Title 26, Chapter 3: Standards, Labeling, and Adulteration of Drugs
and Cosmetics
Definitions
Prohibited Acts
Manufacturing or providing for sale or delivery any drug,
device, cosmetic that is adulterated or misbranded
Committing an act that will result in adulteration or
misbranding of any drug, device, or cosmetic Disseminating
false advertisement
Refusing to permit entry or inspection or taking a
sample Giving a guarantee or undertaking which is
false Removing or disposing of a detained or embargoed
article
Title 26, Chapter 3: Standards, Labeling, and Adulteration of Drugs
and Cosmetics
Inspection of factories, warehouses, establishments, or vehicles
Board of Pharmacy (BOP) or its agents have free access at all
times to factories, warehouses, establishments, or vehicles for the
purpose of conducting an inspection and securing samples, if
applicable. Is a misdemeanor for impeding,
obstructing, hindering, or preventing an agent from performing
his/her duty.
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 1: General Provisions
Practice of Pharmacy
Interpreting, evaluating, or dispensing of
prescription drug orders in patient's best interest;
Participating in drug and device selection,
drug administration, drug regimen reviews, and
drug or drug related research; provision of
patient counseling and the provision of those
acts or services necessary to provide pharmacy
care;
Performing capillary blood tests and
interpreting results as a means to screen
for or monitor disease risk factors and
facilitate patient education, and a pharmacist
performs such functions shall report the results obtained from such
blood tests to the patient's physician of choice;
Compounding and labeling of drug devices
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 2: State Board of Pharmacy (BOP)
BOP has duties, powers, and authority granted by or
necessary for enforcement of Title 26, Chapter 4
BOP is under the jurisdiction of the Secretary of
State and is a division of the Department of
Community Health
The Georgia Board of Pharmacy is comprised of ___ pharmacist(s) and
____ consumer member (s)
7 pharmacists and 1 consumer member
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 2: State Board of Pharmacy
Eligibility requirements for BOP membrers
7 pharmacist members
GA
resident for at least 6
months
Currently licensed to practice in GA and in
good standing Be actively
engaged in the practice of pharmacy in GA Have
5 years experience in GA after licensure
Not officially employed as FT faculty of a
school/college of pharmacy
1 consumer member
Resident
of GA of majority age No connection to pharmaceutical
industry
Who are the members selected by?
The Governor
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 2: State Board of Pharmacy
Power,
duties, and authority for control and regulation of the practice of
pharmacy in Georgia
License pharmacists (exam, transfer, renewal),
pharmacy interns, and pharmacies
Regulate other employees in the Rx Department
(technicians)
Determine and issue standards for recognition and
approval of degree programs and enforcement of requirements of
practical training
Enforce provision s related to
conduct or competence of RPhs (license suspension, revocation, or
restriction)
Right to seize drugs and devices fount to be an
imminent danger to public health and welfare
Establish minimum specifications
for physical facilities, technical equipment, environment, supplies,
personnel, and procedures for storage, compounding, and
dispensing
Regulate and establish minimum standards for the
use and operation of remote automated systems (e.g. skilled nursing
facilities and hospices)
Issue and renew licenses or permits for those
engaged in the manufacture and distribution of drugs, devices, and
DMA (e.g. manufacturers, wholesalers, reverse drug
distributors)
Inspect licensed persons to determine if laws
governing legal distribution of drugs/devices or the practice of
pharmacy is being violated
Identify substances that could be potentially
dangerous to public safety if dispensed without a prescription
Expunge pharmacy related practice records of any
pharmacist whose records consists of EtOH impairment ONLY
and hose record has been clean for 5 years
Restrict inspection or examination of records or access to
any area licensed to BOP, GDNA, DEA, Department of
Community Health or other federal agencies entitled to inspect by
law, subpoena, or court order
Serve as the sole authority to approve or recognize
accreditation or certification programs for specialty practice
Issue cease and desist order
Refer cases for criminal prosecution
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 2: State Board of Pharmacy
Notification to
board of convictions
Licensee, registration holder or permit holder
convicted of a felony must notify the board within 10 days of
conviction
Failure to notify the board will be considered
grounds for license revocation
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 2: State Board of Pharmacy
Georgia Drugs and Narcotics Agency (GDNA)
Agents are registered RPh's in GA BOP appoints
director Director and/or agents have the power to:
Visit and inspect where drugs, devices, or
cosmetics are manufactured, processed, packaged, and sold
Enter and inspect any vehicle used to
transport or hold drugs, devices, or cosmetics
Investigate alleged violations of laws and
regulations regarding drugs, devices, or cosmetics
Take samples Seize and
take possession of articles declared to be
contraband Compel witnesses to appear and
produce evidence via subpoena
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 2: State Board of Pharmacy
Georgia Drugs and Narcotics Agency (GDNA)
Agents have the same authority and power of a
sheriff to make arrests Transfer person
arrested to the county sheriff's custody where the alleged
offense took place
Prepare "the Dangerous Drugs List" - list
of prescription drugs that is approved by the State of Georgia each
year
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
Unlawful to practice pharmacy without license
Practitioners authorized to compound and dispense
to patients in their respective profession are not required
to be licensed by the BOP Must meet the
same standards, record-keeping
requirements, and all other
requirements for dispensing as
pharmacists
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
Qualifications for license
Submit an application to the board and pay a
fee Be of majority age and
good moral character Be a
graduate of an approved school/college of
pharmacy Complete an internship or other
program that meets the board's requirement for
experiential education Successfully pass
required licensure exams
In order for a candidate to be licensed in the state of Georgia, what
is the minimum score he/she is required to make on the NAPLEX examination?
