5 years since tech expiration what must be done?
-be in a tech trainging program and pass exam or hold current PTCB certification before applying to be re-registered
How many hours must a tech have annually? Can they be transferred?
0.5 CEU or 5 contact hours, no
If an extension is approved how long? How long should the tech keep records of thier CE?
1 year, 2 years
What is a job that a tech can do?
acceptance of a refill authorization from a prescriber if there is no change to the orginial prescription
What orgnaization approves the tech trainign program?
Pharmacy Tech Certification Board
In what setting will the board waive the inital registration and examintion fee for a tech?
free clinic pharmacy
In terms of tech what documentation does the pharmacy have to maintain?
-site specific training program and manual for training tech
-doucmentation of successful completeion of site spefici training for the duration of employment and for 2 years after termination
-documentation for current employee: on site, former employees: off site
-documentation that an invidivaul is currently enrolled in approved traning program if they are working towards their tech license
what is the def of practice of pharmacy?
personal health service that is concerned with the art and science of selecting… medicines and devices used in the diagnosis, treatment, prevention of disease, whether compounded or dispensed, maintenance of proper records, providing information, management of patient care under the terms of a collaborative agreement
what is the def of a pharmacy intern?
a student currently enrolled in or a graduate of an approved school of pharmacy who is registered with teh board for the purpose of gaining practical expeience in order to apply for a license
what is the def of tech?
a person registered with the board to assit a pharmacist under the pharmacist’s supervision
what is the def of supervisison?
the direction and control by a pharmacist of the activies of a pharmacy intern or a pharmacy tech whereby the supervising pharmacist is physically present in the pharmacy and is available for immediate oral communication
Where must documentation for vaccines be recorded?
Virginia Immunization Information System
what is the def of personal supervision?
the pharmacist must be physically present and render direct, personal control over the entire service being rendered, instructions given prior, written, oral, electronically are not sufficient
Reasons the board can refuse, revoke, suspend or deny application
-negligent
-unprofessional conduct
-incompetent to practice pharmacy
-drug or alcohol that it is unsafe they practice
-fraud or deciet connected with pharmacy
-activies beyond the scope of practice
-violated laws
-license taken away by the DEA or other federal agency
-denied, suspended, revoked in another state
-felony
Any health regulatory board my suspend or restrict a license if they feel that…
-the person having the license would be a danger to public health or safety
How many board members votes are required for reinstatement of a suspended license?
-3/4
Who owns health care records?
-the health care entity maintaining them
In what instances can health care records be removed?
-court order subpoena or change of ownership
What does HIPPA stand for?
Health Insurance Portability and Accountability Act
What is a health care clearing house?
-public or private entity such as a billing service, repricing company, community health managment information that processes or transfers health infomration
Situations where health care enttites can disclose patient records:
-minor
-emergency situation
-subpena or search warrant
-collect a fee
-defend a health care entity against accusation of wrongful conduct
-contigaious disease
-domestic violence, abuse, neglect
-change of ownership or closing of medical practice
-organ donation
A pharmacist can recieve kickbacks, fee splitting and rebates from a prescriber in exchange for prescription orders if…
fully disclosed to the patient and 3rd party payor in writing
Who must sign the application for a permit to open a pharmacy that is submitted to the board?
the pharmacist in charge who will practice at that site
What must the application for a pharmacy permit contain?
-the corporate and trade name
-any additional pharmacists besides the PIC
-the hours of the pharmacy–> if changes are made to the hours that will last more than a week–> report to the board at least 14 days before the schedule changes
can you own a pharmacy in VA and not be a pharmacist?
yes
what needs to be done if termination of the practice by the pharmacist in charge or upon any change in partnership occurs?
the PIC gives the old permit back to the board
After the time period to find a new PIC has ended and there is still no PIC what happens?
the practice cannot operate as a pharmacy or maintain a stock of prescription drugs on the premsis
What does the director do?
notifies the owner of the pharmacy that the pharmayc no longer has a valid permit and that the owner shall make provision for the proper disposistion of all schedule II through VI drugs and devices within 15 days of the notice–> after 15 days the director will seize any remaning drugs on the premsis–> the director will dispose of the drugs after 6 months from the date of seizure
what must the new PIC do?
an inventory of schedule I-V on hand, inventory done when he becomes PIC and before opening on that business date
how often do pharmacy permits need to be renewed?
annually
a pharmacy permit may not be issued to a pharmacist who is in charge of more than — pharmacies
2
althought not required by law what does the leaving PIC have the opportunity to do?
complete and accurate inventory of schedule II through V, unless the owner submits written notification to the board of why this opporutniyt should not be allowed
a PIC who is absent for more than — days is no longer the PIC
30 days, if the pharmacist knows they will be gone for more than 30 days they are responsible for returning the permit to the board
what occurs in an unanticipated absence by the PIC for 15 days?
if there is no known return date within the next 15 days the owner shall notify the board and find a new PIC
when does the application for the new PIC have to be filed?
within 14 days of the date of resignation/termination of the old PIC
Situations where a special or limited use permit can be given:
-application that lists the regulatory requirements for which a waiver is requested and a breif explanation as to why each requirement should not apply to that practice
-poliyc and procedure manual: type and method of operation, hours of op, schedule of drugs, method of documentation
for a special use pharmacy such as a free clinic that uses volunteer pharmacists and operates no more than 20 hours a week–> grant a waiver to restricted access provisions
-access for repairing equipment or securing a drug delivery
-PIC should be notified before each entry and give permission
-if entry is by a non-pharmacist two people must enter and one fo them must be a nurse, physician or PA
-the key must be in a sealed envelope or container
-the licensed health care professional entering is responsible for resealing the key
-a log book for the nonpharmacists wtih teh following info: date, time, names, purpose of entry, notation that PIC gave permission to enter–> keep log book for 1 year
what changes to a pharmacy require a filed application to the board?
-open a new pharmacy
-acquis an exisiting pharmacy
-change the location of an existing pharmacy
-make strutucal changes to an exisiting pharmacy
-make changes to a previsouly aproved security system
what needs to happen if location or structural changes to a phamracy are to be made?
-inspected by an agent of the board prior to issurance of a permit
if a pharmacy is not ready for an inspection and does not notify the inspector or board at least 24 hours before inspection what happens?
the applicant pays a reinspection fee
can drugs be stocked in the proposed pharmacy/new location before approval from the inspector/board?
no
after a permit is issued when can drugs be stocked in the pharamcy?
no sooner than 2 weeks prior to the pharmacy opening date
after drugs are stocked in a pharmacy who needs to be on site on a daily basis?
a pharmacist
responsibilities of the PIC in a hospital
-establish procedures for proper storage, security and dispensing of drugs throughout the hospital
-reviews of drug therapy
-before opening a satellite pharmacy the PIC shall notify the board, ensure complaince and not stock drugs until inspected and approved
which schedule IV hospital drugs can the PIC authorize to be stored in area outside of the hosptial pharmacy? the PIC can also delegate the ordering and distribution of these to non-pharmacy personnel as long as adequate security and distribution are in the pharmacy’s policy and procedure manual
-large volume parental solution that contain no active therapeutic drugs other than electrolytes
-irrigation solutions
-contrast media
-medical gases (can be stored in an unlocked area except for nitrous oxide)
-sterile surgical trays that may include a schedule IV drug
-blood component and derivates
How often does the PIC have to check the shecudle IV drugs stored outside the hospital pharmacy for compliance?
monthly
the prescription department of a pharmacy can be no less than–
240 square feet
name some areas not counted in the prescription department square footage
-patient waiting area
-counseling area
-devices
-cosmetics
access to stock rooms and rest rooms that is used by the pharmacist cannot be through
the prescription department
a rest room only used by pharmacy personnel is permitted if
there is another restroom outside the prescription department for customers, does not apply to pharmacies bulitt before Nov 1993
can a pharmacy be located inside a trailer or movable facilitiy?
no
what can the pharmacy counter space be used for?
-compounding
-dispensing
-record keeping
a sink must have
hot and cold water
a refrigerator which contains drugs must have a
monitoring thermometer
the PIC is responsible for maintaing the following
-a current dispensing reference
-prescription balances sensitive to 15 mg
what is the def of prescription department?
any contigious or non-contigous areas used for compounding dispensing and storage of all schedule II-IV drugs and devices
who maintains the keys or other means of entry into the prescription department and the alarm code?
pharmacists
what is the procedure for the keys of a pharmacy during emergency access?
-PIC or pharmacist on duty place a key or alamr code in a sealed envelope or container with pharmacist’s name accross the seal
-key/code placed in a safe or other secure place in the pharmacy
interns and techs may possess a key only when…
when a pharmacist is on duty and not allow entry when a pharmacist is not on duty
interns and techs are only allowed in the prescription department when…
a pharmacist is on duty
a tech may enter the prescription deparment to achieve an already verified prescription if..
-unforseen, unplanned absecnce of hte pharmacist
-alternate pharmacist coverage cannot be immediately obtained
-the tech is accompanied by member of pharmacy management
-the tech obtains verbal permissison from teh pharmacist/PIC to use the emergency access key
what needs to be recorded during a tech emergency entry and how long should the record be maintinaed?
-record: -tech name, date, time, signature,
-name title and signature of the person accompanying the tech
-name and telephone number of pharmacist
-name of the patient and nature of emergency
-list of all prescriptions retrieved that day
-time of exit
-maintain this record for one year
how soon after a tech has enetered under emergency access should hte PIC change the alarm code?
48 hours
what must the pharmacy security system have?
-an auxillary power source
-able to send an alarm signal to the monitoring entity when breached if hte communication line is not operational
when is the security system required to be activated?
when the pharmacy is closed
does a pharmacy that is 24 hours need to follow the security system guidelines?
no
where can prescriptions for delivery be stored?
-secure area outside of the prescription department not accessible to the public
-access to these prescriptions is restricted to invidivuals designated by the pharmacist
where do schedule IIs have to be stored?
-in a cabinet/drawer/safe or dispersed with other drugs
-the cabinet/drawer/safe can be unlocked during hours that the prescription department is open and a pharmacist is on duty
where should schedule IV be stored?
schedule IV adnd controlled paraphernealia should not be placed in an area completely removed from prescription department where customers have access to these items and pharamcist cannot exercise control
where should expired/aldutered/misbranded drugs be stored?
designated, seperate area in the prescription department and not mixed with the other stock
requirement for a unit dose dispensing system for hospitals and long term care facilities
equipement outside of the pharmacy used to store drugs for unit dose should be fitted with a locking device that should be locked at all times when unattended
pharmacy’s responsibilities to long term care facilites
-drugs for each patient are kept and stored in the orginally recived containers
-the medication of one patient shall not be transferred to another patient
-each storage cart containing drug is locked
-drugs that are poison or for external use only are kept in a cabinet and seperate from other medications
storage and responsibility of drugs in the emergency room
-responsibility of the PIC
-kept in a secure place away from unauthroried personel and the general public
requirement for after hours access to the pharmacy in hospita setting
-authorized by the PIC
-performed by an authorized nurse
-drugs maintained by the pharmacy at a location outside the pharamcy
-for emegency meds when the pharamcy is closed
-drug in the orginial packaging or prepared and labled by a pharmacist
what must be recorded for after hours access to a pharmacy in a hospital setting and how long should these records be kept?
-date
-patients name
-drug: name, strength, dosage form and soe prescribed
-number of doses removed
-signature of nurse
-1 year
what situation does an after hours drugs access site have to be alarmed?
-if the area is continously open and staffed such as a patient floor or emergency room then the area does not need to be alaamred
-if the area is not an area that is contnously open and staffed then an alarm system needs to be installed and activated at all times
how many days before a pharmacy closes or goes out of business must the owner notify the board?
-14 days
what else must the owner report to the board? what else must the owner do?
-how the drugs schedule ii-VI and records will be disposed of
-if the drugs and records are being transferred to another pharmacy owner than the name and address for the licensed pharmacist must be reported to teh board-active refills transferred to another pharmacy

