PTCB Pharmacy Law &
Regulations
Code of Ethics for Pharmacy Technicians -answer ✅✅1. First consideration is to
ensure the health and safetyof the patient and to use knowledge and skills to the best of
her/his ability in serving others.
2. Supports and promotes honesty and integrity in the profession include duty to
observe law, maintain highest moral and ethical conduct and uphold ethical principles of
the profession.
3. Assists and supports the pharmacists in safe, efficacious and cost effective
distribution of health service.
4. Respects and supports the confidentiality of a patient's records and discloses
pertinent info ONLY with proper authorization.
5. Never assists in dispensing, distribution or engage in activity that will discredit the
profession.
Roles and Responsibilities of Pharm Techs -answer ✅✅1. Enter prescription orders
into the computer.
2. Create a profile of patient's health & insurance info in computer
3. Assist the pharmacist under direct supervision.
4. Help patients dropping off or picking up prescription orders.
Pharmacy Law -answer ✅✅Federal law takes precedence over state law unless the
state law is stricter than federal law.
Laws are principles and regulations established in a community by a governing body,
whether in the form of legislation or policies recognized and reenforced by judicial
decisions.
Laws also provide resolution to conflicts between body
In pharmacy, the goal is to protect the health and welfare of the patients while also
protecting the practitioners from individuals trying to defraud pharmacy to obtain
medications.
The Sources of Law -answer ✅✅Sources of law are the core of laws comes from the
constitution and broken into 4 types.
1. Constitutional Law - drawn from Constitution Bill of Rights
,2. Legislative Law - drawn from legislative branch US congress and State legislatives.
3. Administrative Law - drawn from executive branch the president and states governors
and their cabinets
4. Common Law - also known as CASE LAW, drawn from judicial branch of government
the court system.
Decisions of Law -answer ✅✅1. Criminal law - enforced by state representative against
person or companies. Pertain to violations of criminal statues and codes. Punishments
include monetary fines and imprisonment or death in certain cases and separated into 2
categories.
MISDEMEANOR - lessor crimes that punishable by fines and imprisonment less than 1
year
FELONIES - punishable by larger fines and more than 1 year imprisonment
2. Civil Law - civil wrong doings are referred to as TORT where a plaintiff will bring a suit
against an alleged defendant for cause injuries even unintentional.
3. Contract Law - pertain to an agreement between 2 parties that usually binds
exchange which requires the involved parties to do or not to do a certain things.
Pure, Food and Drug Act -answer ✅✅Prohibit the interstate transportation or sale of
adulterated and misbranded food or drugs.
Food, Drug and Cosmetic Act (FDCA) -answer ✅✅1. FDA was created under this law
2. Requires all new drug applications be filed with the FDA
3. Clearly defined adulteration and misbranding of drugs and food products.
ADULTERATION :
1. Consisting filthy or decomposed substance
2. Prepared, packed and held under unsanitary conditions
3. Prepared in containers composed poisonous substance
4. Claimed drugs recognized by standard but differing in strength, quality or purity of the
drugs.
MISBRANDING
1. False, misleading labeling.
2. Packaging does not bear correct label
3. Failure to bear established name of drug and failure to label adequate directions for
use.
MANUFACTURER DRUG LABELING
OVER-THE-COUNTER PACKAGE LABELING
Durham-Humphrey Act -answer ✅✅Requiring all products have adequate directions for
use
, 1. Separated drugs into two categories, legend and nonlegend.
2. Allows verbal prescriptions over the phone & Allows refills to be called in from
physician's office.
Kefauver-Harris Amendment -answer ✅✅Requires all medication in the US to be pure,
safe and effective.
Comprehensive Drug Abuse Prevention & Control Act
aka Controlled Substances Act (CSA) -answer ✅✅Requires the pharmaceutical
industry to keep records and maintain security measures for certain medications.
DEA was created under this law and Controlled substances are placed in one of five
schedules classifications based on potential for abuse.
the invoice of ordering and receipt of controlled substance III, IV, and V must be dated,
signed, stamped with a RED C and retained in secure location in pharmacy for
minimum of 2 years.
DEA Form 222 - ordering of schedule II drugs (Valid for 60 days after signed)
DEA form 224 - facility dispenses controlled substances must registered with form 224
and must renew every 3 years
DEA Form 41 - destruction of outdated or damaged controlled substances and
submitted one from each year.
DEA Form 106 - discovery of theft of controlled substances
Schedule II Drugs -answer ✅✅Schedule II medication allowed partial filling with
remaining medication to be provided within 72 hours or the quantity becomes VOID
can be either handwritten or computer generated, electronically but must be signed in
ink by the physician but can also be an
Oral prescription for emergency filling prescription and can be issued when physician
must reduce order to writing, prescription is limited to a quantity to treat the patient
during emergency period and physician must write a prescription for this emergency
quantiy, and pharmacy must receives within 7 days of oral order.
Controlled Sub Act also specifies that a DEA permit with FORM 224 is valid for 3 years.
Schedule III to V drugs -answer ✅✅Prescription may be handwritten or computer
generated, telephone or fax but must be signed in ink,
Electronic prescriptions for Schedule III TO V are permitted as well.