75
In order for a candidate to be licensed in the state of Georgia, what
is the minimum score he/she is required to make on the jurisprudence examination?
75
In order for a candidate to be licensed in the state of Georgia, what
is the minimum score he/she is required to make on the Georgia
Practical examination?
75
A score of less than ___ on any section of the Georgia Practical
examination invalidates all the scores from that administration of the
Georgia Practical examination.
70
AT is a graduate of an generally recognized school or college of
pharmacy that is approved by ACPE. AT has applied for licensure in
Georgia. AT took the NAPLEX, MPJE and Georgia Practical exams on the
following dates and AT's exam results are listed below. Is AT eligible
to take the Georgia Practical exam again?
NAPLEX: June 1 (failed); July 15 (passed)
MPJE: June 15 (failed); August 1(passed)
Georgia
Practical: June 10 (failed); August 15 (failed)
Yes
Who may be granted a temporary pharmacist license? Select all that apply.
A pharmacy resident who has submitted evidence he/she has
accepted a pharmacy resident position in the state. A
member of our military service or military spouse.
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
Qualifications for
examination
Licensing exams are available at least 2 times each
year BOP determines content and
subject matter, place, time and date of exam
Exam measures competence of applicant to
engage in practice of pharmacy Anyone who takes the board and
fails, may repeat the exam at regular intervals (it is
administered 4 times a year: January, March, June, and August)
May not take exam more than 3 times
without permission from BOP Anyone who
has taken and failed exam 3 times,
may NOT practice as a pharmacy
intern Must successfully complete
the exam and become licensed within 2 years of the exam
date or the exam results are
invalid If you have not completed at least
one of the exams by the 2 year
deadline, all of your scores are deleted and
you will have to take every exam again.
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
License transfers
RPh's are eligible to transfer licensure from another state to
GA so long as the state that the license was issued in
grants licensure transfers to GA RPh's RPh's
licensed in another state wanting to obtain licensure in GA must:
Apply for licensure
in GA and pay a fee Be of majority
age and good moral character
Provide proof of initial licensure by exam
and proof their licensure in good
standing Provide proof that license(s)
in other state(s) has/have not been suspended, revoked, or
restricted EXCEPT for non-renewal or
failure to obtain required CE At
the time of initial licensure, have all the
qualifications necessary to have been eligible for licensure
in GA Successfully pass required
exams for licensure in GA
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
License transfers
RPh's who have graduated from a pharmacy school recognized by
the Foreign Pharmacy Graduate Examination Committee of NABP
must: Successfully complete of all required
exams Be issued an equivalency certifcate by NABP
Undergo an individual evaluation by the BOP for proficiency
in the English language
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
Temporary licenses
May be issued by the BOP if an applicant produces satisfactory
evidence of fulfilling the requirements for licensure except
by examination and evidence of an emergency situation
justifying a temporary license Temporary (~90 days),
may not be reissued or renewed Pharmacy residents may
be issued a temporary license
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
Renewal of licenses RPh's licenses must be
renewed biennially (q2y) Must pay
fee and meet continuing education
requirements 30 hours of
approved
CE Failure to renew
license requires RPh to apply for reinstatement
Inactive license
RPh may apply to have their license listed as
"inactive" Inactive RPh are exempt from CE
requirements
A pharmacist licensed before or during the first six (6) months of
the biennium (January to June) is required to obtain 30 hours of CE. A
pharmacist licensed during the following twelve (12) months (June to
July) is required to obtain 15 hours of CE. A pharmacist licensed
during the last six (6) months of the biennium is exempt from CE
requirements for that biennium only.
A pharmacist's license is renewed every even numbered year. Assume
you are licensed in June 2022. How many CE credits would you have to
earn in order to renew you license by December 2022?
A pharmacist who is
licensed in January
2021 - June 2021 is required to earn 30 hours of
CE before renewing his/her license in December 2022.
A
pharmacist who is licensed in July 2021 - June 2022 is
required to earn 15 hours of CE before renewing
his/her license in December 2022.
A
pharmacist who is licensed in July 2022 - December
2022 is not required to earn any CE hours before
renewing his/her license in December 2022.
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy: Pharmacy Interns
Required to submit an application and pay a
fee Be of majority age and
good moral character Be
currently enrolled in a school/college of
pharmacy Be a graduate of an approved
school/college obtaining practical experience required for
licensure Be an individual who completed all
requirements of the Foreign Equivalency
Certification Program Expires 5
years after issuance, when an intern is expelled,
suspended, dismissed or withdraws from pharmacy school,
when an intern fails the board exam for the 3rd
time
Which of the following is/are true regarding persons who may register
as pharmacy interns?
Candidate who graduated from a school or college of pharmacy in
another country and who has established educational equivalency by
obtaining a Foreign Pharmacy Graduate Examination Committee certificate.
Which of the following is/are true regarding pharmacy intern
licenses? Select all that apply.
Licenses may be renewed at the discretion of the
Board. Licenses become invalid when a candidate has
taken and failed the Board examination for the third
time. Licenses become invalid when a
candidate becomes a licensed pharmacist.
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
Drug researcher permit
Anyone who is not a pharmacist, pharmacy, drug
wholesaler, distributor, supplier, or practitioner may
handle, possess, utilize controlled substances and/or dangerous
drugs if they are
conducting research, analysis, animal training, or drug
education Must register with the BOP
for a drug researcher permit May not engage in the
sale, distribution, or dispensing of controlled
substances or dangerous drugs
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
Drug therapy
modification certification
Drug therapy modification certification No RPh
is authorized to modify drug therapy unless: They are a
licensed RPh in GA Have successfully
completed a board approved course in drug therapy
modification Complete board approved
CE on drug therapy modification annually
Age certified by the board in drug therapy
modification
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 3: State Board of Pharmacy
Drug
researcher permit
Anyone who supplies DME and submits a 3rd part claim for
reimbursement must have a DME supplier license
Pharmacies, RPh's, hospitals, AmCare surgery centers, SNF's,
and ALF's are exempt from DME supplier license
requirement.