exceptions to public notice for a pharamcy closing or going out of business:
-sudden closing due to fire, destruction, natural disaster
-death
-property seizure
-evicution
-bankruptcy
-owner must notify board as soon as possible
in the event of a change in ownership the owner must notify the board…
14 days in advance
how many years worth of prescription records should be transffered during a change of ownership?
2 years
what does the owner have to do in the event of a change in hours of operation?
-provide notice to teh public and board of hours change unless: change due to emergency circumstances or the change will lead to an increase in the number of hours
-changes must be posted 14 days in advance or as soon as the owner knows of the change due to the emergency circumstances (whcih have to be disclosed)
if the pharmacy is to be closed for more than a week what must be done?
-the owner must post a notice 30 days before the closing
or
-the owner must mail a notice 14 days to every current pharmacy customer having refill authority
-the poster/letter must contain the dates of closure and the name of the pharmacy that prescriptions will be transferred to
during a change of ownership how far back to the records have to be given to the new owner?
-the past 2 years of records
do agents designated by the superintendent of he department of state police have the right to access records? to copy and remove records that arent relevant to an investigation?
yes, no
if the oringial record is removed by agents designated by the superintendent of he department of state police what must be done?
record should be copied and kept in the storage area of the reaminig records that werent removed
what areas are off-limits for state police?
-financial data
-sales data (other than shipment data)
-pricing data
-peronnel data
-research data
where do the state police report violations to? who does the board report violations of article 1 chapter 7 title18.2 to?
Department of Health professions, department of state police
what is the definition of proprietary medicine?
-a nonprescription drug in its unbroken originial package which does not contain any controlled substance
-sold/promoted/advertised to the general public under a trademark
-labeling is correct
-does not include a drug that is only advertised/promoted to professionals, narcotic, prescription drug, injection, has the warning: may be habit forming
what is the definition of storage temp?
the specific directions in monographs with respect to temperatures at which pharmaceutical should be stored otherwise if htey are stored at lower or higher temps may produce undesirable results
what is the def of unit dose container?
single-unit container as defined by USP-NF for articles intended for administration other than the parenteral route as a single dose direct from the container
what is the def of a unit dose package?
a container that contains a particular dose ordered for a patient
what is the def of unit dose system?
a system in which mulitple drugs in unit dose packaging are dispensed in a single container such as a medication drwawer, labeled only with patient name and location
directions for administration are not provided by the pharmacy on the drug packaging or container but are obtained by the person administering using the prescribers order
what is the def of well closed container?
protects the contents from extranoues solids and from loss of teh drug under ordinary or customary conditions of handling, shipping, storage and distribution
what if the def of compliance packaging?
packaging for dispensed drugs which is comprised of a series of containers for solid oral dosage forms and which is designed to assit the user in adminstering or self-administering the drugs in accordance with directions for use
what is the def of a repackaged drug?
drug removed from manufacture’s package and placed in different packaging
what is the def of a safety closure container?
a container which meets the requriements of the federal Poison Prevention Packaging Act of 1970
85% of a test group of 200 children ages 41-52 months are unable to open the container in a 5 min period
80% of children fail to open in 5 min after demonstration
90% of 100 adults can open
what is the def of special packaging?
packaging designed or constructed to be significantly difficult for children under the age of 5 to open within a reasonable time but can be opened by adults
-does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable amount of time
what is the def of terminally illl?
a patient with a terminal condition as defined in 54.1-2982
what is the def of compoudning?
-combinig two or more ingredients to fabricate such ingredients into a single preparation
-by a pharmacist or within a permitted pharmacy pursuant to a prescription or in expectation of a prescription
-can by done by other practiioners: medicine, osteopathy, podiarty, denistry or vet
-can by done for research or teaching–> not for sale or dispensing
what is the def of device?
instruments, including their components parts and accessories used to diagnosis, treat, cure, prevent, mitigation a disease in animals/man or to affect the structure or function of the body of man/animal
the abbreviation OD
doctor of optometry
the abbrevation DC
doctor of chiropractic
the abbreivation DPM
doctor of podiatric medicine
the abbrevitation DMD
doctor of dental medicine
the abbreviation NP or LNP
nurse practioner
the abbreivation LPN
license practical nurse
what is the def of schedule I
-high potentail for abuse
-no accepted medical use in the US or
-lack accepted safety for use in treatment even under medical supervision
meperidine
demerol, schedule II
morphine sulfate
MS Contin, Roxanol, schedule II
oxycodone
Percodan, Percocet, Tylox, Oxycontin, schedule II
hydromorphone
Dilaudid, schedule II
methadone
dolophine, schedule II
fentantyl
subilmaze, schedule II
afentatnyl
alfenta, schedule II
sufentanil
sufenta, schedule II
opium, cocaine, codeine
schedule II
methylphenidate
ritalin, schedule II
amphetamine
biphetamine, schedule II
dextroamphetamine
dexedrine, schedule II
phenmetrazine
schedule II
methamphetamine
Desoxyn, schedule II
pentobarbital (not suppository)
Nembutal, schedule II
secobarbital (not suppository)
seconal, schedule II
amobarbital (not suppository)
amytal, schedule II
codeine in combo with acetaminophen
Tylenol with codeine #2,3,4
Phenaphen with codeine #2,3,4
schedule III
codeine in combo with aspirin
Empirin with codeine #2,3,4
schedule III
hydrocodone
Tussionex, Vicodin, Lorcet Plus, Lortab, Hycodan, Zydone, Anexsia
schedule III
butabarbital
Butisol
schedule III
butalbital (not in combo with APAP)
Fiorinal, Fiorinal with codeine
schedule III
thiopental sodium
Pentothal
schedule III
benzphetamine
Didrex
schedule III
pendimetrazine
Bontril, Prelu-2
schedule III
nandrolone
Anabolin, Androlone, Deca-Durabolin, Durabolin, Hybolin, Nandrobolic
schedule III
stanozolol
Winstrol
schedule III
oxandrolone
Anavar
schedule III
dronabinol
marinol
schedule III
diazepam
Valium
schedule IV
lorazepam
Ativan
schedule IV
alprazolam
Xanax
schedule IV
chlordiazepoxide
Librium
schedule IV
oxazepam
Serax
schedule IV
prazepam
Centrax
schedule IV
triazolam
Halcion
schedule IV
clonazepam
Klonopin
schedule IV
chlorazepate
Tranxene
schedule IV
flurazepam
Dalmane
schedule IV
zolpidem
Ambien
schedule IV
temazepam
restoril
schedule IV
phenobarbital
schedule IV
pentazocine
Talwin
schedule IV
propoxyphene
Darvon
schedule IV
phentermine
Fastin, Ionamin, Adipex-P
schedule IV
diethylproprion
Tepanil, Tenuate
schedule IV
fenfluramine
Pondimin
schedule IV
mazindol
Sanorex
schedule IV
most cough syrups containing codeine
schedule V
diphenoxylate
Lomotil
schedule V
all prescription drugs which are not schedule II-V are
schedule VI
schedule VI drugs include drugs with what kind of labeling?
-Rx only
-caution: federal law prohibits dispensing without prescription
-caution: federal law restricts this device to sales by or use on the order of a physiciain
-caution: federal law restricts this drug to use by or on the order of a vet
what are some reasons drugs are placed in schedule VI?
-toxicity
-potential for harm
-method of use
-collateral measures necessary to its use
-the drug is not generally recognized among experts as being safe for use except by or under the supervision of a practionier with a license to prescribe
list examples of drugs in schedule VI
-digoxin (Lanoxin)
-penicilln v (penicillin VK)
-bupropion hydrochloride (Wellbutrin)
-amoxicillin (Amoxil)
-cephalexin (Keflex)
-tramodol hydrochloride (Ultram)
what is the def of dispense?
-deliver a drug to the ultimate user or research subject or practitioner
-includes: prescribing, administering, packaging, labeling and compounding
-dispensing does not include the transportation of drugs mixed, diluted or reconstituted for practioner to adminster to patient at the site of their medical practice
what is the def of drug?
-articles or substances recognized by the USP-NF or official Homeopathic Pharmacopoeia of the US
-articles or substances intended for the use in the diagnosis, mititagation, cure, treatment, prevention of disease in man/animal
-articles or substances other than food intended to affect the structure or function of man/animal
-does not include devices, componnents or accessories
what is the def of administer?
-the direct application of a controlled substance by injection, inhalation or ingestion or any other means to a patient or research subject
-done by practioner, patient or research subject
what is the def of label?
-display of written, printed or graphic matter upon the immediate container of any article
what is the def of labeling?
-all lables and other written, printed or graphic matter on an article or any of its containers, wrappers or accompanying such article
what is the def of prescription?
-an order for drugs or medical supplies
-written or signed or transmitted by word of mouth, telephone, telegraph or other means of communication to a pharmacist by a phyisican, dentist, vet or other practioner
what is the def of a controlled substance? (VA)
-drug, substance or immediate precursor in schedules I through VI
-this term does not include alcohol or tobacco
any compound, mixture or preparation contaning—-exempted from schedules III, IV or V is schedule VI
stimulant or depressant
def of controlled substance (USC)
-drug, substance or immediate precursor in schedules I-V
-does not include alcohol or tobacco
def of controlled substance (CFR)
-any drug in schedule II-V of the Federal Controlled Substances Act
-or implementing regulations must be dispensed by prescription only as required by the Federal Food Drug and Cosmetic Act
def of drug sample (CFR)
packet card, blister pack, bottle, container or other single package comprised of one or more dosage units of a prescription drug sample intended to be provided by a licensed practioner to a patient in an unbroken/unopen condition
def of new drug (USC)
a new drug except new animal drug or feed which has been investigated for safety and effectivness but has not been used outside of these investigations
what are the criteria for the board’s regulations?
-quality
-quantity
-integrity
-safety
-efficacy
-of drugs, or devices distributed or dispensed or adminstered
is the board allowed to collect drugs or devices that are manufactured, distributed, stored or dispensed in the commonwealth?
yes
what is the normal distribution channel?
chain of custody for a prescripton drug from inital sale by a pharmaceutical manufacturer–> wholesale distributor–> pharmacy or other person dispensing or adminstering the controlled substance
what is pedigree?
a paper document or electronic file recording each distribution of a controlled substance from sale by a manufacturer–> wholesale distributor–> pharmacy or other person dispesning or administering the controlled substance
-excludes returns from the pharmacy to the manufacture or whole saler
in terms of inspection what does the board have the power to do?
drugs, cosmetics or devices which are manufactured, stored or dispensed in the commonwealth
when can the board enter to inspect?
during business hours of the pharmacy or any other place in VA where drugs, cosmetics and devices are manufactured, stored, dispensed
any violations of chapter 34 the board finds who will they report the violations to? how soon does the licensing board initate action?
the appropriate licensing board, 30 days
if a person has a controlled subtance and wishes to dispose of it who can they contact?
Special Agent in Charge of the Administration in the area in which the person is located
if the person wishing to dispose of the controlled substances is a registrant what should they do?
he/she shall list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area
if the person that wants to dispose of the controlled drugs is not a registrant what things should they include in their letter?