Regulations
Code of Ethics for Pharmacy Technicians -answer ✅✅1. First consideration is to
ensure the health and safetyof the patient and to use knowledge and skills to the best of
her/his ability in serving others.
2. Supports and promotes honesty and integrity in the profession include duty to
observe law, maintain highest moral and ethical conduct and uphold ethical principles of
the profession.
3. Assists and supports the pharmacists in safe, efficacious and cost effective
distribution of health service.
4. Respects and supports the confidentiality of a patient's records and discloses
pertinent info ONLY with proper authorization.
5. Never assists in dispensing, distribution or engage in activity that will discredit the
profession.
Roles and Responsibilities of Pharm Techs -answer ✅✅1. Enter prescription orders
into the computer.
2. Create a profile of patient's health & insurance info in computer
3. Assist the pharmacist under direct supervision.
4. Help patients dropping off or picking up prescription orders.
Pharmacy Law -answer ✅✅Federal law takes precedence over state law unless the
state law is stricter than federal law.
Laws are principles and regulations established in a community by a governing body,
whether in the form of legislation or policies recognized and reenforced by judicial
decisions.
Laws also provide resolution to conflicts between body
In pharmacy, the goal is to protect the health and welfare of the patients while also
protecting the practitioners from individuals trying to defraud pharmacy to obtain
medications.
The Sources of Law -answer ✅✅Sources of law are the core of laws comes from the
constitution and broken into 4 types.
1. Constitutional Law - drawn from Constitution Bill of Rights
,2. Legislative Law - drawn from legislative branch US congress and State legislatives.
3. Administrative Law - drawn from executive branch the president and states governors
and their cabinets
4. Common Law - also known as CASE LAW, drawn from judicial branch of government
the court system.
Decisions of Law -answer ✅✅1. Criminal law - enforced by state representative against
person or companies. Pertain to violations of criminal statues and codes. Punishments
include monetary fines and imprisonment or death in certain cases and separated into 2
categories.
MISDEMEANOR - lessor crimes that punishable by fines and imprisonment less than 1
year
FELONIES - punishable by larger fines and more than 1 year imprisonment
2. Civil Law - civil wrong doings are referred to as TORT where a plaintiff will bring a suit
against an alleged defendant for cause injuries even unintentional.
3. Contract Law - pertain to an agreement between 2 parties that usually binds
exchange which requires the involved parties to do or not to do a certain things.
Pure, Food and Drug Act -answer ✅✅Prohibit the interstate transportation or sale of
adulterated and misbranded food or drugs.
Food, Drug and Cosmetic Act (FDCA) -answer ✅✅1. FDA was created under this law
2. Requires all new drug applications be filed with the FDA
3. Clearly defined adulteration and misbranding of drugs and food products.
ADULTERATION :
1. Consisting filthy or decomposed substance
2. Prepared, packed and held under unsanitary conditions
3. Prepared in containers composed poisonous substance
4. Claimed drugs recognized by standard but differing in strength, quality or purity of the
drugs.
MISBRANDING
1. False, misleading labeling.
2. Packaging does not bear correct label
3. Failure to bear established name of drug and failure to label adequate directions for
use.
MANUFACTURER DRUG LABELING
OVER-THE-COUNTER PACKAGE LABELING
Durham-Humphrey Act -answer ✅✅Requiring all products have adequate directions for
use
, 1. Separated drugs into two categories, legend and nonlegend.
2. Allows verbal prescriptions over the phone & Allows refills to be called in from
physician's office.
Kefauver-Harris Amendment -answer ✅✅Requires all medication in the US to be pure,
safe and effective.
Comprehensive Drug Abuse Prevention & Control Act
aka Controlled Substances Act (CSA) -answer ✅✅Requires the pharmaceutical
industry to keep records and maintain security measures for certain medications.
DEA was created under this law and Controlled substances are placed in one of five
schedules classifications based on potential for abuse.
the invoice of ordering and receipt of controlled substance III, IV, and V must be dated,
signed, stamped with a RED C and retained in secure location in pharmacy for
minimum of 2 years.
DEA Form 222 - ordering of schedule II drugs (Valid for 60 days after signed)
DEA form 224 - facility dispenses controlled substances must registered with form 224
and must renew every 3 years
DEA Form 41 - destruction of outdated or damaged controlled substances and
submitted one from each year.
DEA Form 106 - discovery of theft of controlled substances
Schedule II Drugs -answer ✅✅Schedule II medication allowed partial filling with
remaining medication to be provided within 72 hours or the quantity becomes VOID
can be either handwritten or computer generated, electronically but must be signed in
ink by the physician but can also be an
Oral prescription for emergency filling prescription and can be issued when physician
must reduce order to writing, prescription is limited to a quantity to treat the patient
during emergency period and physician must write a prescription for this emergency
quantiy, and pharmacy must receives within 7 days of oral order.
Controlled Sub Act also specifies that a DEA permit with FORM 224 is valid for 3 years.
Schedule III to V drugs -answer ✅✅Prescription may be handwritten or computer
generated, telephone or fax but must be signed in ink,
Electronic prescriptions for Schedule III TO V are permitted as well.