True or False:
Personnel engaged in the delivery of or in-home maintenance
and repair of durable medical equipment (DME) are not required to
provide counseling or instruction to a patient or patient's caregiver
about the proper use of such equipment. The physician or the
physician's agent is responsible for providing counseling or
instruction on how to use and/or repair the equipment.
FALSE
A durable medical equipment supplier must maintain records of all
equipment and devices shipped, mailed, or delivered to patient in
Georgia for a period of at least __ years.
2 years
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 4: Discipline
Grounds for suspension, revocation and refusal of license
Engaging in unprofessional, immoral, unethical,
deceptive, or deleterious conduct or practice harmful to
the public
Incapacitated and unable to engage
in practice of pharmacy with reasonable skill, competence, and
safety to the public
Convicted of a felony, any crime
involving moral turpitude, or guilty of
violations of pharmacy or drug laws
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 4: Discipline
Grounds for suspension, revocation and refusal of license
Failing to pay costs associated in a disciplinary
hearing Becoming unfit or incompetent to
practice because of the use of the alcohol
, narcotics, habit-forming drugs, or stimulants
or any abnormal physical or mental
condition Deemed mentally incompetent
by a court
Violating rules and regulations of the BOP
Regularly using the mail or other common
carrier to sell, distribute, and deliver a Rx to a patient
(exceptions to the rule do exist)
Dispensing different drug (or brand) from what was
prescribed without prior authorization from the prescriber
Title 26, Chapter 4: Pharmacists and Pharmacies
Article 4: Discipline
Grounds for suspension, revocation and refusal of
license
BOP may suspend or revoke the PIC's license
when a complete and accurate record of all controlled
substances on hand, received, manufactured, sold, and
dispensed has not been kept or does not meet inventory
requirements BOP may suspend or
revoke a RPh's license for failure to pay child
support or for defaulting on a student
loans Anyone whose license has been suspended,
revoked, or restricted may petition the board for
reinstatement at regular intervals
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
License required for practice of pharmacy Anyone
engaged in the practice of pharmacy MUST be
licensed Prescriptions may be dispensed
only pursuant to a valid prescription order
You have been requested to provide this medication or
device to a patient by a licensed prescriber
RPh;s have the same CORRESPONDING LIABILITY
for Rx's as the issuing prescriber Valid Rx's
include those by a physician, dentist, podiatrist,
veterinarian, or other licensed person authorized by law to
prescribe Rx's may be accepted by a RPh
or pharmacy intern/extern that is either
written, oral, via electronic visual image (fax), or
electronic data prescription drug order
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Dispensing prescription drugs A hard copy Rx
that has a visual image of the prescriber's electronic signature
that is not faxed to the pharmacy, MUST be
printed on security paper Rx's transmitted
electronically must be sent to the patient's pharmacy of
choice with no
intervening person having access to the
prescription
Prescription drug orders transmitted or received by facsimile or
other electronic means must include which of the following? Select all
that apply.
Name, address and telephone number of the prescriber
Name and address of the patient Time and date of
transmission Prescriber's NPI
Transmission of prescriptions to answering machines and electronic
voice recording devices can be retrieved by whom? Select all that apply.
A licensed pharmacist A pharmacy intern A
pharmacy extern
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Electronic Rx's transmitted by fax or computer must
include: Complete name and address of prescriber
DEA registration of prescriber, if Rx is for a controlled
substance. Prescriber's telephone number
Patient's name and address Transmission time and
date Full name of person transmitting Rx
Practitioner's signature
RPh must exercise professional judgement regarding the
accuracy and authenticity of any electronically transmitted,
issued or produced Rx
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Electronic Rx's transmitted by fax or computer
Name of the person transmitting the prescription drug
order is not required for Rx's transmitted by fax
or computer in the institutional setting
Ex: Hospital pharmacies, nursing home pharmacies, clinic
pharmacies, or pharmacies owned or operated directly by
HMO's
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Remote prescription order entry Hospital pharmacies
may use remote order entry for Rx drug orders
when: RPh is not physically present in the hospital, the
hospital pharmacy is closed, and a licensed RPh will be
present in the hospital within 24
hours At least 1 RPh is
physically present in the hospital At
least 1 RPh is physically present in another hospital within GA
which remotely serves...on weekends <4 hospitals
under the same ownership and have average daily census of
<12 acute patients Applies to
rural part of Georgia with very small hospitals or acute care
hospitals They must get approval
from the BOP. Before a
hospital can engage in remote entry, the pharmacy director must
submit written polices and procedures to the BOP for
approval
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Patient profile Information in the
patient's medication record is confidential and can only be
released to:
Patient Patient's authorized representative
Prescriber Other licensed practitioners caring for the
patient Another RPh Board of Pharmacy, or
Any other person duly authorized to receive such
information
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Prescription refills
Rx's may not be refilled without authorization from the
prescriber When refills are dispensed pursuant to
authorization contained on the original Rx or when no refills are
authorized on the original Rx but refills are subsequently
authorized, the refill
authorization must be recorded on the original
Rx or some other uniformly maintained
record (e.g. computer system) Dispensing RPh must
record refill date, quantity dispensed, and dispensing RPh's
initials
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Prescription refills (26-4-80)
Original Rx's for Schedule III, IV, or V controlled substances
which contain no refill information may not be authorized to be
refilled more than 5 times or after 6 months
from the date of issuance, whichever comes
first. Any authorization for additional refills for
Schedule III, IV, or V controlled substances in excess of 5
refills or after 6 months from the date of issuance shall be
treated as a new Rx
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Prescription refills (26-4-80)
When filling/refilling a Rx, the RPh must exercise
professional judgement No Rx shall be
filled/refilled with greater frequency than the approximate
interval of time than the dosage regimen would indicate unless
there are extenuating circumstances
When a patient no longer seeks treatment
from a practitioner, the patient-practitioner
relationship is terminated Rx's are invalid
6
months after the patient-practitioner
relationship is terminated Patient
has
6 months to
establish a new relationship and get a new Rx
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Prescription refills (26-4-80)
To prevent unintended interruptions in drug therapy for topical
ophthalmic products A RPh may permit refills
without refill authorization or obtaining a new Rx,
refills at 70% of the predicted days supply At the
patient's request, practitioner's may authorize refills
earlier than 70% of the predicted days supply
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
When may an RPh dispense up to a 72-hour supply of a
prescribed medication when he/she are unable to contact the
prescriber to get a refill authorization?