The name and address of the person;

(ii) The name and quantity of each controlled substance to be disposed of;

(iii) How the applicant obtained the substance, if known; and

(iv) The name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant, if known.

the special agent will provide instructions for how to dispose of the controlled substances what are they?

1) By transfer to person registered under the Act and authorized to possess the substance;

(2) By delivery to an agent of the Administration or to the nearest office of the Administration;

(3) By destruction in the presence of an agent of the Administration or other authorized person; or

(4) By such other means as the Special Agent in Charge may determine to assure that the substance does not become available to unauthorized persons.

if a registrant has to frequently dispose of controlled substances what can be done?
-the special agent can authorize the registrant to dispose of the drugs without prior approval by the administration each time
-as long as records of the disposals are kept and periodically filed with teh special agent
-in these instances the agent may place guidelines on the method of disposal and the frequency and detail of reports
if a registrant wishes to modify their authorization to handle controlled substances or to change their address what must they do?
-submit a letter of request to the Registration Unit of the DEA
-the letter should contain the following: name, address, registration number, substances/schedule to be added to their registration or the new address to be addedd to their registration
what should a registrant do that is wishing to add schedule I to their registration for the purpose of research or instructional activiies? do any of these changes in registration require a fee?
three copies of a research protocol describing each research project involving the additional substances, or two copies of a statement describing the nature, extent, and duration of such instructional activities, as appropriate, no
what occurs if the request for modficiation of controlled substance registration is approved?
the registrant will recieve new certificate of registration (DEA Form 223) to the registrant, who shall maintain it with the old certificate of registration until expiration.
what are instances when a person’s DEA registration automatically terminate?
-death
-cease legal existence
-discontinue business
-surrenders registration
if a person surrenders what are they responsible to do in regards to their DEA registration?
duly executed DEA form 104 or any signed writing indicating the desire to surrender a registration.
if a person ceases legal existence or professional practice in terms of DEA registraton what are they responsible for doing?
shall notify the Administrator promptly of such fact
if you wish to transfer a DEA registration what must you do?
shall submit a written request, providing full details regarding the proposed transfer of registration, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration
if someone wishes to discontinue business or the handling of shceduled substances without transferring their DEA registration what must they do?
shall return for cancellation his/her certificate of registration, and any unexecuted order forms in his/her possession, to the Registration Unit, Drug Enforcement Administration.
-Any controlled substances in his/her possession may be disposed of in accordance withSec. 1307.21 of this chapter
if someone wishes to discontinue business or the handling of shceduled substances with transferring their DEA registration and business activies what must they do?

shall submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his/her area, at least 14 days in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limitation in individual instances), the following information:

(1) The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor);

(2) The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee);

(3) Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed);

(4) Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in Schedule I or II (if so, the basic class or class of the substance should be indicated); and

(5) The date on which the transfer of controlled substances will occur.

who can a registrant not employ to handle controlled substnaces?
-convicted of a felony offense relating to controlled substances
-had an application for registration with the DEA denied
-had a DEA registration revoked
-surrendered a DEA registration for cause-means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action
if a significant loss or theft of controlled subtances has occurred what should the registrant do?
Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106
what are some factors to determine whether a loss/theft of controlled substances is significant?

The actual quantity of controlled substances lost in relation to the type of business;

(2) The specific controlled substances lost;

(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;

(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,

(5) Whether the specific controlled substances are likely candidates for diversion;

(6) Local trends and other indicators of the diversion potential of the missing controlled substance

when a registrant distributes a controlled substance and is not registered as a distributor what must they do?
comply with the requirements imposed on nonpractitioners
what form must central fill pharmacies and retail pharmacies use if controlled substances are lost in transport?
DEA Form 106
who has to sign an offical written order for a schedule II drug?
purchasing licensee or by his agent
who keeps the original offical order for any schedule II drug? how long should it be kept?
person who supplies the drugs, 2 years
list some people that a manufacture or wholesale can distribute schedule II drugs to following offical written orders or pursuant to an electronic order, is an official wrritten order needed for schedule III-VI for these people?
-manufacture or whole saler with teh proper permits
-pharmacist
-pharmacy
-licensed practioner of medicine, osteo, podiatry, denistry, vet
-person how has been issued a controlled substance registration certificate, if authorizes a purchase
-special written order for receievg or possessing drugs for official duties
-master of ship or aircraft in which no physician is regularly employed
-to a person in a foregin country
no
if a pharmacy wishes to engage in wholesale distribution of small quantities of prescription drugs without being licensed as wholesale distribiutors what are the maximum sales and dosage percentages? percentage for medical equipment supplier of oxygen without being registsered as a wholesale distributor?
-wholesale distributions of controlled substances (schedule II-V) do not exceed 5% of the gross annual sales of prescription drugs
or
-wholesale distributions of schedules II-V do not exvceed 5% of the total dosage units of schedule II-V dispensed annually
-do not exceed 5% of the gross annual sales of oxygen
except in emergency circumstances where can a pharmacist purchase schedule II-Vi from?
whole sale distributor or warehouser licensed or registered by the board
what do records for schedule II-V have to contain?
-date of receipt
-name and address of the person from whom recieved
-the kind and quantity of drugs received
-the kind and quanitity of drugs produced or removed from process of manufacture
-date of such production or removal from process of manufacture
-show the proportion of morphine, cocaine, ecgonine contained in or produced from crude opium or coca leaves received or produced
how should inventories and records of schedule I-II be stored?
maintained seperartely from other records in the pharamcy
each pharmacy must maintain a perpetual inventory of all schedule II drugs recieved or dispensed with reconcilliation how often? can this be electronic and done by another entity as long as reconcilled just as often?
monthly,yes
where should schedule III, IV V be maintined?
can be seperate from schedule VI or with schedule VI
where do order forms, prescriptions and inventories for schedule II-V need to be stored?
same address as the stock of drugs
what type fo schedule II-V records can be stored offsite if authroized by the DEA? how quickly must they be accessible?
invoices, 48 hours
what do inventories taken need?
signed and dated by the person taking the inventory
indicate whether the inventory was taken at the begining or end of the business day
where do invoices or other records of receipt for schedule VI need to be stored?
on or off site, if off site must be accessible within 48 hours
how must schedule records be filed and how long must they be kept?
chronologically, 2 years
if someone plans to manufacture, compound, process, sell, dispense or dispose of drugs shcedule I-V what do they need to do on the first day of business? during the inventory if there are no controlled substnaces on hand what should they do?
take a complete and accurate inventory, record the lack of controlled susbtanves in the inventory
after an inital inventory is taken when the business opens how frequently must an inventory of schedule I_V be done?
-biennial, every 2 years
characterisitcs of an aldulerated drug or device
-filth, putrid, decomposed substance
-exposed to insanitary conditions
-if it was in a place that does not meet good manufacturing practice
-if it contains poison
-unsafe color additive
-does not meet strength, quality, purity standards
-does not meet strenght, quality, purity that it claims to possess
-mixed with another drug to reduce its quality or strength
if a drug is recognized by both USP-NF and the homeopathic pharmacopiea which organization does it have to meet requirements for?
USP-NF unless it is labeled and offered for sale as a homeopathic drug–> under the hoemopathich requirements
give examples of misbranding a drug
-false or misleading labeling
-if the package does not bear a label containig the name and place of business of the manufacture, packer or distributor
-if any word or statement that is required but is not placed in a readily readable area
-label does not bear the name, quanity and proportion of substance or derivative in juxtaposistion with the statement warning may by habit forming if it contains a habit forming substance
what must a purchaser do wtih DEA form 222?
-keep Copy 3
-submit Copy 1 and 2 to the supplier
if a supplier fills a DEA form 222 order what must they do?
must record on Copies 1 and 2 the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser
what happens if a supplier cannot fill an entire DEA 222 order?
it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the DEA Form 222.
where must the ordered controlled substances be shipped?
only to the purchaser and the location printed by the Administration on the DEA Form 222
what must the supplier do with the DEA form 222?
-The supplier must retain Copy 1 of the DEA Form 222 for his or her files and forward Copy 2 to the Special Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located.
-Copy 2 must be forwarded at the close of the month during which the order is filled.
-If an order is filled by partial shipments, Copy 2 must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires
what must the purchase do to their DEA form 222 copy 3?
the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser
DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States have what exceptions?
-may be shipped to locations other than the location printed on the DEA Form 222
– and in partial shipments at different times not to exceed six months from the date of the order
def of investigational new drug?
new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms “investigational drug” and “investigational new drug” are deemed to be synonymous for purposes of this part
if a drug has been dispensed to a customer and has been removed from the pharamcy premsis can this same drug be dispensed to another customer after it has been returned/exchanged by the pharmacy?
no
list some exceptions to redispensing an already dispensed drug:
-hospital with an on-site hospital pharmacy
when can a device be accepted for return or exchange after it has been sold to the customer?
when the device is in the orgingial manufacture’s sealed packaging
list the two ways a PIC can dispose of unwanted drugs
-transfer the drugs to another person or entity authroized to posses the drugs or provide proper disposal
-burn drugs in an incernator or other board approved method
if the PIC wishes to dispose of drugs that are schedule II-V what procedures need to apply?
-14 days before the destruction date the PIC will provide a written note to the board office that will contain the following
-date, time, manner and place of destruction
-names of the pharmacists that will witness the destrutction (needs to be the PIC and another pharmacist not employed by the pharmacy)
-the DEA destruction form shall be completed and used as the record of all drugs to be destroyed and this should be kept at the pharmacy
-if the destruction date changes or the destuction does not occur a new notice shall be provided to the board office
if a pharmacy is performing bulk reconstitution of an injection or compound or is repackagaing or prepackaging drugs how long should the records be maintained and what should they contain?
1 year or until the expiration (which ever is longer)
-name of drug
-strength
-date repackaged
-quantity prepared
-initials of the verifying pharmacist
-lot/control number
-manufacture/distributor name
-expiration date
the repackaged/reconstituted drug must have what information on its label?
-drug name
-strength
-lot/control number
-manufacture name
-expiration date
if a pharmacy removes drugs from the manufactures original packaging and places them in bulk bins using an automated device what requirements must be followed?
-bin filling record for each bin maintained for 1 year which contains:
-drug name and strength
-manufacture name
-control/lot number
-expiration date
-date of filling
-verifying pharmacists’s initials
if more than one lot number is assinged to a repackaging bin what happens in regard to the expiration date?
the lot which expires first determines the expiration date
in terms of the inventories for controlled drugs what must the record show for drugs that are sold, dispensed, administered or disposed of?
-date of selling/dispensing
-name and address of the person to whom or for use
-or the owner and animal species
-kind and quantity of drugs
if a registrant realizes there has been a loss or theft of controlled substances what should the registrant do?
-report the loss or theft to the board
-the kind and quantity of drugs lost cannot be determined the registrant must do an immediate inventory of schedule I-V
-within 30 days the registrant must provide the board with a listing of the kind, quantity and strength of drugs lost
how long must records regarding controlled substances be kept?
2 year
if the owner of schedule II-V wishes to discontinue dealing such drugs how may they dispose of drugs after receeiving an official written order?
-pharmacy/practioner/agent of pharmacy or practioner under written authorization by the owner may dispose of stock to the manufacture/wholesale/pharmacy/practioner as long as they hold the correct license
if the manufacture of schedule II-V wishes to discontinue dealing such drugs how may they dispose of drugs after receeiving an official written order?
-give to another manufacture or wholesaler who holds a valid permit to deal with these drug
in long term care facilities what happens to discontinued drugs?
-returned to the pharmacy for resale or transferred to another pharmacy for redispensng to the indigent or disposed of
in a long term care facility who must drug destruction be witnessed by?
-at the pharmacy: PIC and another pharmacy employee
-at the facillity: director of nursing and pharmacist/employee authroized to administer medication
how should records be maintained for drugs returned or destroyed at a long term care facility?
-the original of the record of destruction shall be signed and dated by the persons witnessing the destruction and be maintained at the long term care facility for a period of 2 years
-and a copy of the record should be maintained at teh provider pharmacy for 2 years
how long after the drug has been discontinued in a long term care facility must action be taken?
-destroy discontinued or unused drugs or return them to teh pharmacy within 30 days of the drug being discontinued
in an emergency situation a pharmacist may dispense a schedule II after recieving oral authorization from a prescriber if the following conditions are met
-the quantity prescribed and dispensed is limited to treat the patient for the emergency period only
-the oral prescription shall be reduced to writing by the pharamist and contain all the nescessary information except the prescriber’s signature
-within 7 days the prescriber must send a written prescription for the emergency quantity to the pharmacist
-the written prescription on its face should read Authorization for Emergency Dispensing and have the date of the oral order
-the pharmacist must attach the oral order which had been reduced to writing to the written rx from the prescriber
if in an emergency prescribing of a schedule II done orally and the pharmacist does not recieve a written order within 7 days what does the pharamcist need to do?
-notify the nearest office of the Drug Enforcement Administration
what does a scheudle III-V rx need to have to be complete?
-dated and signed by prescriber
-full name and address of the patient
-full name and address of the prescriber
a schedule III-V can be transmitted orally by an agent as long as what is given?
-full name of the agent on the written record
for schedule III or IV how often may they be refilled and what is the maximum time limit they may be refilled from the date written?
5 times, 6 months
how must refills be handled for schedule VI?
-refills are authorized on the face of the prescription or orally by the prescriber
-oral refills should be reduced to writing and filed with the originial prescription
if a prescriber cannot be reached after reasonable efforts to refill a scheudle VI what can the pharmaicst do?
-the pharmacist can refill the prescription if they determine the patient’s health would be in danger without the drug
-the pharmacist must tell the patient the prescriber is unavailable and that the refill is being made without the prescriber authorization
-the pharmacist must inform the prescriber of the refill
-on the revrese side of the prescription the following information must be displayed: date, quantity, prescribers unavailability and rationale for the refill
what are the requirements for an oral prescription agent?
-employee of the prescriber who is under immediate and personal supervision
-if the agent is not an employee than they must hold a valid license allowing for the administration or dispensing of drugs and be specficailly directed by the prescriber
for faxed prescriptions for schedule III-VI what are the requirements?
-only faxed to the pharmacy of the patients choice
-contains all required information and written has the prescribers signature
-an agent may transmit an oral prescription by fax and shall record on the faxed prescription the agents full name and wording that its an oral prescription
a faxed rx is only valid when faxed from the prescribers location except for:
-forwarding a faxed chart from a long term care facility, hospice, home hospice
-forwarding a written prescription by an authorized agent from a long term care facility provided the provider pharmacy maintains written procedures for such transactions and that the original rx is obtained within 7 days and the original shall be attached to teh faxed copy
what is addtional info that must be included on a faxed rx?
-date of the fax
-name, address, phone number and fax number of the authorized prescriber
-the instituion from which the prescription was faxed including address, phone number and fax number
a schedule II rx cannot be faxed to be filled unless it is one of the following conditions:
-long term care facility
-home infusion patients
-hospice
-home hospice
schedule II rx are faxed for what purpose excluding exception conditions?
informational purposes
faxed authorizations for refills must include what information?
-patietn name and address
-drug name and strength
-quantity
-directions for use
-prescriber name
-date of authorization
-prescriber’s signature or agent’s name
who transmits an electronic rx and where does it go? what schedules can be transmitted electronically?
-prescriber or authorized agent
-the patients pharmacy of choice
-schedule II-V
during a transfer what does the transferring pharmacy have to do?
-write the word “void” on the prescription
-on the rx record: name, address and DEA number (except for scheudle VI) of the pharmacy it is being transferred to
-for an oral transfer also need the name of the pharmacist at the other pharamcy
-records the date of teh transfer
during a transfer what does the reciving pharmacy have to do?
-writes the word transfer on the face of the transferred prescription
-date of issuance of the original rx
-orgiinal number of refills
-originial date of dispesning
-number of refills remaining and date of last dispensing
-pharmacy name, address and DEA registry (except for schedule VI) and original rx number for the pharmacy it is coming from
-name of the transferring pharmacist if transfer is oral
if the transferring pharmacies share a common database does a hard copy need to be maintained if the system is capable of generating a hard copy?
no
how many times can a schedule III_V be transferred if the two pharmacies dont share a real time electronic database?
1 time
how many times can a schedule III-V be transferred between two pharmacies who share a real time eletronic online database?
up to the maximum refills permitted by law and the prescriber’s authorization.
For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data