Rx is not a controlled
substance In the RPh's professional
judgement, interruption of therapy may produce
undesirable health consequence s or
physical/mental discomfort RPh
notifies the prescriber within 7 days of
dispensing RPh records the dispensing as a
separate non-refillable Rx. Rx is filled with all other
Rx's and has all required Rx information including the Rx
number from which the Rx was dispensed RPh records
in the patient's record and on the new Rx the
circumstance(s) which warranted dispensing
RPh does not employ this provision regularly
for the same patient for the same medication
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Prescription refills (26-4-80) All out-patient
Rx's dispensed must be labeled appropriately
Pharmacy name and address Prescriber's name
Directions for use Initials or identifying code of
dispensing RPh Prescription number Patient's
name Fill/refill date Any other information
necessary, or in the RPh's professional judgement, appropriate
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Schedule II Controlled Substance Prescriptions
Security paper requirements do not apply to: Rx's
transmitted by phone, fax, or other electronic means
Rx's for hospital inpatinets, nursing home residents, mental
facility inpatients/resident, or prisoners
Person picking up the Rx must present a
government-issued photo ID and the RPh must
document the full name of the person taking possession of the
Rx
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Drug substitution
RPh's may substitute: A drug with the same generic
name in the same strength, quantity, dose and dosage form as the
prescribed name brand product so long as it is
therapeutically and pharmaceutically equivalent
A biological with interchangeable
biological product If a prescriber writes
for a generic product, the RPh must: Dispense the
lowest retail priced drug in stock which is
equivalent
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Drug substitution
Whenever a substitution is made, the RPh must record it
on the original Rx The words
"generic for..." or "interchangeable biological
product for..." or other similar language
must appear on the Rx label or an auxiliary label on the
medication Does not apply to
medications dispensed to hospital in-patients or medications in
specialty packaging
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Drug substitution
Patients may request the RPh not to
substitute a generic product in lieu of the brand
name A prescriber may instruct the RPh
not to substitute a generic in lieu of the brand
name by writing "Brand
Necessary" on the Rx Must be in the
prescriber's handwriting Cannot be pre-printed or
stamped on the Rx When the Rx is electronic,
"Brand Necessary" must be on the Rx in
some way Substitution can only occur with the
prescriber's expressed consent if Brand Necessary has been
conveyed
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Prescription Drugs
Biological Drug Substitution
Within 48 hours of dispensing an interchangeable biological,
the RPh must communicate to the prescriber the specific product
dispensed Must include the name of the product and
manufacturer Do not have to communicate
with the prescriber if it is a refill and the
product dispensed is the same that was
previously dispensed
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Duties requiring professional judgement
When dispensing, only a licensed RPh can perform duties or
functions that require professional judgement RPh's
responsibility to ensure no other pharmacy employee performs or
functions that require professional judgement
RPh's responsibility to ensure that only a RPh, intern/extern
provides counseling to patients or with other licensed healthcare
professionals RPh's responsibility to ensure that only a RPh,
intern/extern accepts telephone Rxs or provides information relative
to a prescription or prescription drugs
Title 26, Chapter 4: Practice of Pharmacies
Article 5: Functions which require professional judgment
The following functions require professional judgment and
may not be performed by a pharmacy technician:
Acceptance of initial oral
prescriptions
Certification of a filled or finished
prescription drug order
Weighing or measuring active ingredients
without a mechanism of verification
Reconstitution of prefabricated medication
without a mechanism of verification
Verification of the constituents of final IV
admixtures for accuracy, efficacy, and patient
utilization
Order entry on patient profiles without
verification by a RPh Provision of drug information
that has not been prepared by or approved by the pharmacist
Title 26, Chapter 4: Practice of Pharmacy
Article 5: Responsibilities of the pharmacist
When dispensing a drug:
RPh must be present and personally supervising
all technician activities RPh is
responsible for all activities involving
preparation of a drug for
delivery When electronic systems are used, technicians may
enter information into the system and prepare labels, BUT it is the
RPh's responsibility to verify accuracy of information
entered and label produced compared to the Rx
RPh is required to review all refills for appropriate
information and determine whether to refill the Rx
Technicians in the dispensing are must be easily
identifiable.
Title 26, Chapter 4: Practice of Pharmacy
Article 5: Responsibilities of the pharmacist
BOP regulates the RPh to tech ratio RPh to
tech ratio is 2:1 RPh tech ratio may be 3:1 so long
at least one technician is certified.
Obtain certification by passing a BOP approved
certificate program, employer's training and assessment
program approved by the Board, or certification through PTCB
or other nationally recognized body.
BOP may consider and approve applications to increase RPh to
tech ratio in hospitals if a request is received in writing
In addition to technicians, RPh may be assisted by and directly
supervise one pharmacy intern and one pharmacy extern
The pharmacist to registered technician ratio shall not exceed one
pharmacist providing direct supervision of _____ registered pharmacy
technicians at any given time.
The pharmacist to registered technician ratio shall not exceed
one pharmacist providing direct supervision of _____ registered
technicians if at least _____ technician is certified.
In addition to pharmacy technicians, a pharmacist may also be
assisted by and directly supervise _____ pharmacy intern(s), _____
pharmacy extern(s), and _____ pharmacy observer(s) at any
The pharmacist to registered technician ratio shall not exceed one
pharmacist providing direct supervision of 2
registered pharmacy technicians at any given time.
The pharmacist to registered technician ratio shall not exceed one
pharmacist providing direct supervision of 3
registered technicians if at least 1 technician is certified.
In addition to pharmacy technicians, a pharmacist may also be
assisted by and directly supervise 1 pharmacy
intern(s), 1 pharmacy extern(s), and
1 pharmacy observer(s) at any
Title 26, Chapter 4: Practice of Pharmacy
Article 5: Patient record systems
Pharmacies must have a patient record system that allows for
immediate retrieval of information to identify previously dispensed
drugs at the time a Rx is presented for dispensing
Must make reasonable effort to obtain, record, and
maintain: Patient's full name Patient's
address and telephone number Patient's date of
birth Patient's gender Patient's known
allergies, reactions, or idiosyncrasies Patient's
chronic disease sites Any other drugs, including OTC's,
the patient may take
How long must a pharmacist maintain patient records?
At least 2 years
What must be included in patient records?
List of all prescriptions dispensed Rx number
Name Strength of medication Quantity and date
dispensed Name of dispensing RPh
True or False: RPh must review the patient record and each Rx
presented for dispensing
TRUE
What does the pharmacist look for when assessing patient records?
Overutilization or underutilization Drug-disease
contraindications Incorrect dose, dosage form, or
duration Clinical abuse or misuse Therapeutic
duplication Drug-drug interactions Drug-allergy
interactions
What happens when a pharmacist fails to review a patient record?
Disciplinary action (suspension, revocation, or restriction)
Who must personally offer patient counseling?
Pharmacist, intern, and extern
True or false: Patient counseling can occur in person AND by telephone.
TRUE
What must patient counseling include?
Name and description of drug Dosage form, dose, route,
and duration Intended use and expected action or
result Any special directions or precautions for preparation,
administration or use by the patient Common severe side
effects or adverse effects Techniques for
self-monitoring Proper storage Refill
information Action to take in the event of a missed dose
Any other relevant information
Which of the following duties or functions may be performed by a
registered pharmacy technician? Select all that apply.
Reconstitute a prefabricated medication so long as there is a
mechanism for verification.
Weigh or measure active ingredients so long as there is a mechanism
for verification.
Enter an order on patient medication profiles with verification by
a pharmacist.
Who is patient counseling not for?
Hospital in-patients or other institutions where other HCPs are
authorized to administer medications Inmates/prisoners
Patients receiving medication from the DPH Patients or
caregivers who refuse consultation or counseling
Who establishes the rules that govern compounding and distribution to
ensure compliance with USP-NF standards?
The BOP
What must all products compounded by a licensed outsourcing facility
be compounded in accordance with?
Good Manufacturing Practices established by the FDA.
Title 26, Chapter 4: Practice of Pharmacy
Article 5: Compounding and drug distribution
Compounds for nonpatient-specific sterile products to be provided to
practitioners for use in patient care or altering or repackaging drugs
for practitioners to use in their office must be done by an
outsourcing facility.
Title 26, Chapter 4: Practice of Pharmacy
Article 6: Pharmacy licenses
True or false: All facilities involved in the manufacture,
production, sale, or distribution of drugs or devices used in pharmacy
practice are required to be licensed by the BOP.
TRUE
True or False: Each pharmacy must have a pharmacist-in-charge (PIC)
TRUE
Glossary of Terms for Title 16: Chapter 13: Controlled Substances
Knowingly - having general
knowledge that a machine, instrument, tool, item of
equipment, contrivance, or device is a drug related
object; or having reasonable grounds to
believe that, to the average person, any such object is a drug
related item
Controlled Substance - a drug, substance, or
immediate precursor in Schedules I through V
Dangerous Drug - any drug, other than a controlled
substance, which cannot be dispensed without a valid prescription
order
Anything that is NOT in a controlled
substance schedule.
Dispense - to deliver to the ultimate user by
lawful order of a practitioner
Glossary of Terms for Title 16: Chapter 13: Controlled Substances
Dependent, dependency, physical dependency, psychological
dependency, or psychic dependency
State of dependence by an individual upon a
substance, arising from the use of that substance, that is
characterized by behavioral and other responses
that include the loss of self-control or a strong
compulsion to use
the substance on a continuous basis in
order to experience some effect.