(i) The date of the original dispensing.

(ii) The number of refills remaining and the date(s) and locations of previous refills.

(iii) The transferring pharmacy’s name, address, DEA registration number, and prescription number for each dispensing.

(iv) The name of the pharmacist transferring the prescription.

(v) The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different

how long do the orignal and transferred prescriptions have to be maintained?
2 years from the date of last refill.
what kinds of patient specific data should be recorded and maintained at the pharmacy?
-name
-address
-gender
-phone number
-birthday
-allergies
-list of meds
who can issue a prescription for a controlled substance? who can they issue it to? what other requirement is needed?
-physician
-osteopathy
-podiatry
-denstiry
-vet
-nurse practioner
-physician assistant
-TPA certified optometristto people or animals for which a bona fide relationship exists between prescriber and patient

what is the def of a bona fide practioner-patient-pharmacist relationship?
-practioner prescribes–>pharmacist dispenses in good faith that the patient is within the course of professional practice
what are the requirements of a bona fide relationship?
practioner shall
1. medical/drug history is obtained
2. give info to the patient about the benefits and risks of the drug being prescribed
3. perform an exam of the patient
4. do inerventions and follow up care esepcially if a drug has serious side effects
a prescription can be filled if there is no bona fide patient-practionre-pharmacist relationship?
no
what type of practioners are accepted for out of state controlled substances prescriptions?
-physcians
-osteopathy
-podiatry
-dentist
-vet
when can a prescriber prescribe schedule VI antibiotics to someone who is in close contact with a diagnosed patient?
-person has a bona fide relationship with the diagnosed patient
-urgency to being treatment because of communicable disease
-close contact person has bona fide relationship except for physical exam
-emergency treament is needed to prevent imminent risk of death, life threatening illness of serious disability
who is included as a practioner in VA?
-physician
-dentist
-nurse practioner
-physician assistant
-TPA optometist
-vet
-scientific investigator
what does a presription from a medical intern or resident in a hospital need to contain?
-prescribers signature
-prescribers name, address and telephone number
-identification number given to the prescriber by the hospital (DEA number assigned to teh hospital pharamcy + suffix assigned by the instituion)
-the assigned number is only valid while the person is at that site for their residency
the board has the authority to change the schedule of the drug after looking at the following characteristics, these characteristics are also looked at federally and whether a drug is controlled is determined by who?
-actual or relative potential for abuse
-scientific evidence of its pharmacological effect
-state of the current scientific knowledge
-history and current pattern of abuse
-scope, duration and significance of abuse
-the risk to public health
-the potential of the substance to produce pyschic or physical dependence
-whether the substance is an immediate precuros of a substance already controlled
-attorney general
a pharmacist may dispense a generic instead of the brand unless the folllowing:
-the prescriber writes on the rx: brand medically necessary
-the patient insists on wanting the brand
if a pharamcist dispenses a generic instead of a brand what must the pharmacist do?
-inform the customer of the substituion
-put on permament record and the rx label the brand name and manufacture of generic
-label the drug with the generic name and the words “generic for” and the brand name
-the generic must be at a lower retail price than the brand
what are the requirements for a written rx?
-in ink or typed
-name, address and phone number of prescriber
-prescriber DEA number if for controlled substance
-the prescribers info can be on the rx by one of the follwoing: preprinted, electronically printed, type written, rubber stamped or printed by hand
-first and last name of the patient
-address of patient (put on rx by either prescriber, agent or dispenser) or the address of the patient can be recorded by the dispenser into an electronic database instead of on the rx itself
-dated and signed by the prescriber
a written prescription cannot contain more than one medication except for the following
-chart orders for patients in hosptials, long term care, home infusion or hospice
-pharamcy operated by or for Department of Corrections, Department of Juvenille Justice, central pharamcy of teh Department of Health, central outpaitnet pharmacy Department of Behavioral Health and Development Services
-prescriptions for patients in adult and juvinellie detention centers, local or regional jails, work release centers operated by Department of Corrections
can a vet prescribe a controlled substance for a human?
no
what are the ways a vet can prescribe?
written or oral
what information is required on a vet rx?
-signed and dated by prescriber
-full name and address of the owner of the animal
-species of animal
-full name, address and resgsitry number of the prescriber
what is the def of therapeutically equivalent?
-drug products that contain the same active ingreidnts and are indentical in sterngth, dosage form, route of administration and are classified as being therapeutically equivalent by the FDA pursuant to the def of therapeutically equivalent set forth in the orange book (approved drug products with therapeutic equivalence evaluations”
what must a pharmacist due before dispensing a new rx to the patient?
conduct a prospective drug review
what should the drug review for an intial rx by the pharmacist include?
-therapeutic duplication
-drug-disease contraindications
-drug-drug interactions
-serious interactions wtih non-prescription
-incorrect drug dosage or duration of treatment
-drug allergy interactions
-clinical abuse or misuse
what are the requirements for a controlled substance rx?
dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.
for an rx for gamma-hydroxybutyric acid what is needed?
practitioner shall note on the face of the prescription the medical need of the patient for the prescription.
what must be done by the prescriber for a computer generated rx that is printed out or faxed?
practitioner must be manually signed
pharmacys managing long term care patients must do what monthly?
-review of drug therapy to determine irregularities: drug therapy interactions, drug administration or transcription errors
-the pharmacist doing the review must sign and date the review
-any found irregulatrites must be brought to the attention of the attending practioner
what does a schedule II prescription need to have?
-date and signature of prescriber
-full name and address of the patient (owner) + speciies of animal
-full name, address and registry number of the person doing the prescribing
in what form can a schedule II be dispensed in an emergency situation?
oral
can an rx for a schedule II be refilled?
no
a scheudle II cannot be filled if it is more than — time after the date the rx was written
6 months
how should a pharmacist record their initals when dispensing using an automated data processing system?
-on the rx in an automated data processing system
-or on another record that is accurate from which dispensing information is reterivable and in which the orgiginal rx and any information maintained in such data processing system can be easily found
when a schedule II is dispensed what must the pharmacist due in regards to the label?
-the container in which the drug is dispensed must have
-the rx serial number or the name of the drug
-date of inital filling
-name and address of the pharmacy
-name of the patient
-name of the prescriber (except for drugs dispensed to a patient in a hospital from a chart order)
-directions
what information is needed on the label of the drug?
-name and address of the dispenser
-serial number and date of the rx or of its filling
-name of the prescriber
-name of the patient
-directions for use
-cautionary statements
how should the refilling of an rx for schedule III-V be handled?
-each refilling shall be entered on the back of the rx or on anothe record and be intialed and dated by the pharmacist as of the date of dispensing
-if the pharmacist only initials and dates the rx then it is assumed the entire quantity was dispensed
what is the procedure for a partial dispense of a schedule III-V?
-each partial dispensing is recorded in the same manner as refilling
-the total quantity of the drug dispensed in all partial dispensing does not exceed the total quantity prescribed
-no partial dispensing can occur 6 months after the date the rx was written
if a schedule III-V is dispensed earlier than should be when refilled what should occur?
pharmacist documents a valid reason for the nescestiy of the early refill
how long is a schedule VI rx valid for? speical exceptions?
-cannot be dispensed or refilled past 1 year
-unless the prescriber authorizes dispensing or refilling for a longer period of time not to exceed 2 years
what are the requirements for a drug label?
-drug name and strenght
-generic name for drugs wtih a single active ingredient (does not apply to hospital or long term care facility)
-the words generic for and the brand name if the generic was dispensed when the brand was written (does not apply to hospital or long term care facility)
-the number of dosage units/mL dispensed
each drug dispensed to a person in a household shall be dispensed the drug in what?
special packaging
-exceptions:
-otherwise directed by the practioner
-otherwise directed by the purchaser
-or when the drug is exempt from the Poison Prevention Packaging Act of 1970
-if non-speical packaging is requested a notation shall be made on the dispensing record or other retreivable record
if a pharmacy uses an alternative way of record dispensing information what must be done?
–record the date of dispensing
-record the initals of the pharmacist dispensing
-these records must be maintained onsite for a period of 2 years
-using an alt record: maintain a current policy and procedure manual documenting the procedures for using the record, how the record is integrated into the total dispensing record system and how the data included in the record shall be interpreted
does the board have authority to exempt any drug from the special packaging requriements of the Poison Prevention Packaging Act of 1970?
yes
who has authority to request that the drug not be dispensed in a child safety container?
-prescriber
-purchaser
why does the customer need to sign a release form to dispense their medication in a non-child safe container?
-to avoid the pharamcist being held liable
what is the def of compounding? requirements?
-combining of two or more ingreidents to create a single preparation
-done by a pharmacist
-requires a valid prescription
-can also be done by or for a md, osteo, podiatry, dentist or vet if authorized to dispense a controlled substance
a pharmacist must offer to counsel on a new rx?
yes
list different methods of “offer to counsel’
-face to face communication
-sign for customers
-notification on the bag
-notification on the drug bottle
-telephone
list examples of what a pharmacist can counsel on
-name and description of the medicine
-doage form, route of administration and duration of drug therapy
-special directions
-precautions
-adverese reactions or interactions
-monitoring
-storage
-refill info
-missed dose
a pharmacist’s offer to counsel does not apply to what settings?
-inpatient hospital
-inpatient nursing home
what is required to be on the label of schedule II-IV drugs? exception?
-”Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
-This statement
is not required to appear on the
label of a controlled substance dispensed
for use in clinical investigations
which are ”blind.’
how many hours does a pharmacist have to dispense a partial fill of a schedule II if they are out of stock of the medication? what is needed if the remainder of the partial fill would occur past this point? what must a pharmacist do to fill a parital fill?
-72
-no further quantity of a schedule II can be supplied past 72 hours without a new prescription
-make a notation of the quantity filled on the face of the rx
in a long term care facility how is partial dispensgin for schedule II handled?
-pharmacist shall record on the back of the RX or on another appropriate record: date of the partail dispensing, quantity dispensed, remaining quantity to be dispensed and the identification of the dispsening pharmacist
-the rx is valid for dispensing for 60 days
information for dispensing of schedule II prescriptions in a long term care facility may be stored in a computer if the following are met
-output
-the oringial rx number
-date of issue
-id of prescriber
-id of the patient
-drug dose, strength and quantity
-list of partial dispensing
-immediate real time updating of the rx record for each partial dispensing
how are schedule II drugs handlded for a terminal illness?
-practioner classifies the patient has terminally ill and the pharmacist shall veriy and record on the rx the terminally ill status
-each partial filling the pharmacist shall record the date, quantity dispensed, remanign qunatity authorized to be dispensed and the identity of the dispensing pharmacist
-prior to partial filling the pharmacist shall determine if its necessary
-may not be filled for 60 days past the written date
what is the Prescription Drug Donation program?
-created by regulations established by yhe board
-program to accept previsouly dispensed unused to give to indigent people
-drugs must have their integrity assured before they can be dispensed
-drugs must be in the manufactures original sealed containers or sealed in unit dose packaging
-can give schedule II-V if not prohibited by federal law
is a pharmaceutical company liable for a claim or injury from the storage, donation, acceptance, transfer or dispensing of any drug in a drug distribution program?
no
if a practioner is treating a detox patient what can they do?
-adminster or dispense directly
a narcotic drug listed in any schedule
-cannot prescribe
-if they meet both conidtions:
-has registered DEA with a narcotic treatment program and The practitioner is in compliance with DEA regulations regarding treatment qualifications, security, records, and unsupervised use of the drugs pursuant to the Act
if a practioner is does not have a DEA with a narcotic treatment program what can they do in an emergnecy withdrawal situation?
-administer but not prescribe drugs for the time being while a referral to a DEA registered prescriber takes place