Glossary of Terms for Title 16: Chapter 13: Controlled Substances
A practitioner is defined as: A
physician, dentist, pharmacist, podiatrist,
veterinarian, or other person licensed and registered
who is authorized to distribute, dispense, or administer a
controlled substance in the course of professional practice
A pharmacy, hospital, or other institution
licensed and registered authorized to distribute, dispense, or
administer a controlled substance in the course of professional
practice
Advanced practice registered nurse (APRN) acting
under his/her nurse protocol authorized and registered with the
federal Drug Enforcement Administration and appropriate state
authorities A physician's assistant
(PA) acting under his/her protocol authorized and
registered with the federal Drug Enforcement Administration and
appropriate state authorities
Glossary of Terms for Title 16: Chapter 13: Controlled Substances
Ultimate user or end user is the
person who lawfully possesses a controlled substance or dangerous
drug for his or her own use, for the use by a member of his or her
household, or for administering to an animal owned by him or her or
by a member of his or her household. The end user can
be anyone, not just the person who is actually taking the
drug. This includes the caregiver.
Pursuant
In accordance with the law (a law or legal document)
When the BOP decides to add a substance to Article 2, they consider:
Actual or relative potential for abuse
Scientific evidence of a substances�
pharmacological effect, if known State of current
scientific knowledge regarding the substance
History and current pattern of abuse;
Scope, duration, and significance of abuse
Risk to the public health Potential of the
substance to produce psychic or physiological dependence
liability Whether the substance is an
immediate precursor to a substance already
controlled under Article 2
Designation, deletion, or rescheduling of a
substance under federal law(s) that �control� controlled
substances
Exempt Schedule V Sales
It is unlawful for one to obtain, sell,
dispense or dispose of Schedule V
non-pseudoephedrine (non-PSE) substances
Exempt Schedule V Sales
Exceptions to this rule include:
A physician may dispense Schedule V substances
for legitimate medical purposes in the normal
course of professional practice A licensed pharmacist may
sell/dispense an exempt non-PSE Schedule V
substance without a prescription
What is the most that a pharmacist may dispense of a
non-pseudoephdrine substance to an individual?
A pharmacist may not dispense more than 4oz or 32
dosage units of any exempt
non-PSE substance to an individual within a 48-hour
period The pharmacist must apply
reasonable means and effort to determine that the
purchase is being used for a legitimate medical
purpose
Where must the sale of ALL non-PSE Schedule V
substances be recorded?
All sales of non-PSE Schedule V substances must be
recorded in the pharmacy�s Exempt Narcotic Sales
log
What must be contained within the Exempt Narcotic Sales
Log Records?
Name, address, city, state and zip code of the purchaser
Date of transaction Name, kind, quantity and intended
use of Schedule V substance to be purchased Signature of
the purchaser and dispensing pharmacist
When is it appropriate NOT to sell a Non-PSE
Schedule V substance without a prescription?
The product's manufacturer packaging is greater than 4
oz or contains more than 32 dosage units
You cannot "break" a larger package
size If the label contains a
Federal Caution or Warning Statement If
the package contains any Legend, Warning, or Rx only indication,
then a prescription is required
Ephedrine & Pseudoephedrine
It is unlawful to possess >300 dosage units or
9gm, of ephedrine or pseudoephedrine (PSE)
whichever is smaller It is unlawful to
possess any amount of ephedrine or PSE with the intent of
manufacturing amphetamine/methamphetamine (meth)
Sales of products containing ephedrine and PSE are restricted by
law
Where must all PSE containing products be stored?
"Behind" the pharmacy's prescription
department counter
What must ALL personnel who sell PSE-containing
products complete as required by the Combat Methamphetamine Epidemic
Act of 2005?
DEA's self-certification training
What must products, where the sole ingredient is PSE, be in?
blister packaging
What are the restrictions placed on a pharmacist when selling or
dispensing ephedrine & PSE products without a prescription?
A pharmacist may sell or dispense to an individual, without a
prescription, up to 3.6g every 24 hours, or a maximum of
9g every 30 days, of a PSE-containing product if:
After applying reasonable means it is
determined that the purchased product will be used for
legitimate medical purposes Proper
record keeping procedures (written or electronic)
are followed
What must be produced by a purchaser of PSE-containing products?
A
valid government-issued photo
ID to use in verifying the patient's name on
the photo-ID matches the name in the logbook.
It is against the law (unlawful) to sell how many packages of any
PSE-containing product?
Greater than (>) 3 packages of ANY PSE containing product
Real-Time Electronic Logging System
Pharmacies shall, BEFORE completing a sale of
a nonprescription product which contains ephedrine or
pseudoephedrine, electronically track all such sales and
submit the required information to a real-time electronic logging
system. A pharmacy shall not
complete the sale of a nonprescription product which contains
ephedrine or pseudoephedrine if the real-time electronic
logging system generates a stop sale alert
What are pharmacies able to do in the event that there is a
mechanical or electronic failure of the real-time electronic logging system?
The pharmacy shall maintain a written log or an alternative
electronic recording mechanism UNTIL the pharmacy is able
to comply with the electronic logging requirement
What must all controlled substance prescriptions include?
Name and address of the person for whom it is prescribed
Drug name, strength and quantity to be dispensed
Directions for use Signature, name, address, telephone
number, and DEA number of the prescribing
practitioner Number of refills authorized, if applicable
(not allowed for
Schedule II drugs) Date prescription was
written
What MUST a pharmacist do when receiving a Schedule
III, IV, and V verbal prescription order?
Reduced it in writing upon receipt
True or False: Prescription orders for Schedule III, IV, and V drugs
may be written, electronic, transmitted via facsimile
(faxed), or provided verbally to the pharmacist.
TRUE
True or False: Schedule III, IV, or V prescription orders
MAY be filled or refilled more than 6 months from the date
written or refilled more than 5
times, whichever comes first.
False
There can be a total of 6 fills (5 refills + 1 fill of the
original prescription) There may only be refilled or filled
within a 6 month period and refilled 5 times.
What must Schedule II Prescriptions be written on in the state of Georgia?
tamper proof paper
When can a faxed C-II prescription serve as the original hard-copy?
When a prescription drug order is for terminally ill patients in
hospice care or for patients residing in a long-term care facility.
The prescription must meet
all requirements There must be two-step verification
Registration process Systems must meet all
standards
What are the guidelines for a pharmacist dispensing an emergency C-II
prescription orally?
A situation in which the prescribing practitioner determines
that: Immediate administration of a Schedule II drug
is necessary There is no appropriate alternative
treatment It is not reasonably possible for the
practitioner to provide a written drug order prior to
dispensing
What must a pharmacist do when receiving an emergency C-II drug order?
Reduce it in writing immediately
True or False: The quantity dispensed for an emergency C-II
prescription is NOT limited to the emergency period.
False
The quantity prescribed and dispensed
must be limited to the "emergency period"
What must the prescriber do within 7 days of oral authorization of a
C-II prescription?
He/she must produce a written prescription and deliver it to the
pharmacy for the emergency quantity prescribed
What must a written prescription for an emergency authorization have
written on it?
Authorization for Emergency Dispensing" written across its
face and the date of the oral order
Who must be notified if the prescriber fails to produce a written
prescription within 7 days?
GDNA (Georgia Drugs and Narcotics)
GDNA Agents are allowed to:
Carry firearms while performing official duties
Execute/serve search warrants arrest warrants, administrative
inspect on warrants, subpoenas, and summons issued by the state
Make arrests without warrant for any offense under Article 2
of Title 15 committed in their presence, or if there is
probable cause to believe that the person has committed or is
committing a violation which may constitute a felony Make
seizures of property, pursuant to Article 2, Chapter 13, Title
16 Perform other law enforcement duties as the State Board of
Pharmacy or the director of the Georgia Drugs and Narcotics Agency
designates
A warrant must be executed and returned within ___ days of issuance
10
Administrative Inspections and Warrants
If probable cause exists, an administrative warrant
may be issued by a judge authorizing the inspection and seizure of
property
What must the warrant identify?
The area, premises, building, registrant (pharmacy or
pharmacist) or conveyance, to be inspected, the
purpose of the inspection, and if appropriate,
the type of property to be inspected and/or seized,
and designate the judicial officer to whom it shall be
returned to
When authorized by an inspection warrant, GDNA agents may:
Inspect and copy records required by law to be kept
Inspect all pertinent equipment, materials, containers and
label Inventory controlled substance stock
What may GDNA agents inspect without a warrant?
Any books and records if the owner, operator or
person in charge
consents Any situation that
present imminent danger to health or safety
In an exceptional or emergency situation where
time or opportunity to apply for a warrant is lacking All
other situations in which warrant is not constitutionally
required
Programs and Research on Controlled Substance Abuse and Prevention
The BOP and GDNA have programs designed to prevent and deter
the misuse and abuse of controlled substances
The BOP and GDNA actively encourages research
on the misuse and use of controlled substances
Methadone treatment programs,
narcotic treatment programs and
opioid treatment programs are available
What are the 3 programs available from the BOP and GDNA that prevent
or deter misuse and abuse of controlled substances?
Methadone, narcotic, and opioid
What is OTP?
OTP (opioid treatment programs) is an opioid replacement
program or narcotic treatment program licensed and/or
authorized by the State of GA Department of Human
Resources, the Substance Abuse and Mental Health Services
Administration and the DEA (Drug Enforcement Administration)
What are the actions of OTP (opioid treatment programs)?
Use narcotic replacement procedures for individuals dependent on
opium, morphine, heroin or nay derivative or similar synthetic drug
What must ALL OTP clinics have?
An on-site pharmacy licensed with the BOP Must have
sufficient floor space to ensure that drugs are
prepared in sanitary, well-lit, and enclosed space
Space must be at least 150 square feet
Other physical requirements are similar to retail pharmacy
requirements EXCEPT OTP must have an
adequate supply of drugs used in OTP clinic setting rather than
rather than commonly used drugs
How much space must an OTP clinic have?
At least 150 square feet
What is the purpose of PDMP? (Georgia Prescription Drug
Monitoring Program)
Reducing the abuse of controlled substances
Encouraging a better quality of healthcare by promoting the
proper use of medication to treat pain and terminal illness
Reducing duplicative prescribing and overprescribing of
controlled substances
When were all prescribers with DEA numbers required to be registered
with PDMP?
January 1, 2018
When must those prescribers who received a DEA number after January
1, 2018 be registered with the PDMP?
30 days from the date they receive their DEA number
When shall a prescriber who is prescribing a controlled substance
review PDMP? (On and after July 1, 2018)
The first time he/she prescribes a controlled substance and at least
once every 90 days thereafter
When is a prescriber not required to check PDMP?
Rx is for no more than a 3 days supply and
no more than 26 pills Patient is in a
hospital or healthcare facility Patient
had outpatient surgery and Rx is for 10
days supply or less and for no more than 40
pills Patient is terminally ill or being
supervised by Hospice Patient is
receiving treatment for cancer
True or False: Dispensers ARE required to obtain
information about a patient from PDMP.
False
Dispensers are encouraged to obtain such information while
keeping in mind that the purpose of such data base includes reducing
duplicative prescribing and overprescribing of controlled
substances We have all liability removed from us as
dispensers if we do not check for the person on PDMP
True or False: Dispensers do NOT have a duty and
shall not be held civilly liable for NOT seeking or
obtaining information from PDMP
True
Dispensers shall not have a duty and shall not be
held civilly liable for damages to any person in any civil or
administrative action or criminally responsible for injury, death,
or loss to person or property on the basis that the dispenser did
or did not seek or obtain information from the PDMP
What is the definition of a dangerous drug?