-can only adminsieter for one days worth at a time
-can only administer for 3 days total
when may a practioner prescribe drugs in regards to narcotic treatment program?
administer or dispense (including prescribe) any Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment to a narcotic dependent person if the practitioner complies with the requirements of §1301.28 of this chapter
in a hospital or long term care facility how is the prescribing of schedule II drugs handled?
-signed order
-verbal order taken by a licensed nurse or pharmacist who will reduce the order to writing—> the order must be signed by the prescriber in 72 hours
in a unit dose dispensning system in a hospital or long term care facility how must labeling be handlded?
-all dosages and drugs shall be labeled with drug name, strength, lot number and expiration date
-a patient’s indivdual drug drawer shall be labled with patient’s name and location
who else can handle drug orders in a hospital or long term care facility?
-properlly trained personell may transcribe prescribers drug orders to a patient profile card, fill the medication carts and perform other such duties related to a unit dose distribution system provided these are done under the personal supervision of a pharmacist
where must all unit dose drugs intended for interal use by stored?
-maintined in the patient’s individual drawer or tray unless special storage conditions are necessary
-a back up dose of not more than one dose can be maintained in the patients tray/drawer
for unit dose dispensing for hosptials and long term care how should records be maintained?
-maintained in the pharmacy for 1 year
-shows the date of the cart filling
-the location of the drug cart
-intials of the person who filled the cart
-initials of the pharmacist checking the cart
when must a patient profile record or medication card be accepted as the dispensing record of the pharmacy for unit dispensing systems only subject to the following coniditions?
-the record of dispensing must be entered on the patient profile or medication card at the time the drug drawer or tray is filled
-in the case of schedule II-V drugs after the patient profile reocrd or medication card has been completed the card must be maintained for 2 years
in terms of dispesning for hospitals and long term care facilities that only allow a licensed person to administer a drug what should be done?
-a max of 7 day supply for a solid oral drug
what additional requirements apply to long term care facilites in which unlicensed persons administer drugs?
-pharmacy shall dispense no more than a 72 hour supply of solid oral dosage form at any one time
-the pharmacy should provide training for the particualr unit dose being used for the personnel administering the drug
-the pharmacy shall provide a medication administration record to the facility listing each drug to be administered with full dosage directions with no abbreviations
-the drugs in a unit dose system shall be placed in slots wihtin a drawer labeled or coded to indicate time of administration
how should a pharmacist handle all schedule II-VI delivered drugs to a hospital unit?
-check all drugs as floor stock before they leave the pharmacy and shall inital or sign manually or electronically the record of distribution verifying the accuracy of the distribution
-a delivery receipt shall be obtained for all schedule II-V drugs supplied as floor stock: date, drug name, strength, quantity, hospital unit receivng the drug, manual/electronic signature of the dispensing pharmacist and the recieving nurse
what shall be used to document administration of schedule II_V drugs when a floor stock system is being used for these drugs? what should be done wiht this record?
-record of disposition/administration
-record shall be returned to the pharmacy within 3 months of its issue
-the PIC or designee shall: match records with delivery recpeits to verify that all records are returned, periodically audit reutrned admin records for completenesss (pt name, dose, date and time of admin, signature of person administering the drug and date the record is returned), verify that all addoitions/deductions to inventory are recorded, initall the returned record
all should floor stock drug records be maintained?
-filed chronologically and retained for two years form the date of return at the address of the pharmacy
-schedule VI records may be maintained in offsite storage or an electronic image and is readily retriavable within 48 hours
what conditions must be met for pharmayc to prepare a drug kit for a licensed medical emergency servcies agency?
-The PIC shall be responsbile for all rx drugs in the kit
-pharmacist shall check each drug kit after filling the kit and inital the filling record certifying the accuracy and integrity of hte contents in the kit
-kit is sealed to deter theft or loss
-when the drug kit is opened the kit shall be returned to the pharmacy and exchanged for an unopened kit, the record of drugs administered shall accompany the opened kit when exchanged, an accurate record shall be maintained by the pharmacy on exchange of the drug kit for a period of 1 year
-the record of drugs adminisetered shall be maintained as part of the pharmacy records for 2 years
-IV soluntions can be stored seperately outside the kit
what is the protocol for emergency medical servcies technicain administering a drug?
-an oral order or written standing order of a practioner
-oral orders shall be reduced to writing by the tech and signed by the practioner
-written orders shall be signed by the operational medical director of the emergency medical services agency
-the tech shall make a record of all drugs administered to the patient and this record is signed by the practioner who assumes responsibility for the patient at the hospital
-if the patient is not transported to the hospital or if the attending medical practioner at the hospital refuses to sign the record a copy of this record shall be signed and placed in delivery to the hospital pharmacy who was responsible for the kit exchange by the agnecy;s operational medical director within 7 days of admin
in a long term care facilitiy who prepares an emergency kit and who adminsters the drugs?
-prepared by pharmacist
-kit access is restricted to nurse, pharmacist, prescriber
what conditions can a drug be administered in a long term care facility from an emergency kit?
-absence of the drug would threaten the survival of the paitents
-contents determined by the pharmacist in consultation with medical staff
-shall be limited to drugs for administration by injection or inhalation only wiht the exception of nitro SL
-the kit is sealed to prevent loss of drugs: once the seal is broken it wont be able to be resealed, the seal should have an identifer and pharmacy maintains the record until the seal is broken
-the kit shall have a form with the following information: name of the person opening the kit, date, tiem and name of quantity of items removed, the opened kit is maintained under secure conditions and returned ot the pharmayc within 72 hours for replinishing
-any drug used in teh kit shall be covered by a prescription signed by the prescriber when legally required within 72 hours
in addition to an emergency box or stat drug box what else must a long temr care faciliity who only allow licensed persons to administer medication have on hand as stock? who determines these things?
-IV fluids, irrigation fluids, heparin flush kits, medicinal gases sterile water and saline and prescription devices
-determine by the pharmacist in consulattation with the medical staff
how do you apply for a waiver of reporting requirements?
-individual or entity files a request in writing on a form provided by the department
-granted by the director
what requirements musts be met to recieve a waiver for reporting requirements?
-hisotry of compliance with laws and regulations and may include but not limited to:
-substantial hardship created by a natural disaster or other emergency
-dispensing in a controlled research project approved by a regionally accredited institution of higher education or under the supervision of a governmental agency
what is the process and act for recviign a wavier for reporting requirements?
-Administrative Process Act
-a waiver may be granted by a subordinate designee of the director on a case-by-case basis subject to terms and conditions stated in an order with a specifived time period and subject to being vacated
-an appeal of the inital decision may be filed wih the director–>director shall appoint an informal fact finding conference–> make a recommendation to the director–> the decision of the director is final
how shoudl reported data be transmitted?
-to the department or its agent within 7 days of dispensing as provided in the Electronic Reporting Standard for Prescription Monitoring Programs 4.1 of the American Society of Automation in Pharmacy
-transmitted in a file format provided by the department and shall be transmitted by a media acceptable to the vendor contracted by the director of the program
-transmisson shall begin on a date specified by the director no less than 30 days from notifications by the director to dispensors required to report
-data not accepted ybt eh vendor due to errors or omissons should be corrected and resubmitted within 5 business days
what are the required data elements for reporting?
-DEA registration number of the dispenser
-total number of refills ordered
-whether the rx is new or a refill
-date the rx was written by the presciber
what is the criteria for mandatory disclosure of information to the director?
-an individual shall be registered with the director as an authorized agent entited to recieve reports
-request for registration shall contain an attestation from the applicants employer of eligibility and identiy of such person
-registration as an agent shall expire on June 30 of each even numbered year
-agetn can only request info related to a specific investigation or in the case of a request from the Health Practionres Intervention Program disclosure of info related to a speciic applicant
when and who is inspected by one or more officers or
employees duly designated by the Secretary?
-every such establishment
engaged in the manufacture, propagation,
compounding, or processing of a drug or drugs or
of a device or devices classified in class II or III
-at least once in
the two-year period beginning with the date of
registration of such establishment pursuant to
this section and at least once in every successive
two-year period thereafter.
what is the def of a vet drug?
A drug intended for use by animals
other than man, other than a veterinary feed directive
drug intended for use in animal feed or
an animal feed bearing or containing a veterinary
feed directive drug, which—
(i) because of its toxicity or other potentiality
for harmful effect, or the method of its
use, or the collateral measures necessary for
its use, is not safe for animal use except under
the professional supervision of a licensed veterinarian,
what are the requirements for an emergency stat box for a correctional facility?
-prepared by a correctional facility pharmacy provided that the facility employs one or more full time physicians, registered nurse, licensed practical nurses or physicain assistants
what is the definition of a covered substance?
-all controlled substances included in schedules II,III and IV that are required to be reported to the Prescription Monitoring Program
directors role in the prescription monitoring program
-director shall establish, maintain and administer an electornic system to monitor the dispensing of covered substances
-the director may enter into contracts for the implementation and mainteance of the prescription monitoring program
-shall provide dispensers with a basic file layout to enable electronic transmisson of the information, if the dispeners is unable to transmits the information electronically the director shall provide an alternative means of data transmisson
-shall establish an advisory committee within the department to assist in the implementation and evaluation of the rx monitoring program
what information must a dispeser report upon dispensing a covered substance?
-recipeint name, address and date of birth
-the covered substance that was dispensed to the reciepeint
-the quantity of the covered substance
-date of dispensing
-prescribers identifier number
-dispenser’s idfentififer number
what are the exemptions to reporting on covered substances?
-dispensing manufacture samples
-dispensed pursuant to an indigent patient program offered by a pharmaceutical manufacture
-dispensing of covered substances by a practioner of the healing arts to the patient in a bona-fide medical emergency or when pharmaceutical services are not available
-administering covered substances
-dispesning within a licensed narcotic maintenance treatment program
-dispensing to inpatient: hospitals or nursing homes, hospice
-dispensing by vets to animals
what type of misdeamnor would someone be guilty of if htey have unlawful access to personal information or diclose confidential informatoin? same for information in the Prescription Monitorign Program
Class 1
what is the limitations placed on distributing hypodermic needles or syringes, gelatin capsules, quinine or any of its salts?
-if it is more than 1/4 ounce it is restricted to licensed pharmacists or to others who have recieved a license or permit from the board
for hypodermic needles or syringes, gelatin capsules, quinine or any of its salts the pharmacist must do what in regards to dispensing?
–ask the customer for ID, including proof of age
-ask the customer for written legitmiate purposes (except for telephone orders for such an item where the customer is in known good standing)
-time of dispensing keep the following on record: name and quantity of the device/ite,, price, name and address of hte customer, reason for purchase and pharmacist initals
-these things cannot be sold or distributed to anyone under the age of 16 except by a physician
what is the type of misdeamnor for someone who permits or causes directly or indirectly such controlled paraphenilla to be used for any other purpose other than which it is lawfully inteded is guilty of
Class 1 misdeamnor
how must insulin be dispensed?
-by a licensed pharmacist or under the supervision of a licensed pharmacist
what are the conditionsn that must be met to dispense a schedule V drug without a rx?
-only by a pharmacist directly to the person
-the customer must be 18 years of age
-the customer must have ID proof
-pharmacist knows it is being dispensed for medical purpose only
-max doses in 48 hours: 200 mg opium, 270 mg codine, 130 mg dihydrocodeinone, 65 mg ethylmorphine or more than 32 5/10 mg of diphenoxylate
-record: date of dispensing, name and quantity of preparation, name and address of the person who it was dispensed to, initals of pharmacist
what is the federal def of a controlled drug?
Any drug that is a controlled substance
listed in schedule II, III, IV, or
V of the Federal Controlled Substances
Act or implementing regulations must
be dispensed by prescription only as required
by section 503(b)(1) of the Federal
Food, Drug, and Cosmetic Act unless
specifically exempted in § 290.2.
what are the federal exemptions from needing a prescription for controlled drugs?
compound,
mixture, or preparation containing
not more than 200 milligrams
of codeine per 100 milliliters or per 100
grams that also includes one or more
nonnarcotic active medicinal ingredients
what are emergency situations where using an oral rx for a schedule II is allowed?
which the prescribing
practitioner determines:
(a) That immediate administration of
the controlled substance is necessary,
for proper treatment of the intended
ultimate user; and
(b) That no appropriate alternative
treatment is available, including administration
of a drug which is not a
controlled substance under schedule II
of the Act, and
(c) That it is not reasonably possible
for the prescribing practitioner to provide
a written prescription to be presented
to the person dispensing the
substance, prior to the dispensing.
what is the federal def of a new drug substances?
New drug substance means any
substance that when used in the manufacture,
processing, or packing of a
drug, causes that drug to be a new
drug, but does not include intermediates
used in the synthesis of such substance.
reasons a drug is considered new
-active substance or a menstruum, excipient,
carrier, coating, or other component
-The newness for a drug use of a
combination of two or more substances,
none of which is a new drug.
-The newness for drug use of the
proportion of a substance in a combination,
even though such combination
containing such substance in other proportion
is not a new drug.
-(4) The newness of use of such drug in
diagnosing, curing, mitigating, treating,
or preventing a disease, or to affect
a structure or function of the
body, even though such drug is not a
new drug when used in another disease
or to affect another structure or function
of the body.
– The newness of a dosage, or method
or duration of administration or application,
or other condition of use prescribed,
recommended, or suggested in
the labeling of such drug, even though
such drug when used in other dosage,
or other method or duration of administration
or application, or different
condition, is not a new drug.
what federal requirements are needed to be an over the counter drug?
-good manufacturing practices
-The establishment(s) in which the
drug product is manufactured is registered
-The advertising for the product
prescribes, recommends, or suggests its
use only under the conditions stated in
the labeling
-The product contains only suitable
inactive ingredients which are
safe in the amounts administered and
do not interfere with the effectiveness
of the preparation
-The labeling for all drugs contains
the general warning: ”Keep out of
reach of children.” [highlighted in bold
type]. The labeling of drugs shall also
state as follows: For drugs used by oral
administration, ”In case of overdose,
get medical help or contact a Poison
Control Center right away”; for drugs
used topically, rectally, or vaginally
and not intended for oral ingestion, ”If
swallowed, get medical help or contact
a Poison Control Center right away”;
and for drugs used topically and intended
for oral use, ”If more than used
for” (insert intended use, e.g., pain) ”is
accidentally swallowed, get medical
help or contact a Poison Control Center
right away.”
who has to be registered wtih the DEA?
Every entity involved in DEA manufacture, distribution, purchase or dispensing must be registered with DEA except ultimate consumer-includes long term care facility
Provides tight control and accountability
Not every INDIVIDUAL health care practitioner must be registered but employer or affiliated health care setting must be registered-pharmacist doesn’t have to register but if the pharmacy wants to distribute the controlled substances have to register
-CVS pharmacy: each pharmacy has to have a DEA registration
what activities require DEA registering?
Manufacturing, dispensing, researching, narcotic treatment programs, chemical analysis, and import and export of controlled substances
Each entity must provide separate registrations for each site where it conducts business
where does each entity have to register with the DEA?
Manufacturers and distributors (wholesalers) register each year at the end of the month assigned by DEA for the registration year (21 CFR 1301.13©)
Pharmacies, hospitals/clinics, teaching institutions must register once every three years in the month assigned by DEA (21 CFR 1301.13(d))
Most entities can reapply for reregistration within 60 days of expiration except importers/exporters that permits 120 day timeframe (21 CFR 1301.13(b))
who is exempt from registering with the DEA?
Agents or employees of registered manufacturer, distributor, or dispenser of any controlled substance when acting in the usual course of business or employment
Common or contract carrier or warehouseman or an employee thereof possessing the controlled substance in the normal course of business
FedEx, UPS, USPS, etc need not be registered
But, distinguish between entities registered with DEA to destroy controlled substances already dispensed
what are the practioniner requirements for registering with the DEA?
Physicians, dentists, veterinarians or other state-authorized prescribers must register with DEA (21 CFR 1300.01(b)(17))
DEA requires that each practitioner receive a unique DEA registration for each state that he/she practices medicine
when can a prescriber use a hospital’s DEA number to prescribe?
-Dispensing, administering, or prescribing is in usual course of professional practice
-Individual practitioner authorized by jurisdiction in which he is practicing
-Hospital or other institution where he is employed assures that the individual can dispense, administer, or prescribe drugs within the jurisdiction
-Individual acting within the scope of employment of hospital or institution
-Hospital or institution maintains a list of internal codes accessible to other DEA registrants and law enforcement personnel upon request
what are teh registration requirements for dispensers conducting research?
-Registered dispensers may conduct research without a separate registration for SII-V
-Applicant must submit protocol including
–Name and qualifications of the investigator
–Institutional affiliation
–Description of the project
–Copies of the IND and description of the security procedures used
what are the registration and reregistration requirements with the DEA?
-DEA issues Certificate of Registration (21 -CFR 1301.13a) before business can begin
-DEA issues renewal notices 60 days prior to expiration
-Registrants not receiving renewal notices must notify DEA within 45 days of expiration
-Registrants that do not renew in a timely manner face penalties and fines
what is the FDA def of a cosmetic?
-Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body for purposes of:
–Cleansing
–Beautifying
–Promoting attractiveness or
–Altering appearance and
-Articles intended for use as a component of any such article
what is the difference between an OTC drug and a cosmetic?
-Articles that are used for “treatment” then, it will be regulated as a drug
-If regulated as a drug, then it must include the OTC drug labeling
-Does not suggest that non-drug products are safer the OTC drug products
what is the VA def of a proprietary drug?
-Drugs that meet FDA requirements for OTC medications
-Cannot be a controlled substance or require a label indicating that it might be habit-forming
-Cannot be a product that must be administered by a licensed practitioner or dispensed by a pharmacy
what are the manufactuer labeling and packaging requirements for controlled drugs?
-Commercial containers of controlled substances must be labeled with the designated schedule by placing the C-I, C-II, C-III, C-IV, C-V or
-Symbol may be a C with the schedule number inside of it (21 CFR §1302.04)
what does the DEA require of inventory of controlled substances?
-Name of substance
-Dosage form and strength
-Number of units or volume in each container and
-Number of containers
-Date of receipt
-Name, address, and registration number of supplier
what does VA required of controlled substance records?
-Date of receipt
-Name and address of person or entity drugs received
-Kind and quantity of drugs received
-Kind and quantity of drugs removed or produced from process of manufacture
-Dates of production or removal from manufacture
what are the 3 ways controlled substance records can be filed according to the DEA?
A.
One for CII
One for C III, IV, V
One for all other non-controlled substances
B.
One for CII
One for CIII, IV, V and non-controlled substances
C.
One for all CII-V controlled substances
One for non-controlled drugs
can chain pharmacies maintain some controlled substance records at a central location as long as they notify the DEA and the records are available within 48 hours?
yes
what are the rules for counting controlled drugs?
-CI or CII must make an exact count or measure of each substance in inventory
-CIII-V may make an estimated count except if for containers holding more than 1000 tablets or capsules which require an exact count
DEA forms: ordering CII
-registration for pharmacies, hospitals and clinics
-registration for manufactures and distributors
-registration for narcotic treatment programs
-form for loss of controlled substances
-form for destruction/disposal of controlled substances
-222
-224
-225
-363
-106
-41
when can a fax serve as the rx for a schedule II?
-Narcotic substance compounded by pharmacy for direct administration to patient by parenteral, IV, IM, SQ, or in intraspinal infusion (21 CFR 1306.11(e)
-Residents of long-term care facilities (21 CFR 1306.11(f))
-Hospice setting certified by the Medicare program or licensed by state (21 CFR 1306.11(g))
Individual may be in a home hospice setting, does not have to be institutional
what does the VA label require for schedule III-VI?
-Rx number or name of drug
-Date of initial filling
-Pharmacist or pharmacy name and address
-Name of patient or name of animal and owner
-Name of prescriber
-Directions for use
when are you exempt from registering as a distributor?
when returning controlled substances to a wholesaler or a manufacturer by a registrant
what are exclusions from federal scheduling?
-A manufacturer or other entity may petition DEA for exclusion of a substance under any of the federal schedules
-DEA accepts or denies the request, notifies applicant, and
-DEA must issue a public notice with details of the final order in the Federal Register open for public comment for at least 60 days
definition and examples of schedule I?
-Schedule I: high potential for abuse; no currently accepted medical use in US; lack of accepted information on safety even under medical supervision
–Some researchers may legally conduct experiments with these drugs if properly registered with DEA
–Even if states pass laws/referendums approving medical use of Schedule I drugs, until recognized by DEA, cannot enforce
definition and examples of schedule II?
-Schedule II: high potential for abuse; currently accepted medical treatment in US or currently accepted medical use with severe restrictions; abuse can lead to severe physical or psychological dependence
–Commonly prescribed drugs include: Ritalin and other amphetamines for ADHD; Percocet and its generic equivalents; Oxycodone and generic equivalents; Dilaudid and generic equivalents
definition and examples of schedule III?
-Schedule III: high potential for abuse but less than drugs in SI and SII; currently accepted medical use in US; abuse may lead to moderate or low physical dependence or high psychological dependence
–Categories include: barbiturates; APAP/ASA with codeine; weight loss agents with amphetamine; anabolic steroids; GHB; paregoric
defintion and examples of schedule IV?
-Schedule IV: low potential for abuse relative to drugs or other substances in SIII; current accepted medical use in US; abuse may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in SIII
–Categories include: drugs with NMT 1 mg difenoxin and not less than 25 mcg of atropine sulfate per dosage unit; benzodiazepines; barbital; chloral hydrate; certain stimulants such as diethylpropion and phentermine
defintion and examples of schedule V?
-Schedule V: low potential for abuse relative to drugs or other substances in SIV; current accepted medical use in US; abuse may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in SIV
–In many states, including VA, SV drugs can be sold by a pharmacist without a prescription
–Common agents include Robitussin with codeine and generic versions
what are the guidlines for DEA inspections in DEA registered entities?
-allows DEA to enter premises of registrants where controlled substances or records are maintained and may
–Examine and copy all records related to controlled substance distribution, prescribing or dispensing (not financial records)
–Inspect the premises
–Inventory controlled substances
-Inspector must state the purpose for the inspection along with a written notice to which the owner or the pharmacist in charge must consent need to contact the owner before inspection occurs
definition of light resistant container
means a container that protects the contents from the effects of light by
virtue of the specific properties of the material of which it is composed, including any coating
applied to it. Alternatively, a clear and colorless or a translucent container may be made lightresistant
by means of an opaque covering, in which case the label of the container bears a statement
that the opaque covering is needed until the contents have been used
pursuant to an oral or written order what may a prescriber who is licensed to administer and possess radiopharmaceuticals do?
-may authorize a nuclear medicine technologist to administer radiopharmaceuticals under the prescribers supervisison
pursuant to an oral or written order a prescriber may allow a registered nurse or licensed practical nurse to possess what?
-epinephrine for admin in emergency medical conditions
-heparin and sterile normal saline for maintenance of IV access lines
the board of health allows emergency medical tech so possess what?
epinephrine
pursuant to an oral or written order a prescriber may allow a licensed atheletic trainer to possess and administer what?