Any drug other than a drug listed in any schedule of
Article 2, which under the Federal Food, Drug and
Cosmetic Act requires a prescription Any other drug or
substance declared so by the GA General Assembly to
be a dangerous drug
True or False: BOP may delete drugs from the dangerous drugs list
TRUE
What does the BOP consider before deleting a drug from the dangerous
drugs list?
Actual or relative potential for abuse
Scientific evidence of pharmacological
effect State of current scientific
knowledge about the drug History and current
pattern of abuse, if any Scope, duration
and significance of abuse Potential to
produce psychic or physiological dependency
Whether the drug is listed under the
Food Drug and Cosmetic Act
What must be contained on written prescription drug orders for
dangerous drugs?
Date of issuance Name and address of the patient
Name, strength and quantity of drug to be dispensed
Directions for use Number of refills permitted
Printed name, address, and telephone of the prescriber
Prescriber's signature
What be information must be placed on the container (label) for a
dangerous drug?
Patient's name Name of physician prescribing the
drug Expiration date, if applicable Name and address
of the dispensing pharmacy Date prescription was
dispensed
Who may sell or exchange dangerous drugs?
By a drug manufacturer, wholesaler, distributor or
supplier who holds a license/registration
issued in accordance with the Federal Food, Drug and Cosmetic Act
and has a permit issued by the BOP By a
pharmacy, but drugs can only be distributed by a
licensed pharmacist By a practitioner of the
healing arts (prescribers or persons who can write
prescriptions By a manufacturer's sales
representative when a written request is made by a
practitioner for a complimentary sample
How long must records be kept for all dangerous drugs received,
purchased, manufactured, sold or dispensed?
At least two years
True or False: It is unlawful to sell, give away, barter, exchange,
distribute or possess any dangerous drugs unless authorized to do so.
TRUE
True or False: All controlled substances and/or dangerous drugs must
be kept in the original container in which they were dispensed in by
the pharmacist or practitioner of the healing arts
TRUE
Fraud, Forgery or Concealment
No one should obtain, attempt to obtain, or have administered
any dangerous drug by means of: Fraud, deceit, or
misrepresentation Forgery or alteration of any
prescription Concealment of material fact Use of
a false name or giving a false address
Who may prescribe or order the use of a dangerous drug?
A registered prescriber
What are the requirements for a registered prescriber who is
prescribing or ordering a dangerous drug?
Licensed and/or authorized by the state to prescribe dangerous
drugs Acting in the usual course of professional
practice Prescribing or ordering a dangerous drug for a
legitimate medical purpose
When must an individual notify the appropriate licensing authority
who is convicted of a criminal offense (manufacture, distribution,
sale or possession of a controlled substance or marijuana)?
Within 10 days of the conviction
What will the licensing authority do in response?
Upon notification, the licensing authority will suspend
or revoke the license, permit, registration or
certification as follows: 1st conviction: license is
suspended for a period of not less than
3 months. If the conviction is for a
misdemeanor, the licensing authority may impose a lesser
sanction or no sanction at all 2nd conviction or
subsequent conviction - license is revoked
What happens if an individual fails to notify the licensing authority
of a conviction?
This is considered grounds for revocation of
the license, permit, registration, or certification
How may a licensed individual go about becoming reinstated?
A licensed individual may be entitled to reinstatement of
his/her license upon completion of an approved drug abuse treatment
and education program
True or false: Suspension and revocation are intended to be the minimum sanctions employed
TRUE
Who is allowed to remove dangerous drugs from Article 3?
Georgia General Assembly
Who oversees Article 3?
Georgia General Assembly
What MAY the Georgia Board of Pharmacy do between
Article 2 and Article 3?
They may transfer a drug on Article 3 (Dangerous Drugs List) and put
it on Article 2 (Controlled-Substances List)
Article 2 is overseen ONLY by whom?
The Georgia Board of Pharmacy
What does "exempt" mean for a non-PSE containing Schedule V
substance? (For example: Cheratussin AC)
It means that it this drug may be sold without a prescription.
Professional judgement must used to determine that
a legitimate medical purpose exists, the total
sale volume must not exceed 4 oz, and the sale is
record in the pharmacy's Exempt Narcotics Sale
Log
AJ is a longstanding patient at your pharmacy and has been taking
metformin 500mg, bid, for the last 15 years. He comes into the
pharmacy asking for a refill on his metformin. Upon review of his
profile, you notice that he does not have a refill remaining on his
prescription and his doctor's office is already closed for the
weekend. What are you legally allowed to do help AJ?
It must be a new, non-refillable prescription for a 72-hour
supply of metformin It must be reduced to writing
The hardcopy references the prescription number of the original
prescription that no longer has refills
VM enters your pharmacy to have a prescription filled for a 30-day
supply of alprazolam 1 mg (a schedule III-controlled substance) for
her panic attacks written by Dr. Jones today. The prescription has 3
additional refills. Describe the legal requirements pertaining to use
of prescritpion drug monitoring program (PDMP)
The physician must check PDMP prior to filling the prescription today
and again in 90 days prior to dispensing the third refill to VM.
The physician must check PDMP the first time they fill
a controlled substance (before they prescribe it) for a patient and
subsequently every 90 days after. Pharmacists do not have
to check PDMP but they are encouraged to check PDMP
and will not be held responsible for not checking PDMP or for
checking PDMP.