-topical corticosteroids
-topical lidocaine
-other schedule VI topical drugs
-epinephrine for anaphylactic shock
pursuant to an oral or written order a prescriber may allow a licensed physical therapists to possess and administer what?
-topical corticosteroids
-topical lidocaine
-any other schedule VI topical drug
pursuant to an oral or written order a registered or licensed practical nurse (under supervision of RN) may administer what in the absence of a prescriber?
PPD tuberculin purififed protein derivative
pursuant to a written order or protocol a prescriber may authorize with the consent of parents in regard to a child with diabetes
-an employee of a school board who is trained in admin of insulin and glucagon assist in the admin when a licensed nurse, nurse practioner, physicain of physican assisstnat is not present
a prescriber may authorize pursuant to a protocol that who can administer vaccines to adults when a practioiner is not physically present?
-pharmacists
-registered nurses
-licensed practical nurses (under the immediate supervision of a registered nurse)
pursuant to a written order what may a dentist authroize a hygientist to adminsster?
-topical oral fluorides
-topical oral anethstics
-topical antimicrobail agents for periodontal pocket lesions
-any other schedule VI topical drug
-schedule VI nitrous oxide and oxygen inhalation analgesia
-shcedule VI local anthesisa
pursuant to an oral or written order the prescriber may authorize nurses certified as sexual assualt examiners to possess and administer what? abrrevation for nurse?
-SANE-A
-preventive medications for victims of sexual assualt
medication aides registered by the board of nursing may administer what to residnet of asisted living facility?
drugs that would otherwise by self-administered
if someone has recieved training and they are authroized by the State Health Commissioner what may they do?
administer drugs and devices during a disaster or state emergnecy, bioterrism or public helath emergency
-the drugs and devices are nessecarry for health
a nurse or dental hygientist may adminster topical oral fluoride to who and when?
-children 6 months to 3 years pursuant to an oral or written order/protocoal wiht an MD, dentist or osteopathic medicine
people that are allowed to administer controlled substnaces in a hospital are authorized to administer what?
-influenza or pneumoccoccal vaccine
purusant to a specfic order for a patient and under the supervision fo the prescriber, a prescriber may authorize the administration of controlled substances by trained personnnel except for the following routes
-IV
-intrathecal
-epidural
who may administer influenza to minors when the prescriber is not physically present?
-pharmacist
-registered nurse
-licensed practical nurse (under the supervision of an RN)
-medical emergnecy technician intermediate
-medical technicain-paramedic
who must a dialysis technician recieve certification from?
-Board of Health Professions
what are the requirements of an automated data processing system for the storage and retrival of original and refill dispensing information
-a schedule VI prescription can be stored electronically as long as it is accessible within 48 hours
-storing an electronic instead of a hard copy for schedule II-V is only allowed if allowed by federal law
how long must a computer system provide retrival via a computer monitor or printout for past rx?
2 years
in regards to dispensing information in automated processing records what must each pharmacist do?
printout for each day’s prescritption data shall be verifed, signed and dated by the individual pharmacist who dispensed the rx
if a drug is not able to dispensed in the USP-NF type of packaging for that drug what must it be dispensed in?
well closed container
what are the standards for customized patient medication packaging?
-allows for the seperation of individual containers
-labels for each individual container shall be labeled with the idenity of the drug
-main packaging label shall contain all the required elements for an outpaitiet rx label and shall contain a physical description identifying each solid dosage form in the individual container
-series of individual containers/pockets labeled with specific date and time, when the contents are to be taken
what must be included on the label of a compounded rx?
-beyond-use-date
a pharamcist may compound drug products before receving an rx based on a routine, regulary observed prescribing pattern, what must be on the label?
-name and strength of compounded medication or a list of active ingreidnts and strengths
-pharmacy’s rx number for the compound
-beyond use date
-quantity
a pharmacist may provide compounded products to what types of practionres and what must be included on the label?
-medicine, osteopathy, podiatry, dentistry, vet
-For Administering in Prescriber Practice Location Only
-name and strength of compounded medication or list of active ingredients and strengths
-pharmacy’s rx number for the compound
-beyond use date
-quantity
pharmacists must perform of personally supervise the compounding process which includes what?
-final check for accuracy and conformity
-correct ingreidents and calculations
-accurate and precise measurements
-appropriate conditions and procedures
-appearance of the final product
what are the requirements for using a bulk drug substance when compounding?
-comply with monograph/standards of USP
-manufactured in an establishment registered with the FDA
-distributed by a licensed wholesaler: so that the pharamcist can establish purity and safety (lot anaylysis, manufacture reputation or reliability of the source)
a pharamcist may not compound inordinate amounts of drug products that are copies of commercially available products except for the following:
-the compounding of a commercial product that at the time is not available
-the mixing of two or more commercial products regardless if the end product is commercially available
what needs to be recorded for a compound pursuant to a rx for a single patient where only manufactures finished products are used as components in the compound?
-name and quantity of all components
-date of compounding and dispensing
-rx number
-total quantity of finished prodcut
-signature/initals of the tech/pharmacist doing the compound
-signature of the pharmacist verifying the accuracy
what needs to be recorded for products compounded in bulk or batch in advance of dispensing when bulk drug substances are used?
-generic name and the name of the manufacture of each componenet
-manufacture’s lot number and expiration date
-the source of aquiststion of the component
-the unit or package size and the number of units or packages prepared
-beyond use date
centralized/remote processing of an rx does not include dispensing but includes what activities?
-recveign, interpreting, anlyzing or clarifying rx
-entering rx and patient data
-transfering rx info
-prospective drug review
-obtaining a refill or substitution authroization
-interpreting clinical data
-perform therapeutic intervention
-provide drug information or counseling
a pharmacy may outsourse rx processing except for dispening to another pharmacy in VA or a registered non-resident pharmacy in the following conditions:
-pharmacies have the same owner or a written contract describing the scope of services
-the pharmacies shall share a common electronic file or have technology which allows sufficient info necessary to process a non-dispensing function
if a pharmacy outsources rx processing to another pharmacy what must be done in terms of customers?
-notify customers
-one time written notification or a sign posted in the pharmacy
a policy and procedure manual that relates to central or remote processing shall be maintained at each pharmacy to include the following information
-responsibilties of each pharmacy
-name, address, telephone number and permit and registration of all pharmacies invloved
-procedures for protecting confidentialtiy and integrity of patient information
-procedures for ensuring that pharmacists perform prospective drug reviews
-procedure for maintaing required records
-procedures for complying wiht laws and regulations regarding counseling
-procedures for objectively and systematically monitoring and evaluating the quality of the program to resolve and improve services
what other records do central/remote processing pharmacies have to keep?
-for each rx processed: each individual processing function and identity of the pharmacist or pharmacy tech who performs a processing function
-a record showing each processing task
-identity of the person performing each task
-location where the task was performed
who are the only people that can administer drugs from a stat drug box?
-licensed nurse
-pharmacist
-prescriber
what information must be included on a form for a stat drug box?
-name of the person opening the box
-date, time and name and quanitty of times removed
where should the listing of drugs in stat box be kept?
-in the pharmacy
-attached to the box at the facility
-policy and procedure manual
what is the expirationd date for the stat box based on?
-the first drug in the box that will expire
what are the limitations for controlled drugs in the stat box?
-no more than 20 solid dosage units per schedule II-V except that one unit of liquid not to exceed 30 mL (which may be substituted for a solid dosage unit)
what must hte PIC in a hospital establish if it wishes to place drugs in an automated drug dispensing system?
-procedures for accurate stocking and proper storage
-ensuring accountability for and security of drugs
what kind of security needs to be in place for hospital drugs in an automated dispensing system?
-preventing unauthroized access
-complying with federal abd state regulations for prescribing and dispensing controlled substances
-maintaining patient confidentiality
what type of packaginag must drugs be in if theyrae in a automated drug dispensing system in a hospital?
-manufactures orginial container or unit dose containers
what procedures must the PIC for a hospital pharmacy using an automated dispensing system establish?
-periodically inspecting and auditing automated drug dispensing systems to insure proper storage, security and accountability
-reviewing the operation and maintenance of automated drug dispensing systems
if a hospital pharmacy uses automated dispensing system who establishes regulations for the miniumum requirements for random periodic inspections and monthy audits to assure proper storgae, securtiy and accountability of all drugs?
the Board of Pharmacy
if a drug is not personally hand delivered directly to a patient what must be done?
-written notification placed in the shipping noting that some chemical degradation may occur (toll free number about chemical degradation)
what happens if a schedule VI is not personally hand delivered to the patient?
-the delivery location shall hold a current permit, license or registration wtih the board that authorizes the posession of controlled substances at that location
who are the only health care professionals that are allowed to repackage a dispensed delivered drug at at community services board or behavioral health authority facility?
-pharmacist
-pharm tech
-nurse
who shall determine by using information from the Prescription Monitoring Program criteria for misuse?
the Director of the board with an advisory panel
in an automated device for dispensing prior to removal of drugs from the pharmacy a record must be generated with teh following information
-date
-drug name
-dosage form
-strength
-quantntiy
-hopsital unit
-unique identifier
-initlas of the person loading the automated device
-initals of the pharmacist checking drugs to be removed
automated dispensing devices must be capabale of producing a hard copy record of the follwoing info
-paitent name
-drug name and strength
-dose withdrawan
-dose to be adminsitered
-date and time of withdrawal from the device
-identity of the person withdrawaing the drug
the PIC must conduct a monthyl review for schdeudle II-V in an automated dispensing device to include the following
-reconcile records of all quantities of schedule II-V removed from phamacy and loaded into the device
-discrepancy report for any issues–> resolved in 72 hours by PIC
-sample of administration records from each device per month fro possible diversion by fraud (sample shall be a 24 hour time period)
-ensure a valid medical order exists for a sample of doses adminstered
-check for compliance with writtten procedures for security and the use of automated dispensing devices
how often must automated dispensing devices be inspected to verify proper storage, location of drugs within the device, expiration dates, security of drugs and validity of access codes?
monthyl by pharmacy personnel
records for automated dispensing devices must be kept in the pharmacy providing the services for the hospital except
-manual schedule VI distribution records can be stored offsite or electronically if they are accessbile within 48 hours
-distribution and delivery records and required signatures may be generated or maintined electronically in the following conidtions: unique identifier that is restricted to the indviidual required to inital or sign the record, the records are maintained in a read-only format that cannot be altered after the information is recorded, the system can produce a hard copy printout upon request
what are the requirements for hard copy distribution and adminsitration records for audits for automated dispensing systems to be maintained offsite?
-readily retrieved
-read-only format
-seperate log is maintained for a period of two years showing dates of audit and rewivew, the identity of the automated dispensig device, the time period covered by the audit and review and intitals of the reviewers
when can the director disclose information?
-to the customer with a valid photo id, person is over 18 and the id has a notarized signature
-to a prescriber to establish a treament history-prescriber must present DEA
-regulatory authority conducting an investigation or disciplinary decision on granting of a license or certificate provided teh request is related to an allegation of a possible controlled substance violation
-gov enttities charged with the investigation and prosecution of the dispenser, prescriber or recipeint in VA Medicaid Program provided the request is accompanied with the signature of the official within the Office of the Attorney General
-dispenser for the purpose of establishing rx history for a specific person to assit in determing the validtity of a rx provided the request is accompanied by the dispensers license number
what is a Class I medical device?

A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.

(ii)A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it—
(I)is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and

(II)does not present a potential unreasonable risk of illness or injury,
is to be regulated by the controls referred to in clause

what is a class II medical device?
A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 360(k) of this title), recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.
what is a class III medical device?

be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and

(II) cannot be classified as a class II device because insufficient information exists to determine that the special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness, and

(ii)
(I)is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or

(II)presents a potential unreasonable risk of illness or injury,
is to be subject, in accordance with section 360e of this title, to premarket approval to provide reasonable assurance of its safety and effectiveness.

what is the registration process for producers of drugs and devices?

On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary his name, places of business, and all such establishments.

(2)During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments.

who does not have to register as a producer of a drug substance?
-pharmacies which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail
-practitioners licensed by law to prescribe or administer drugs or devices and who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice;(3)persons who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in research, teaching, or chemical analysis and not for sale;

(4)any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or

(5)such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that registration by such classes of persons in accordance with this section is not necessary for the protection of the public health

when the producer register what else must they do?
Every person who registers with the Secretary under subsection (b), (c), (d), or (i) of this section shall, at the time of registration under any such subsection, file with the Secretary a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by its established name
give more examples of a misbranded drug
-Label or labeling must not be false or misleading
-Package must contain information on manufacturer, packer, or distributor
-Must contain all statements, words or designs required or approved by FDA, including package inserts, MedGuides, etc
-Controlled substances must contain “Warning-May be Habit Forming”
-Prescription drugs must have established name or ingredient prominently displayed
-Proprietary name must be included in type 1/2 the size of established name-Information regarding dosages that might be dangerous to health or unsafe
-Information related to dangers of use in children
-Special packaging requirements to prevent deterioration, etc.
-If it fails to meet conditions of the Poison Prevention Packaging Act

how must schedule III-V prescriptions be filed?
-in a seperate file labeled schedule III_V or that they are readily retrieavble
-need to be stamped with a red C no less than one inch hgih
-however if a pharmacy uses an electronic system which permits identification by prescription number and retrieval of original documents by prescirbers name, patients name, drug dispensed and date filled then the requirement to mark the hard copy of an rx with a red C is waived

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